Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00963235
First received: August 20, 2009
Last updated: April 17, 2013
Last verified: April 2013
Results First Received: April 17, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: HIV Infections
Pneumococcal Infections
Interventions: Biological: 13-valent pneumococcal conjugate vaccine
Procedure: Blood draw

  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
13vPnC Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.

Participant Flow:   Overall Study
    13vPnC  
STARTED     331  
Vaccinated Dose 1     329  
Vaccinated Dose 2     300  
Vaccinated Dose 3     279  
Completed Dose 3 1-month Blood Draw     277  
COMPLETED     271  
NOT COMPLETED     60  
Withdrawal by Subject                 22  
Lost to Follow-up                 14  
Failed to return                 9  
Protocol Violation                 7  
Adverse Event                 5  
Physician Decision                 2  
Unspecified                 1  



  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 participants who received at least 1 dose of study vaccine.

Reporting Groups
  Description
13vPnC Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.

Baseline Measures
    13vPnC  
Number of Participants  
[units: participants]
  329  
Age  
[units: years]
Mean ± Standard Deviation
  47.3  ± 9.10  
Gender  
[units: participants]
 
Female     66  
Male     263  



  Outcome Measures
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1.  Primary:   Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC   [ Time Frame: 1 month post-dose 2, 1 month post-dose 3 ]

2.  Secondary:   Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC   [ Time Frame: 1 month post-dose 2, 1 month post-dose 3 ]

3.  Secondary:   Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC   [ Time Frame: 1 month post-dose 1, 1 month post-dose 2 ]

4.  Secondary:   Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC   [ Time Frame: 1 month post-dose 2, 1 month post-dose 3 ]

5.  Secondary:   Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC   [ Time Frame: 1 month post-dose 1, 1 month post-dose 2 ]

6.  Secondary:   Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC   [ Time Frame: 1 month post-dose 2, 1 month post-dose 3 ]

7.  Secondary:   Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC   [ Time Frame: 1 month post-dose 1, 1 month post-dose 2 ]

8.  Other Pre-specified:   Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1   [ Time Frame: Within 14 days post-dose 1 ]

9.  Other Pre-specified:   Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2   [ Time Frame: Within 14 days post-dose 2 ]

10.  Other Pre-specified:   Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3   [ Time Frame: Within 14 days post-dose 3 ]

11.  Other Pre-specified:   Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1   [ Time Frame: Within 14 days post-dose 1 ]

12.  Other Pre-specified:   Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2   [ Time Frame: Within 14 days post-dose 2 ]

13.  Other Pre-specified:   Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3   [ Time Frame: Within 14 days post-dose 3 ]


  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: NCT00963235     History of Changes
Other Study ID Numbers: 6115A1-3017, B1851028
Study First Received: August 20, 2009
Results First Received: April 17, 2013
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration