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

December 21, 2007
December 26, 2007
January 2006
Not Provided
The pneumococcal and meningococcal responses achieved after the infant series [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00581035 on ClinicalTrials.gov Archive Site
The pneumococcal and meningococcal responses achieved after the toddler dose [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Safety and Ability to Produce Immune Response of Prevenar and Meningitec Given at the Same Time
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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy
  • 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
  • Biological: Prevenar
    1 dose at 2,3.5,6 and 12 months
  • Biological: Meningitec
    1 dose at 2,6 and 12 months
  • Experimental: 1
    Prevenar and Meningitec
    Intervention: Biological: Prevenar and Meningitec
  • Experimental: 2
    Prevenar
    Intervention: Biological: Prevenar
  • Experimental: 3
    Meningitec
    Intervention: Biological: Meningitec
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
712
May 2007
Not Provided

Inclusion Criteria:

  • Healthy infants aged 6 to 9 weeks
Both
42 Days to 63 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00581035
6114A1-500
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP