Study Assessing the Effect of Medications to Prevent Feve... | NCT01392378 | Trialant
NCT01392378
Sponsor
Pfizer
Status
Completed
Last Update Posted
Feb 26, 2014Estimated
Enrollment
908Actual
Phase
Phase 4
Conditions
Pneumococcal Vaccines
Interventions
13-valent pneumococcal conjugate vaccine
INFANRIX hexa
Paracetamol
13-valent pneumococcal conjugate vaccine
INFANRIX hexa
Ibuprofen
13-valent pneumococcal conjugate vaccine
INFANRIX hexa
Paracetamol
13-valent pneumococcal conjugate vaccine
INFANRIX hexa
Ibuprofen
13-valent pneumococcal conjugate vaccine
INFANRIX hexa
Countries
Poland
Protocol Section
Identification Module
NCT ID
NCT01392378
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B1851047
Secondary IDs
ID
Type
Description
Link
6096A1-4027
Brief Title
Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
Official Title
A Phase 4, Randomized, Open-Label Trial To Assess The Impact Of Prophylactic Antipyretic Medication On The Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine Given With Routine Pediatric Vaccinations In Healthy Infants
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2011
Primary Completion Date
Jan 2013Actual
Completion Date
Jan 2013Actual
First Submitted Date
Jul 8, 2011
First Submission Date that Met QC Criteria
Jul 8, 2011
First Posted Date
Jul 12, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 10, 2014
Results First Submitted that Met QC Criteria
Jan 10, 2014
Results First Posted Date
Feb 26, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 10, 2014
Last Update Posted Date
Feb 26, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.
Detailed Description
Not provided
Conditions Module
Conditions
Pneumococcal Vaccines
Keywords
Prevenar 13
13vPnC
Antipyretic medication
Healthy subjects
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
908Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1
Experimental
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of paracetamol on the day of each vaccination.
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of ibuprofen on the day of each vaccination.the first dose.
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of paracetamol on the day of each vaccination.
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of ibuprofen on the day of each vaccination.
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Group 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
1 month after the infant series
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged 2 months (56 to 98 days) at time of enrollment.
Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria:
Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib conjugate vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Allergy or contraindication to paracetamol or ibuprofen administration.
Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines.
Wysocki J, Center KJ, Brzostek J, Majda-Stanislawska E, Szymanski H, Szenborn L, Czajka H, Hasiec B, Dziduch J, Jackowska T, Witor A, Kopinska E, Konior R, Giardina PC, Sundaraiyer V, Patterson S, Gruber WC, Scott DA, Gurtman A. A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations. Vaccine. 2017 Apr 4;35(15):1926-1935. doi: 10.1016/j.vaccine.2017.02.035. Epub 2017 Mar 3.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Periods
Title
Milestones
Reasons Not Completed
Infant Series
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Group 5
Experimental
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. This group does not receive any antipyretic medication as part of the study.
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Group 1
Paracetamol
Drug
Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
Group 1
13-valent pneumococcal conjugate vaccine
Biological
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Group 2
INFANRIX hexa
Biological
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Group 2
Ibuprofen
Drug
Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
Group 2
13-valent pneumococcal conjugate vaccine
Biological
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Group 3
INFANRIX hexa
Biological
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Group 3
Paracetamol
Drug
Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
Group 3
13-valent pneumococcal conjugate vaccine
Biological
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Group 4
INFANRIX hexa
Biological
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Group 4
Ibuprofen
Drug
Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
Group 4
13-valent pneumococcal conjugate vaccine
Biological
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Group 5
INFANRIX hexa
Biological
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Group 5
1 month after the infant series
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.
1 month after the toddler dose
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
Percentage of participants achieving serotype-specific pneumococcal OPA titer >= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13.
1 month after the infant series
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series
Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.
1 month after the infant series
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series
Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.
1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.
1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.
1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.
1 month after the toddler dose
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.
1 month after the toddler dose
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.6 EU/mL, FHA >=16.1 EU/mL, PRN >=24.0 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.
1 month after the infant series
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.8 EU/mL, FHA >=46.5 EU/mL, PRN >=43.5 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.
1 month after the toddler dose
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1
Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree Celsius (degree C), greater than (>) 39 but <=40 degree C and >40 degree C.
Within 4 days after infant series Dose 1
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.
Within 4 days after infant series Dose 2
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.
Within 4 days after infant series Dose 3
Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.
Within 4 days after toddler dose
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).
Baseline up to 1 Month (28 to 42 days) after infant series
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment).
1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).
Toddler dose up to 1 Month (28 to 42 days) after toddler dose
Specjalistyczny ZOZ nad Matka i Dzieckiem, Oddzial Obserwacyjno Zakazny A, Szpital Dzieciecy
Poznan
61-734
Poland
NZLA Michalkowice Jarosz i Partnerzy
Siemianowice Śląskie
41-103
Poland
NZOZ Nasz Lekarz
Torun
87-100
Poland
Szpital im. Sw. Jadwigi Slaskiej, Oddzia Pediatryczny
Trzebnica
55-100
Poland
DEN-MED Gabinet Lekarsko-Stomatologiczny Joanna i Jacek Witwiccy
Warsaw
02-127
Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw
50-345
Poland
NZOZ Salmed
Łęczna
21-010
Poland
FG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
FG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
FG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
FG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
FG000173 subjects
FG001176 subjects
FG002172 subjects
FG003177 subjects
FG004210 subjects
Vaccinated Dose 1
FG000173 subjects
FG001176 subjects
FG002172 subjects
FG003177 subjects
FG004210 subjects
Vaccinated Dose 2
FG000171 subjects
FG001174 subjects
FG002172 subjects
FG003177 subjects
FG004210 subjects
Vaccinated Dose 3
FG000170 subjects
FG001174 subjects
FG002172 subjects
FG003176 subjects
FG004210 subjects
COMPLETED
FG000169 subjects
FG001174 subjects
FG002172 subjects
FG003175 subjects
FG004210 subjects
NOT COMPLETED
FG0004 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Parent
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
After Infant Series
Type
Comment
Milestone Data
STARTED
FG000169 subjects
FG001174 subjects
FG002172 subjects
FG003175 subjects
FG004210 subjects
COMPLETED
FG000169 subjects
FG001173 subjects
FG002170 subjects
FG003175 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000169 subjects
FG001173 subjects
FG002170 subjects
FG003175 subjects
FG004209 subjects
COMPLETED
FG000169 subjects
FG001172 subjects
FG002170 subjects
FG003173 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
BG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
BG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
BG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
BG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000173
BG001176
BG002172
BG003177
BG004210
BG005908
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
days
Title
Denominators
Categories
Title
Measurements
BG00065.1± 9.5
BG00166.5± 10.1
BG00265.6± 9.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00087
BG00189
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Modified intent-to-treat (mITT) infant immunogenicity set: all eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization,may have had received additional anti-pyretic medication,had blood drawn within specified time frames,had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
microgram per milliliter (mcg/mL)
1 month after the infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
Units
Counts
Participants
OG000138
OG001155
OG002148
OG003
Title
Denominators
Categories
4 (n = 137, 155, 148, 146, 210)
Title
Measurements
OG0001.64(1.44 to 1.87)
OG0011.99(1.76 to 2.25)
OG0021.48(1.31 to 1.68)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0856
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.81
2-Sided
95
0.69
0.96
No
Superiority or Other
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.
mITT toddler immunogenicity set: eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization, received all vaccinations, may have had received additional anti-pyretic medication, had blood drawn within specified time frames, had no major protocol violations.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Secondary
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
Percentage of participants achieving serotype-specific pneumococcal OPA titer >= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13.
mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Secondary
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
Posted
Geometric Mean
95% Confidence Interval
titer
1 month after the infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series
Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.
mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.
mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
1 month after the infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.
mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after the infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.
mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Posted
Geometric Mean
95% Confidence Interval
mIU/mL
1 month after the infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
Secondary
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series
Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.
mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
titer
1 month after the infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.
mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.
mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.
mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.
mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
Posted
Geometric Mean
95% Confidence Interval
mIU/mL
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
Secondary
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.
mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Geometric Mean
95% Confidence Interval
titer
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
Secondary
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.6 EU/mL, FHA >=16.1 EU/mL, PRN >=24.0 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.
mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Secondary
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.8 EU/mL, FHA >=46.5 EU/mL, PRN >=43.5 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.
mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.
Posted
Number
95% Confidence Interval
percentage of participants
1 month after the toddler dose
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Secondary
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1
Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree Celsius (degree C), greater than (>) 39 but <=40 degree C and >40 degree C.
Safety analysis set Dose 1: participants who received Dose 1 of 13vPnC/INFANRIX hexa in infant series, had Adverse Event (AE) or temperature data. 'N'(number of participants analyzed)=participants reported yes for >=1 day or no for all days, 'n'=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.
Posted
Number
percentage of participants
Within 4 days after infant series Dose 1
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Secondary
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.
Safety analysis set Dose 2: participants who received Dose 2 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for >=1 day or no for all days, 'n'=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.
Posted
Number
percentage of participants
Within 4 days after infant series Dose 2
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Secondary
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.
Safety analysis set Dose 3: participants who received Dose 3 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for >=1 day or no for all days, 'n'=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.
Posted
Number
percentage of participants
Within 4 days after infant series Dose 3
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Secondary
Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.
Safety analysis set toddler dose: participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for >=1 day or no for all days, 'n' =participants reporting yes for >=1 day or no for all days for specified event for each arm, respectively.
Posted
Number
percentage of participants
Within 4 days after toddler dose
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Secondary
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).
Safety analysis set Dose 1 included all participants who receive Dose 1 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.
Posted
Number
participants
Baseline up to 1 Month (28 to 42 days) after infant series
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Secondary
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment).
Safety analysis set Dose 3 included all participants who receive Dose 3 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.
Posted
Number
participants
1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Secondary
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).
Safety analysis set toddler dose included all participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available.
Posted
Number
participants
Toddler dose up to 1 Month (28 to 42 days) after toddler dose
ID
Title
Description
OG000
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily
Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
Time Frame
AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary: fever (up to 4 days after each vaccine dose).
Description
Safety population: participants who received at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (fever, systematic assessment) and events collected on case report form at each visit (nonsystematic assessment).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
7
173
57
173
EG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
3
176
71
176
EG002
13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
11
172
67
172
EG003
13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
8
177
72
177
EG004
13vPnC + INFANRIX Hexa - Infant Series
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series (Inf Ser).
10
210
80
210
EG005
13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
14
174
6
174
EG007
13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
10
172
3
172
EG008
13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
11
176
4
176
EG009
13vPnC + INFANRIX Hexa - After Infant Series
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series, assessed after the infant series blood draw up to toddler dose.
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, along with ibuprofen suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
1
175
76
175
EG014
13vPnC + INFANRIX Hexa - Toddler Dose
Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 366 to 425 days of age, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
1
209
50
209
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG0030 affected177 at risk
EG0040 affected210 at risk
EG0050 affected170 at risk
EG0060 affected174 at risk
EG0070 affected172 at risk
EG0080 affected176 at risk
EG0090 affected210 at risk
EG0100 affected169 at risk
EG0110 affected173 at risk
EG0120 affected170 at risk
EG0130 affected175 at risk
EG0140 affected209 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Pertussis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected173 at risk
EG0010 affected176 at risk
EG0023 affected172 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0012 affected176 at risk
EG0021 affected172 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Ventricular septal defect
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Gastroenteritis Escherichia coli
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Exposure to toxic agent
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Movement disorder
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Breath holding
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0021 affected172 at risk
EG0030 affected177 at risk
EG0040 affected210 at risk
EG0050 affected170 at risk
EG0060 affected174 at risk
EG0070 affected172 at risk
EG0080 affected176 at risk
EG0090 affected210 at risk
EG0100 affected169 at risk
EG0110 affected173 at risk
EG0120 affected170 at risk
EG0130 affected175 at risk
EG0141 affected209 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0002 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Atrial septal defect
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Patent ductus arteriosus
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0013 affected176 at risk
EG0027 affected172 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0023 affected172 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0012 affected176 at risk
EG0025 affected172 at risk
EG003
Dyschezia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Intestinal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Adverse drug reaction
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Crying
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Irritability
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected173 at risk
EG0016 affected176 at risk
EG0025 affected172 at risk
EG003
Vaccination site nodule
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Milk allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Anal abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0009 affected173 at risk
EG0018 affected176 at risk
EG00211 affected172 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Conjunctivitis infective
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0014 affected176 at risk
EG0021 affected172 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Impetigo
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0012 affected176 at risk
EG0023 affected172 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG00011 affected173 at risk
EG0016 affected176 at risk
EG00210 affected172 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0022 affected172 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected173 at risk
EG0016 affected176 at risk
EG0025 affected172 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected173 at risk
EG0017 affected176 at risk
EG0024 affected172 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected173 at risk
EG0017 affected176 at risk
EG00211 affected172 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG00015 affected173 at risk
EG00112 affected176 at risk
EG00214 affected172 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0023 affected172 at risk
EG003
Varicella
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0012 affected176 at risk
EG0020 affected172 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Mouth injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Cardiac murmur
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0012 affected176 at risk
EG0023 affected172 at risk
EG003
Calcium metabolism disorder
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Weight gain poor
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Hypertonia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Hypotonia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Neuromyopathy
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Apathy
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Hypercalciuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Genital labial adhesions
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0021 affected172 at risk
EG003
Cafe au lait spots
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected173 at risk
EG0011 affected176 at risk
EG0021 affected172 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected173 at risk
EG0012 affected176 at risk
EG0021 affected172 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0021 affected172 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0012 affected176 at risk
EG0021 affected172 at risk
EG003
Skin depigmentation
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0011 affected176 at risk
EG0020 affected172 at risk
EG003
Keratosis follicular
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Food allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Psychomotor retardation
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Vesicoureteric reflux
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Breast enlargement
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Vaccination site swelling
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Coxsackie viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Weight increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected173 at risk
EG0010 affected176 at risk
EG0020 affected172 at risk
EG003
Fever >=38, <=39 degree C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG00049 affected149 at risk
EG00171 affected157 at risk
EG00227 affected147 at risk
EG003
Fever >39, <=40 degree C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG0002 affected138 at risk
EG0012 affected145 at risk
EG0021 affected137 at risk
EG003
Fever >40 degree C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose
EG0000 affected138 at risk
EG0010 affected145 at risk
EG0020 affected137 at risk
EG003
Fever >=38, <=39 degree C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG00037 affected141 at risk
EG00165 affected152 at risk
EG00230 affected140 at risk
EG003
Fever >39, <=40 degree C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG0002 affected133 at risk
EG0011 affected140 at risk
EG0022 affected134 at risk
EG003
Fever >40 degree C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected133 at risk
EG003
Fever >=38, <=39 degree C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG00030 affected136 at risk
EG00145 affected146 at risk
EG00223 affected135 at risk
EG003
Fever >39, <=40 degree C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3
EG0002 affected129 at risk
EG0014 affected137 at risk
EG0021 affected125 at risk
EG003
Fever >40 degree C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.
EG0000 affected128 at risk
EG0010 affected136 at risk
EG0021 affected126 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
C541235
diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine
D000082
Acetaminophen
D007052
Ibuprofen
Ancestor Terms
ID
Term
D000083
Acetanilides
D000813
Anilides
D000577
Amides
D009930
Organic Chemicals
D000814
Aniline Compounds
D000588
Amines
D010666
Phenylpropionates
D000146
Acids, Carbocyclic
D002264
Carboxylic Acids
Browse Leaves
Not provided
Browse Branches
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0 subjects
0 subjects
0 subjects
209 subjects
1 subjects
0 subjects
FG0040 subjects
Withdrawal by Parent
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
208 subjects
1 subjects
1 subjects
FG0040 subjects
Withdrawal by Parent
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
66.4
± 10.3
BG00465.6± 9.4
BG00565.8± 9.8
75
BG00379
BG00498
BG005428
Male
BG00086
BG00187
BG00297
BG00398
BG004112
BG005480
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
147
OG004210
OG003
2.07
(1.82 to 2.34)
OG0042.02(1.82 to 2.25)
6B (n = 136, 155, 148, 146, 210)
Title
Measurements
OG0000.68(0.55 to 0.83)
OG0010.91(0.76 to 1.10)
OG0020.56(0.46 to 0.68)
OG0030.90(0.74 to 1.09)
OG0040.81(0.69 to 0.96)
9V (n = 138, 155, 148, 147, 210)
Title
Measurements
OG0001.13(1.01 to 1.27)
OG0011.45(1.30 to 1.61)
OG0021.17(1.05 to 1.30)
OG0031.40(1.26 to 1.56)
OG0041.31(1.19 to 1.43)
14 (n = 138, 155, 148, 147, 210)
Title
Measurements
OG0004.45(3.76 to 5.26)
OG0014.73(4.04 to 5.54)
OG0024.75(4.04 to 5.58)
OG0035.26(4.48 to 6.19)
OG0045.38(4.70 to 6.16)
18C (n = 138, 155, 148, 147, 210)
Title
Measurements
OG0001.47(1.29 to 1.66)
OG0011.73(1.54 to 1.95)
OG0021.25(1.11 to 1.42)
OG0031.75(1.55 to 1.97)
OG0041.54(1.39 to 1.70)
19F (n = 138, 155, 148, 147, 210)
Title
Measurements
OG0001.78(1.57 to 2.02)
OG0012.30(2.04 to 2.59)
OG0021.59(1.41 to 1.80)
OG0032.04(1.81 to 2.31)
OG0041.99(1.80 to 2.20)
23F (n= 137, 155, 148, 146, 210)
Title
Measurements
OG0000.85(0.72 to 1.00)
OG0011.19(1.02 to 1.40)
OG0020.73(0.62 to 0.86)
OG0031.07(0.91 to 1.26)
OG0041.04(0.91 to 1.19)
1 (n = 138, 155, 148, 147, 210)
Title
Measurements
OG0001.12(0.98 to 1.27)
OG0011.50(1.33 to 1.69)
OG0021.02(0.90 to 1.16)
OG0031.29(1.14 to 1.47)
OG0041.25(1.12 to 1.38)
3 (n = 138, 155, 148, 147, 210)
Title
Measurements
OG0000.71(0.63 to 0.79)
OG0010.83(0.75 to 0.93)
OG0020.57(0.51 to 0.64)
OG0030.84(0.75 to 0.94)
OG0040.88(0.79 to 0.96)
5 (n = 137, 155, 148, 146, 210)
Title
Measurements
OG0000.79(0.69 to 0.91)
OG0010.98(0.86 to 1.11)
OG0020.63(0.55 to 0.72)
OG0030.90(0.78 to 1.02)
OG0040.81(0.73 to 0.91)
6A (n = 138, 155, 148, 146, 210)
Title
Measurements
OG0000.97(0.84 to 1.13)
OG0011.25(1.09 to 1.44)
OG0020.85(0.74 to 0.98)
OG0031.22(1.06 to 1.41)
OG0041.10(0.97 to 1.24)
7F (n = 138, 155, 148, 146, 210)
Title
Measurements
OG0001.94(1.74 to 2.16)
OG0012.22(2.01 to 2.46)
OG0021.83(1.65 to 2.03)
OG0032.28(2.06 to 2.53)
OG0042.15(1.97 to 2.34)
19A (n = 137, 155, 148, 146, 210)
Title
Measurements
OG0002.70(2.38 to 3.07)
OG0013.39(3.01 to 3.82)
OG0022.53(2.24 to 2.86)
OG0033.14(2.77 to 3.55)
OG0043.02(2.72 to 3.34)
OG001
OG004
Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8546
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.99
2-Sided
95
0.84
1.16
No
Superiority or Other
OG002
OG004
Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0012
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.73
2-Sided
95
0.62
0.86
No
Superiority or Other
OG003
OG004
Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.02
2-Sided
95
0.87
1.20
No
Superiority or Other
OG000
OG004
Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2412
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.83
2-Sided
95
0.64
1.08
No
Superiority or Other
OG001
OG004
Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.4548
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.13
2-Sided
95
0.88
1.44
No
Superiority or Other
OG002
OG004
Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0093
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.69
2-Sided
95
0.53
0.88
No
Superiority or Other
OG003
OG004
Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.10
2-Sided
95
0.86
1.42
No
Superiority or Other
OG000
OG004
Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.1749
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.87
2-Sided
95
0.75
1.00
No
Superiority or Other
OG001
OG004
Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.3121
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.11
2-Sided
95
0.96
1.27
No
Superiority or Other
OG002
OG004
Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.1351
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.89
2-Sided
95
0.78
1.03
No
Superiority or Other
OG003
OG004
Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.07
2-Sided
95
0.93
1.24
No
Superiority or Other
OG000
OG004
Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2158
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.83
2-Sided
95
0.67
1.03
No
Superiority or Other
OG001
OG004
Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.3279
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.88
2-Sided
95
0.71
1.08
No
Superiority or Other
OG002
OG004
Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2472
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.88
2-Sided
95
0.72
1.09
No
Superiority or Other
OG003
OG004
Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.98
2-Sided
95
0.79
1.21
No
Superiority or Other
OG000
OG004
Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6193
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.95
2-Sided
95
0.81
1.12
No
Superiority or Other
OG001
OG004
Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.3121
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.13
2-Sided
95
0.96
1.32
No
Superiority or Other
OG002
OG004
Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0191
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.82
2-Sided
95
0.70
0.96
No
Superiority or Other
OG003
OG004
Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.14
2-Sided
95
0.97
1.33
No
Superiority or Other
OG000
OG004
Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2412
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.90
2-Sided
95
0.76
1.05
No
Superiority or Other
OG001
OG004
Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.3121
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.15
2-Sided
95
0.99
1.35
No
Superiority or Other
OG002
OG004
Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0135
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.80
2-Sided
95
0.68
0.94
No
Superiority or Other
OG003
OG004
Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.03
2-Sided
95
0.87
1.21
No
Superiority or Other
OG000
OG004
Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.1749
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.81
2-Sided
95
0.66
1.00
No
Superiority or Other
OG001
OG004
Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.3121
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.15
2-Sided
95
0.93
1.41
No
Superiority or Other
OG002
OG004
Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0038
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.70
2-Sided
95
0.57
0.86
No
Superiority or Other
OG003
OG004
Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.03
2-Sided
95
0.84
1.27
No
Superiority or Other
OG000
OG004
Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2412
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.90
2-Sided
95
0.76
1.06
No
Superiority or Other
OG001
OG004
Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2053
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.20
2-Sided
95
1.02
1.41
No
Superiority or Other
OG002
OG004
Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0241
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.82
2-Sided
95
0.70
0.96
No
Superiority or Other
OG003
OG004
Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.04
2-Sided
95
0.88
1.22
No
Superiority or Other
OG000
OG004
Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0732
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.81
2-Sided
95
0.69
0.94
No
Superiority or Other
OG001
OG004
Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6090
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.95
2-Sided
95
0.82
1.10
No
Superiority or Other
OG002
OG004
Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
<0.0001
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.65
2-Sided
95
0.56
0.76
No
Superiority or Other
OG003
OG004
Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.96
2-Sided
95
0.82
1.11
No
Superiority or Other
OG000
OG004
Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7828
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.98
2-Sided
95
0.82
1.16
No
Superiority or Other
OG001
OG004
Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2053
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.21
2-Sided
95
1.02
1.43
No
Superiority or Other
OG002
OG004
Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0093
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.77
2-Sided
95
0.65
0.92
No
Superiority or Other
OG003
OG004
Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.11
2-Sided
95
0.93
1.31
No
Superiority or Other
OG000
OG004
Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2412
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.88
2-Sided
95
0.73
1.07
No
Superiority or Other
OG001
OG004
Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.3121
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.14
2-Sided
95
0.95
1.37
No
Superiority or Other
OG002
OG004
Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0135
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.77
2-Sided
95
0.64
0.93
No
Superiority or Other
OG003
OG004
Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.11
2-Sided
95
0.92
1.34
No
Superiority or Other
OG000
OG004
Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2412
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.90
2-Sided
95
0.79
1.03
No
Superiority or Other
OG001
OG004
Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6652
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.03
2-Sided
95
0.91
1.18
No
Superiority or Other
OG002
OG004
Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0275
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.85
2-Sided
95
0.75
0.98
No
Superiority or Other
OG003
OG004
Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.06
2-Sided
95
0.93
1.21
No
Superiority or Other
OG000
OG004
Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2412
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.90
2-Sided
95
0.76
1.06
No
Superiority or Other
OG001
OG004
Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.3121
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.13
2-Sided
95
0.96
1.32
No
Superiority or Other
OG002
OG004
Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0387
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.84
2-Sided
95
0.72
0.99
No
Superiority or Other
OG003
OG004
Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8414
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.04
2-Sided
95
0.89
1.22
No
Superiority or Other
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000138
OG001155
OG002148
OG003147
OG004210
Title
Denominators
Categories
4 (n = 137, 155, 148, 146, 210)
Title
Measurements
OG00096.4(91.69 to 98.80)
OG00197.4(93.52 to 99.29)
OG00296.6(92.29 to 98.89)
OG00397.3(93.13 to 99.25)
OG00498.1(95.20 to 99.48)
6B (n = 136, 155, 148, 146, 210)
Title
Measurements
OG00072.8(64.50 to 80.07)
OG00180.0(72.83 to 85.99)
OG00261.5(53.14 to 69.36)
OG003
9V (n = 138, 155, 148, 147, 210)
Title
Measurements
OG00094.2(88.90 to 97.46)
OG00199.4(96.46 to 99.98)
OG00295.9(91.39 to 98.50)
OG003
14 (n = 138, 155, 148, 147, 210)
Title
Measurements
OG000100.0(97.36 to 100.00)
OG00198.7(95.42 to 99.84)
OG00299.3(96.29 to 99.98)
OG003
18C (n = 138, 155, 148, 147, 210)
Title
Measurements
OG00096.4(91.75 to 98.81)
OG00197.4(93.52 to 99.29)
OG00295.3(90.50 to 98.08)
OG003
19F (n = 138, 155, 148, 147, 210)
Title
Measurements
OG00097.1(92.74 to 99.20)
OG00199.4(96.46 to 99.98)
OG00295.3(90.50 to 98.08)
OG003
23F (n = 137, 155, 148, 146, 210)
Title
Measurements
OG00086.1(79.19 to 91.44)
OG00190.3(84.54 to 94.48)
OG00274.3(66.50 to 81.15)
OG003
1 (n = 138, 155, 148, 147, 210)
Title
Measurements
OG00094.2(88.90 to 97.46)
OG00197.4(93.52 to 99.29)
OG00290.5(84.64 to 94.73)
OG003
3 (n = 138, 155, 148, 147, 210)
Title
Measurements
OG00083.3(76.05 to 89.13)
OG00189.7(83.78 to 93.98)
OG00281.1(73.83 to 87.05)
OG003
5 (n = 137, 155, 148, 146, 210)
Title
Measurements
OG00084.7(77.53 to 90.25)
OG00191.0(85.31 to 94.97)
OG00276.4(68.68 to 82.94)
OG003
6A (n = 138, 155, 148, 146, 210)
Title
Measurements
OG00086.2(79.34 to 91.50)
OG00192.3(86.87 to 95.94)
OG00283.1(76.08 to 88.76)
OG003
7F (n = 138, 155, 148, 146, 210)
Title
Measurements
OG000100.0(97.36 to 100.00)
OG00199.4(96.46 to 99.98)
OG00297.3(93.22 to 99.26)
OG003
19A (n = 137, 155, 148, 146, 210)
Title
Measurements
OG00098.5(94.83 to 99.82)
OG00199.4(96.46 to 99.98)
OG00298.0(94.19 to 99.58)
OG003
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000130
OG001144
OG002143
OG003139
OG004206
Title
Denominators
Categories
4 (n = 130, 144, 143, 139, 206)
Title
Measurements
OG0003.07(2.66 to 3.54)
OG0013.43(3.00 to 3.93)
OG0022.97(2.60 to 3.41)
OG0033.43(2.99 to 3.94)
OG0043.10(2.77 to 3.48)
6B (n = 130, 144, 143, 139, 206)
Title
Measurements
OG0006.70(5.76 to 7.78)
OG0018.01(6.94 to 9.24)
OG0026.38(5.53 to 7.36)
OG003
9V (n = 130, 144, 143, 139, 206)
Title
Measurements
OG0002.15(1.93 to 2.40)
OG0012.23(2.01 to 2.47)
OG0022.17(1.96 to 2.41)
OG003
14 (n = 130, 144, 143, 139, 206)
Title
Measurements
OG0008.10(7.04 to 9.31)
OG0018.40(7.36 to 9.59)
OG0027.95(6.96 to 9.08)
OG003
18C (n = 130, 144, 143, 139, 206)
Title
Measurements
OG0001.35(1.20 to 1.53)
OG0011.68(1.49 to 1.88)
OG0021.36(1.21 to 1.53)
OG003
19F (n = 130, 144, 143, 139, 206)
Title
Measurements
OG0008.41(7.17 to 9.87)
OG0018.99(7.72 to 10.46)
OG0027.53(6.47 to 8.76)
OG003
23F (n = 130, 144, 142, 139, 206)
Title
Measurements
OG0002.34(2.01 to 2.73)
OG0012.96(2.56 to 3.43)
OG0022.37(2.05 to 2.75)
OG003
1 (n = 130, 144, 143, 139, 206)
Title
Measurements
OG0002.80(2.47 to 3.17)
OG0013.22(2.85 to 3.62)
OG0022.66(2.36 to 3.00)
OG003
3 (n = 129, 144, 143, 138, 203)
Title
Measurements
OG0000.46(0.40 to 0.52)
OG0010.54(0.47 to 0.61)
OG0020.46(0.40 to 0.52)
OG003
5 (n = 130, 144, 143, 139, 206)
Title
Measurements
OG0002.33(2.07 to 2.63)
OG0012.75(2.46 to 3.07)
OG0022.40(2.15 to 2.69)
OG003
6A (n = 130, 144, 143, 139, 206)
Title
Measurements
OG0005.12(4.48 to 5.86)
OG0015.73(5.04 to 6.50)
OG0025.27(4.64 to 5.99)
OG003
7F (n = 130, 144, 142, 139, 206)
Title
Measurements
OG0003.79(3.42 to 4.19)
OG0013.89(3.54 to 4.28)
OG0023.56(3.23 to 3.92)
OG003
19A (n = 129, 144, 142, 139, 206)
Title
Measurements
OG0007.11(6.22 to 8.12)
OG0017.99(7.04 to 9.06)
OG0027.31(6.43 to 8.30)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9350
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.99
2-Sided
95
0.82
1.19
No
Superiority or Other
OG001
OG004
Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.11
2-Sided
95
0.93
1.32
No
Superiority or Other
OG002
OG004
Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6922
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.96
2-Sided
95
0.80
1.14
No
Superiority or Other
OG003
OG004
Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9765
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.11
2-Sided
95
0.93
1.32
No
Superiority or Other
OG000
OG004
Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6915
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.95
2-Sided
95
0.78
1.15
No
Superiority or Other
OG001
OG004
Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.13
2-Sided
95
0.94
1.36
No
Superiority or Other
OG002
OG004
Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.4389
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.90
2-Sided
95
0.75
1.09
No
Superiority or Other
OG003
OG004
Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9765
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.03
2-Sided
95
0.85
1.24
No
Superiority or Other
OG000
OG004
Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9350
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.99
2-Sided
95
0.87
1.14
No
Superiority or Other
OG001
OG004
Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.03
2-Sided
95
0.90
1.18
No
Superiority or Other
OG002
OG004
Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9430
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.00
2-Sided
95
0.88
1.15
No
Superiority or Other
OG003
OG004
Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9765
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.98
2-Sided
95
0.85
1.12
No
Superiority or Other
OG000
OG004
Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.5167
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.89
2-Sided
95
0.74
1.06
No
Superiority or Other
OG001
OG004
Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.92
2-Sided
95
0.78
1.10
No
Superiority or Other
OG002
OG004
Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2514
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.87
2-Sided
95
0.73
1.04
No
Superiority or Other
OG003
OG004
Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9872
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.00
2-Sided
95
0.84
1.19
No
Superiority or Other
OG000
OG004
Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2582
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.85
2-Sided
95
0.73
1.00
No
Superiority or Other
OG001
OG004
Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.06
2-Sided
95
0.91
1.23
No
Superiority or Other
OG002
OG004
Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2514
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.86
2-Sided
95
0.74
1.00
No
Superiority or Other
OG003
OG004
Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9765
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.03
2-Sided
95
0.88
1.20
No
Superiority or Other
OG000
OG004
Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6915
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.06
2-Sided
95
0.86
1.30
No
Superiority or Other
OG001
OG004
Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.13
2-Sided
95
0.93
1.38
No
Superiority or Other
OG002
OG004
Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6922
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.95
2-Sided
95
0.78
1.15
No
Superiority or Other
OG003
OG004
Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9872
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.01
2-Sided
95
0.83
1.23
No
Superiority or Other
OG000
OG004
Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.3609
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.85
2-Sided
95
0.70
1.04
No
Superiority or Other
OG001
OG004
Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.08
2-Sided
95
0.89
1.30
No
Superiority or Other
OG002
OG004
Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2514
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.86
2-Sided
95
0.71
1.05
No
Superiority or Other
OG003
OG004
Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9765
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.04
2-Sided
95
0.86
1.26
No
Superiority or Other
OG000
OG004
Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6304
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.92
2-Sided
95
0.79
1.08
No
Superiority or Other
OG001
OG004
Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.06
2-Sided
95
0.91
1.24
No
Superiority or Other
OG002
OG004
Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2514
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.88
2-Sided
95
0.75
1.03
No
Superiority or Other
OG003
OG004
Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9765
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.03
2-Sided
95
0.88
1.20
No
Superiority or Other
OG000
OG004
Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2582
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.84
2-Sided
95
0.71
1.01
No
Superiority or Other
OG001
OG004
Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9279
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.99
2-Sided
95
0.84
1.18
No
Superiority or Other
OG002
OG004
Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2514
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.85
2-Sided
95
0.72
1.01
No
Superiority or Other
OG003
OG004
Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9765
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.90
2-Sided
95
0.76
1.07
No
Superiority or Other
OG000
OG004
Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.1424
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.82
2-Sided
95
0.71
0.96
No
Superiority or Other
OG001
OG004
Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.97
2-Sided
95
0.84
1.12
No
Superiority or Other
OG002
OG004
Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2514
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.85
2-Sided
95
0.73
0.98
No
Superiority or Other
OG003
OG004
Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9765
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.92
2-Sided
95
0.79
1.07
No
Superiority or Other
OG000
OG004
Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6304
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.93
2-Sided
95
0.78
1.10
No
Superiority or Other
OG001
OG004
Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.04
2-Sided
95
0.88
1.22
No
Superiority or Other
OG002
OG004
Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6922
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.95
2-Sided
95
0.81
1.13
No
Superiority or Other
OG003
OG004
Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9765
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.97
2-Sided
95
0.82
1.15
No
Superiority or Other
OG000
OG004
Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6572
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.95
2-Sided
95
0.84
1.08
No
Superiority or Other
OG001
OG004
Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.98
2-Sided
95
0.86
1.11
No
Superiority or Other
OG002
OG004
Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2514
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.89
2-Sided
95
0.79
1.01
No
Superiority or Other
OG003
OG004
Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9872
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.00
2-Sided
95
0.88
1.13
No
Superiority or Other
OG000
OG004
Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6304
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.92
2-Sided
95
0.78
1.09
No
Superiority or Other
OG001
OG004
Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7918
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.04
2-Sided
95
0.88
1.22
No
Superiority or Other
OG002
OG004
Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.6922
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.95
2-Sided
95
0.80
1.12
No
Superiority or Other
OG003
OG004
Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9765
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.95
2-Sided
95
0.81
1.13
No
Superiority or Other
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG00046
OG00148
OG00244
OG00344
OG00476
Title
Denominators
Categories
4 (n = 37, 46, 42, 41, 61)
Title
Measurements
OG000100.0(90.5 to 100.0)
OG001100.0(92.3 to 100.0)
OG002100.0(91.6 to 100.0)
OG003100.0(91.4 to 100.0)
OG004100.0(94.1 to 100.0)
6B (n = 36, 45, 43, 40, 62)
Title
Measurements
OG00094.4(81.3 to 99.3)
OG00188.9(75.9 to 96.3)
OG00288.4(74.9 to 96.1)
OG003
9V (n = 37, 48, 42, 41, 65)
Title
Measurements
OG00062.2(44.8 to 77.5)
OG00166.7(51.6 to 79.6)
OG00259.5(43.3 to 74.4)
OG003
14 (n = 38, 48, 41, 41, 64)
Title
Measurements
OG00089.5(75.2 to 97.1)
OG00197.9(88.9 to 99.9)
OG002100.0(91.4 to 100.0)
OG003
18C (n = 37, 47, 41, 41, 62)
Title
Measurements
OG000100.0(90.5 to 100.0)
OG00195.7(85.5 to 99.5)
OG002100.0(91.4 to 100.0)
OG003
19F (n = 37, 46, 41, 42, 63)
Title
Measurements
OG00097.3(85.8 to 99.9)
OG00187.0(73.7 to 95.1)
OG00290.2(76.9 to 97.3)
OG003
23F (n = 38, 45, 42, 42, 63)
Title
Measurements
OG00092.1(78.6 to 98.3)
OG00197.8(88.2 to 99.9)
OG00292.9(80.5 to 98.5)
OG003
1 (n = 42, 42, 43, 44, 74)
Title
Measurements
OG00047.6(32.0 to 63.6)
OG00142.9(27.7 to 59.0)
OG00230.2(17.2 to 46.1)
OG003
3 (n = 41, 41, 39, 39, 69)
Title
Measurements
OG00097.6(87.1 to 99.9)
OG00197.6(87.1 to 99.9)
OG00297.4(86.5 to 99.9)
OG003
5 (n = 42, 43, 44, 42, 73)
Title
Measurements
OG00092.9(80.5 to 98.5)
OG00190.7(77.9 to 97.4)
OG00286.4(72.6 to 94.8)
OG003
6A (n = 46, 42, 39, 39, 76)
Title
Measurements
OG00093.5(82.1 to 98.6)
OG001100.0(91.6 to 100.0)
OG002100.0(91.0 to 100.0)
OG003
7F (n = 46, 42, 40, 39, 76)
Title
Measurements
OG000100.0(92.3 to 100.0)
OG001100.0(91.6 to 100.0)
OG002100.0(91.2 to 100.0)
OG003
19A (n = 42, 44, 41, 42, 74)
Title
Measurements
OG00092.9(80.5 to 98.5)
OG001100.0(92.0 to 100.0)
OG00290.2(76.9 to 97.3)
OG003
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG00046
OG00148
OG00244
OG00344
OG00476
Title
Denominators
Categories
4 (n = 37, 46, 42, 41, 61)
Title
Measurements
OG0001269(961.2 to 1674.2)
OG0011135(885.2 to 1456.1)
OG0021240(955.9 to 1609.3)
OG0031361(1045.4 to 1771.0)
OG0041086(874.9 to 1347.9)
6B (n = 36, 45, 43, 40, 62)
Title
Measurements
OG000794(450.4 to 1399.6)
OG001655(394.6 to 1087.9)
OG002470(279.9 to 789.7)
OG003
9V (n = 37, 48, 42, 41, 65)
Title
Measurements
OG000120(52.5 to 274.2)
OG001166(80.5 to 343.3)
OG00293(43.0 to 203.0)
OG003
14 (n = 38, 48, 41, 41, 64)
Title
Measurements
OG000435(277.2 to 683.5)
OG001622(416.0 to 928.6)
OG002650(420.7 to 1003.0)
OG003
18C (n = 37, 47, 41, 41, 62)
Title
Measurements
OG0001094(777.8 to 1539.2)
OG001853(630.0 to 1154.3)
OG002877(634.1 to 1212.7)
OG003
19F (n = 37, 46, 41, 42, 63)
Title
Measurements
OG000346(219.7 to 545.4)
OG001221(146.8 to 331.9)
OG002165(106.8 to 253.4)
OG003
23F (n = 38, 45, 42, 42, 63)
Title
Measurements
OG000342(211.6 to 552.6)
OG001441(283.7 to 685.4)
OG002332(210.0 to 523.4)
OG003
1 (n = 42, 42, 43, 44, 74)
Title
Measurements
OG00012(8.7 to 17.7)
OG00111(7.5 to 15.4)
OG0028(5.5 to 11.2)
OG003
3 (n = 41, 41, 39, 39, 69)
Title
Measurements
OG00072(57.4 to 91.1)
OG00176(60.4 to 95.7)
OG00256(44.1 to 70.8)
OG003
5 (n = 42, 43, 44, 42, 73)
Title
Measurements
OG00086(59.7 to 122.7)
OG00196(67.4 to 137.3)
OG00254(37.7 to 76.2)
OG003
6A (n = 46, 42, 39, 39, 76)
Title
Measurements
OG0001060(784.5 to 1431.1)
OG0011681(1227.3 to 2302.3)
OG0021228(886.0 to 1701.9)
OG003
7F (n = 46, 42, 40, 39, 76)
Title
Measurements
OG0001766(1387.0 to 2247.7)
OG0011907(1481.0 to 2454.6)
OG0021747(1348.6 to 2263.3)
OG003
19A (n = 42, 44, 41, 42, 74)
Title
Measurements
OG000185(127.8 to 268.3)
OG001257(178.5 to 368.5)
OG002163(112.3 to 237.9)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7148
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.2
2-Sided
95
0.82
1.66
No
Superiority or Other
OG001
OG004
Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7907
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.0
2-Sided
95
0.75
1.45
No
Superiority or Other
OG002
OG004
Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.4765
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.1
2-Sided
95
0.81
1.60
No
Superiority or Other
OG003
OG004
Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.5037
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.3
2-Sided
95
0.89
1.76
No
Superiority or Other
OG000
OG004
Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9414
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.1
2-Sided
95
0.52
2.17
No
Superiority or Other
OG001
OG004
Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7907
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.9
2-Sided
95
0.45
1.71
No
Superiority or Other
OG002
OG004
Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2900
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.6
2-Sided
95
0.32
1.23
No
Superiority or Other
OG003
OG004
Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8826
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.9
2-Sided
95
0.44
1.77
No
Superiority or Other
OG000
OG004
Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.5823
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.5
2-Sided
95
0.18
1.40
No
Superiority or Other
OG001
OG004
Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7636
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.27
1.80
No
Superiority or Other
OG002
OG004
Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2407
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.4
2-Sided
95
0.14
1.05
No
Superiority or Other
OG003
OG004
Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8826
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.2
2-Sided
95
0.43
3.22
No
Superiority or Other
OG000
OG004
Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0961
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.5
2-Sided
95
0.26
0.81
No
Superiority or Other
OG001
OG004
Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7636
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.38
1.11
No
Superiority or Other
OG002
OG004
Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2900
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.39
1.19
No
Superiority or Other
OG003
OG004
Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8826
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.0
2-Sided
95
0.60
1.82
No
Superiority or Other
OG000
OG004
Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9925
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.0
2-Sided
95
0.65
1.54
No
Superiority or Other
OG001
OG004
Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7636
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.8
2-Sided
95
0.52
1.17
No
Superiority or Other
OG002
OG004
Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.3929
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.8
2-Sided
95
0.53
1.22
No
Superiority or Other
OG003
OG004
Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8826
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.9
2-Sided
95
0.62
1.43
No
Superiority or Other
OG000
OG004
Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7433
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.2
2-Sided
95
0.70
2.20
No
Superiority or Other
OG001
OG004
Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7636
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.8
2-Sided
95
0.46
1.35
No
Superiority or Other
OG002
OG004
Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2407
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.6
2-Sided
95
0.34
1.03
No
Superiority or Other
OG003
OG004
Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8826
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.1
2-Sided
95
0.61
1.83
No
Superiority or Other
OG000
OG004
Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9414
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.9
2-Sided
95
0.51
1.71
No
Superiority or Other
OG001
OG004
Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7636
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.2
2-Sided
95
0.68
2.14
No
Superiority or Other
OG002
OG004
Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7380
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.9
2-Sided
95
0.50
1.63
No
Superiority or Other
OG003
OG004
Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8826
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.9
2-Sided
95
0.49
1.58
No
Superiority or Other
OG000
OG004
Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.9414
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.1
2-Sided
95
0.67
1.65
No
Superiority or Other
OG001
OG004
Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7907
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.9
2-Sided
95
0.58
1.43
No
Superiority or Other
OG002
OG004
Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2407
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.43
1.04
No
Superiority or Other
OG003
OG004
Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2670
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.42
1.02
No
Superiority or Other
OG000
OG004
Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.5823
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.8
2-Sided
95
0.62
1.11
No
Superiority or Other
OG001
OG004
Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7636
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.9
2-Sided
95
0.65
1.16
No
Superiority or Other
OG002
OG004
Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.0422
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.6
2-Sided
95
0.48
0.86
No
Superiority or Other
OG003
OG004
Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2670
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.53
0.96
No
Superiority or Other
OG000
OG004
Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8454
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.1
2-Sided
95
0.72
1.78
No
Superiority or Other
OG001
OG004
Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7636
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.3
2-Sided
95
0.81
2.00
No
Superiority or Other
OG002
OG004
Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2824
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.45
1.11
No
Superiority or Other
OG003
OG004
Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.5155
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.3
2-Sided
95
0.83
2.06
No
Superiority or Other
OG000
OG004
Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.5823
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.50
1.06
No
Superiority or Other
OG001
OG004
Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7636
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.1
2-Sided
95
0.78
1.70
No
Superiority or Other
OG002
OG004
Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.4644
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.8
2-Sided
95
0.56
1.25
No
Superiority or Other
OG003
OG004
Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.8826
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.9
2-Sided
95
0.59
1.31
No
Superiority or Other
OG000
OG004
Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.5823
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.8
2-Sided
95
0.61
1.13
No
Superiority or Other
OG001
OG004
Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7636
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.9
2-Sided
95
0.65
1.23
No
Superiority or Other
OG002
OG004
Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.3299
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.8
2-Sided
95
0.60
1.13
No
Superiority or Other
OG003
OG004
Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2670
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.54
1.03
No
Superiority or Other
OG000
OG004
Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.5823
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.8
2-Sided
95
0.48
1.23
No
Superiority or Other
OG001
OG004
Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.7907
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.1
2-Sided
95
0.68
1.69
No
Superiority or Other
OG002
OG004
Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2742
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.43
1.09
No
Superiority or Other
OG003
OG004
Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.2670
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.7
2-Sided
95
0.42
1.05
No
Superiority or Other
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000136
OG001146
OG002144
OG003139
OG004198
Title
Denominators
Categories
Title
Measurements
OG0000.54(0.44 to 0.66)
OG0010.59(0.49 to 0.73)
OG0020.49(0.40 to 0.60)
OG0030.51(0.42 to 0.63)
OG0040.58(0.49 to 0.69)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.813
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.93
2-Sided
95
0.71
1.22
No
Superiority or Other
OG001
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.845
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.03
2-Sided
95
0.79
1.34
No
Superiority or Other
OG002
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.461
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.85
2-Sided
95
0.65
1.11
No
Superiority or Other
OG003
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.545
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.89
2-Sided
95
0.68
1.16
No
Superiority or Other
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000132
OG001143
OG002141
OG003131
OG004193
Title
Denominators
Categories
Pertussis PT
Title
Measurements
OG00040.86(36.49 to 45.76)
OG00143.51(39.02 to 48.51)
OG00240.27(36.09 to 44.93)
OG00339.26(35.04 to 43.98)
OG00444.85(40.84 to 49.25)
Pertussis FHA
Title
Measurements
OG00046.29(41.49 to 51.65)
OG00140.65(36.59 to 45.16)
OG00241.32(37.16 to 45.94)
OG003
Pertussis PRN
Title
Measurements
OG00072.90(63.26 to 84.01)
OG00171.26(62.18 to 81.66)
OG00265.82(57.38 to 75.50)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.712
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.91
2-Sided
95
0.79
1.06
No
Superiority or Other
OG001
OG004
Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.837
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.97
2-Sided
95
0.84
1.12
No
Superiority or Other
OG002
OG004
Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.357
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.90
2-Sided
95
0.78
1.04
No
Superiority or Other
OG003
OG004
Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.190
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.88
2-Sided
95
0.76
1.01
No
Superiority or Other
OG000
OG004
Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.813
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.96
2-Sided
95
0.83
1.10
No
Superiority or Other
OG001
OG004
Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.136
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.84
2-Sided
95
0.73
0.96
No
Superiority or Other
OG002
OG004
Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.104
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.85
2-Sided
95
0.74
0.98
No
Superiority or Other
OG003
OG004
Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
<0.001
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.73
2-Sided
95
0.64
0.85
No
Superiority or Other
OG000
OG004
Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.712
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.86
2-Sided
95
0.72
1.04
No
Superiority or Other
OG001
OG004
Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.206
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.84
2-Sided
95
0.70
1.01
No
Superiority or Other
OG002
OG004
Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.066
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.78
2-Sided
95
0.65
0.93
No
Superiority or Other
OG003
OG004
Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.085
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.81
2-Sided
95
0.67
0.97
No
Superiority or Other
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000132
OG001143
OG002141
OG003131
OG004193
Title
Denominators
Categories
Tetanus
Title
Measurements
OG0000.73(0.65 to 0.83)
OG0010.70(0.62 to 0.79)
OG0020.69(0.61 to 0.77)
OG0030.60(0.53 to 0.68)
OG0040.82(0.74 to 0.90)
Diphtheria
Title
Measurements
OG0000.62(0.56 to 0.69)
OG0010.68(0.61 to 0.75)
OG0020.61(0.55 to 0.68)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.712
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.90
2-Sided
95
0.77
1.06
No
Superiority or Other
OG001
OG004
Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.206
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.86
2-Sided
95
0.74
1.00
No
Superiority or Other
OG002
OG004
Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.104
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.84
2-Sided
95
0.72
0.98
No
Superiority or Other
OG003
OG004
Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.001
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.74
2-Sided
95
0.63
0.87
No
Superiority or Other
OG000
OG004
Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.813
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.95
2-Sided
95
0.82
1.09
No
Superiority or Other
OG001
OG004
Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.837
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.03
2-Sided
95
0.90
1.19
No
Superiority or Other
OG002
OG004
Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.534
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.93
2-Sided
95
0.81
1.07
No
Superiority or Other
OG003
OG004
Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.961
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.00
2-Sided
95
0.87
1.15
No
Superiority or Other
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000105
OG001116
OG002120
OG003112
OG004156
Title
Denominators
Categories
Title
Measurements
OG000756.42(589.71 to 970.26)
OG001770.93(608.34 to 976.98)
OG002689.34(546.12 to 870.11)
OG003599.12(470.78 to 762.43)
OG004733.29(597.81 to 899.46)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.850
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.03
2-Sided
95
0.75
1.42
No
Superiority or Other
OG001
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.837
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.05
2-Sided
95
0.77
1.44
No
Superiority or Other
OG002
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.695
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.94
2-Sided
95
0.69
1.28
No
Superiority or Other
OG003
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.408
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.82
2-Sided
95
0.60
1.12
No
Superiority or Other
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG00089
OG001105
OG00293
OG00384
OG004135
Title
Denominators
Categories
Poliomyelitis Type 1
Title
Measurements
OG00068.11(53.14 to 87.30)
OG00166.59(52.98 to 83.68)
OG00267.43(52.89 to 85.96)
OG00370.66(54.73 to 91.23)
OG00472.02(58.88 to 88.10)
Poliomyelitis Type 2
Title
Measurements
OG00079.60(61.54 to 102.95)
OG00173.52(58.01 to 93.16)
OG00262.12(48.30 to 79.90)
OG003
Poliomyelitis Type 3
Title
Measurements
OG000246.22(192.84 to 314.38)
OG001184.03(146.96 to 230.46)
OG002257.92(203.08 to 327.56)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.813
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.95
2-Sided
95
0.69
1.30
No
Superiority or Other
OG001
OG004
Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.837
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.92
2-Sided
95
0.68
1.25
No
Superiority or Other
OG002
OG004
Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.695
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.94
2-Sided
95
0.68
1.28
No
Superiority or Other
OG003
OG004
Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.961
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.98
2-Sided
95
0.71
1.36
No
Superiority or Other
OG000
OG004
Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.808
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.18
2-Sided
95
0.85
1.65
No
Superiority or Other
OG001
OG004
Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.837
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.09
2-Sided
95
0.80
1.50
No
Superiority or Other
OG002
OG004
Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.695
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.92
2-Sided
95
0.66
1.28
No
Superiority or Other
OG003
OG004
Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.408
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.82
2-Sided
95
0.58
1.15
No
Superiority or Other
OG000
OG004
Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.813
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.07
2-Sided
95
0.78
1.46
No
Superiority or Other
OG001
OG004
Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.343
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.80
2-Sided
95
0.59
1.08
No
Superiority or Other
OG002
OG004
Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.695
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.12
2-Sided
95
0.82
1.52
No
Superiority or Other
OG003
OG004
Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.925
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.95
2-Sided
95
0.69
1.31
No
Superiority or Other
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000126
OG001135
OG002141
OG003138
OG004202
Title
Denominators
Categories
Title
Measurements
OG0009.65(7.74 to 12.03)
OG0019.35(7.55 to 11.57)
OG0028.25(6.69 to 10.16)
OG0037.84(6.35 to 9.68)
OG0048.96(7.53 to 10.67)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.910
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.08
2-Sided
95
0.81
1.43
No
Superiority or Other
OG001
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.850
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.04
2-Sided
95
0.79
1.37
No
Superiority or Other
OG002
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.868
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.92
2-Sided
95
0.70
1.21
No
Superiority or Other
OG003
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.914
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.87
2-Sided
95
0.67
1.15
No
Superiority or Other
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000123
OG001137
OG002141
OG003136
OG004199
Title
Denominators
Categories
Pertussis PT
Title
Measurements
OG00077.43(68.12 to 88.02)
OG00176.93(68.13 to 86.87)
OG00273.72(65.40 to 83.10)
OG00373.38(64.96 to 82.90)
OG00474.01(66.91 to 81.86)
Pertussis FHA
Title
Measurements
OG000115.55(104.32 to 128.00)
OG001117.87(106.98 to 129.87)
OG002123.56(112.30 to 135.95)
OG003
Pertussis PRN
Title
Measurements
OG000158.28(136.30 to 183.81)
OG001156.98(136.24 to 180.87)
OG002160.96(139.98 to 185.08)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.910
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.05
2-Sided
95
0.89
1.23
No
Superiority or Other
OG001
OG004
Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.850
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.04
2-Sided
95
0.89
1.22
No
Superiority or Other
OG002
OG004
Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.961
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.00
2-Sided
95
0.85
1.16
No
Superiority or Other
OG003
OG004
Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.916
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.99
2-Sided
95
0.85
1.16
No
Superiority or Other
OG000
OG004
Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.910
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.99
2-Sided
95
0.87
1.12
No
Superiority or Other
OG001
OG004
Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.909
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.01
2-Sided
95
0.89
1.14
No
Superiority or Other
OG002
OG004
Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.868
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.06
2-Sided
95
0.93
1.20
No
Superiority or Other
OG003
OG004
Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.914
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.92
2-Sided
95
0.81
1.05
No
Superiority or Other
OG000
OG004
Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.910
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.92
2-Sided
95
0.76
1.11
No
Superiority or Other
OG001
OG004
Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.850
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.91
2-Sided
95
0.76
1.09
No
Superiority or Other
OG002
OG004
Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.868
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.93
2-Sided
95
0.78
1.12
No
Superiority or Other
OG003
OG004
Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.914
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.92
2-Sided
95
0.76
1.10
No
Superiority or Other
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000123
OG001137
OG002141
OG003136
OG004199
Title
Denominators
Categories
Tetanus
Title
Measurements
OG0002.54(2.28 to 2.83)
OG0012.50(2.26 to 2.77)
OG0022.60(2.35 to 2.88)
OG0032.29(2.07 to 2.54)
OG0042.66(2.44 to 2.89)
Diphtheria
Title
Measurements
OG0001.64(1.49 to 1.80)
OG0011.94(1.77 to 2.12)
OG0021.69(1.54 to 1.84)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.910
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.96
2-Sided
95
0.83
1.10
No
Superiority or Other
OG001
OG004
Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.850
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.94
2-Sided
95
0.82
1.07
No
Superiority or Other
OG002
OG004
Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.939
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.98
2-Sided
95
0.86
1.12
No
Superiority or Other
OG003
OG004
Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.279
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.86
2-Sided
95
0.75
0.98
No
Superiority or Other
OG000
OG004
Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.149
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.86
2-Sided
95
0.76
0.97
No
Superiority or Other
OG001
OG004
Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.850
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.02
2-Sided
95
0.91
1.14
No
Superiority or Other
OG002
OG004
Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.394
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.89
2-Sided
95
0.79
0.99
No
Superiority or Other
OG003
OG004
Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.916
P-values were adjusted using false discovery rate procedure.
GMC Ratio
0.98
2-Sided
95
0.87
1.10
No
Superiority or Other
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000119
OG001131
OG002133
OG003133
OG004191
Title
Denominators
Categories
Title
Measurements
OG0004868.61(3750.57 to 6319.94)
OG0014148.04(3234.82 to 5319.08)
OG0024250.41(3320.88 to 5440.13)
OG0034263.28(3330.93 to 5456.60)
OG0043866.37(3146.78 to 4750.52)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.869
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.26
2-Sided
95
0.90
1.76
No
Superiority or Other
OG001
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.850
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.07
2-Sided
95
0.78
1.48
No
Superiority or Other
OG002
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.868
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.10
2-Sided
95
0.80
1.52
No
Superiority or Other
OG003
OG004
Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.916
P-values were adjusted using false discovery rate procedure.
GMC Ratio
1.10
2-Sided
95
0.80
1.52
No
Superiority or Other
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000123
OG001133
OG002141
OG003136
OG004201
Title
Denominators
Categories
Poliomyelitis Type 1
Title
Measurements
OG000399.56(332.13 to 480.68)
OG001426.63(357.15 to 509.62)
OG002443.97(373.58 to 527.63)
OG003415.45(348.48 to 495.29)
OG004406.37(351.67 to 469.59)
Poliomyelitis Type 2
Title
Measurements
OG000613.18(515.30 to 729.65)
OG001586.30(496.01 to 693.03)
OG002587.56(499.47 to 691.18)
OG003
Poliomyelitis Type 3
Title
Measurements
OG0001205.80(1001.18 to 1452.24)
OG0011045.57(874.35 to 1250.32)
OG0021210.29(1017.32 to 1439.87)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.910
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.98
2-Sided
95
0.78
1.24
No
Superiority or Other
OG001
OG004
Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.850
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.05
2-Sided
95
0.83
1.32
No
Superiority or Other
OG002
OG004
Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.868
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.09
2-Sided
95
0.87
1.37
No
Superiority or Other
OG003
OG004
Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.916
P-values were adjusted using false discovery rate procedure.
GMT Ratio
1.02
2-Sided
95
0.81
1.28
No
Superiority or Other
OG000
OG004
Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.910
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.99
2-Sided
95
0.79
1.23
No
Superiority or Other
OG001
OG004
Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.850
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.94
2-Sided
95
0.76
1.17
No
Superiority or Other
OG002
OG004
Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.868
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.95
2-Sided
95
0.77
1.17
No
Superiority or Other
OG003
OG004
Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.916
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.98
2-Sided
95
0.79
1.21
No
Superiority or Other
OG000
OG004
Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.910
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.97
2-Sided
95
0.77
1.23
No
Superiority or Other
OG001
OG004
Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.850
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.84
2-Sided
95
0.67
1.06
No
Superiority or Other
OG002
OG004
Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.939
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.98
2-Sided
95
0.78
1.23
No
Superiority or Other
OG003
OG004
Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.
General Linear Model
0.916
P-values were adjusted using false discovery rate procedure.
GMT Ratio
0.96
2-Sided
95
0.76
1.21
No
Superiority or Other
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000149
OG001157
OG002147
OG003155
OG004187
Title
Denominators
Categories
Fever >=38, <=39 degree C (n= 149,157,147,155,187)
Title
Measurements
OG00032.9
OG00145.2
OG00218.4
OG00334.2
OG00441.7
Fever >39, <=40 degree C (n = 138,145,137,146,170)
Title
Measurements
OG0001.4
OG0011.4
OG0020.7
OG003
Fever >40 degree C (n = 138,145,137,146,170)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000141
OG001152
OG002140
OG003159
OG004181
Title
Denominators
Categories
Fever >=38, <=39 degree C (n= 141,152,140,159,181)
Title
Measurements
OG00026.2
OG00142.8
OG00221.4
OG00344.0
OG00439.8
Fever >39, <=40 degree C (n = 133,140,134,145,164)
Title
Measurements
OG0001.5
OG0010.7
OG0021.5
OG003
Fever >40 degree C (n = 131,140,133,144,164)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000136
OG001146
OG002135
OG003141
OG004175
Title
Denominators
Categories
Fever >=38, <=39 degree C (n= 136,146,135,141,175)
Title
Measurements
OG00022.1
OG00130.8
OG00217.0
OG00333.3
OG00429.7
Fever >39, <=40 degree C (n = 129,137,125,136,167)
Title
Measurements
OG0001.6
OG0012.9
OG0020.8
OG003
Fever >40 degree C (n = 128,136,126,135,166)
Title
Measurements
OG0000.0
OG0010.0
OG0020.8
OG003
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000133
OG001140
OG002134
OG003144
OG004162
Title
Denominators
Categories
Fever >=38, <=39 degree C (n= 133,140,134,144,162)
Title
Measurements
OG00031.6
OG00137.1
OG00237.3
OG00350.0
OG00430.2
Fever >39, <=40 degree C (n = 128,127,118,123,150)
Title
Measurements
OG0005.5
OG0017.1
OG0024.2
OG003
Fever >40 degree C (n = 123,125,117,122,150)
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000173
OG001176
OG002172
OG003177
OG004210
Title
Denominators
Categories
Non-SAEs
Title
Measurements
OG00057
OG00171
OG00267
OG00372
OG00480
SAEs
Title
Measurements
OG0007
OG0013
OG00211
OG003
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Units
Counts
Participants
OG000170
OG001174
OG002172
OG003176
OG004210
Title
Denominators
Categories
Non-SAEs
Title
Measurements
OG0003
OG0016
OG0023
OG0034
OG0048
SAEs
Title
Measurements
OG0006
OG00114
OG00210
OG003
OG001
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
OG002
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
OG003
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
OG004
13vPnC + INFANRIX Hexa
Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.