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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00581035
First received: December 21, 2007
Last updated: December 26, 2007
Last verified: December 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Biological: Prevenar and Meningitec
Biological: Prevenar
Biological: Meningitec
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • The pneumococcal and meningococcal responses achieved after the infant series [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The pneumococcal and meningococcal responses achieved after the toddler dose [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

Enrollment: 712
Study Start Date: January 2006
Study Completion Date: May 2007
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   42 Days to 63 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants aged 6 to 9 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581035

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581035     History of Changes
Other Study ID Numbers: 6114A1-500
Study First Received: December 21, 2007
Last Updated: December 26, 2007
Health Authority: Poland: Ministry of Health

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Meningococcal disease
pneumococcal disease
meningitis

ClinicalTrials.gov processed this record on May 22, 2013