Study Evaluating a 13-valent Pneumococcal Conjugate Vacci... | NCT00366899 | Trialant
NCT00366899
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Feb 22, 2013Estimated
Enrollment
605Actual
Phase
Phase 3
Conditions
Vaccines, Pneumococcal
Interventions
13-valent pneumococcal conjugate vaccine
7 valent pneumococcal conjugate vaccine
Countries
Italy
Protocol Section
Identification Module
NCT ID
NCT00366899
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-500
Secondary IDs
Not provided
Brief Title
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants
Official Title
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety,Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in Italy
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2013
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
Oct 2006
Primary Completion Date
Jul 2008Actual
Completion Date
Jul 2008Actual
First Submitted Date
Aug 17, 2006
First Submission Date that Met QC Criteria
Aug 18, 2006
First Posted Date
Aug 21, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 26, 2010
Results First Submitted that Met QC Criteria
Jan 17, 2013
Results First Posted Date
Feb 22, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 26, 2009
Certification/Extension First Submitted that Passed QC Review
Jul 31, 2009
Certification/Extension First Posted Date
Sep 30, 2009Estimated
Last Update Submitted Date
Jan 17, 2013
Last Update Posted Date
Feb 22, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Italy.
Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
During the 4-day period after each dose
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.
One month after the infant series (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Other Outcomes
Measure
Description
Time Frame
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Percentage of subjects achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. (This is not a geometric mean comparison as suggested by the table row heading).
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Aged 3 months (75 to 105 days) at time of enrollment.
Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3.
Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.
Exclusion criteria:
Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression.
History of culture-proven invasive disease caused by S pneumoniae or Hib.
Major known congenital malformation or serious chronic disorder.
Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.
Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis® [MedImmune]).
Participation in another investigational trial. Participation in purely observational studies was acceptable.
Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period. One subject was prerandomized and counted twice.
Recruitment Details
Participants were recruited in Italy from October 2006 to March 2007.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.
2
one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose
GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.
One month after the infant series (6 months of age) and the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).
one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).
one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of Polio as measured using a polio in vitro plaque neutralization.
one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)
One month after the toddler dose (12 months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
One month after toddler dose (12 months of age)
one month after infant series dose 2 and after the toddler dose
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay(OPA) for7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
one month after infant series dose 2 and after the toddler dose
Naples
Campania
80122
Italy
Naples
Campania
80139
Italy
Bologna
Emilia-Romagna
40138
Italy
Rome
Lazio
00100
Italy
Rome
Lazio
00165
Italy
Genoa
Liguria
16132
Italy
Milan
Lombardy
20122
Italy
Novara
Piedmont
28100
Italy
Sassari
Sardinia
07100
Italy
Palermo
Sicily
90100
Italy
Ragusa
Sicily
97100
Italy
Florence
Tuscany
50132
Italy
FG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
FG000303 subjects1 participant was counted twice, 1 participant randomized to 13vPnC, incorrectly received 7vPnC
FG001303 subjects1 participant randomized to 7vPnC but never vaccinated
Vaccinated Dose 1
FG000302 subjects2 participants randomized to 13vPnC, incorrectly received 7vPnC
FG001302 subjects
Vaccinated Dose 2
FG000296 subjects1 participant randomized to 13vPnC, incorrectly received 7vPnC
FG001293 subjects
COMPLETED
FG000294 subjects
FG001291 subjects
NOT COMPLETED
FG0009 subjects
FG00112 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0004 subjects
FG0017 subjects
Protocol Violation
FG0002 subjects
FG0011 subjects
Failed to return
FG0001 subjects
FG0011 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
Randomized but not consented
FG0001 subjects
FG0010 subjects
After Infant Series
Type
Comment
Milestone Data
STARTED
FG000294 subjects
FG001291 subjects
COMPLETED
FG000287 subjects
FG001282 subjects
NOT COMPLETED
FG0007 subjects
FG0019 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0004 subjects
FG0013 subjects
Withdrawal by Subject
FG0001 subjects
FG001
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000287 subjects
FG001282 subjects
COMPLETED
FG000285 subjects
FG001281 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
Protocol Violation
FG0001 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
BG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000303
BG001303
BG002606
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
months
Title
Denominators
Categories
Title
Measurements
BG0002.9± 0.3
BG0012.9± 0.3
BG0022.9± 0.3
Gender
1 gender unknown
Number
participants
Title
Denominators
Categories
Female
Title
Measurements
BG000138
BG001133
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
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Posted
Mar 2010
Number
Percentage of Participants
During the 4-day period after each dose
ID
Title
Description
OG000
13vPnC Dose 1
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
OG001
7vPnC Dose 1
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
OG002
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
OG003
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
OG004
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
OG005
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Units
Counts
Participants
OG000302
OG001302
OG002296
OG003
Title
Denominators
Categories
Tenderness - Any (n=234,243,214,215,199,188)
Title
Measurements
OG00032.1
OG00130.0
OG00230.4
OG003
Primary
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Posted
Mar 2010
Number
Percentage of Participants
During the 4-day period after each dose
ID
Title
Description
OG000
13vPnC Dose 1
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
OG001
7vPnC Dose 1
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
OG002
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.
Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant antibody concentration/titer for the given concomitant antigen.
Posted
Mar 2010
Number
95% Confidence Interval
percentage of participants
One month after the infant series (6 months of age) and after the toddler dose (12 months of age)
ID
Title
Description
OG000
13vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG001
7vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
Primary
Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)
Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
EU/mL
one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
ID
Title
Description
OG000
13vPnC After 2-Dose Infant Series
Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG001
7vPnC After 2-Dose Infant Series
Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG002
13vPnC After Toddler Dose
Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Other Pre-specified
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Percentage of subjects achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. (This is not a geometric mean comparison as suggested by the table row heading).
OPAs were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
% Achieving OPA Titer ≥1:8
one month after infant series dose 2 and after the toddler dose
ID
Title
Description
OG000
13vPnC After 2-Dose Infant Series
Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG001
13vPnC After Toddler Dose
Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Units
Counts
Other Pre-specified
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay(OPA) for7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
OPAS were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
Titers
one month after infant series dose 2 and after the toddler dose
ID
Title
Description
OG000
13vPnC After 2-Dose Infant Series
Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG001
13vPnC After Toddler Dose
Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Units
Counts
Participants
Primary
Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose
GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.
Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.
Posted
Number
95% Confidence Interval
mIU/mL
One month after the infant series (6 months of age) and the toddler dose (12 months of age)
ID
Title
Description
OG000
13vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG001
7vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG002
13vPnC After Toddler Dose
Participants received one single 0.5 mL 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
OG003
Primary
Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).
Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
μg/mL
one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
ID
Title
Description
OG000
13vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG001
7vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG002
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Primary
Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).
Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
IU/mL
one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
ID
Title
Description
OG000
13vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG001
7vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG002
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Primary
Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of Polio as measured using a polio in vitro plaque neutralization.
Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
Titers
one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
ID
Title
Description
OG000
13vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG001
7vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG002
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Primary
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
The evaluable pneumococcal immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Posted
Mar 2010
Number
95% Confidence Interval
percentage of participants
one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)
ID
Title
Description
OG000
13vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG001
13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
μg/mL
One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)
ID
Title
Description
OG000
13vPnC After 2-Dose Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
OG001
13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Units
Counts
Participants
Secondary
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Evaluable pneumococcal immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.
Posted
Mar 2010
Number
95% Confidence Interval
percentage of participants
One month after the toddler dose (12 months of age)
ID
Title
Description
OG000
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
OG001
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Units
Counts
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
μg/mL
One month after toddler dose (12 months of age)
ID
Title
Description
OG000
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
OG001
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
Units
Counts
Participants
Time Frame
Not provided
Description
Not provided
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 Infant Series
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
6
303
188
303
EG001
7vPnC Infant Series
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
10
303
183
303
EG002
13vPnC Post-Infant Series
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
8
294
96
294
EG003
7vPnC Post-Infant Series
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
11
291
90
291
EG004
13vPnC Toddler Series
Participants received one single 0.5mL dose of 13vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
3
287
165
287
EG005
7vPnC Toddler Series
Participants received one single 0.5mL dose of 7vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
1
282
170
282
EG006
13vPnC 6-Month Follow-up
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
9
290
1
290
EG007
7vPnC 6-Month Follow-up
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
11
288
0
288
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anal fissure
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG0030 affected291 at risk
EG0040 affected287 at risk
EG0050 affected282 at risk
EG0060 affected290 at risk
EG0070 affected288 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected303 at risk
EG0013 affected303 at risk
EG0020 affected294 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Cellulitis orbital
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Crying
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Decreased activity
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Epstein-Barr virus infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0022 affected294 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0011 affected303 at risk
EG0023 affected294 at risk
EG003
Gastroenteritis adenovirus
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Hypokinesia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Infantile spasms
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Kawasaki's disease
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Meningism
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Otits media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Pelizaeus-Merzbacher disease
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Syncope vasovagal
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG00075 affected234 at risk
EG00173 affected243 at risk
EG0020 affected0 at risk
EG0030 affected0 at risk
EG004
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 2 Infant Series
EG00065 affected214 at risk
EG00179 affected215 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG0006 affected224 at risk
EG0018 affected231 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 2 Infant Series
EG0009 affected199 at risk
EG00110 affected199 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG00044 affected232 at risk
EG00147 affected240 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 2 Infant Series
EG00051 affected207 at risk
EG00160 affected209 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG00041 affected232 at risk
EG00144 affected240 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 2 Infant Series
EG00045 affected207 at risk
EG00155 affected208 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG0008 affected223 at risk
EG0017 affected229 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 2 Infant Series
EG00011 affected198 at risk
EG00110 affected195 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG0000 affected222 at risk
EG0010 affected229 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 2 Infant Series
EG0000 affected197 at risk
EG0010 affected194 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG00060 affected233 at risk
EG00165 affected245 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 2 Infant Series
EG00067 affected213 at risk
EG00173 affected212 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG00056 affected233 at risk
EG00160 affected244 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 2 Infant Series
EG00060 affected211 at risk
EG00168 affected211 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG0006 affected222 at risk
EG0017 affected231 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 2 Infant Series
EG00011 affected200 at risk
EG0017 affected195 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG0000 affected222 at risk
EG0010 affected229 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reaction
Systematic Assessment
Dose 2 Infant Series
EG0000 affected197 at risk
EG0010 affected194 at risk
EG0020 affected0 at risk
EG003
Fever ≥38°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG000103 affected247 at risk
EG00195 affected246 at risk
EG0020 affected0 at risk
EG003
Fever ≥38°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG000126 affected227 at risk
EG001137 affected226 at risk
EG0020 affected0 at risk
EG003
Fever >39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG0008 affected224 at risk
EG00111 affected233 at risk
EG0020 affected0 at risk
EG003
Fever >39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00014 affected204 at risk
EG00114 affected201 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG0000 affected222 at risk
EG0010 affected230 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG0000 affected198 at risk
EG0010 affected195 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG00087 affected246 at risk
EG00185 affected248 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG000104 affected220 at risk
EG00199 affected218 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG000188 affected258 at risk
EG001165 affected259 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG000185 affected245 at risk
EG001183 affected243 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG000177 affected269 at risk
EG001178 affected276 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG000129 affected226 at risk
EG001131 affected232 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Dose 1 Infant Series & Toddler Dose
EG00096 affected244 at risk
EG00188 affected242 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Dose 2 Infant Series
EG00089 affected222 at risk
EG00189 affected213 at risk
EG0020 affected0 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected303 at risk
EG0015 affected303 at risk
EG0021 affected294 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Thyroid cyst
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0014 affected303 at risk
EG0021 affected294 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0005 affected303 at risk
EG00112 affected303 at risk
EG0022 affected294 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0015 affected303 at risk
EG0021 affected294 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0012 affected303 at risk
EG0020 affected294 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0012 affected303 at risk
EG0020 affected294 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Infantile colic
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Perianal erythema
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Regurgitation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG00024 affected303 at risk
EG00123 affected303 at risk
EG00233 affected294 at risk
EG003
Irritability
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0012 affected303 at risk
EG0020 affected294 at risk
EG003
Injection site swelling
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG00013 affected303 at risk
EG00110 affected303 at risk
EG0028 affected294 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG00011 affected303 at risk
EG00110 affected303 at risk
EG0026 affected294 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0008 affected303 at risk
EG0019 affected303 at risk
EG0021 affected294 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0008 affected303 at risk
EG0016 affected303 at risk
EG00216 affected294 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0006 affected303 at risk
EG0015 affected303 at risk
EG0024 affected294 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected303 at risk
EG0016 affected303 at risk
EG0020 affected294 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected303 at risk
EG0014 affected303 at risk
EG0024 affected294 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected303 at risk
EG0013 affected303 at risk
EG00216 affected294 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected303 at risk
EG0012 affected303 at risk
EG0027 affected294 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0015 affected303 at risk
EG0021 affected294 at risk
EG003
Varicella
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0013 affected303 at risk
EG0028 affected294 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0012 affected303 at risk
EG0023 affected294 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0012 affected303 at risk
EG0021 affected294 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Tracheitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0012 affected303 at risk
EG0021 affected294 at risk
EG003
Viral skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Impetigo
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0022 affected294 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0021 affected294 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0023 affected294 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0022 affected294 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Erythema infectiosum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Roseola
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG00018 affected303 at risk
EG00118 affected303 at risk
EG0028 affected294 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected303 at risk
EG0013 affected303 at risk
EG0020 affected294 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected303 at risk
EG0010 affected303 at risk
EG0023 affected294 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected303 at risk
EG0015 affected303 at risk
EG0021 affected294 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0021 affected294 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected303 at risk
EG0010 affected303 at risk
EG0021 affected294 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0011 affected303 at risk
EG0020 affected294 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected303 at risk
EG0010 affected303 at risk
EG0020 affected294 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
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.
Difference
-0.4
95
-2.2
1.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥16 EU/mL threshold was calculated.
Difference
0.0
95
-4.0
3.8
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated
Difference
0.0
95
-1.6
1.4
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated.
Difference
0.0
95
-1.6
1.4
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Pertussis FHA the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥31 EU/mL threshold was calculated.
Difference
-0.90
95
-5.0
2.9
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.
Difference
0.0
95
-1.5
1.4
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Pertactin the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥40 EU/mL threshold was calculated.
Difference
-3.2
95
-7.8
1.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.
Difference
0.7
95
-3.6
5.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated.
Difference
-3.2
95
-9.1
2.4
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.
Difference
0.7
95
-8.2
9.5
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Diptheria the difference in percentages between the two groups ( 13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.
Difference
0.0
95
-1.8
1.6
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Diptheria the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.
Difference
-3.5
95
-8.3
0.8
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Tetanus the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.
Difference
1.7
95
-3.9
7.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Difference
-0.1
95
-2.3
1.7
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Polio Type 2 the difference in percentage between the two groups ( 13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Difference
-1.0
95
-5.0
2.8
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG000
OG001
For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Difference
0.7
95
-1.6
2.9
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated
Difference
0.0
95
-1.6
1.7
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥21 EU/mL threshold was calculated.
Difference
-2.7
95
-7.3
1.8
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated
Difference
0.0
95
-1.6
1.7
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated
Difference
0.0
95
-1.6
1.7
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥162 EU/mL threshold was calculated
Difference
-0.1
95
-4.3
4.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.
Difference
0.0
95
-1.6
1.7
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥106 EU/mL threshold was calculated.
Difference
-0.5
95
-4.7
3.7
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.
Difference
-0.4
95
-3.0
2.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated
Difference
1.4
95
-0.8
4.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.
Difference
4.0
95
-0.4
8.7
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.
Difference
0.0
95
-2.3
2.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated
Difference
0.0
95
-2.3
2.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.
Difference
3.8
95
-1.7
10.9
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Difference
0.0
95
-2.4
2.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Difference
0.0
95
-2.4
2.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG002
OG003
For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Difference
0.0
95
-2.4
2.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
OG003
7vPnC After Toddler Dose
Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Units
Counts
Participants
OG000275
OG001279
OG002254
OG003261
Title
Denominators
Categories
Pertussis FHA
Title
Measurements
OG000102.87(94.35 to 112.16)
OG001105.17(97.25 to 113.73)
OG002463.23(425.19 to 504.67)
OG003456.55(415.06 to 502.18)
Pertussis PT
Title
Measurements
OG00050.01(45.82 to 54.58)
OG00148.44(44.71 to 52.49)
OG00260.89(55.61 to 66.67)
OG003
Pertussis PRN
Title
Measurements
OG000167.76(149.54 to 188.18)
OG001166.19(150.28 to 183.78)
OG002339.30(309.16 to 372.38)
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
OG001
For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.98
95
0.87
1.10
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.03
95
0.92
1.16
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.01
95
0.87
1.17
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.01
95
0.89
1.15
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.94
95
0.83
1.07
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.94
95
0.82
1.07
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Participants
OG000100
OG001100
Title
Denominators
Categories
Common Serotypes - Serotype 4
Title
Measurements
OG000100.0(96.3 to 100.0)
OG001100.0(95.8 to 100.0)
Common Serotypes - Serotype 6B
Title
Measurements
OG00090.0(82.4 to 95.1)
OG00199.0(94.3 to 100.0)
Common Serotypes - Serotype 9V
Title
Measurements
OG000100.0(96.3 to 100.0)
OG001100.0(96.1 to 100.0)
Common Serotypes - Serotype 14
Title
Measurements
OG000100.0(96.3 to 100.0)
OG001100.0(96.2 to 100.0)
Common Serotypes - Serotype 18C
Title
Measurements
OG00097.0(91.4 to 99.4)
OG001100.0(96.3 to 100.0)
Common Serotypes - Serotype 19F
Title
Measurements
OG00096.0(90.1 to 98.9)
OG00197.9(92.7 to 99.7)
Common Serotypes - Serotype 23F
Title
Measurements
OG00097.0(91.4 to 99.4)
OG001100.0(96.3 to 100.0)
Additional Serotypes - Serotype 1
Title
Measurements
OG00094.8(88.3 to 98.3)
OG001100.0(96.2 to 100.0)
Additional Serotypes - Serotype 3
Title
Measurements
OG00099.0(94.6 to 100.0)
OG001100.0(96.2 to 100.0)
Additional Serotypes - Serotype 5
Title
Measurements
OG00096.0(90.0 to 98.9)
OG001100.0(96.1 to 100.0)
Additional Serotypes - Serotype 6A
Title
Measurements
OG00095.9(89.9 to 98.9)
OG001100.0(96.2 to 100.0)
Additional Serotypes - Serotype 7F
Title
Measurements
OG000100.0(96.4 to 100.0)
OG001100.0(96.2 to 100.0)
Additional Serotypes - Serotype 19A
Title
Measurements
OG00095.6(89.0 to 98.8)
OG001100.0(96.0 to 100.0)
OG000100
OG001100
Title
Denominators
Categories
Common Serotypes - Serotype 4
Title
Measurements
OG000526.69(431.88 to 642.32)
OG0011276.21(1025.09 to 1588.85)
Common Serotypes - Serotype 6B
Title
Measurements
OG000191.34(133.35 to 274.55)
OG0012383.31(1850.47 to 3069.57)
Common Serotypes - Serotype 9V
Title
Measurements
OG0003585.80(2787.34 to 4612.99)
OG00116384.00(13066.97 to 20543.06)
Common Serotypes - Serotype 14
Title
Measurements
OG0001882.96(1446.51 to 2451.10)
OG0011903.89(1580.90 to 2292.88)
Common Serotypes - Serotype 18C
Title
Measurements
OG000294.48(221.80 to 390.98)
OG0011324.41(1063.57 to 1649.22)
Common Serotypes - Serotype 19F
Title
Measurements
OG000222.86(170.46 to 291.37)
OG001391.97(296.34 to 518.46)
Common Serotypes - Serotype 23F
Title
Measurements
OG000487.51(356.25 to 667.13)
OG0013679.67(2971.61 to 4556.44)
Additional Serotypes - Serotype 1
Title
Measurements
OG00062.63(47.59 to 82.41)
OG001294.07(226.88 to 381.15)
Additional Serotypes - Serotype 3
Title
Measurements
OG000176.07(144.89 to 213.96)
OG001504.66(435.71 to 584.53)
Additional Serotypes - Serotype 5
Title
Measurements
OG000127.11(99.36 to 162.60)
OG001333.24(274.24 to 404.94)
Additional Serotypes - Serotype 6A
Title
Measurements
OG000541.81(392.09 to 748.68)
OG0012217.29(1821.95 to 2698.42)
Additional Serotypes - Serotype 7F
Title
Measurements
OG0005914.33(4710.83 to 7425.30)
OG00114886.35(12560.25 to 17643.22)
Additional Serotypes - Serotype 19F
Title
Measurements
OG000157.59(118.91 to 208.84)
OG0011415.08(1140.56 to 1755.66)
7vPnC After Toddler Dose
Participants received one single 0.5 mL 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Units
Counts
Participants
OG000273
OG001276
OG002252
OG003255
Title
Denominators
Categories
Title
Measurements
OG000260.46(214.47 to 316.31)
OG001272.67(220.83 to 336.68)
OG0021655.30(1343.30 to 2039.77)
OG0032284.95(1878.82 to 2778.88)
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
OG001
For Hepatitis b the geometric mean concentration (GMC) ratio (13vPnC/7vPnC) was calculated
Ratio
0.96
95
0.72
1.27
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the geometric mean concentration (GMC)/geometric mean titer (GMT) ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Hepatitis b the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.72
95
0.54
0.96
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG003
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Units
Counts
Participants
OG000231
OG001267
OG002235
OG003218
Title
Denominators
Categories
Title
Measurements
OG0000.99(0.80 to 1.21)
OG0011.00(0.83 to 1.20)
OG0029.09(7.80 to 10.60)
OG0038.85(7.37 to 10.62)
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
OG001
or Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.99
95
0.75
1.30
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.03
95
0.81
1.30
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG003
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Units
Counts
Participants
OG000275
OG001279
OG002254
OG003261
Title
Denominators
Categories
Diptheria (n=207,240,164,190)
Title
Measurements
OG0000.52(0.46 to 0.60)
OG0010.67(0.59 to 0.76)
OG0022.77(2.45 to 3.13)
OG0033.71(3.28 to 4.20)
Tetanus (n=155,214,125,96)
Title
Measurements
OG0000.53(0.45 to 0.63)
OG0010.63(0.53 to 0.74)
OG0022.62(2.12 to 3.25)
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
OG001
For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.78
95
0.65
0.94
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.85
95
0.67
1.08
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.75
95
0.63
0.89
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.25
95
0.88
1.79
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG003
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Units
Counts
Participants
OG000275
OG001279
OG002254
OG003261
Title
Denominators
Categories
Polio Type 1 (n=207,262,156,179)
Title
Measurements
OG000180.72(154.31 to 211.64)
OG001207.17(178.64 to 240.25)
OG002924.52(782.71 to 1092.03)
OG0031348.04(1163.56 to 1561.77)
Polio Type 2 (n=205,262,153,175)
Title
Measurements
OG000123.74(102.68 to 149.13)
OG001130.39(109.96 to 154.63)
OG0021141.62(958.68 to 1359.47)
OG003
Polio Type 3 (n=205,262,153,178)
Title
Measurements
OG000397.32(327.00 to 482.76)
OG001452.14(382.57 to 534.35)
OG0021567.64(1289.72 to 1905.45)
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
OG001
For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.87
95
0.70
1.08
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.95
95
0.74
1.22
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.88
95
0.68
1.13
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.69
95
0.55
0.86
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.85
95
0.68
1.07
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.65
95
0.51
0.83
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).