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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Infections

Treatments: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 13vPnC + TIV

Study type: Interventional

Funder types: Industry

Identifiers

NCT00492557

6115A1-3008

Details and patient eligibility

About

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).

Enrollment: 1,185 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,185 participants in 2 patient groups

13vPnC+TIV Followed by Placebo 1 month later

Experimental group

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

Placebo+TIV Followed by 13vPnC 1 month later

Active Comparator group

Treatment:

Biological: 13vPnC + TIV