Study Evaluating a 13-Valent Pneumococcal Conjugate Vacci... | NCT00474539 | Trialant
NCT00474539
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Mar 5, 2013Estimated
Enrollment
449Actual
Phase
Phase 3
Conditions
Vaccines, Pneumococcal
Interventions
13-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine
Countries
Spain
Protocol Section
Identification Module
NCT ID
NCT00474539
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-3007
Secondary IDs
Not provided
Brief Title
Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy 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 a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain
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
Jul 2007
Primary Completion Date
Mar 2009Actual
Completion Date
Mar 2009Actual
First Submitted Date
May 15, 2007
First Submission Date that Met QC Criteria
May 15, 2007
First Posted Date
May 17, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 26, 2010
Results First Submitted that Met QC Criteria
Jan 22, 2013
Results First Posted Date
Mar 5, 2013Estimated
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 22, 2013
Last Update Posted Date
Mar 5, 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 Spain.
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
One month after infant series dose (at 5 months of age)
Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).
One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.
One month after toddler dose (at 16 months of age)
Other 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 (Sig)(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 (Mod) (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy 2-month-old infants
Available for the entire study period
Exclusion criteria:
Previous vaccination with any vaccine before the start of the study
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 the inclusion/exclusion criteria without a screening period.
Recruitment Details
Participants were recruited in Spain from 4 July 2007 to 23 July 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 meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.
One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), 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
A Coruña
15405
Spain
AlmerÃa
4007
Spain
AlmerÃa
4009
Spain
AlmerÃa
4120
Spain
Barcelona
8195
Spain
Barcelona
8930
Spain
Madrid
28041
Spain
Madrid
28900
Spain
Madrid
28922
Spain
Madrid
28942
Spain
Málaga
29015
Spain
Málaga
29200
Spain
Ourense
32005
Spain
Pamplona
31008
Spain
Santiago de Compostela
15706
Spain
Seville
41013
Spain
Valencia
46008
Spain
Valencia
46011
Spain
Valencia
46021
Spain
Valencia
46022
Spain
Valencia
46023
Spain
Valencia
46024
Spain
Valencia
46183
Spain
Valencia
46200
Spain
Valencia
46930
Spain
Vigo
36204
Spain
FG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
FG000223 subjectsOne participant was randomized to 7vPnC, but received 13vPnC.
FG001226 subjectsOne participant was randomized to 7vPnC, but received 13vPnC.
Vaccinated Dose 1
FG000218 subjects
FG001226 subjects
Vaccinated Dose 2
FG000217 subjects
FG001222 subjects
Vaccinated Dose 3
FG000214 subjects
FG001221 subjects
COMPLETED
FG000213 subjects
FG001220 subjects
NOT COMPLETED
FG00010 subjects
FG0016 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0003 subjects
FG0014 subjects
Randomization error
FG0005 subjects
FG0010 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
After Infant Series
Type
Comment
Milestone Data
STARTED
FG000213 subjects
FG001220 subjects
COMPLETED
FG000209 subjects
FG001220 subjects
NOT COMPLETED
FG0004 subjects
FG0010 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0003 subjects
FG0010 subjects
Withdrawal by Subject
FG0001 subjects
FG001
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000209 subjects
FG001220 subjects
COMPLETED
FG000208 subjects
FG001220 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
Type
Comment
Reasons
Protocol Violation
FG0001 subjects
FG0010 subjects
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 meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
BG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000219
BG001225
BG002444
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
BG0002.1± 0.4
BG0012.0± 0.4
BG0022.1± 0.4
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000104
BG001116
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 Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given concomitant vaccine component.
Posted
Mar 2010
Number
95% Confidence Interval
percentage of participants
One month after infant series dose (at 5 months of age)
ID
Title
Description
OG000
13vPnC After Infant Series Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
OG001
7vPnC After Infant Series Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
Units
Counts
Participants
OG000206
OG001218
Title
Denominators
Categories
Title
Measurements
OG00098.5(95.8 to 99.7)
OG00199.1(96.7 to 99.9)
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 Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at >=1:8 titer was calculated
Difference
-0.5
95
-3.3
2.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (>) -10%.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig)(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 (Mod) (2.5 to 7.0 cm); Severe (Sev) (>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 NeisVac-C and Infanrix hexa at the 2-month visit.
OG001
7vPnC Dose 1
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
OG002
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), 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 NeisVac-C and Infanrix hexa at the 2-month visit.
OG001
7vPnC Dose 1
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
OG002
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
Primary
Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
The evaluable 2-dose 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
Geometric Mean
95% Confidence Interval
titer
One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
ID
Title
Description
OG000
13vPnC After Infant Series Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
OG001
7vPnC After Infant Series Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2)
OG002
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
Primary
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).
The evaluable 3-dose 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 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
ID
Title
Description
OG000
13vPnC After Infant Series Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
OG001
7vPnC After Infant Series Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
OG002
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Primary
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
The evaluable 3-dose 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
Geometric Mean
95% Confidence Interval
IU/mL
One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
ID
Title
Description
OG000
13vPnC After Infant Series Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
OG001
7vPnC After Infant Series Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
OG002
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Primary
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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 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 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
ID
Title
Description
OG000
13vPnC After Infant Series Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
OG001
13vPnC After Infant Series Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
Primary
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.
The evaluable 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
Geometric Mean
95% Confidence Interval
μg/mL
One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
ID
Title
Description
OG000
13vPnC After Infant Series Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
OG001
13vPnC After Infant Series Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
Secondary
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Evaluable immunogenicity (per protocol) population consisting of eligible participants 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 IgG antibody concentration to the given concomitant vaccine component.
Posted
Number
95% Confidence Interval
percentage of participants
One month after toddler dose (at 16 months of age)
ID
Title
Description
OG000
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
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 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
6
218
204
218
EG001
7vPnC Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
8
226
211
225
EG002
13vPnC Post-Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
9
218
6
218
EG003
7vPnC Post-Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
6
226
13
225
EG004
13vPnC Toddler Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
1
218
171
209
EG005
7vPnC Toddler Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
0
226
179
218
EG006
13vPnC 6-Month Follow-up
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
4
218
4
218
EG007
7vPnC 6-Month Follow-up
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
9
226
2
224
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Aphthous stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG0030 affected226 at risk
EG0040 affected218 at risk
EG0050 affected226 at risk
EG0060 affected218 at risk
EG0071 affected226 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0021 affected218 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0012 affected226 at risk
EG0022 affected218 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0021 affected218 at risk
EG003
Bronchospams
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Coleliac disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0021 affected218 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0021 affected218 at risk
EG003
Enterocolitis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0021 affected218 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0021 affected218 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0011 affected226 at risk
EG0020 affected218 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected226 at risk
EG0020 affected218 at risk
EG003
Increased bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0021 affected218 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Orchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected226 at risk
EG0021 affected218 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected226 at risk
EG0020 affected218 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0011 affected226 at risk
EG0021 affected218 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0021 affected218 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0011 affected226 at risk
EG0021 affected218 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected226 at risk
EG0020 affected218 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected226 at risk
EG0020 affected218 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenitis
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG0030 affected225 at risk
EG0040 affected209 at risk
EG0051 affected218 at risk
EG0060 affected218 at risk
EG0070 affected224 at risk
Phimosis
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Thalassaemia beta
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0003 affected218 at risk
EG00111 affected225 at risk
EG0020 affected218 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0008 affected218 at risk
EG0019 affected225 at risk
EG0020 affected218 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected218 at risk
EG0014 affected225 at risk
EG0020 affected218 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected218 at risk
EG0012 affected225 at risk
EG0020 affected218 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0012 affected225 at risk
EG0020 affected218 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Abnormal faeces
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Infantile colic
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0006 affected218 at risk
EG0019 affected225 at risk
EG0020 affected218 at risk
EG003
Irritability
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Developmental delay
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Milk allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Food allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0021 affected218 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG00021 affected218 at risk
EG00127 affected225 at risk
EG0020 affected218 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG00023 affected218 at risk
EG00124 affected225 at risk
EG0021 affected218 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG00019 affected218 at risk
EG00115 affected225 at risk
EG0020 affected218 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG00012 affected218 at risk
EG00117 affected225 at risk
EG0020 affected218 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0009 affected218 at risk
EG00114 affected225 at risk
EG0020 affected218 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0009 affected218 at risk
EG00113 affected225 at risk
EG0020 affected218 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0005 affected218 at risk
EG0018 affected225 at risk
EG0020 affected218 at risk
EG003
Otitis media
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected218 at risk
EG0018 affected225 at risk
EG0020 affected218 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected218 at risk
EG0017 affected225 at risk
EG0020 affected218 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0005 affected218 at risk
EG0015 affected225 at risk
EG0020 affected218 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected218 at risk
EG0012 affected225 at risk
EG0020 affected218 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected218 at risk
EG0013 affected225 at risk
EG0020 affected218 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0014 affected225 at risk
EG0020 affected218 at risk
EG003
Candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0013 affected225 at risk
EG0020 affected218 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0012 affected225 at risk
EG0020 affected218 at risk
EG003
Varicella
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0012 affected225 at risk
EG0020 affected218 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Campylobacter intestinal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Croup infectious
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Exanthema subitum
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Herpangina
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Paronychia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Roseola
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Viral skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Injection site abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0021 affected218 at risk
EG003
Oral herpes
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Lice infestation
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Viral rash
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Burns third degree
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Cow's milk intolerance
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Somnolence
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0004 affected218 at risk
EG0012 affected225 at risk
EG0020 affected218 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0015 affected225 at risk
EG0020 affected218 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected218 at risk
EG0013 affected225 at risk
EG0021 affected218 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0021 affected218 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Infantile asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected218 at risk
EG0013 affected225 at risk
EG0021 affected218 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0016 affected225 at risk
EG0020 affected218 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected218 at risk
EG0012 affected225 at risk
EG0020 affected218 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0011 affected225 at risk
EG0020 affected218 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected218 at risk
EG0010 affected225 at risk
EG0020 affected218 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
EG000199 affected218 at risk
EG001205 affected225 at risk
EG0020 affected0 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (any)
EG000182 affected218 at risk
EG001180 affected225 at risk
EG0020 affected0 at risk
EG003
Tenderness (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (any)
EG000170 affected218 at risk
EG001175 affected225 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
EG000199 affected218 at risk
EG001200 affected225 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (significant)
EG000177 affected218 at risk
EG001177 affected225 at risk
EG0020 affected0 at risk
EG003
Tenderness (significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (significant)
EG000167 affected218 at risk
EG001169 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose;Induration (any)=present at site of vaccination.
EG000196 affected218 at risk
EG001200 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (any)
EG000182 affected218 at risk
EG001177 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (any)
EG000171 affected218 at risk
EG001170 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
EG000196 affected218 at risk
EG001200 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (mild)
EG000182 affected218 at risk
EG001177 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (mild)
EG000171 affected218 at risk
EG001170 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.
EG000196 affected218 at risk
EG001196 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (moderate)
EG000177 affected218 at risk
EG001175 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (moderate)
EG000166 affected218 at risk
EG001168 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Induration (severe) >7.0 cm.
EG000196 affected218 at risk
EG001196 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (severe)
EG000177 affected218 at risk
EG001175 affected225 at risk
EG0020 affected0 at risk
EG003
Induration (severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (severe)
EG000166 affected218 at risk
EG001168 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
EG000197 affected218 at risk
EG001199 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (any)
EG000181 affected218 at risk
EG001180 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (any)
EG000172 affected218 at risk
EG001172 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 centimeters (cm) to 2.0 cm.
EG000197 affected218 at risk
EG001198 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (mild)
EG000180 affected218 at risk
EG001180 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (mild)
EG000172 affected218 at risk
EG001171 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
EG000196 affected218 at risk
EG001197 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (moderate)
EG000178 affected218 at risk
EG001175 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (moderate)
EG000166 affected218 at risk
EG001169 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Erythema (severe) >7.0 cm.
EG000196 affected218 at risk
EG001196 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (severe)
EG000177 affected218 at risk
EG001175 affected225 at risk
EG0020 affected0 at risk
EG003
Erythema (severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (severe)
EG000166 affected218 at risk
EG001168 affected225 at risk
EG0020 affected0 at risk
EG003
Fever ≥38°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever ≥38°C but ≤39°C
EG000201 affected218 at risk
EG001204 affected225 at risk
EG0020 affected0 at risk
EG003
Fever ≥38°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever ≥38°C but ≤39°C
EG000181 affected218 at risk
EG001189 affected225 at risk
EG0020 affected0 at risk
EG003
Fever ≥38°C but ≤39°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever ≥38°C but ≤39°C
EG000172 affected218 at risk
EG001176 affected225 at risk
EG0020 affected0 at risk
EG003
Fever >39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever >39°C but ≤40°C
EG000196 affected218 at risk
EG001196 affected225 at risk
EG0020 affected0 at risk
EG003
Fever >39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever >39°C but ≤40°C
EG000177 affected218 at risk
EG001176 affected225 at risk
EG0020 affected0 at risk
EG003
Fever >39°C but ≤40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever >39°C but ≤40°C
EG000166 affected218 at risk
EG001168 affected225 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Fever >40°C
EG000196 affected218 at risk
EG001197 affected225 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever >40°C
EG000177 affected218 at risk
EG001175 affected225 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever >40°C
EG000166 affected218 at risk
EG001168 affected225 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased appetite
EG000204 affected218 at risk
EG001207 affected225 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased appetite
EG000189 affected218 at risk
EG001191 affected225 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased appetite
EG000178 affected218 at risk
EG001178 affected225 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Irritability
EG000202 affected218 at risk
EG001211 affected225 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Irritability
EG000192 affected218 at risk
EG001190 affected225 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Irritability
EG000179 affected218 at risk
EG001188 affected225 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Increased sleep
EG000204 affected218 at risk
EG001206 affected225 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Increased sleep
EG000189 affected218 at risk
EG001187 affected225 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Increased sleep
EG000175 affected218 at risk
EG001174 affected225 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased sleep
EG000196 affected218 at risk
EG001204 affected225 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased sleep
EG000183 affected218 at risk
EG001187 affected225 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased sleep
EG000175 affected218 at risk
EG001178 affected225 at risk
EG0020 affected0 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.
Point of Contact
Title
Organization
Phone
Extension
Email
U. S. Contact Center
Wyeth
clintrialresults@wyeth.com
ID
Term
D000069443
Heptavalent Pneumococcal Conjugate Vaccine
Ancestor Terms
ID
Term
D022242
Pneumococcal Vaccines
D022541
Streptococcal Vaccines
D001428
Bacterial Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
D017778
Vaccines, Combined
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
220
Male
BG000115
BG001109
BG002224
OG003
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
OG004
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
OG005
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
OG006
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
OG007
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
Units
Counts
Participants
OG000206
OG001218
OG002164
OG003172
Title
Denominators
Categories
Title
Measurements
OG000654.55(557.75 to 768.16)
OG001757.04(648.45 to 883.81)
OG0022573.06(2176.29 to 3042.16)
OG0032098.12(1779.65 to 2473.58)
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 Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated
Ratio
0.86
95
0.69
1.08
Yes
Non-Inferiority or Equivalence
Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated
Ratio
1.23
95
0.97
1.55
Yes
Non-Inferiority or Equivalence
Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the 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 NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Units
Counts
Participants
OG000197
OG001212
OG002164
OG003172
Title
Denominators
Categories
Diphtheria ≥0.10 IU/mL
Title
Measurements
OG00098.5(95.6 to 99.7)
OG00199.1(96.6 to 99.9)
OG002100.0(97.8 to 100.0)
OG003100.0(97.9 to 100.0)
Diphtheria ≥0.01 IU/mL
Title
Measurements
OG000100.0(98.1 to 100.0)
OG001100.0(98.3 to 100.0)
OG002100.0(97.8 to 100.0)
OG003
Tetanus ≥0.10 IU/mL
Title
Measurements
OG00096.6(92.6 to 98.7)
OG00196.7(93.0 to 98.8)
OG002100.0(97.8 to 100.0)
OG003
Tetanus ≥0.01 IU/mL
Title
Measurements
OG000100.0(97.9 to 100.0)
OG001100.0(98.0 to 100.0)
OG002100.0(97.8 to 100.0)
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 the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated
Difference
-0.6
95
-3.5
2.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated
Difference
0.0
95
-1.9
1.7
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated
Difference
-0.2
95
-4.4
4.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated
Difference
0.0
95
-2.1
2.0
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG002
OG003
For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated
Ratio
0.0
95
-2.2
2.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG002
OG003
For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated
Ratio
0.0
95
-2.2
2.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG002
OG003
For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated
Ratio
0.0
95
-2.3
2.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG002
OG003
For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated
Ratio
0.0
95
-2.3
2.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG003
7vPnC After Toddler Dose
SParticipants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Units
Counts
Participants
OG000197
OG001212
OG002164
OG003172
Title
Denominators
Categories
Diphtheria
Title
Measurements
OG0000.79(0.69 to 0.90)
OG0010.92(0.81 to 1.04)
OG0023.00(2.63 to 3.41)
OG0033.23(2.88 to 3.63)
Tetanus
Title
Measurements
OG0001.10(0.94 to 1.27)
OG0011.20(1.04 to 1.39)
OG0023.29(2.83 to 3.83)
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
0.86
95
0.72
1.03
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 ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For tetanus the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.91
95
0.74
1.12
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 ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.93
95
0.78
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 ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For tetanus the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.00
95
0.81
1.24
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 ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Units
Counts
Participants
OG000206
OG001197
OG002212
Title
Denominators
Categories
Common Serotypes - Serotype 4
Title
Measurements
OG00092.5(87.9 to 95.7)
OG00198.5(95.7 to 99.7)
OG002100.0(97.7 to 100.0)
Common Serotypes - Serotype 6B
Title
Measurements
OG00027.9(21.8 to 34.7)
OG00194.9(90.9 to 97.5)
OG002100.0(97.7 to 100.0)
Common Serotypes - Serotype 9V
Title
Measurements
OG00089.9(84.8 to 93.7)
OG00197.0(93.5 to 98.9)
OG00299.3(96.3 to 100.0)
Common Serotypes - Serotype 14
Title
Measurements
OG00091.0(86.1 to 94.6)
OG00197.0(93.6 to 98.9)
OG00299.4(96.6 to 100.0)
Common Serotypes - Serotype 18C
Title
Measurements
OG00088.9(83.7 to 92.9)
OG00199.0(96.4 to 99.9)
OG00298.8(95.6 to 99.8)
Common Serotypes - Serotype 19F
Title
Measurements
OG000100.0(98.2 to 100.0)
OG00199.0(96.4 to 99.9)
OG00298.7(95.5 to 99.8)
Common Serotypes - Serotype 23F
Title
Measurements
OG00055.8(48.6 to 62.8)
OG00193.0(88.5 to 96.1)
OG00298.1(94.7 to 99.6)
Additional Serotypes - Serotype 1
Title
Measurements
OG00096.0(92.2 to 98.2)
OG00198.5(95.7 to 99.7)
OG00298.8(95.6 to 99.8)
Additional Serotypes - Serotype 3
Title
Measurements
OG00073.8(67.1 to 79.9)
OG00186.2(80.5 to 90.7)
OG00293.6(88.6 to 96.9)
Additional Serotypes - Serotype 5
Title
Measurements
OG00086.4(80.8 to 90.8)
OG00196.0(92.2 to 98.2)
OG002100.0(97.6 to 100.0)
Additional Serotypes - Serotype 6A
Title
Measurements
OG00080.8(74.6 to 86.0)
OG00199.0(96.4 to 99.9)
OG00299.4(96.5 to 100.0)
Additional Serotypes - Serotype 7F
Title
Measurements
OG00094.5(90.3 to 97.2)
OG001100.0(98.2 to 100.0)
OG00299.4(96.5 to 100.0)
Additional Serotypes - Serotype 19A
Title
Measurements
OG00092.9(88.4 to 96.1)
OG00199.5(97.2 to 100.0)
OG002100.0(97.5 to 100.0)
OG002
13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
Units
Counts
Participants
OG000206
OG001197
OG002212
Title
Denominators
Categories
Common Serotypes - Serotype 4
Title
Measurements
OG0001.55(1.35 to 1.78)
OG0012.32(2.08 to 2.60)
OG0023.88(3.42 to 4.40)
Common Serotypes - Serotype 6B
Title
Measurements
OG0000.21(0.18 to 0.25)
OG0012.59(2.20 to 3.05)
OG00212.25(10.78 to 13.92)
Common Serotypes - Serotype 9V
Title
Measurements
OG0001.15(1.01 to 1.32)
OG0011.51(1.35 to 1.68)
OG0022.67(2.34 to 3.05)
Common Serotypes - Serotype 14
Title
Measurements
OG0001.94(1.64 to 2.29)
OG0014.51(3.89 to 5.22)
OG0029.82(8.54 to 11.30)
Common Serotypes - Serotype 18C
Title
Measurements
OG0001.30(1.11 to 1.51)
OG0011.86(1.68 to 2.07)
OG0022.29(2.01 to 2.61)
Common Serotypes - Serotype 19F
Title
Measurements
OG0002.98(2.60 to 3.41)
OG0012.46(2.21 to 2.74)
OG0026.11(5.21 to 7.16)
Common Serotypes - Serotype 23F
Title
Measurements
OG0000.40(0.34 to 0.48)
OG0011.67(1.44 to 1.94)
OG0023.96(3.43 to 4.59)
Additional Serotypes - Serotype 1
Title
Measurements
OG0001.87(1.61 to 2.16)
OG0012.95(2.61 to 3.33)
OG0024.60(3.94 to 5.37)
Additional Serotypes - Serotype 3
Title
Measurements
OG0000.54(0.48 to 0.61)
OG0010.85(0.76 to 0.95)
OG0021.04(0.91 to 1.19)
Additional Serotypes - Serotype 5
Title
Measurements
OG0000.88(0.77 to 1.00)
OG0011.83(1.62 to 2.06)
OG0023.69(3.26 to 4.18)
Additional Serotypes - Serotype 6A
Title
Measurements
OG0000.81(0.70 to 0.95)
OG0013.08(2.76 to 3.44)
OG0027.71(6.75 to 8.80)
Additional Serotypes - Serotype 7F
Title
Measurements
OG0001.51(1.33 to 1.71)
OG0013.41(3.11 to 3.74)
OG0025.66(4.90 to 6.53)
Additional Serotypes - Serotype 19A
Title
Measurements
OG0001.52(1.31 to 1.76)
OG0012.50(2.27 to 2.75)
OG00210.21(8.92 to 11.68)
OG001
7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
Units
Counts
Participants
OG000164
OG001172
Title
Denominators
Categories
Title
Measurements
OG000100.0(97.8 to 100.0)
OG00199.4(96.80 to 100.0)
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 Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 1:8 titer was calculated.
Difference
0.6
95
-1.7
3.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.