Study Evaluating Pneumococcal Vaccine in Healthy Infants
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ClinicalTrials.gov Identifier: NCT00205803 
Recruitment Status :
Completed
First Posted : September 20, 2005
Results First Posted : August 15, 2012
Last Update Posted : August 15, 2012

Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Type:  Interventional 

Study Design:  Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Prevention 
Conditions: 
Healthy Subjects Pneumococcal Infections 
Interventions: 
Biological: 13Valent Pneumococcal Conjugate Vaccine (13vPnC) Biological: 7Valent Pneumococcal Conjugate Vaccine (7vPnC) 
Participant Flow
Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations 

Participants were recruited in the United States from September 2004 to September 2005. 
PreAssignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment 

Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Participant Flow for 3 periods
Period 1: Infant Series
13vPnC  7vPnC  

STARTED  122  127 
Vaccinated Dose 1  121  126 
Vaccinated Dose 2  115  122 
Vaccinated Dose 3  110  118 
COMPLETED  104  116 
NOT COMPLETED  18  11 
Lost to Followup  10  4 
Withdrawal by Subject  2  5 
Physician Decision  3  1 
Protocol Violation  1  0 
Lost Kaiser coverage  0  1 
Noncompliant  1  0 
Sponsor request  1  0 
Period 2: After Infant Series
13vPnC  7vPnC  

STARTED  104  116 
COMPLETED  86  103 
NOT COMPLETED  18  13 
Adverse Event  1  1 
Protocol Violation  1  1 
Lost to Followup  2  1 
Physician Decision  3  2 
Withdrawal by Subject  1  4 
Other  10  4 
Period 3: Toddler Dose
13vPnC  7vPnC  

STARTED  86  103 
COMPLETED  84  100 
NOT COMPLETED  2  3 
Lost to Followup  2  3 
Outcome Measures
1. Primary:  Percentage of Participants Reporting PreSpecified Local Reactions [ Time Frame: Within 15 days after each dose ] 
Measure Type  Primary 

Measure Title  Percentage of Participants Reporting PreSpecified Local Reactions 
Measure Description  Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category. 
Time Frame  Within 15 days after each dose 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

The safety population included all participants who received at least 1 dose of vaccine;(n)=number of participants with known values. 
Reporting Groups
Description  

13vPnC Dose 1  Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1). 
7vPnc Dose 1  Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1). 
13vPnC Dose 2  Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2). 
7vPnC Dose 2  Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2). 
13vPnC Dose 3  Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3). 
7vPnC Dose 3  Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3). 
13vPnC Toddler Dose  Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). 
7vPnC Toddler Dose  Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). 
Measured Values
13vPnC Dose 1  7vPnc Dose 1  13vPnC Dose 2  7vPnC Dose 2  13vPnC Dose 3  7vPnC Dose 3  13vPnC Toddler Dose  7vPnC Toddler Dose  

Participants Analyzed  121  126  115  122  110  118  86  103 
Percentage of Participants Reporting PreSpecified Local Reactions [Units: Percentage of participants] 

TendernessAny (n=119,124,110,118,107,117,85,101)  34.5  43.5  28.2  36.4  24.3  25.6  22.4  29.7 
TendernessSig. (n=119,124,110,118,107,117,85,101)  8.4  5.6  1.8  8.5  4.7  6.0  2.4  4.0 
IndurationAny (n=119,124,110,118,107,117,85,100)  21.8  19.4  16.4  19.5  16.8  18.8  18.8  17.0 
IndurationMild (n=119,123,110,117,107,116,85,100)  20.2  17.9  16.4  17.1  16.8  17.2  18.8  17.0 
IndurationMod. (n=119,123,110,117,107,116,85,100)  3.4  2.4  3.6  3.4  0.0  4.3  2.4  3.0 
IndurationSev. (n=119,123,110,117,107,116,85,100)  0.0  0.0  0.0  0.0  0.0  0.0  0.0  0.0 
ErythemaAny (n=119,124,111,118,107,117, 85,100)  21.0  19.4  16.2  17.8  17.8  19.7  24.7  19.0 
ErythemaMild (n=119,124,110,117,106,116,85,99)  20.2  19.4  13.6  17.1  16.0  18.1  24.7  16.2 
ErythemaMod. (n=119,124,108,117,106,116,85,99)  2.5  0.0  2.8  0.0  0.9  2.6  3.5  5.1 
ErythemaSevere (n=119,124,108,117,106,116,85,99)  0.0  0.0  0.0  0.0  0.0  0.0  0.0  0.0 
No statistical analysis provided for Percentage of Participants Reporting PreSpecified Local Reactions
2. Primary:  Percentage of Participants Reporting PreSpecified Systemic Events [ Time Frame: Within 15 days after each dose ] 
Measure Type  Primary 

Measure Title  Percentage of Participants Reporting PreSpecified Systemic Events 
Measure Description  Systemic events (fever [Fv] ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category. 
Time Frame  Within 15 days after each dose 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

The safety population included all participants who received at least 1 dose of vaccine; (n)=number of participants with known values. 
Reporting Groups
Description  

13vPnC Dose 1  Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1). 
7vPnc Dose 1  Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1). 
13vPnC Dose 2  Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2). 
7vPnC Dose 2  Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2). 
13vPnC Dose 3  Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3). 
7vPnC Dose 3  Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3). 
13vPnC Toddler Dose  Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). 
7vPnC Toddler Dose  Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). 
Measured Values
13vPnC Dose 1  7vPnc Dose 1  13vPnC Dose 2  7vPnC Dose 2  13vPnC Dose 3  7vPnC Dose 3  13vPnC Toddler Dose  7vPnC Toddler Dose  

Participants Analyzed  121  126  115  122  110  118  86  103 
Percentage of Participants Reporting PreSpecified Systemic Events [Units: Percentage of participants] 

Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94)  16.7  16.5  21.6  24.6  20.0  20.4  14.1  12.8 
Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94)  2.7  0.8  3.9  3.5  2.0  0.9  2.6  0.0 
Fv >40°C (n=113,121,102,113,100,113,76,94)  0.0  0.0  0.0  0.0  0.0  0.0  0.0  0.0 
Decr. Appetite (n=118,124,110,118,107,117,85,101)  30.5  31.5  22.7  22.9  27.1  30.8  22.4  21.8 
Decr. Sleep (n=118,124,110,118,107,117,84,101)  18.6  17.7  24.5  19.5  21.5  18.8  13.1  14.9 
Increased Sleep (n=119,124,111,118,107,117,86,101)  56.3  54.0  42.3  46.6  34.6  41.0  27.9  43.6 
Irritability (n=118,124,110,118,107,117,85,101)  66.9  71.0  62.7  56.8  51.4  53.8  38.8  47.5 
Med.Prevent Sx (n=95,101,86,96,83,93,85,102)  29.5  33.7  34.9  32.3  36.1  43.0  17.6  35.3 
Med.Treat Symptoms (n=94,101,86,96,84,94,85,101)  44.7  34.7  48.8  50.0  42.9  47.9  29.4  27.7 
No statistical analysis provided for Percentage of Participants Reporting PreSpecified Systemic Events
3. Primary:  Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series [ Time Frame: one month after 3dose infant series (at 7 months of age) ] 
Measure Type  Primary 

Measure Title  Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series 
Measure Description  Percentage 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. Exact 2sided CI based on the observed proportion of participants. 
Time Frame  one month after 3dose infant series (at 7 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  94  108 
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series [Units: Percentage of participants] Number (95% Confidence Interval) 

Common Serotypes  Serotype 4 (n=94,107) 
96.81 (90.96 to 99.34) 
99.07 (94.90 to 99.98) 
Common Serotypes  Serotype 6B (n=94,107) 
88.30 (80.03 to 94.01) 
88.79 (81.23 to 94.07) 
Common Serotypes  Serotype 9V (n=94,108) 
96.81 (90.96 to 99.34) 
99.07 (94.95 to 99.98) 
Common Serotypes  Serotype 14 (n=94,107) 
97.87 (92.52 to 99.74) 
97.20 (92.02 to 99.42) 
Common Serotypes  Serotype 18C (n=94,106) 
96.81 (90.96 to 99.34) 
99.06 (94.86 to 99.98) 
Common Serotypes  Serotype 19F (n=94,106) 
97.87 (92.52 to 99.74) 
97.17 (91.95 to 99.41) 
Common Serotypes  Serotype 23F (n=94,108) 
94.68 (88.02 to 98.25) 
95.37 (89.53 to 98.48) 
Additional Serotypes  Serotype 1 (n=94,108) 
97.87 (92.52 to 99.74) 
25.00 (17.17 to 34.25) 
Additional Serotypes  Serotype 3 (n=94,107) 
98.94 (94.21 to 99.97) 
14.02 (8.06 to 22.07) 
Additional Serotypes  Serotype 5 (n=93,107) 
100.00 (96.11 to 100.00) 
42.06 (32.58 to 51.99) 
Additional Serotypes  Serotype 6A (n=93,106) 
96.77 (90.86 to 99.33) 
33.96 (25.04 to 43.80) 
Additional Serotypes  Serotype 7F (n=94,105) 
98.94 (94.21 to 99.97) 
6.67 (2.72 to 13.25) 
Additional Serotypes  Serotype 19A (n=94,107) 
100.00 (96.15 to 100.00) 
94.39 (88.19 to 97.91) 
Statistical Analysis 1 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  2.26 
95% Confidence Interval  8.08 to 2.33 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 4 the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.49 
95% Confidence Interval  9.93 to 8.65 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 6B the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  2.27 
95% Confidence Interval  8.07 to 2.26 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 9V the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 4 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.68 
95% Confidence Interval  4.96 to 6.16 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 14 the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 5 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  2.25 
95% Confidence Interval  8.18 to 2.36 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 18C the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 6 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.70 
95% Confidence Interval  4.84 to 6.32 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 19F the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 7 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.69 
95% Confidence Interval  7.75 to 5.86 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 23F the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 8 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  72.87 
95% Confidence Interval  63.32 to 81.07 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 1 the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 9 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  84.92 
95% Confidence Interval  76.73 to 91.05 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 3 the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 10 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  57.94 
95% Confidence Interval  48.01 to 67.42 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 5 the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 11 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  62.81 
95% Confidence Interval  52.33 to 72.20 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 6A the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 12 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  92.27 
95% Confidence Interval  85.26 to 96.54 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 7F the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 13 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  5.61 
95% Confidence Interval  1.23 to 11.86 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 19A the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
4. Secondary:  Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: One month after the toddler dose (at 13 to 16 months of age) ] 
Measure Type  Secondary 

Measure Title  Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose 
Measure Description  Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2sided CI based on the observed proportion of participants. 
Time Frame  One month after the toddler dose (at 13 to 16 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

The AllAvailable Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinate posttoddler dose IgG antibody concentration to the given serotype. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  85  102 
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [Units: Percentage of participants] Number (95% Confidence Interval) 

Common Serotypes  Serotype 4 (n=78,94) 
97.4 (91.0 to 99.7) 
98.9 (94.2 to 100.0) 
Common Serotypes  Serotype 6B (n=78,93) 
100.0 (95.4 to 100.0) 
100.0 (96.1 to 100.0) 
Common Serotypes  Serotype 9V (n=78,94) 
98.7 (93.1 to 100.0) 
100.0 (96.2 to 100.0) 
Common Serotypes  Serotype 14 (n=78,93) 
100.0 (95.4 to 100.0) 
100.0 (96.1 to 100.0) 
Common Serotypes  Serotype 18C (n=78,94) 
100.0 (95.4 to 100.0) 
100.0 (96.2 to 100.0) 
Common Serotypes  Serotype 19F (n=78,93) 
100.0 (95.4 to 100.0) 
100.0 (96.1 to 100.0) 
Common Serotypes  Serotype 23F (n=78,93) 
100.0 (95.4 to 100.0) 
97.8 (92.4 to 99.7) 
Additional Serotypes  Serotype 1 (n=78,91) 
100.00 (95.4 to 100.00) 
2.2 (0.3 to 7.7) 
Additional Serotypes  Serotype 3 (n=78,92) 
92.3 (84.0 to 97.1) 
8.7 (3.8 to 16.4) 
Additional Serotypes  Serotype 5 (n=78,78) 
100.0 (95.4 to 100.0) 
70.5 (59.1 to 80.3) 
Additional Serotypes  Serotype 6A (n=78,92) 
100.0 (95.4 to 100.0) 
88.0 (79.6 to 93.9) 
Additional Serotypes  Serotype 7F (n=78,85) 
100.0 (95.4 to 100.0) 
5.9 (1.9 to 13.2) 
Additional Serotypes  Serotype 19A (n=78,93) 
100.0 (95.4 to 100.0) 
100.0 (96.1 to 100.0) 
Statistical Analysis 1 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  1.5 
95% Confidence Interval  7.9 to 3.6 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 4 the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.0 
95% Confidence Interval  4.6 to 4.0 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 6B the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  1.3 
95% Confidence Interval  6.9 to 2.8 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 9V the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 4 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.0 
95% Confidence Interval  4.6 to 4.0 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 14 the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 5 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.0 
95% Confidence Interval  4.7 to 3.9 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 18C the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 6 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.0 
95% Confidence Interval  4.6 to 4.0 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 19F the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 7 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  2.2 
95% Confidence Interval  2.6 to 7.7 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 23F the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 8 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  97.8 
95% Confidence Interval  92.3 to 99.7 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 1 the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 9 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  83.6 
95% Confidence Interval  73.2 to 90.8 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 3 the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 10 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  29.5 
95% Confidence Interval  19.7 to 40.9 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 5 the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 11 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  12.0 
95% Confidence Interval  5.9 to 20.4 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 6A the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 12 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  94.1 
95% Confidence Interval  86.8 to 98.1 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 7F the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 13 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.0 
95% Confidence Interval  4.6 to 4.0 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 19A the difference in percentages between the two groups (13vPnC  7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
5. Secondary:  Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series [ Time Frame: One month after 3dose infant series (at 7 months of age) ] 
Measure Type  Secondary 

Measure Title  Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series 
Measure Description  Antibody geometric mean concentration (GMC) as measured by enzymelinked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2sided 95% CI were evaluated. 
Time Frame  One month after 3dose infant series (at 7 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate antibody concentration for the specified serotype. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  94  108 
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series [Units: μg/mL] Geometric Mean (95% Confidence Interval) 

Common Serotypes  Serotype 4 (n=94,107) 
1.81 (1.54 to 2.13) 
2.40 (2.01 to 2.87) 
Common Serotypes  Serotype 6B (n=94,107) 
2.74 (2.02 to 3.71) 
2.86 (2.09 to 3.91) 
Common Serotypes  Serotype 9V (n=94,108) 
1.52 (1.29 to 1.78) 
1.78 (1.55 to 2.05) 
Common Serotypes  Serotype 14 (n=94,107) 
4.24 (3.44 to 5.23) 
5.19 (4.13 to 6.52) 
Common Serotypes  Serotype 18C (n=94,106) 
1.53 (1.30 to 1.80) 
2.46 (2.08 to 2.91) 
Common Serotypes  Serotype 19F (n=94,106) 
2.21 (1.87 to 2.61) 
2.58 (2.17 to 3.08) 
Common Serotypes  Serotype 23F (n=94,108) 
1.39 (1.15 to 1.67) 
1.81 (1.51 to 2.19) 
Additional Serotypes  Serotype 1 (n=94,108) 
2.57 (2.14 to 3.08) 
0.06 (0.05 to 0.09) 
Additional Serotypes  Serotype 3 (n=94,107) 
1.40 (1.20 to 1.62) 
0.09 (0.07 to 0.11) 
Additional Serotypes  Serotype 5 (n=93,107) 
2.41 (2.07 to 2.80) 
0.28 (0.22 to 0.34) 
Additional Serotypes  Serotype 6A (n=93,106) 
2.36 (1.89 to 2.94) 
0.25 (0.20 to 0.30) 
Additional Serotypes  Serotype 7F (n=94,105) 
1.85 (1.62 to 2.11) 
0.07 (0.06 to 0.08) 
Additional Serotypes  Serotype 19A (n=94,107) 
1.93 (1.64 to 2.27) 
1.12 (0.96 to 1.32) 
Statistical Analysis 1 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  0.76 
95% Confidence Interval  0.59 to 0.96 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  0.96 
95% Confidence Interval  0.62 to 1.48 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.85 
95% Confidence Interval  0.69 to 1.05 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 4 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  0.82 
95% Confidence Interval  0.60 to 1.11 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 5 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  0.62 
95% Confidence Interval  0.49 to 0.79 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 6 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  0.86 
95% Confidence Interval  0.67 to 1.09 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 7 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  0.77 
95% Confidence Interval  0.59 to 1.00 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 8 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  39.78 
95% Confidence Interval  27.47 to 57.63 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 9 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  15.56 
95% Confidence Interval  11.63 to 20.81 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 10 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  8.67 
95% Confidence Interval  6.65 to 11.29 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 11 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  9.60 
95% Confidence Interval  7.07 to 13.04 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 12 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  26.78 
95% Confidence Interval  20.97 to 34.22 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 13 for Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  1.71 
95% Confidence Interval  1.36 to 2.16 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
6. Secondary:  Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose [ Time Frame: Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age) ] 
Measure Type  Secondary 

Measure Title  Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose 
Measure Description  Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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. 
Time Frame  Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

AllAvailable Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to proposed analysis;(n)= number of participants with a determinate antibody concentration for the specified serotype. 
Reporting Groups
Description  

13vPnC Before Toddler Dose  Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). 
7vPnC Before Toddler Dose  Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). 
13vPnC After Toddler Dose  Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC After Toddler Dose  Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC Before Toddler Dose  7vPnC Before Toddler Dose  13vPnC After Toddler Dose  7vPnC After Toddler Dose  

Participants Analyzed  85  102  85  102 
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose [Units: μg/mL] Geometric Mean (95% Confidence Interval) 

Common SerotypesSerotype 4 (n=83,100,78,94) 
0.33 (0.28 to 0.40) 
0.48 (0.41 to 0.56) 
2.86 (2.31 to 3.55) 
4.09 (3.34 to 5.00) 
Common SerotypesSerotype 6B (n=82,98,78,93) 
0.84 (0.69 to 1.03) 
0.95 (0.77 to 1.18) 
11.03 (8.78 to 13.86) 
11.85 (9.63 to 14.56) 
Common SerotypesSerotype 9V (n=83,100,78,94) 
0.43 (0.37 to 0.51) 
0.43 (0.37 to 0.50) 
2.55 (2.15 to 3.02) 
2.75 (2.37 to 3.18) 
Common SerotypesSerotype 14 (n=83,100,78,93) 
1.59 (1.27 to 2.00) 
2.00 (1.66 to 2.41) 
7.68 (6.08 to 9.70) 
10.24 (8.23 to 12.74) 
Common SerotypesSerotype 18C (n=83,100,78,94) 
0.25 (0.22 to 0.30) 
0.40 (0.34 to 0.46) 
2.57 (2.08 to 3.18) 
4.08 (3.42 to 4.87) 
Common SerotypesSerotype 19F (n=82,100,78,93) 
0.81 (0.66 to 1.00) 
0.60 (0.49 to 0.72) 
6.34 (5.06 to 7.94) 
3.97 (3.26 to 4.85) 
Common SerotypesSerotype 23F (n=83,100,78,93) 
0.29 (0.24 to 0.36) 
0.38 (0.31 to 0.47) 
3.36 (2.70 to 4.18) 
4.79 (3.86 to 5.94) 
Additional SerotypesSerotype 1 (n=83,90,78,91) 
0.68 (0.56 to 0.82) 
0.04 (0.03 to 0.04) 
3.44 (2.79 to 4.23) 
0.03 (0.03 to 0.04) 
Additional SerotypesSerotype 3 (n=83,98,78,92) 
0.27 (0.23 to 0.32) 
0.09 (0.07 to 0.12) 
1.11 (0.94 to 1.33) 
0.10 (0.08 to 0.12) 
Additional SerotypesSerotype 5 (n=83,92,78,78) 
1.01 (0.87 to 1.18) 
0.40 (0.31 to 0.50) 
3.92 (3.27 to 4.69) 
0.56 (0.45 to 0.70) 
Additional SerotypesSerotype 6A (n=82,96,78,92) 
0.81 (0.68 to 0.96) 
0.27 (0.22 to 0.33) 
8.06 (6.60 to 9.85) 
1.68 (1.27 to 2.21) 
Additional SerotypesSerotype 7F (n=83,91,78,85) 
0.58 (0.50 to 0.67) 
0.04 (0.03 to 0.05) 
2.67 (2.26 to 3.16) 
0.05 (0.04 to 0.06) 
Additional SerotypesSerotype19A (n=83,100,78,93) 
0.85 (0.67 to 1.09) 
0.64 (0.52 to 0.79) 
5.60 (4.60 to 6.83) 
2.82 (2.32 to 3.41) 
No statistical analysis provided for Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
7. Secondary:  Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: One month after the infant series (7 months of age) ] 
Measure Type  Secondary 

Measure Title  Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series 
Measure Description  Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin [FHA], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented. 
Time Frame  One month after the infant series (7 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody level to the given concomitant vaccine component. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  94  108 
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series [Units: Percentage of participants] Number (95% Confidence Interval) 

Hib (PRP) 0.15 μg/mL (n=84,87) 
89.29 (80.63 to 94.98) 
86.21 (77.15 to 92.66) 
Hib (PRP) 1.0 μg/mL (n=84,87) 
70.24 (59.27 to 79.73) 
63.22 (52.20 to 73.31) 
Diphtheria 0.01 IU/mL (n=38,48) 
100.00 (90.75 to 100.00) 
100.00 (92.60 to 100.00) 
Diphtheria 0.1 IU/mL (n=38,48) 
100.00 (90.75 to 100.00) 
100.00 (92.60 to 100.00) 
Tetanus 0.01 IU/mL (n=38,48) 
100.00 (90.75 to 100.00) 
100.00 (92.60 to 100.00) 
Tetanus 0.1 IU/mL (n=38,48) 
100.00 (90.75 to 100.00) 
100.00 (92.60 to 100.00) 
Polio Type 1 (antibody threshold ≥1:8) (n=61,64) 
100.00 (94.13 to 100.00) 
100.00 (94.40 to 100.00) 
Polio Type 2 (antibody threshold ≥1:8) (n=61,64) 
98.36 (91.20 to 99.96) 
100.00 (9.40 to 100.00) 
Polio Type 3 (antibody threshold ≥1:8) (n=61,63) 
98.36 (91.20 to 99.96) 
100.00 (94.31 to 100.00) 
Hepatitis b 10 mIU/mL (n=38,48) 
100.00 (90.75 to 100.00) 
100.00 (92.60 to 100.00) 
Pertussis  FHA 82.00 EU/MI (n=65,68) 
93.85 (84.99 to 98.30) 
95.59 (87.64 to 99.08) 
Pertussis  Pertussis Toxoid 43.00 EU/mL (n=65,68) 
89.23 (79.06 to 95.56) 
95.59 (87.64 to 99.08) 
Pertussis  Pertactin 18.00 EU/mL (n=65,68) 
96.92 (89.32 to 99.63) 
95.59 (87.64 to 99.08) 
Statistical Analysis 1 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  3.08 
95% Confidence Interval  7.22 to 13.73 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC  7vPnC) at 0.15 µg/mL threshold was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  7.02 
95% Confidence Interval  7.28 to 21.14 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC  7vPnC) at 1.0 µg/mL threshold was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.00 
95% Confidence Interval  9.38 to 7.73 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Diphtheria the difference in percentage between the two groups (13vPnC  7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 4 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.00 
95% Confidence Interval  9.38 to 7.73 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Tetanus the difference in percentage between the two groups (13vPnC  7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 5 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.00 
95% Confidence Interval  5.97 to 5.68 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Polio Type 1 the difference in percentage between the two groups (13vPnC  7vPnC) at 1:8 threshold was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 6 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  1.64 
95% Confidence Interval  8.80 to 4.24 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Polio Type 2 the difference in percentage between the two groups (13vPnC  7vPnC) at 1:8 threshold was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 7 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  1.64 
95% Confidence Interval  8.80 to 4.21 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Polio Type 3 the difference in percentage between the two groups (13vPnC  7vPnC) at 1:8 threshold was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 8 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  0.00 
95% Confidence Interval  9.38 to 7.73 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Hepatitis b the difference in percentage between the two groups (13vPnC  7vPnC) at 10 mIU/mL threshold was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 9 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  1.74 
95% Confidence Interval  11.00 to 6.99 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Pertussis  FHA the difference in percentage between the two groups (13vPnC  7vPnC) at 82.00 EU/MI threshold was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 10 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  6.36 
95% Confidence Interval  17.03 to 3.16 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Pertussis  PT the difference in percentage between the two groups (13vPnC  7vPnC) at 43.00 EU/mL threshold was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 11 for Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Difference ^{[3]}  1.33 
95% Confidence Interval  6.79 to 9.68 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For Pertussis  Pertactin the difference in percentage between the two groups (13vPnC  7vPnC) at 18.00 EU/mL threshold was calculated  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
8. Secondary:  Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ] 
Measure Type  Secondary 

Measure Title  Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series 
Measure Description  No text entered. 
Time Frame  one month after the infant series (7 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  84  87 
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series [Units: μg/mL] Geometric Mean (95% Confidence Interval) 
1.99 (1.34 to 2.97) 
1.64 (1.09 to 2.47) 
Statistical Analysis 1 for Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  1.21 
95% Confidence Interval  0.69 to 2.14 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
9. Secondary:  Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ] 
Measure Type  Secondary 

Measure Title  Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series 
Measure Description  GMCs of antihepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented. 
Time Frame  one month after the infant series (7 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  38  48 
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series [Units: Milli International Units (mIU)/mL] Geometric Mean (95% Confidence Interval) 
1257.74 (904.77 to 1748.42) 
1300.01 (976.91 to 1729.99) 
Statistical Analysis 1 for Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  0.97 
95% Confidence Interval  0.63 to 1.48 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
10. Secondary:  Geometric Mean Antibody Concentration Diphtheria Toxoid and AntiTetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ] 
Measure Type  Secondary 

Measure Title  Geometric Mean Antibody Concentration Diphtheria Toxoid and AntiTetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series 
Measure Description  No text entered. 
Time Frame  one month after the infant series (7 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  38  48 
Geometric Mean Antibody Concentration Diphtheria Toxoid and AntiTetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series [Units: IU/mL] Geometric Mean (95% Confidence Interval) 

Diphtheria Toxoid 
0.86 (0.65 to 1.14) 
1.04 (0.80 to 1.34) 
AntiTetanus Toxoid 
0.93 (0.72 to 1.22) 
0.97 (0.73 to 1.28) 
Statistical Analysis 1 for Geometric Mean Antibody Concentration Diphtheria Toxoid and AntiTetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  0.83 
95% Confidence Interval  0.57 to 1.21 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
11. Secondary:  Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ] 
Measure Type  Secondary 

Measure Title  Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series 
Measure Description  No text entered. 
Time Frame  one month after the infant series (7 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a postinfant series blood sample. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  94  108 
Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series [Units: Titer] Geometric Mean (95% Confidence Interval) 

Polio Type 1 (n=61,64) 
483.72 (352.52 to 663.75) 
479.79 (361.79 to 636.26) 
Polio Type 2 (n=61,64) 
368.26 (250.75 to 540.84) 
403.45 (249.90 to 551.96) 
Polio Type 3 (n=61,63) 
914.01 (638.80 to 1307.80) 
812.75 (577.32 to 1144.18) 
Statistical Analysis 1 for Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  1.01 
95% Confidence Interval  0.66 to 1.53 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Polio Type 1  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  0.91 
95% Confidence Interval  0.56 to 1.49 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Polio Type 2  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  1.12 
95% Confidence Interval  0.69 to 1.84 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Polio Type 3  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
12. Secondary:  Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ] 
Measure Type  Secondary 

Measure Title  Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series 
Measure Description  No text entered. 
Time Frame  one month after the infant series (7 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  65  68 
Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series [Units: EU/mL] Geometric Mean (95% Confidence Interval) 

Pertussis  filamentous hemagglutinin (FHA) 
207.85 (178.72 to 241.74) 
225.12 (191.97 to 264.01) 
Pertussis  pertussis toxoid (PT) 
98.68 (82.89 to 117.49) 
96.58 (86.45 to 107.89) 
Pertussis  pertactin 
141.23 (113.02 to 176.48) 
135.51 (107.13 to 171.41) 
Statistical Analysis 1 for Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  0.92 
95% Confidence Interval  0.74 to 1.15 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Pertussis  FHA  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  1.02 
95% Confidence Interval  0.83 to 1.25 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Pertussis  PT  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Ratio ^{[3]}  1.04 
95% Confidence Interval  0.76 to 1.44 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Pertussis  Pertactin  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
13. Secondary:  Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series [ Time Frame: one month after the infant series (7 months of age) ] 
Measure Type  Secondary 

Measure Title  Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series 
Measure Description  Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. 
Time Frame  one month after the infant series (7 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody titer to the given serotype. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  94  108 
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series [Units: Percentage of participants] Number (95% Confidence Interval) 

Common Serotypes  Serotype 4 (n=30,33) 
96.67 (82.78 to 99.92) 
100.00 (89.42 to 100.00) 
Common Serotypes  Serotype 6B (n=27,30) 
92.59 (75.71 to 99.09) 
93.33 (77.93 to 99.18) 
Common Serotypes  Serotype 9V (n=27,27) 
100.00 (87.23 to 100.00) 
100.00 (87.23 to 100.00) 
Common Serotypes  Serotype 14 (n=27,30) 
100.00 (87.23 to 100.00) 
100.00 (88.43 to 100.00) 
Common Serotypes  Serotype 18C (n=27,30) 
100.00 (87.23 to 100.00) 
96.67 (82.78 to 99.92) 
Common Serotypes  Serotype 19F (n=25,25) 
84.00 (63.92 to 95.46) 
80.00 (59.30 to 93.17) 
Common Serotypes  Serotype 23F (n=27,26) 
92.59 (75.71 to 99.09) 
100.00 (86.77 to 100.00) 
Additional Serotypes  Serotype 1 (n=30,32) 
83.33 (65.28 to 94.36) 
6.25 (0.77 to 20.81) 
Additional Serotypes  Serotype 3 (n=25,29) 
80.00 (59.30 to 93.17) 
3.45 (0.09 to 17.76) 
Additional Serotypes  Serotype 5 (n=30,33) 
100.00 (88.43 to 100.00) 
6.06 (0.74 to 20.23) 
Additional Serotypes  Serotype 6A (n=25,29) 
96.00 (79.65 to 99.90) 
48.28 (29.45 to 67.47) 
Additional Serotypes  Serotype 7F (n=22,24) 
100.00 (84.56 to 100.00) 
20.83 (7.13 to 42.15) 
Additional Serotypes  Serotype 19A (n=22,24) 
77.27 (54.63 to 92.18) 
12.50 (2.66 to 32.36) 
No statistical analysis provided for Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3Dose Infant Series
14. Secondary:  Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: One month after the toddler dose (13 to 16 months of age) ] 
Measure Type  Secondary 

Measure Title  Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose 
Measure Description  Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer. 
Time Frame  One month after the toddler dose (13 to 16 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Allavailable (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)= number of participants with determinant posttoddler dose antibody titer to the given serotype. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  85  102 
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [Units: Percentage of participants] Number (95% Confidence Interval) 

Additional Serotypes  Serotype 6A (n=73,70) 
100.00 (95.1 to 100.00) 
90.0 (80.5 to 95.9) 
Additional Serotypes  Serotype 19A (n=71,72) 
100.00 (94.9 to 100.00) 
51.4 (39.3 to 63.3) 
No statistical analysis provided for Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
15. Secondary:  Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: One month after the Toddler Dose (13 to 16 months of age) ] 
Measure Type  Secondary 

Measure Title  Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose 
Measure Description  Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer. 
Time Frame  One month after the Toddler Dose (13 to 16 months of age) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Allavailable (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinant antibody titer for the specified serotype. 
Reporting Groups
Description  

13vPnC  Participants received one single 0.5 mL dose of 13valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
7vPnC  Participants received one single 0.5mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 1215 months of age (toddler dose). 
Measured Values
13vPnC  7vPnC  

Participants Analyzed  85  102 
Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [Units: Titer] Geometric Mean (95% Confidence Interval) 

Additional Serotypes  Serotype 6A (n=73,70) 
2147.58 (1630.73 to 2828.23) 
599.90 (375.83 to 957.54) 
Additional Serotypes  Serotype 19A (n=71,72) 
802.24 (633.92 to 1015.24) 
36.62 (21.09 to 63.59) 
No statistical analysis provided for Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data 

No text entered. 
More Information
Certain Agreements:
Results Point of Contact:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Principal Investigators are NOT employed by the organization sponsoring the study.  
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.  
The agreement is:

Results Point of Contact:
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 18007181021
email: ClinicalTrials.gov_Inquiries@pfizer.com
Organization: Pfizer, Inc.
phone: 18007181021
email: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party:  Wyeth is now a wholly owned subsidiary of Pfizer 
ClinicalTrials.gov Identifier:  NCT00205803 History of Changes 
Other Study ID Numbers: 
6096A1003 
First Submitted:  September 19, 2005 
First Posted:  September 20, 2005 
Results First Submitted:  March 26, 2010 
Results First Posted:  August 15, 2012 
Last Update Posted:  August 15, 2012 