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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Infections

Treatments: Biological: 23vPS; Biological: 13 valent Pneumococcal Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546572

B1851024

6115A1-3005

Details and patient eligibility

About

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.

Enrollment: 938 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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938 participants in 2 patient groups

1

Experimental group

Description:

Receives 13vPnC at year 0 and 13vPnC at year 1

Treatment:

Biological: 13 valent Pneumococcal Conjugate Vaccine

2

Active Comparator group

Description:

Receives 23vPS at year 0 and 13vPnC at year 1

Treatment:

Biological: 23vPS