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Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00683410
First received: May 21, 2008
Last updated: October 15, 2010
Last verified: October 2010
Results First Received: October 15, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Intervention: Biological: Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prevenar 7v Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection

Participant Flow:   Overall Study
    Prevenar 7v  
STARTED     3366  
Vaccinated Dose 1     3240  
Vaccinated Dose 2     1623  
Vaccinated Dose 3     817  
Vaccinated Dose 4     175  
COMPLETED     3366  
NOT COMPLETED     0  



  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
Prevenar 7v Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection

Baseline Measures
    Prevenar 7v  
Number of Participants  
[units: participants]
  3366  
Age  
[units: weeks]
Mean ± Standard Deviation
  43.6  ± 50.9  
Gender  
[units: participants]
 
Female     1576  
Male     1790  



  Outcome Measures

1.  Primary:   Number of Participants With Spontaneous Adverse Events   [ Time Frame: 30 days post injection up to 3 years ]


  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


Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00683410     History of Changes
Other Study ID Numbers: 0887X-102339
Study First Received: May 21, 2008
Results First Received: October 15, 2010
Last Updated: October 15, 2010
Health Authority: Philippines: Bureau of Food and Drugs