Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00314041
First received: April 10, 2006
Last updated: February 20, 2013
Last verified: February 2013
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Purpose
Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines.
Booster phase: To compare the safety of and production of antibodies by MnCC with and without MMR and to compare the antibody response to that produced by a low dose of plain polysaccharide vaccine as a way of investigating immune memory
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis, Meningococcal |
Biological: Meningococcal C Biological: DTP/Hib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Randomized, Double-blind, Controlled, Active Comparator, Phase II Study to Assess the Tolerance and Immunogenicity of Conjugate Meningococcal C (MnCC) Vaccine in Infants When Administered in Conjunction With Primary DTP/Hib Vaccination at 2, 3, and 4 Months of Age. |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Antibody responses to MnCC and concomitant vaccines
Secondary Outcome Measures:
- Safety and reactogenicity
| Estimated Enrollment: | 240 |
| Study Start Date: | June 1997 |
| Study Completion Date: | April 1998 |
| Primary Completion Date: | April 1998 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 7 Weeks to 10 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy infants 7-10 weeks of age eligible to receive routine immunization
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314041
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 |
| Principal Investigator: | Trial Manager | For United Kingdom, ukmedinfo@wyeth.com |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00314041 History of Changes |
| Other Study ID Numbers: | 6029A1 D110 P500 |
| Study First Received: | April 10, 2006 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Infant Conjugate vaccine Meningococcal Antibody |
Immune memory Health Meningococcal Vaccines |
Additional relevant MeSH terms:
|
Meningitis Meningitis, Meningococcal Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Meningitis, Bacterial |
Central Nervous System Bacterial Infections Bacterial Infections Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections |
ClinicalTrials.gov processed this record on June 17, 2013