Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01646398
First received: May 10, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.


Condition Intervention Phase
Pneumococcal Vaccines
Pneumococcal Conjugate Vaccine
 Biological: 13-valent pneumococcal conjugate vaccine
Biological: 23-valent pneumococcal polysaccharide vaccine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Modified Double-Blind, Active-Controlled Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Japanese Elderly Adults Aged 65 Years Old And Older Who Are Naive To Pneumococcal Vaccine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMT) for the 12 common serotypes contained in 13vPnC and 23vPS [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving a 4-fold rise in OPA titers for serotype 6A. [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The serotype-specific OPA GMTs for the 12 common serotypes contained in 13vPnC and 23vPS and serotype 6A [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]

Enrollment: 764
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: >= 65-year age group-13vPnC Biological: 13-valent pneumococcal conjugate vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Other Name: 13vPnC
Active Comparator: >= 65-year age group-23vPS Biological: 23-valent pneumococcal polysaccharide vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Other Name: 23VPS

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.
  2. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.

Exclusion Criteria:

  1. History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
  2. Previous vaccination with any licensed or experimental pneumococcal vaccine.
  3. Documented Streptococcus pneumoniae infection within the past 5 years.
  4. Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646398

Locations
Japan
Seishinkai Inoue Hospital
Itoshima, Fukuoka, Japan
Yokohama Minoru Clinic
Yokohama, Kanagawa, Japan
Sone Clinic
Shinjuku-ku, Tokyo, Japan
Oda Clinic
Shinjuku-ku, Tokyo, Japan
Medical Co. LTA Sumida Hospital
Sumida-ku, Tokyo, Japan
Medical Co.LTA PS Clinic
Fukuoka, Japan
Uzumasa Medical Clinic
Kyoto, Japan
Senbon Hospital
Osaka, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01646398     History of Changes
Other Study ID Numbers: B1851088
Study First Received: May 10, 2012
Last Updated: November 28, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
13VPNC
23VPS

ClinicalTrials.gov processed this record on June 18, 2013