Study Evaluating Pneumococcal Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00205803
First received: September 19, 2005
Last updated: July 6, 2012
Last verified: July 2012
Results First Received: March 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   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
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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  
Unspecified                 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  
Number of Participants  
[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
  Show All Outcome Measures

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

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

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) ]

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) ]

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) ]
  Hide Outcome Measure 5

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)  
Safety Issue No  

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  
Number of 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
Ratio [2] 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] 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
Ratio [2] 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] 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
Difference [2] 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] 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
Ratio [2] 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] 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
Ratio [2] 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] 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
Ratio [2] 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] 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
Ratio [2] 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] 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
Ratio [2] 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] 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
Ratio [2] 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] 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
Ratio [2] 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] 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
Ratio [2] 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] 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
Ratio [2] 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] 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
Ratio [2] 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] 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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
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:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00205803     History of Changes
Other Study ID Numbers: 6096A1-003
Study First Received: September 19, 2005
Results First Received: March 26, 2010
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration