Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00962780
First received: August 18, 2009
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: March 17, 2014  
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 (13vPnC)
Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
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, 23vPS (Pediatric Participants) Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
13vPnC, 23vPS (Adult Participants) Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).

Participant Flow:   Overall Study
    13vPnC, 23vPS (Pediatric Participants)     13vPnC, 23vPS (Adult Participants)  
STARTED     151     152  
Vaccinated 13vPnC Dose 1     150     151  
Vaccinated 13vPnC Dose 2     145     145  
Vaccinated 13vPnC Dose 3     144     142  
Vaccinated 23vPS Dose     143     139  
COMPLETED     141     138  
NOT COMPLETED     10     14  
Death                 0                 1  
Protocol Violation                 9                 4  
Withdrawal by Subject                 1                 8  
Unspecified                 0                 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 all enrolled participants who received at least 1 dose of investigational product.

Reporting Groups
  Description
13vPnC, 23vPS (Pediatric Participants) Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
13vPnC, 23vPS (Adult Participants) Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
Total Total of all reporting groups

Baseline Measures
    13vPnC, 23vPS (Pediatric Participants)     13vPnC, 23vPS (Adult Participants)     Total  
Number of Participants  
[units: participants]
  150     151     301  
Age  
[units: years]
Mean (Standard Deviation)
  10.3  (3.04)     41.2  (8.45)     25.8  (16.72)  
Gender  
[units: participants]
     
Female     76     88     164  
Male     74     63     137  



  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 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants   [ Time Frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3 ]

2.  Secondary:   Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants   [ Time Frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3 ]

3.  Secondary:   Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants   [ Time Frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3 ]

4.  Secondary:   Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants   [ Time Frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3 ]

5.  Secondary:   Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants   [ Time Frame: 1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3 ]

6.  Other Pre-specified:   Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants   [ Time Frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 ]

7.  Other Pre-specified:   Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants   [ Time Frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 ]

8.  Other Pre-specified:   Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants   [ Time Frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 ]

9.  Other Pre-specified:   Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants   [ Time Frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1 ]

10.  Other Pre-specified:   Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants   [ Time Frame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose ]

11.  Other Pre-specified:   Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants   [ Time Frame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose ]

12.  Other Pre-specified:   Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants   [ Time Frame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose ]

13.  Other Pre-specified:   Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants   [ Time Frame: 1 month after 13vPnC Dose 3, 1 month after 23vPS Dose ]

14.  Other Pre-specified:   Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1   [ Time Frame: Within 14 days after 13vPnC Dose 1 ]

15.  Other Pre-specified:   Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2   [ Time Frame: Within 14 days after 13vPnC Dose 2 ]

16.  Other Pre-specified:   Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3   [ Time Frame: Within 14 days after 13vPnC Dose 3 ]

17.  Other Pre-specified:   Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1   [ Time Frame: Within 14 days after 13vPnC Dose 1 ]

18.  Other Pre-specified:   Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2   [ Time Frame: Within 14 days after 13vPnC Dose 2 ]

19.  Other Pre-specified:   Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3   [ Time Frame: Within 14 days after 13vPnC 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 by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00962780     History of Changes
Obsolete Identifiers: NCT01098370
Other Study ID Numbers: 6115A1-3002, B1851021
Study First Received: August 18, 2009
Results First Received: March 17, 2014
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration