Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults

Phase 3

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 13vPnC + TIV

• Registration Number: NCT00492557
• Lead Sponsor: Pfizer

Brief Summary

The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent influenza vaccine (TIV) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Study Start: 2007-09
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Disposition First Submitted: 2009-01-21
• Disposition First Submitted QC: 2009-09-24
• Disposition First Posted: 2009-09-28
• Status Verified: 2012-01
• Results First Submitted: 2012-01-17
• Results First Submitted QC: 2012-01-17
• Last Update Submitted: 2012-01-17
• Results First Posted: 2012-02-17
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1185

Inclusion Criteria

• Generally healthy male or female adults 65 years of age or older.
• Available for the duration of the trial - approximately 2 months.
• No previous vaccination with any pneumococcal vaccine.
• No history of severe adverse reaction associated with a vaccine.
• No allergy to egg proteins (eggs or egg products) and chicken proteins.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
13vPnC+TIV Followed by Placebo 1 month later	13-valent pneumococcal conjugate vaccine	-
Placebo+TIV Followed by 13vPnC 1 month later	13vPnC + TIV	-

Primary Outcome Measures

Name	Time	Method
TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)	Baseline and 1 month after TIV vaccination	Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)	1 month after 13vPnC vaccination	IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.