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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:
NCT00366340
First received: August 17, 2006
Last updated: June 28, 2012
Last verified: June 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: Vaccines, Pneumococcal
Interventions: Biological: 13-valent pneumococcal conjugate vaccine
Biological: 7-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 Germany from October 2006 to April 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 Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)

Participant Flow for 3 periods

Period 1:   Infant Series
    13vPnC     7vPnC  
STARTED     301     303  
Vaccinated Dose 1     300     303  
Vaccinated Dose 2     296     297  
Vaccinated Dose 3     294     293  
COMPLETED     293     293  
NOT COMPLETED     8     10  
Protocol Violation                 3                 4  
Withdrawal by Subject                 3                 3  
Adverse Event                 0                 2  
Lost to Follow-up                 1                 1  
Failure to return                 1                 0  

Period 2:   After the Infant Series
    13vPnC     7vPnC  
STARTED     293     293  
COMPLETED     290     287  
NOT COMPLETED     3     6  
Parent/legal guardian request                 1                 1  
Failed to return                 0                 1  
Protocol Violation                 2                 2  
Adverse Event                 0                 1  
Lost to Follow-up                 0                 1  

Period 3:   Toddler Dose
    13vPnC     7vPnC  
STARTED     290     287  
COMPLETED     289     286  
NOT COMPLETED     1     1  
Failed to return                 1                 0  
Parent/legal guardian request                 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 Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
7vPnC Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
Total Total of all reporting groups

Baseline Measures
    13vPnC     7vPnC     Total  
Number of Participants  
[units: participants]
  301     303     604  
Age  
[units: months]
Mean ± Standard Deviation
  2.5  ± 0.6     2.5  ± 0.6     2.5  ± 0.6  
Gender  
[units: participants]
     
Female     151     127     278  
Male     150     176     326  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series   [ Time Frame: One month after 3-dose infant series (5 months of age) ]

2.  Primary:   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 (5 months of age) ]

3.  Primary:   Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.   [ Time Frame: One month after 3-dose infant series (5 months of age) ]

4.  Primary:   Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series   [ Time Frame: One month after 3-dose infant series (5 months of age) ]

5.  Primary:   Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose   [ Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) ]

6.  Primary:   Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose   [ Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) ]

7.  Primary:   Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose   [ Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) ]

8.  Primary:   Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose   [ Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age) ]

9.  Primary:   Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose   [ Time Frame: Immediately before (12 months of age) and one month after the toddler dose (13 months of age) ]

10.  Primary:   Percentage of Participants Reporting Pre-Specified Local Reactions   [ Time Frame: Day 1 through 4 after each dose ]

11.  Primary:   Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)   [ Time Frame: Day 1 through 4 after each dose ]

12.  Primary:   Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)   [ Time Frame: Day 1 through 4 after each dose ]


  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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  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: NCT00366340     History of Changes
Other Study ID Numbers: 6096A1-006
Study First Received: August 17, 2006
Results First Received: March 26, 2010
Last Updated: June 28, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
United States: Food and Drug Administration