Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

Phase 3

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: 13 valent Pneumococcal Conjugate Vaccine; Biological: 23vPS

• Registration Number: NCT00546572
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-19
• Study Start: 2007-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-04-29
• Results First Submitted QC: 2011-04-29
• Results First Posted: 2011-05-30
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-12
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 938

Inclusion Criteria

• Male or Female aged 70 years or older.
• Documented vaccination with 1 dose of 23vPS at least 5 years previous.
• Healthy.

Exclusion Criteria

• Receipt of more than one dose of 23vPS prior to enrollment.
• History of severe adverse reaction to a vaccine.
• Immunodeficiency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	13 valent Pneumococcal Conjugate Vaccine	Receives 13vPnC at year 0 and 13vPnC at year 1
2	23vPS	Receives 23vPS at year 0 and 13vPnC at year 1

Primary Outcome Measures

Name	Time	Method
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)	1 month after Vax 1 / Year 0	Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)	Baseline, 1 month after Vax 1 / Year 0	OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.

Secondary Outcome Measures

Name	Time	Method
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)	1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1	Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)	1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1	Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)	1 month after Vax 1 / Year 0	Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)	1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1	Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇪 Uppsala, Sweden