Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00464945
First received: April 23, 2007
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 (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Pneumococcal Vaccines
Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine

  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 Poland from June 2007 to August 2007.

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 inclusion/exclusion criteria without a screening period.

Reporting Groups
  Description
13vPnC Manufacturing Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
13vPnC Pilot Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).

Participant Flow for 3 periods

Period 1:   Infant Series
    13vPnC Manufacturing     13vPnC Pilot  
STARTED     135     134  
Vaccinated Dose 1     134     134  
Vaccinated Dose 2     132     133  
Vaccinated Dose 3     132     133  
COMPLETED     131     133  
NOT COMPLETED     4     1  
Withdrawal by parent/guardian request                 2                 1  
Protocol Violation                 1                 0  
Lost to Follow-up                 1                 0  

Period 2:   After Infant Series
    13vPnC Manufacturing     13vPnC Pilot  
STARTED     131     133  
COMPLETED     131     131  
NOT COMPLETED     0     2  
Withdrawal by Subject                 0                 2  

Period 3:   Toddler Dose
    13vPnC Manufacturing     13vPnC Pilot  
STARTED     131     131  
COMPLETED     131     130  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  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 Manufacturing Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
13vPnC Pilot Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
Total Total of all reporting groups

Baseline Measures
    13vPnC Manufacturing     13vPnC Pilot     Total  
Number of Participants  
[units: participants]
  135     134     269  
Age  
[units: months]
Mean ± Standard Deviation
  2.1  ± 0.6     2.1  ± 0.5     2.1  ± 0.5  
Gender  
[units: participants]
     
Female     65     67     132  
Male     70     67     137  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series   [ Time Frame: One month after 3-dose infant series (5 months of age) ]

2.  Primary:   Percentage of Participants Reporting Pre-Specified Local Reactions   [ Time Frame: During the 4-day period after each dose ]

3.  Primary:   Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)   [ Time Frame: During the 4-day period after each dose ]

4.  Primary:   Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)   [ Time Frame: During the 4-day period after toddler dose ]

5.  Primary:   Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series   [ Time Frame: One month after 3-dose infant series (5 months of age) ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.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: NCT00464945     History of Changes
Other Study ID Numbers: 6096A1-3000
Study First Received: April 23, 2007
Results First Received: March 26, 2010
Last Updated: July 6, 2012
Health Authority: Poland: Ministry of Health
United States: Food and Drug Administration