Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00562354
First received: November 20, 2007
Last updated: October 5, 2011
Last verified: October 2011
Results First Received: August 11, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Healthy
Intervention: Biological: 13vPnC

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
271 participants were enrolled; 270 were vaccinated with study vaccine.

Reporting Groups
  Description
13vPnC (50 to 64 Years of Age) 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.

Participant Flow:   Overall Study
    13vPnC (50 to 64 Years of Age)     13vPnC (≥65 Years of Age)  
STARTED     134     137  
Received Study Treatment     134     136  
Evaluable Immunogenicity Population     134     134  
COMPLETED     134     135  
NOT COMPLETED     0     2  
Physician Decision                 0                 1  
Lost to Follow-up                 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.
No text entered.

Reporting Groups
  Description
13vPnC (50 to 64 Years of Age) 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Total Total of all reporting groups

Baseline Measures
    13vPnC (50 to 64 Years of Age)     13vPnC (≥65 Years of Age)     Total  
Number of Participants  
[units: participants]
  134     134     268  
Age  
[units: years]
Mean ± Standard Deviation
  57.5  ± 4.0     70.5  ± 4.4     64.0  ± 7.7  
Gender  
[units: participants]
     
Female     76     70     146  
Male     58     64     122  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population   [ Time Frame: 1 month after vaccination ]

2.  Primary:   Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years   [ Time Frame: 1 month after vaccination ]

3.  Primary:   Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population   [ Time Frame: Prevaccination (Day 1), 1 month after vaccination ]

4.  Primary:   Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years   [ Time Frame: Prevaccination (Day 1), 1 month after vaccination ]

5.  Secondary:   Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group   [ Time Frame: 1 month after vaccination ]

6.  Secondary:   Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population   [ Time Frame: 1 month after vaccination ]

7.  Secondary:   Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years   [ Time Frame: 1 month after vaccination ]

8.  Secondary:   Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group   [ Time Frame: 1 month after vaccination ]

9.  Secondary:   Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population   [ Time Frame: 1 month after vaccination ]

10.  Secondary:   Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years   [ Time Frame: 1 month after vaccination ]

11.  Secondary:   Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group   [ Time Frame: 1 month after vaccination ]

12.  Secondary:   Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population   [ Time Frame: 1 month after vaccination ]

13.  Secondary:   Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years   [ Time Frame: 1 month after vaccination ]

14.  Secondary:   Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group   [ Time Frame: 1 month after vaccination ]

15.  Secondary:   Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population   [ Time Frame: 1 month after vaccination ]

16.  Secondary:   Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years   [ Time Frame: 1 month after vaccination ]

17.  Secondary:   Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group   [ Time Frame: 1 month after vaccination ]

18.  Secondary:   Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population   [ Time Frame: 1 month after vaccination ]

19.  Secondary:   Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years   [ Time Frame: 1 month after vaccination ]

20.  Secondary:   Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population   [ Time Frame: Day 1 through 14 ]

21.  Secondary:   Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years   [ Time Frame: Day 1 through 14 ]

22.  Secondary:   Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population   [ Time Frame: Day 1 through 14 ]

23.  Secondary:   Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years   [ Time Frame: Day 1 through 14 ]


  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: NCT00562354     History of Changes
Other Study ID Numbers: 6115A1-3004
Study First Received: November 20, 2007
Results First Received: August 11, 2011
Last Updated: October 5, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency