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

December 26, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomised Open Label Phase 4 Study 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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

712

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy infants aged 6 to 9 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Prevenar and Meningitec
Biological: 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
Experimental: 2
Prevenar
Biological: Prevenar
1 dose at 2,3.5,6 and 12 months
Experimental: 3
Meningitec
Biological: Meningitec
1 dose at 2,6 and 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The pneumococcal and meningococcal responses achieved after the infant series
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The pneumococcal and meningococcal responses achieved after the toddler dose
Time Frame: 13 months
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

December 27, 2007

Study Record Updates

Last Update Posted (Estimate)

December 27, 2007

Last Update Submitted That Met QC Criteria

December 26, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6114A1-500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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