13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India

Pfizer

Status and phase: Completed; Phase 4

Conditions: Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC

Treatments: Procedure: Blood sample collection; Biological: 13-valent Pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02034877

B1851140

2014-001174-34 (EudraCT Number)

Details and patient eligibility

About

This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.

Enrollment: 1,200 patients

Sex: All

Ages: 6 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.

Exclusion criteria

Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine within the last year

Trial design

1,200 participants in 1 patient group

1

Experimental group

Treatment:

Procedure: Blood sample collection

Biological: 13-valent Pneumococcal conjugate vaccine