Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

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

Completed

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Key information

Conditions

Meningitis, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Meningitis Meningitis, Bacterial Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

7 week–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy infants 7-10 weeks of age eligible to receive routine immunization

Treatment and study plan

Meningococcal C

Biological

DTP/Hib

Biological

Primary outcomes

Antibody responses to MnCC and concomitant vaccines

Secondary outcomes

Safety and reactogenicity

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start: 1997
Primary completion: 1998
Study completion: 1998
First posted: Apr 12, 2006
Registry last updated: Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed