ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01646398
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : September 20, 2013
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Pneumococcal Vaccines
Pneumococcal Conjugate Vaccine
Interventions: Biological: 13-valent pneumococcal conjugate vaccine
Biological: 23-valent pneumococcal polysaccharide vaccine

  Participant Flow

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
No text entered.

Reporting Groups
  Description
13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
23vPS 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.

Participant Flow:   Overall Study
    13vPnC   23vPS
STARTED   382   382 
COMPLETED   381   382 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 



  Baseline Characteristics

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 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
23vPS 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Total Total of all reporting groups

Baseline Measures
   13vPnC   23vPS   Total 
Overall Participants Analyzed 
[Units: Participants]
 382   382   764 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.0  (4.08)   69.7  (3.66)   69.9  (3.87) 
Gender 
[Units: Participants]
     
Female   198   187   385 
Male   184   195   379 


  Outcome Measures

1.  Primary:   Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination   [ Time Frame: One month after vaccination ]

2.  Primary:   Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination   [ Time Frame: One month after vaccination ]

3.  Secondary:   Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination   [ Time Frame: One month after vaccination ]

4.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination   [ Time Frame: Within 14 days after vaccination ]

5.  Other Pre-specified:   Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination   [ Time Frame: Within 14 days after vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01646398     History of Changes
Other Study ID Numbers: B1851088
First Submitted: May 10, 2012
First Posted: July 20, 2012
Results First Submitted: July 17, 2013
Results First Posted: September 20, 2013
Last Update Posted: September 20, 2013