Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01521897
First received: September 14, 2011
Last updated: December 14, 2015
Last verified: December 2015
Results First Received: December 14, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Pneumococcal Vaccine
Streptococcus Pneumoniae
Intervention: Biological: 7-valent vaccine injection

  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™ (7-valent) Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.

Participant Flow:   Overall Study
    Prevenar™ (7-valent)  
STARTED     1143  
COMPLETED     1120  
NOT COMPLETED     23  
Protocol Violation                 18  
Lost to Follow-up                 5  



  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.
In total, 1143 participants were enrolled in this study. Of the 1143 participants, 23 participants were excluded from the baseline analysis for the reasons of protocol violation and lost to follow-up.

Reporting Groups
  Description
Prevenar™ (7-valent) Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.

Baseline Measures
    Prevenar™ (7-valent)  
Number of Participants  
[units: participants]
  1120  
Age, Customized [1]
[units: Participants]
 
2 to 4 < Months     528  
4 to 6 < Months     516  
6 to 7 < Months     76  
Gender [2]
[units: Participants]
 
Female     550  
Male     570  
[1] Participants were vaccinated with Prevenar™ (7-valent) according to the Japanese package insert (age in months at the first vaccination).
[2] Participants were vaccinated with Prevenar™ (7-valent) according to the Japanese package insert.



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Reactions   [ Time Frame: 28 days ]

2.  Secondary:   Number of Participants With Serious Adverse Events   [ Time Frame: 28 days ]

3.  Secondary:   Number of Participants With Injection Site Reactions   [ Time Frame: 28 days ]

4.  Secondary:   Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination   [ Time Frame: 28 days ]

5.  Secondary:   Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination   [ Time Frame: 28 days ]

6.  Other Pre-specified:   Number of Participants by Month of Age at Each Vaccination Time   [ Time Frame: 28 days ]

7.  Other Pre-specified:   Number of Participants by Vaccination Sites at Each Vaccination Time   [ Time Frame: 28 days ]

8.  Other Pre-specified:   Number of Participants by Pattern of Concomitant Vaccines   [ Time Frame: 28 days ]

9.  Other Pre-specified:   Number of Participants by Pattern of Concomitant Vaccination Sites   [ Time Frame: 28 days ]


  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: Pfizer
ClinicalTrials.gov Identifier: NCT01521897     History of Changes
Other Study ID Numbers: 0887X1-4447
B1841005 ( Other Identifier: Alias Study Number )
Study First Received: September 14, 2011
Results First Received: December 14, 2015
Last Updated: December 14, 2015
Health Authority: United States: Food and Drug Administration