Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00488826
First received: June 18, 2007
Last updated: January 15, 2010
Last verified: January 2010
Results First Received: March 31, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Pneumococcal Infections
Interventions: Biological: 7-valent pneumococcal conjugate vaccine
Biological: Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP)

  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
Subjects were recruited in China from September 2006 to May 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were enrolled into study according to inclusion/exclusion criteria without a screening period.

Reporting Groups
  Description
7vPnC Separately 7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
7vPnC + DTaP Concurrently 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
DTaP Alone DTaP administered at 3, 4, and 5 months of age.

Participant Flow:   Overall Study
    7vPnC Separately     7vPnC + DTaP Concurrently     DTaP Alone  
STARTED     300     296     204  
COMPLETED     244     244     178  
NOT COMPLETED     56     52     26  
Withdrawal by Subject                 40                 35                 19  
Protocol Violation                 0                 0                 2  
Adverse Event                 9                 15                 4  
Lost to Follow-up                 5                 1                 0  
Protocol Deviations                 2                 1                 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
7vPnC Separately 7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
7vPnC + DTaP Concurrently 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
DTaP Alone DTaP administered at 3, 4, and 5 months of age.
Total Total of all reporting groups

Baseline Measures
    7vPnC Separately     7vPnC + DTaP Concurrently     DTaP Alone     Total  
Number of Participants  
[units: participants]
  300     296     204     800  
Age  
[units: months]
Median ± Standard Deviation
  3.5  ± 1.0     3.5  ± 1.0     3.5  ± 1.7     3.5  ± 1.23  
Gender  
[units: participants]
       
Female     142     133     81     356  
Male     158     163     123     444  



  Outcome Measures
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1.  Primary:   Concentration of Serotype-Specific IgG Antibodies   [ Time Frame: 7 months ]

2.  Secondary:   Concentration of Serotype-Specific IgG Antibodies   [ Time Frame: 7 months ]


  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


ClinicalTrials.gov Identifier: NCT00488826     History of Changes
Other Study ID Numbers: 0887X-101518
Study First Received: June 18, 2007
Results First Received: March 31, 2009
Last Updated: January 15, 2010
Health Authority: China: Food and Drug Administration