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

Vaccines, Pneumococcal Conjugate Vaccine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269672
• Other study ID #: 6115A1-500
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2005
• Last updated: August 4, 2010
• Start date: September 2005
• Est. completion date: February 2007

Study information

• Verified date: August 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 915
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccines, Pneumococcal Conjugate Vaccine

Intervention

Biological:
• 13-valent Pneumococcal Conjugate Vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.
Secondary	Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).
Secondary	Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC.