Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults (CAPITA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00744263
First received: August 27, 2008
Last updated: October 1, 2014
Last verified: October 2014
Results First Received: October 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Pneumonia, Pneumococcal
Pneumococcal Infections
13-valent Pneumococcal Vaccine
Interventions: Biological: VACCINE: placebo
Biological: VACCINE: 13-valent pneumococcal conjugate 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
Of 84496 participants who were randomized in this study, 2011 participants were included in the immunogenicity subset. Participants in the immunogenicity subset were analyzed for local reactions and systemic events as per planned analysis.

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 Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
Placebo Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.

Participant Flow:   Overall Study
    13vPnC     Placebo  
STARTED     42240     42256  
COMPLETED     37004     36936  
NOT COMPLETED     5236     5320  
Death                 3006                 3005  
Lost to Follow-up                 2038                 2135  
Withdrawal by Subject                 166                 150  
Physician Decision                 20                 23  
Protocol Violation                 3                 5  
Adverse Event                 1                 0  
Unspecified                 2                 2  



  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 population included all participants who received study vaccine and who had any safety data.

Reporting Groups
  Description
13vPnC Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
Placebo Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
Total Total of all reporting groups

Baseline Measures
    13vPnC     Placebo     Total  
Number of Participants  
[units: participants]
  42237     42255     84492  
Age  
[units: years]
Mean ± Standard Deviation
  72.8  ± 5.7     72.8  ± 5.6     72.8  ± 5.7  
Gender  
[units: participants]
     
Female     18790     18454     37244  
Male     23447     23801     47248  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)   [ Time Frame: Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years) ]

2.  Secondary:   Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)   [ Time Frame: Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years) ]

3.  Secondary:   Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases   [ Time Frame: Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years) ]

4.  Other Pre-specified:   Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination   [ Time Frame: Within 7 days after vaccination ]

5.  Other Pre-specified:   Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination   [ Time Frame: Within 7 days after vaccination ]

6.  Other Pre-specified:   Percentage of Participants Who Died   [ Time Frame: From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years) ]

7.  Other Pre-specified:   Percentage of Participants With Newly Diagnosed Chronic Medical Condition   [ Time Frame: From 1 month after vaccination up to 6 months after vaccination ]


  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: NCT00744263     History of Changes
Other Study ID Numbers: 6115A1-3006, B1851025
Study First Received: August 27, 2008
Results First Received: October 1, 2014
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration