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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Biological: Prevenar; Biological: Meningitec; Biological: Prevenar and Meningitec

Study type: Interventional

Funder types: Industry

Identifiers

NCT00581035

6114A1-500

Details and patient eligibility

About

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

Enrollment: 712 patients

Sex: All

Ages: 42 to 63 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy infants aged 6 to 9 weeks

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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712 participants in 3 patient groups

1

Experimental group

Description:

Prevenar and Meningitec

Treatment:

Biological: Prevenar and Meningitec

2

Experimental group

Description:

Prevenar

Treatment:

Biological: Prevenar

3

Experimental group

Description:

Meningitec

Treatment:

Biological: Meningitec