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Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396434
First received: June 22, 2011
Last updated: December 5, 2016
Last verified: January 2016
Results First Received: December 5, 2016  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Pneumococcal Disease
Intervention: Biological: Prevenar 13

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
13vPnC (Prevenar 13), Cohort 1 Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
13vPnC (Prevenar 13), Cohort 2 13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
13vPnC (Prevenar 13), Cohort 3 13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.

Participant Flow:   Overall Study
    13vPnC (Prevenar 13), Cohort 1   13vPnC (Prevenar 13), Cohort 2   13vPnC (Prevenar 13), Cohort 3
STARTED   2817   175   14 
COMPLETED   2806   175   14 
NOT COMPLETED   11   0   0 
Lost to Follow-up                1                0                0 
Unspecified                10                0                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.
All participants who received at least 1 dose of 13vPnC.

Reporting Groups
  Description
13vPnC (Prevenar 13), Cohort 1 Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
13vPnC (Prevenar 13), Cohort 2 13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
13vPnC (Prevenar 13), Cohort 3 13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
Total Total of all reporting groups

Baseline Measures
   13vPnC (Prevenar 13), Cohort 1   13vPnC (Prevenar 13), Cohort 2   13vPnC (Prevenar 13), Cohort 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 2817   175   14   3006 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Age at enrollment (years)   0.5  (0.94)   65.1  (10.60)   0.7  (1.54)   4.3  (15.37) 
Gender 
[Units: Participants]
Count of Participants
       
Female      1402  49.8%      115  65.7%      6  42.9%      1523  50.7% 
Male      1415  50.2%      60  34.3%      8  57.1%      1483  49.3% 
Race/Ethnicity, Customized 
[Units: Participants]
       
Asian   2783   175   14   2972 
Other   24   0   0   24 
White   8   0   0   8 
Black   2   0   0   2 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period ]


  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
The use of 13vPnC was based on the investigator's clinical judgment and was assumed to be consistent with the product's approved label.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01396434     History of Changes
Other Study ID Numbers: B1851076
Study First Received: June 22, 2011
Results First Received: December 5, 2016
Last Updated: December 5, 2016