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Prevenar13 Post Market Surveillance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509105
First Posted: January 12, 2012
Last Update Posted: February 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: December 20, 2016  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Healthy
Intervention: Biological: 13-valent pneumococcal 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
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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 13 Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.

Participant Flow:   Overall Study
    Prevenar 13
STARTED   649 
COMPLETED   649 
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.
Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up.

Reporting Groups
  Description
Prevenar 13 Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.

Baseline Measures
   Prevenar 13 
Overall Participants Analyzed 
[Units: Participants]
 649 
Age 
[Units: Months]
Mean (Standard Deviation)
 
Mean Age   4.26  (12.86) 
Gender 
[Units: Participants]
Count of Participants
 
Female      321  49.5% 
Male      328  50.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1   [ Time Frame: Within 7 days after Vaccination 1 ]

2.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2   [ Time Frame: Within 7 days after Vaccination 2 ]

3.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3   [ Time Frame: Within 7 days after Vaccination 3 ]

4.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4   [ Time Frame: Within 28 days after Vaccination 4 ]

5.  Primary:   Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1   [ Time Frame: Within 7 days after Vaccination 1 ]

6.  Primary:   Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2   [ Time Frame: Within 7 days after Vaccination 2 ]

7.  Primary:   Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3   [ Time Frame: Within 7 days after Vaccination 3 ]

8.  Primary:   Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4   [ Time Frame: Within 28 days after Vaccination 4 ]

9.  Secondary:   Duration of Adverse Events (AEs)   [ Time Frame: Baseline up to 28 days after last dose of study vaccination (13 Months) ]

10.  Secondary:   Number of Participants With Adverse Events (AEs) by Severity   [ Time Frame: Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4 ]

11.  Secondary:   Number of Participants With Outcome in Response to Adverse Events (AEs)   [ Time Frame: Baseline up to 28 days after last dose of study vaccination (13 Months) ]

12.  Secondary:   Number of Participants Discontinued Due to Adverse Events   [ Time Frame: Baseline up to 28 days after last dose of study vaccination (13 Months) ]


  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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01509105     History of Changes
Other Study ID Numbers: 6096A1-4029
B1851057 ( Other Identifier: Alias Study Number )
First Submitted: September 30, 2011
First Posted: January 12, 2012
Results First Submitted: December 20, 2016
Results First Posted: February 13, 2017
Last Update Posted: February 13, 2017