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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:
ClinicalTrials.gov Identifier:
NCT00581035
First Posted: December 27, 2007
Last Update Posted: December 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   42 Days to 63 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants aged 6 to 9 weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581035     History of Changes
Other Study ID Numbers: 6114A1-500
First Submitted: December 21, 2007
First Posted: December 27, 2007
Last Update Posted: December 27, 2007
Last Verified: December 2007

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

Additional relevant MeSH terms:
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs