Study Evaluating the Safety and Ability to Produce Immune Response of Prevenar and Meningitec Given at the Same Time

Wyeth is now a wholly owned subsidiary of Pfizer712 enrolled

Overview

The purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

712

Conditions

Healthy

Interventions

Prevenar and MeningitecBIOLOGICAL

1 dose of Prevenar at 2,3.5,6 and 12 months and 1 dose of Meningitec at 2,6 and 12 months

PrevenarBIOLOGICAL

1 dose at 2,3.5,6 and 12 months

MeningitecBIOLOGICAL

1 dose at 2,6 and 12 months

Eligibility

Sex: ALLMin age: 42 DaysMax age: 63 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy infants aged 6 to 9 weeks

Outcomes

Primary Outcomes

The pneumococcal and meningococcal responses achieved after the infant series

Time frame: 7 months

Secondary Outcomes

The pneumococcal and meningococcal responses achieved after the toddler dose

Time frame: 13 months

Data from ClinicalTrials.gov

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