A Study To Evaluate The Persistence Of The Antibody Response Elicited By 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Adults Who Have Previously Been Vaccinated With Either 2 Doses Of 13vPnC Or 13vPnC And 23-Valent Pneumococcal Polysaccharide Vaccine In Different Sequential Order In Study 6115A1-3010 Or 6115A1 3005

Pfizer1 site in 1 country962 target enrollmentDecember 2009

ConditionsHealthy

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 962
Locations: 1
Primary Endpoint: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the levels of antibodies 1 year after receiving the second vaccine dose in two groups of adults over the age of 60: (1) those who have previously received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) and (2) those who have previously received 1 dose of 13vPnc and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). This study will also assess whether the use of the 2 vaccines, 13vPnC and 23vPS, administered in different sequential order results in different prolonged antibody levels. This study is limited to individuals who participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572).

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

October 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Only study volunteers who received both assigned vaccinations at visit 1 and visit 4 when they participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572)

Exclusion Criteria

•Vaccination with any licensed or experimental pneumococcal vaccine since being enrolled in the 6115A1-3005 (NCT00546572) or 6115A1-3010 (NCT00574548) study (other than study vaccines permitted in 6115A1-3010 or 6115A1-3005)

Outcomes

Primary Outcomes

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)

Time Frame: Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)

Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)

Time Frame: Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)

Secondary Outcomes

Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)(Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)(Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)(Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)(Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)(Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)(Month 1/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)(Month 0/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)(Month 0/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)(Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)(Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)(Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)(Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)(Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)(Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)(Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)(Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Baseline; Follow-up Study NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)(Month 0/Year 1 (Parent Study NCT00546572), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)(Month 0/Year 1 (Parent Study NCT00574548))
Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)(Month 0/Year 1 (Parent Study NCT00546572))