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Study Evaluating Pneumococcal Vaccine in Healthy Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205803
First Posted: September 20, 2005
Last Update Posted: August 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
Results First Submitted: March 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Prevention
Conditions: Healthy Subjects
Pneumococcal Infections
Interventions: Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)

  Participant Flow
  Hide 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.

Pre-Assignment 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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 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 Follow-up                10                4 
Withdrawal by Subject                2                5 
Physician Decision                3                1 
Protocol Violation                1                0 
Lost Kaiser coverage                0                1 
Non-compliant                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 Follow-up                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 Follow-up                2                3 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
13vPnC Participants received one single 0.5 mL dose of 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).
Total Total of all reporting groups

Baseline Measures
   13vPnC   7vPnC   Total 
Overall Participants Analyzed 
[Units: Participants]
 121   126   247 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 9.2  (1.4)   9.1  (1.2)   9.2  (1.3) 
Gender 
[Units: Patients]
     
Female   58   59   117 
Male   63   67   130 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Percentage of Participants Reporting Pre-Specified Local Reactions   [ Time Frame: Within 15 days after each dose ]

Measure Type Primary
Measure Title Percentage of Participants Reporting Pre-Specified 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 
[Units: Participants]
 121   126   115   122   110   118   86   103 
Percentage of Participants Reporting Pre-Specified Local Reactions 
[Units: Percentage of participants]
               
Tenderness-Any (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 
Tenderness-Sig. (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 
Induration-Any (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 
Induration-Mild (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 
Induration-Mod. (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 
Induration-Sev. (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 
Erythema-Any (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 
Erythema-Mild (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 
Erythema-Mod. (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 
Erythema-Severe (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 Pre-Specified Local Reactions



2.  Primary:   Percentage of Participants Reporting Pre-Specified Systemic Events   [ Time Frame: Within 15 days after each dose ]

Measure Type Primary
Measure Title Percentage of Participants Reporting Pre-Specified 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 
[Units: Participants]
 121   126   115   122   110   118   86   103 
Percentage of Participants Reporting Pre-Specified 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 Pre-Specified Systemic Events



3.  Primary:   Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series   [ Time Frame: one month after 3-dose 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 3-Dose 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 2-sided CI based on the observed proportion of participants.
Time Frame one month after 3-dose 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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 94   108 
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 2-sided 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 All-Available 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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 3-Dose Infant Series   [ Time Frame: One month after 3-dose 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 3-Dose Infant Series
Measure Description Antibody geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Time Frame One month after 3-dose 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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 94   108 
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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 3-Dose 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 non-inferiority 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.
All-Available 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 12-15 months of age (toddler dose).
7vPnC After Toddler Dose Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 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 
[Units: Participants]
 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype 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 Serotypes-Serotype19A (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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 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 non-inferiority 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 anti-hepatitis 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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 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 non-inferiority 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 Anti-Tetanus 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 Anti-Tetanus 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 13-valent 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 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 38   48 
Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus 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) 
Anti-Tetanus 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 Anti-Tetanus 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 non-inferiority 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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 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 non-inferiority 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 non-inferiority 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 non-inferiority 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 3-Dose 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 3-Dose 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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 94   108 
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose 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 3-Dose 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.
All-available (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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 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.
All-available (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 13-valent 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 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent 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 12-15 months of age (toddler dose).

Measured Values
   13vPnC   7vPnC 
Participants Analyzed 
[Units: Participants]
 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




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


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