Study to Evaluate a 13-valent Pneumococcal Conjugate Vacc... | NCT00366678 | Trialant
NCT00366678
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Aug 15, 2012Estimated
Enrollment
613Actual
Phase
Phase 3
Conditions
Vaccines, Pneumococcal
Interventions
13-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine
Pentavac
Countries
France
Protocol Section
Identification Module
NCT ID
NCT00366678
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-008
Secondary IDs
Not provided
Brief Title
Study to Evaluate 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 Pediatric Vaccinations in France.
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Jul 2012
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
Nov 2008Actual
Completion Date
Nov 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
Jul 6, 2012
Results First Posted Date
Aug 15, 2012Estimated
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
Oct 1, 2009Estimated
Last Update Submitted Date
Jul 6, 2012
Last Update Posted Date
Aug 15, 2012Estimated
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
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The 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 pediatric vaccines in France.
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
13-valent pneumococcal conjugate vaccine
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.
One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group
One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group
One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group
One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy 2-month-old infants.
Available for the entire study period.
Exclusion criteria:
· Known contraindication to vaccines.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
42 Days
Maximum Age
98 Days
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director
Trial Manager
For France, infomedfrance@wyeth.com
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Albi
81000
France
References Module
No data available
No data is available for this block.
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.
Recruitment Details
Participants were recruited in France from October 2006 to July 2007.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC/13vPnC Vaccine
Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
7-valent pneumococcal conjugate vaccine
Pentavac
Drug
The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
13-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine
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 the 3-Dose Infant Series (at 5 months of age)
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness (Tender)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 (Sev) (>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 [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 [med] 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
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
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. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.
One month after the 3-Dose Infant Series (at 5 months of age)
One month after the toddler dose (at 13 months of age)
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
One month after the Toddler Dose (at 13 months of age)
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
One month after the toddler dose (at 13 months of age)
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
One month after the toddler dose (at 13 months of age)
Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
FG002
7vPnC/13vPnC Vaccine
Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC)coadministered with Pentavac at 12 months of age (toddler dose).
FG000304 subjects
FG001309 subjects
FG0020 subjects
Vaccinated Dose 1
FG000302 subjects
FG001309 subjects
FG0020 subjects
Vaccinated Dose 2
FG000295 subjects
FG001304 subjects
FG0020 subjects
Vaccinated Dose 3
FG000291 subjects
FG001302 subjects
FG0020 subjects
COMPLETED
FG000290 subjects
FG001299 subjects
FG0020 subjects
NOT COMPLETED
FG00014 subjects
FG00110 subjects
FG0020 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0008 subjects
FG0016 subjects
FG0020 subjects
Protocol Violation
FG0004 subjects
FG0013 subjects
FG0020 subjects
Failed to return
FG0001 subjects
FG0011 subjects
FG0020 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
After Infant
Type
Comment
Milestone Data
STARTED
FG000290 subjects
FG001299 subjects
FG0020 subjects
COMPLETED
FG000273 subjects
FG001289 subjects
FG0020 subjects
NOT COMPLETED
FG00017 subjects
FG00110 subjects
FG0020 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0008 subjects
FG0014 subjects
FG0020 subjects
Lost to Follow-up
FG000
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000273 subjects
FG001152 subjects
FG002137 subjects
COMPLETED
FG000268 subjects
FG001151 subjects
FG002137 subjects
NOT COMPLETED
FG0005 subjects
FG0011 subjects
FG0020 subjects
Type
Comment
Reasons
Protocol Violation
FG0002 subjects
FG0011 subjects
FG0020 subjects
Failed to return
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC/13vPnC Vaccine
Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
BG001
7vPnC/7vPnC Vaccine
Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000304
BG001309
BG002613
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± 0.5
BG0012.1± 0.5
BG0022.1± 0.5
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000169
BG001164
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 Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen 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 the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
ID
Title
Description
OG000
13vPnC After the Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC After the Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG002
13vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG003
7vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
OG000266
OG001263
OG002241
OG003
Title
Denominators
Categories
Pertussis - PT Infant ≥5 Toddler 5 (EU/mL)
Title
Measurements
OG000100.0(98.6 to 100.0)
OG001100.0(98.6 to 100.0)
OG002100.0(98.5 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 Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated
Difference
0.0
95
-1.4
1.4
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%.
Secondary
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
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.
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 antibody concentration for the specified serotype.
Posted
Mar 2010
Number
95% Confidence Interval
percentage of participants
One month after the toddler dose (at 13 months of age)
ID
Title
Description
OG000
13vPnC Infant Series / 13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC Infant Series / 7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Secondary
Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups
Antibody GMC as measured by ELISA for 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
Geometric Mean
95% Confidence Interval
μg/mL
One month after the Toddler Dose (at 13 months of age)
ID
Title
Description
OG000
13vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG001
13vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
OG002
7vPnC/7vPnC Before Toddler Dose
Secondary
Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 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 the toddler dose (at 13 months of age)
ID
Title
Description
OG000
13vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
Secondary
Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose
GMT as measured by opsonophagocytic activity assay (OPA) for 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
Geometric Mean
95% Confidence Interval
titer
One month after the toddler dose (at 13 months of age)
ID
Title
Description
OG000
13vPnC/13vPnC After Toddler Dose
Subjects received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, 4, and 12 months of age.
OG001
7vPnC/13vPnC After Toddler Dose
Subjects received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
Units
Counts
Participants
Primary
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group
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
IU/mL
One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
ID
Title
Description
OG000
13vPnC After the Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
OG001
7vPnC After the Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
OG002
13vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
Primary
Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group
Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Posted
Number
95% Confidence Interval
μg/mL
One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
ID
Title
Description
OG000
13vPnC After the Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC After the Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG002
13vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG003
Primary
Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group
Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Posted
Number
95% Confidence Interval
titer
One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
ID
Title
Description
OG000
13vPnC After the Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC After the Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG002
13vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Primary
Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group
Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Posted
Number
95% Confidence Interval
EU/mL
One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)
ID
Title
Description
OG000
13vPnC After the Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG001
7vPnC After the Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG002
13vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Primary
Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC
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.
Evaluable immunogenicity (per protocol) population 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 immunoglobulin G (IgG) antibody concentration to the given serotype.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
percentage of participants
One month after the 3-Dose Infant Series (at 5 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
Units
Counts
Participants
OG000
Primary
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected using an electronic diary. Tenderness (Tender)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 (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 a vaccine containing Pentavac at 2 months of age (infant series).
OG001
7vPnC Dose 1
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
OG002
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
Primary
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 [med] 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 a vaccine containing Pentavac at 2 months of age (infant series).
OG001
7vPnC Dose 1
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
OG002
13vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC
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. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.
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; (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 the 3-Dose Infant Series (at 5 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
Units
Counts
Participants
OG000
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 a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
5
304
142
304
EG001
7vPnC Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
5
309
162
309
EG002
13vPnC Post-Infant Series
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
8
290
12
290
EG003
7vPnC Post-Infant Series
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
5
299
11
299
EG004
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
2
273
125
272
EG005
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
0
152
64
152
EG006
7vPnC/ 13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
2
134
63
137
EG007
13vPnC / 13vPnC 6-Month Follow-up
Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
6
267
2
267
EG008
7vPnC / 7vPnC 6-Month Follow-up
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
1
150
2
150
EG009
7vPnC / 13vPnC 6-Month Follow-up
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and at 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
0
133
2
133
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaphylactic reaction
Immune system disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG0030 affected299 at risk
EG0040 affected273 at risk
EG0050 affected152 at risk
EG0060 affected134 at risk
EG0070 affected267 at risk
EG0080 affected150 at risk
EG0090 affected133 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0021 affected290 at risk
EG003
Bronchiolitis
Infections and infestations
Non-systematic Assessment
EG0002 affected304 at risk
EG0011 affected309 at risk
EG0021 affected290 at risk
EG003
Bronchitis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0021 affected290 at risk
EG003
Bronchopneumonia
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Ear infection
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0021 affected290 at risk
EG003
Foreign body aspiration
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Gastroenteritis
Infections and infestations
Non-systematic Assessment
EG0001 affected304 at risk
EG0011 affected309 at risk
EG0022 affected290 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0021 affected290 at risk
EG003
Head injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0021 affected290 at risk
EG003
Hypotonia
Nervous system disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Meningitis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Nasopharyngitis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0021 affected290 at risk
EG003
Otitis media acute
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Pneumonia
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Pyelonephritis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Pyrexia
General disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0021 affected290 at risk
EG003
Urinary tract infection
Infections and infestations
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG0031 affected299 at risk
EG0040 affected272 at risk
EG0050 affected152 at risk
EG0060 affected137 at risk
EG0070 affected267 at risk
EG0080 affected150 at risk
EG0090 affected133 at risk
Microcytic anaemia
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0021 affected290 at risk
EG003
Dacryostenosis congenital
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Ear pain
Ear and labyrinth disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Conjunctivitis
Eye disorders
Non-systematic Assessment
EG0006 affected304 at risk
EG00113 affected309 at risk
EG0020 affected290 at risk
EG003
Hypermetropia
Eye disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Non-systematic Assessment
EG0006 affected304 at risk
EG0013 affected309 at risk
EG0021 affected290 at risk
EG003
Vomiting
Gastrointestinal disorders
Non-systematic Assessment
EG0007 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Regurgitation
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0014 affected309 at risk
EG0020 affected290 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Non-systematic Assessment
EG0002 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Dental discomfort
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Infantile colic
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Anal fissure
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Colitis
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Oesophagitis
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Toothache
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Injection site erythema
General disorders
Non-systematic Assessment
EG00017 affected304 at risk
EG00116 affected309 at risk
EG0020 affected290 at risk
EG003
Pyrexia
General disorders
Non-systematic Assessment
EG00010 affected304 at risk
EG00113 affected309 at risk
EG0020 affected290 at risk
EG003
Chills
General disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Hyperthermia
General disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Injection site induration
General disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Injection site pain
General disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Injection site reaction
General disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Injection site swelling
General disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Milk allergy
Immune system disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Rhinitis
Infections and infestations
Non-systematic Assessment
EG00025 affected304 at risk
EG00139 affected309 at risk
EG0020 affected290 at risk
EG003
Nasopharyngitis
Infections and infestations
Non-systematic Assessment
EG00023 affected304 at risk
EG00132 affected309 at risk
EG0020 affected290 at risk
EG003
Gastroenteritis
Infections and infestations
Non-systematic Assessment
EG0008 affected304 at risk
EG00119 affected309 at risk
EG0022 affected290 at risk
EG003
Bronchiolitis
Infections and infestations
Non-systematic Assessment
EG00014 affected304 at risk
EG0015 affected309 at risk
EG0020 affected290 at risk
EG003
Bronchitis
Infections and infestations
Non-systematic Assessment
EG0006 affected304 at risk
EG00112 affected309 at risk
EG0022 affected290 at risk
EG003
Ear infection
Infections and infestations
Non-systematic Assessment
EG0005 affected304 at risk
EG0018 affected309 at risk
EG0021 affected290 at risk
EG003
Tracheitis
Infections and infestations
Non-systematic Assessment
EG0003 affected304 at risk
EG0019 affected309 at risk
EG0020 affected290 at risk
EG003
Varicella
Infections and infestations
Non-systematic Assessment
EG0005 affected304 at risk
EG0016 affected309 at risk
EG0020 affected290 at risk
EG003
Pharyngitis
Infections and infestations
Non-systematic Assessment
EG0004 affected304 at risk
EG0015 affected309 at risk
EG0020 affected290 at risk
EG003
Bronchitis viral
Infections and infestations
Non-systematic Assessment
EG0002 affected304 at risk
EG0013 affected309 at risk
EG0020 affected290 at risk
EG003
Fungal skin infection
Infections and infestations
Non-systematic Assessment
EG0003 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Rhinotracheitis
Infections and infestations
Non-systematic Assessment
EG0002 affected304 at risk
EG0013 affected309 at risk
EG0020 affected290 at risk
EG003
Roseola
Infections and infestations
Non-systematic Assessment
EG0001 affected304 at risk
EG0013 affected309 at risk
EG0020 affected290 at risk
EG003
Viral infection
Infections and infestations
Non-systematic Assessment
EG0002 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Fungal infection
Infections and infestations
Non-systematic Assessment
EG0003 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Laryngitis
Infections and infestations
Non-systematic Assessment
EG0001 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Oral candidiasis
Infections and infestations
Non-systematic Assessment
EG0003 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Candidiasis
Infections and infestations
Non-systematic Assessment
EG0001 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Rhinolaryngitis
Infections and infestations
Non-systematic Assessment
EG0001 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Urinary tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Viral skin infection
Infections and infestations
Non-systematic Assessment
EG0001 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Dacryocystitis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Erythema infectiosum
Infections and infestations
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Furuncle
Infections and infestations
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Influenza
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Otitis media
Infections and infestations
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Otitis media acute
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Tracheobronchitis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Otitis media chronic
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0021 affected290 at risk
EG003
Exanthema subitum
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Genital candidiasis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Human herpesvirus 6 infection
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Oral herpes
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Pyelonephritis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Tonsillitis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Infectious mononucleosis
Infections and infestations
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Bacteria stool identified
Investigations
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Anorexia
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Facial palsy
Nervous system disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Crying
Psychiatric disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Agitation
Psychiatric disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0004 affected304 at risk
EG0016 affected309 at risk
EG0020 affected290 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0003 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Allergic respiratory disease
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0011 affected309 at risk
EG0023 affected290 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG00013 affected304 at risk
EG0018 affected309 at risk
EG0021 affected290 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0013 affected309 at risk
EG0020 affected290 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0012 affected309 at risk
EG0020 affected290 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Nail bed inflammation
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Rash morbilliform
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 at risk
EG003
Child abuse
Social circumstances
Non-systematic Assessment
EG0000 affected304 at risk
EG0011 affected309 at risk
EG0020 affected290 at risk
EG003
Haematoma
Vascular disorders
Non-systematic Assessment
EG0001 affected304 at risk
EG0010 affected309 at risk
EG0020 affected290 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.
EG00098 affected256 at risk
EG00199 affected257 at risk
EG0020 affected0 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (any)
EG00074 affected223 at risk
EG00195 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)
EG00076 affected210 at risk
EG00166 affected206 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.
EG00013 affected237 at risk
EG00112 affected245 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (significant)
EG00011 affected203 at risk
EG00114 affected208 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Tenderness (significant)
EG0007 affected188 at risk
EG0016 affected193 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.
EG000105 affected254 at risk
EG00199 affected256 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (any)
EG000113 affected226 at risk
EG001128 affected235 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (any)
EG000105 affected217 at risk
EG001112 affected219 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.
EG00092 affected249 at risk
EG00191 affected255 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (mild)
EG000104 affected223 at risk
EG001119 affected232 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (mild)
EG00095 affected213 at risk
EG00198 affected214 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.
EG00035 affected243 at risk
EG00123 affected246 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (moderate)
EG00029 affected207 at risk
EG00130 affected208 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (moderate)
EG00027 affected193 at risk
EG00131 affected194 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.
EG0000 affected235 at risk
EG0010 affected244 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (severe)
EG0000 affected199 at risk
EG0010 affected203 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Induration (severe)
EG0000 affected184 at risk
EG0010 affected188 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.
EG000114 affected256 at risk
EG001122 affected260 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (any)
EG000126 affected236 at risk
EG001140 affected241 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (any)
EG000126 affected226 at risk
EG001132 affected223 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 cm to 2.0 cm.
EG000103 affected252 at risk
EG001118 affected259 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (mild)
EG000119 affected234 at risk
EG001136 affected240 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (mild)
EG000117 affected223 at risk
EG001123 affected221 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.
EG00023 affected241 at risk
EG0019 affected245 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (moderate)
EG00015 affected205 at risk
EG00114 affected206 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (moderate)
EG00017 affected190 at risk
EG00124 affected192 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.
EG0000 affected234 at risk
EG0010 affected244 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (severe)
EG0000 affected199 at risk
EG0010 affected203 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 3; Erythema (severe)
EG0000 affected184 at risk
EG0010 affected188 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 degrees C but ≤39 degrees C
EG00033 affected244 at risk
EG00125 affected250 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 degrees C but ≤39 degrees C
EG00042 affected212 at risk
EG00155 affected217 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 degrees C but ≤39 degrees C
EG00054 affected201 at risk
EG00158 affected208 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 degrees C but ≤40 degrees C
EG0002 affected238 at risk
EG0011 affected245 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 degrees C but ≤40 degrees C
EG0002 affected201 at risk
EG0015 affected205 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 degrees C but ≤40 degrees C
EG0001 affected184 at risk
EG0013 affected191 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 degrees C
EG0000 affected238 at risk
EG0010 affected245 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever >40 degrees C
EG0000 affected200 at risk
EG0010 affected205 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Fever >40 degrees C
EG0001 affected184 at risk
EG0010 affected190 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased appetite
EG00060 affected243 at risk
EG00158 affected251 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased appetite
EG00039 affected211 at risk
EG00157 affected218 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased appetite
EG00045 affected194 at risk
EG00142 affected199 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Irritability
EG000142 affected261 at risk
EG001139 affected265 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Irritability
EG000112 affected232 at risk
EG001118 affected238 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Irritability
EG00091 affected217 at risk
EG00185 affected211 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Increased sleep
EG00087 affected256 at risk
EG001107 affected259 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Increased sleep
EG00061 affected215 at risk
EG00173 affected227 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Increased sleep
EG00046 affected194 at risk
EG00158 affected204 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased sleep
EG00069 affected246 at risk
EG00152 affected253 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased sleep
EG00057 affected215 at risk
EG00159 affected218 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 3; Decreased sleep
EG00051 affected203 at risk
EG00141 affected196 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.
For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥26.00 EU/mL) threshold was calculated
Difference
-0.7
95
-4.8
3.3
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 Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated
Difference
0.0
95
-1.4
1.4
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 Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥36.00 EU/mL) threshold was calculated
Difference
-2.3
95
-6.4
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 Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥7.82 EU/mL) threshold was calculated
Difference
0.0
95
-1.4
1.4
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 Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated
Difference
0.0
95
-1.7
2.7
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%.
OG002
OG003
For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (17.00 EU/mL) threshold was calculated
Difference
2.1
95
-1.4
6.8
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 Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated
Difference
0.0
95
-1.7
2.7
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%.
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
-1.7
2.7
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%.
OG002
OG003
For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (75.00 EU/mL) threshold was calculated
Difference
-3.0
95
-8.0
2.5
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 percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated
Difference
-8.0
95
-14.9
-1.2
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%.
OG000
OG001
For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated
Difference
0.0
95
-1.4
1.4
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 percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated
Difference
2.7
95
-3.7
9.2
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%.
OG000
OG001
For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated
Difference
0.0
95
-1.5
1.5
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 percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated
Difference
-0.8
95
-3.1
1.8
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 percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated
Difference
0.0
95
-1.7
2.7
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%.
OG002
OG003
For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated
Difference
-2.3
95
-5.8
1.8
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 percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated
Difference
0.0
95
-1.7
2.7
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 Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
Difference
-2.3
95
-7.6
3.0
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 Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
Difference
-4.3
95
-11.4
2.6
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 Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
Difference
-0.3
95
-5.0
4.3
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 Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
Difference
-0.5
95
-3.6
3.5
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 Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
Difference
-0.5
95
-3.1
3.0
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 Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated
Difference
-0.8
95
-3.1
1.9
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 Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated
Difference
0.9
95
-3.2
5.0
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 Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated
Difference
-4.5
95
-13.2
4.4
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 Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated
Difference
0.0
95
-1.7
2.8
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 Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated
Difference
0.2
95
-3.1
4.5
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
7vPnC Infant Series / 13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
0.0
95
-1.7
2.9
No
Superiority or Other
OG000
OG002
For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
Difference
0.9
95
-0.9
4.9
No
Superiority or Other
OG001
OG002
For serotype 4 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
-0.9
95
-4.9
2.1
No
Superiority or Other
OG000
OG001
For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
0.4
95
-1.8
3.8
No
Superiority or Other
OG000
OG002
For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
Difference
1.4
95
-1.1
5.9
No
Superiority or Other
OG001
OG002
For serotype 6B the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
-1.1
95
-5.8
2.7
No
Superiority or Other
OG000
OG001
For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
0.0
95
-1.7
2.9
No
Superiority or Other
OG000
OG002
For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
Difference
0.0
95
-1.8
3.3
No
Superiority or Other
OG001
OG002
For serotype 9V the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
0.0
95
-3.3
3.0
No
Superiority or Other
OG000
OG001
For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
-0.4
95
-2.5
2.4
No
Superiority or Other
OG000
OG002
For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
Difference
0.5
95
-1.8
4.4
No
Superiority or Other
OG001
OG002
For serotype 14 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
-0.9
95
-4.9
2.1
No
Superiority or Other
OG000
OG001
For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
0.4
95
-1.8
3.8
No
Superiority or Other
OG000
OG002
For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
Difference
1.3
95
-1.1
5.7
No
Superiority or Other
OG001
OG002
For serotype 18C the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
-1.0
95
-5.5
2.8
No
Superiority or Other
OG000
OG001
For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
0.2
95
-3.1
4.7
No
Superiority or Other
OG000
OG002
For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
Difference
0.5
95
-2.9
5.4
No
Superiority or Other
OG001
OG002
For serotype 19F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
-0.3
95
-5.5
4.4
No
Superiority or Other
OG000
OG001
For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
0.4
95
-1.8
3.9
No
Superiority or Other
OG000
OG002
For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated
Difference
0.5
95
-1.9
4.4
No
Superiority or Other
OG001
OG002
For serotype 23F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated
Difference
-0.1
95
-4.1
3.7
No
Superiority or Other
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
OG003
7vPnC/7vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
OG004
7vPnC/13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
OG005
7vPnC/13vPnC After Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.87
95
0.73
1.03
No
Superiority or Other
OG003
OG005
For serotype 4 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.83
95
0.67
1.03
No
Superiority or Other
OG001
OG005
For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
1.04
95
0.86
1.26
No
Superiority or Other
OG001
OG003
For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.93
95
0.77
1.13
No
Superiority or Other
OG003
OG005
For serotype 6B after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
1.07
95
0.82
1.40
No
Superiority or Other
OG001
OG005
For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.87
95
0.69
1.10
No
Superiority or Other
OG001
OG003
For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.80
95
0.68
0.94
No
Superiority or Other
OG003
OG005
For serotype 9V after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.71
95
0.59
0.85
No
Superiority or Other
OG001
OG005
For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
1.13
95
0.95
1.33
No
Superiority or Other
OG001
OG003
For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.88
95
0.73
1.06
No
Superiority or Other
OG003
OG005
For serotype 14 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.72
95
0.58
0.90
No
Superiority or Other
OG001
OG005
For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
1.22
95
1.00
1.49
No
Superiority or Other
OG001
OG003
For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.82
95
0.69
0.97
No
Superiority or Other
OG003
OG005
For serotype 18C after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.86
95
0.69
1.08
No
Superiority or Other
OG001
OG005
For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.95
95
0.78
1.15
No
Superiority or Other
OG001
OG003
For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
1.26
95
1.00
1.59
No
Superiority or Other
OG003
OG005
For serotype 19F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.91
95
0.68
1.20
No
Superiority or Other
OG001
OG005
For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
1.39
95
1.08
1.79
No
Superiority or Other
OG001
OG003
For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.81
95
0.67
1.00
No
Superiority or Other
OG003
OG005
For serotype 23F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.85
95
0.67
1.07
No
Superiority or Other
OG001
OG005
For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated
Ratio
0.96
95
0.78
1.19
No
Superiority or Other
Units
Counts
Participants
OG000241
OG001121
Title
Denominators
Categories
Additional Serotypes - Serotype 1
Title
Measurements
OG000100.0(95.9 to 100.0)
OG00198.9(94.0 to 100.0)
Additional Serotypes - Serotype 3
Title
Measurements
OG000100.0(95.9 to 100.0)
OG00197.8(92.2 to 99.7)
Additional Serotypes - Serotype 5
Title
Measurements
OG000100.0(95.9 to 100.0)
OG00197.8(92.2 to 99.7)
Additional Serotypes - Serotype 6A
Title
Measurements
OG000100.0(95.8 to 100.0)
OG00198.9(94.0 to 100.0)
Additional Serotypes - Serotype 7F
Title
Measurements
OG000100.0(95.8 to 100.0)
OG001100.0(95.9 to 100.0)
Additional Serotypes - Serotype 19A
Title
Measurements
OG00098.8(93.7 to 100.0)
OG00197.8(92.2 to 99.7)
OG000241
OG001121
Title
Denominators
Categories
Additional Serotypes - Serotype 1
Title
Measurements
OG000126.00(99.87 to 158.97)
OG00161.58(47.72 to 79.47)
Additional Serotypes - Serotype 3
Title
Measurements
OG000345.33(296.06 to 402.80)
OG001428.88(346.69 to 530.56)
Additional Serotypes - Serotype 5
Title
Measurements
OG000244.18(200.14 to 297.92)
OG001130.99(103.68 to 165.50)
Additional Serotypes - Serotype 6A
Title
Measurements
OG0001346.83(1143.98 to 1585.65)
OG001891.44(694.76 to 1143.81)
Additional Serotypes - Serotype 7F
Title
Measurements
OG0008126.24(6657.36 to 9919.21)
OG00117034.59(14316.59 to 20268.60)
Additional Serotypes - Serotype 19A
Title
Measurements
OG000804.06(615.90 to 1049.71)
OG0011072.43(799.06 to 1439.32)
OG003
7vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
Units
Counts
Participants
OG000266
OG001263
OG002241
OG003133
Title
Denominators
Categories
Diphtheria
Title
Measurements
OG0000.19(0.17 to 0.21)
OG0010.24(0.22 to 0.27)
OG0022.09(1.87 to 2.34)
OG0032.60(2.26 to 2.99)
Tetanus
Title
Measurements
OG0000.20(0.18 to 0.22)
OG0010.21(0.19 to 0.23)
OG0021.08(0.94 to 1.24)
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 GMC ratio was calculated
Ratio
0.77
95
0.66
0.90
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 was calculated
Ratio
0.94
95
0.82
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 ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG002
OG003
For Diphtheria the GMC ratio was calculated
Ratio
0.80
95
0.67
0.97
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 was calculated
Ratio
0.86
95
0.69
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 ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
7vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
OG000244
OG001241
OG002240
OG003132
Title
Denominators
Categories
Title
Measurements
OG0001.28(1.10 to 1.49)
OG0011.40(1.19 to 1.64)
OG00212.15(10.54 to 14.00)
OG00311.68(9.66 to 14.13)
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 Hib (PRP) the GMC ratio was calculated
Ratio
0.91
95
0.73
1.14
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 Hib (PRP) the GMC ratio was calculated
Ratio
1.04
95
0.82
1.32
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).
OG003
7vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
OG000258
OG001256
OG002239
OG003129
Title
Denominators
Categories
Polio Type 1
Title
Measurements
OG00024.99(21.37 to 29.23)
OG00128.33(24.40 to 32.89)
OG002253.05(207.15 to 309.11)
OG003250.56(193.17 to 324.99)
Polio Type 2
Title
Measurements
OG00017.75(15.07 to 20.92)
OG00121.55(18.43 to 25.20)
OG002408.34(338.94 to 491.95)
OG003
Polio Type 3
Title
Measurements
OG00041.08(34.08 to 49.52)
OG00152.95(43.26 to 64.82)
OG002536.32(436.46 to 659.02)
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 was calculated
Ratio
0.88
95
0.71
1.09
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 Polio Type 2 the GMC ratio was calculated
Ratio
0.82
95
0.66
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 Polio Type 3 the GMC ratio was calculated
Ratio
0.78
95
0.59
1.02
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 Polio Type 1 the GMC ratio was calculated
Ratio
1.01
95
0.72
1.41
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 Polio Type 2 the GMC ratio was calculated
Ratio
0.98
95
0.72
1.34
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 Polio Type 3 the GMC ratio was calculated
Ratio
0.84
95
0.60
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 ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG003
7vPnC After the Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
Units
Counts
Participants
OG000263
OG001262
OG002239
OG003133
Title
Denominators
Categories
Pertussis - FHA
Title
Measurements
OG00097.12(89.84 to 104.98)
OG001111.23(102.80 to 120.35)
OG002204.28(185.65 to 224.79)
OG003241.08(210.92 to 275.55)
Pertussis - PT
Title
Measurements
OG00062.94(58.80 to 67.38)
OG00168.20(63.60 to 73.14)
OG00261.09(56.19 to 66.40)
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 was calculated
Ratio
0.87
95
0.78
0.98
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 Pertussis - PT the GMC ratio was calculated
Ratio
0.92
95
0.84
1.02
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 Pertussis - FHA the GMC ratio was calculated
Ratio
0.85
95
0.72
1.00
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 Pertussis - PT the GMC ratio was calculated
Ratio
0.99
95
0.86
1.14
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).
266
Title
Denominators
Categories
Common Serotypes - Serotype 4 (n=244)
Title
Measurements
OG00091.4(87.1 to 94.6)
Common Serotypes - Serotype 6B (n=241)
Title
Measurements
OG00072.6(66.5 to 78.1)
Common Serotypes - Serotype 9V (n=238)
Title
Measurements
OG00092.9(88.8 to 95.8)
Common Serotypes - Serotype 14 (n=236)
Title
Measurements
OG00094.9(91.3 to 97.3)
Common Serotypes - Serotype 18C (n=242)
Title
Measurements
OG00090.5(86.1 to 93.9)
Common Serotypes - Serotype 19F (n=241)
Title
Measurements
OG00097.9(95.2 to 99.3)
Common Serotypes - Serotype 23F (n=244)
Title
Measurements
OG00082.8(77.5 to 87.3)
Additional Serotypes - Serotype 1 (n=240)
Title
Measurements
OG00090.8(86.5 to 94.2)
Additional Serotypes - Serotype 3 (n=242)
Title
Measurements
OG00096.3(93.1 to 98.3)
Additional Serotypes - Serotype 5 (n=243)
Title
Measurements
OG00084.0(78.7 to 88.3)
Additional Serotypes - Serotype 6A (n=243)
Title
Measurements
OG00085.6(80.5 to 89.8)
Additional Serotypes - Serotype 7F (n=238)
Title
Measurements
OG00097.5(94.6 to 99.1)
Additional Serotypes - Serotype 19A (n=244)
Title
Measurements
OG00097.5(94.7 to 99.1)
OG003
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
OG004
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
OG005
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
OG006
13vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
OG007
7vPnC/7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
OG008
7vPnC/13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).