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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Biological: Prevenar; Biological: Meningitec; Biological: Prevenar and Meningitec

• Registration Number: NCT00581035
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study Completion: 2007-05
• Status Verified: 2007-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-26
• Last Update Submitted: 2007-12-26
• Study First Posted: 2007-12-27
• Last Update Posted: 2007-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 712

Inclusion Criteria

• Healthy infants aged 6 to 9 weeks

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Prevenar	Prevenar
3	Meningitec	Meningitec
1	Prevenar and Meningitec	Prevenar and Meningitec

Primary Outcome Measures

Name	Time	Method
The pneumococcal and meningococcal responses achieved after the infant series	7 months

Secondary Outcome Measures

Name	Time	Method
The pneumococcal and meningococcal responses achieved after the toddler dose	13 months