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

NCT ID: NCT00581035

Last Updated: 2007-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

712 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Healthy

Keywords

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Meningococcal disease pneumococcal disease meningitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Prevenar and Meningitec

Group Type EXPERIMENTAL

Prevenar and Meningitec

Intervention Type BIOLOGICAL

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

2

Prevenar

Group Type EXPERIMENTAL

Prevenar

Intervention Type BIOLOGICAL

1 dose at 2,3.5,6 and 12 months

3

Meningitec

Group Type EXPERIMENTAL

Meningitec

Intervention Type BIOLOGICAL

1 dose at 2,6 and 12 months

Interventions

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Prevenar and Meningitec

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

Intervention Type BIOLOGICAL

Prevenar

1 dose at 2,3.5,6 and 12 months

Intervention Type BIOLOGICAL

Meningitec

1 dose at 2,6 and 12 months

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy infants aged 6 to 9 weeks
Minimum Eligible Age

42 Days

Maximum Eligible Age

63 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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6114A1-500

Identifier Type: -

Identifier Source: org_study_id