Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal

Treatments: Biological: 13-valent pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708682

6096A1-3009

Details and patient eligibility

About

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.

Enrollment: 225 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone
• Able to complete three blood draws during study
• At least 3.5 kg at enrollment

Exclusion criteria

• Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
• Immune deficiency, bleeding disorder or significant chronic medical condition

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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225 participants in 1 patient group

A

Experimental group

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine