Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00269672
First received: December 21, 2005
Last updated: August 4, 2010
Last verified: August 2010
  Purpose

There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate vaccines enhances the immune response in infants. There is no data so far evaluating whether this also applies to adults. The objective of this study is to compare the immune response of 2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to select a formulation and to compare the immune response to the chosen 13vPnC formulation relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).


Condition Intervention Phase
Vaccines, Pneumococcal Conjugate Vaccine
Biological: 13-valent Pneumococcal Conjugate Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized, Open Label, Controlled Phase II Study to Evaluate Safety, Tolerability and Immunogenicity After Two Different 13-Valent Pneumococcal Conjugate Vaccine Formulations in Elderly Subjects Aged 65 Years and Older Who Are Naive to Previous 23vPS Immunization

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.

Secondary Outcome Measures:
  • Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).
  • Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC.

Enrollment: 915
Study Start Date: September 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Male and female adults 65 years of age and older.
  • Determined by medical history, physical examination, and clinical judgment to be eligible for the study.
  • Expected to be available for the duration of the trial (up to approximately 13 months).

Exclusion Criteria:

  • Received previous immunization with 23vPS.
  • Serious chronic disorders including metastatic malignancy
  • Known or suspected hypersensitivity to any vaccine or vaccine components
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269672

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00269672     History of Changes
Other Study ID Numbers: 6115A1-500
Study First Received: December 21, 2005
Last Updated: August 4, 2010
Health Authority: South Africa: Medicines Control Council

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
vaccine

ClinicalTrials.gov processed this record on September 30, 2014