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


  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.
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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
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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) ]

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
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