Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

Wyeth

Status and phase

Completed

Phase 3

Conditions

Pneumococcal Vaccines

Treatments

Biological: 13 valent Pneumococcal Conjugate Vaccine

Biological: 23-valent Pneumococcal Polysaccharide Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00574548

B1851027

6115A1-3010

Details and patient eligibility

About

The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.

Enrollment

720 patients

Sex

All

Ages

60 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or Female, aged 60 to 64 years.
Healthy.

Exclusion criteria

Previous vaccination with any licensed or experimental pneumococcal vaccine.
History of severe adverse reaction associated with a vaccine.
Immunodeficiency.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

720 participants in 3 patient groups

Group 1.1

Experimental group

Description:

Group 1.1 = 13vPnC then 13vPnC

Treatment:

Biological: 13 valent Pneumococcal Conjugate Vaccine

Group 1.2

Experimental group

Description:

Group 1.2 = 13vPnC then 23vPS

Treatment:

Biological: 23-valent Pneumococcal Polysaccharide Vaccine

Biological: 13 valent Pneumococcal Conjugate Vaccine

Group 2

Experimental group

Description:

Group 2 = 23vPS then 13vPnC

Treatment:

Biological: 23-valent Pneumococcal Polysaccharide Vaccine

Biological: 13 valent Pneumococcal Conjugate Vaccine

Trial contacts and locations

6

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