This trial is active, not recruiting.

Condition meningococcal disease; meningococcal meningitis
Treatment · meningococcal c conjugate vaccine; meningococcal a/c polysaccharide vaccine (partial dose)
Phase phase 4
Sponsor Chiron Corporation
Start date September 2003
Trial size 264 participants
Trial identifier NCT00262015, M14P2


The purpose of this study is to determine when a memory immune response after re-vaccination with Meningococcal C conjugate vaccine (Menjugate) or challenge with Meningococcal A/C polysaccharide vaccine can be observed, after initial vaccination with Meningococcal C conjugate vaccine during the UK immunization campaign

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

To measure immunological memory response to N. meningitidis serogroup C after those who received a partial dose of Meningococcal A/C Polysaccharide vaccine and in subjects who received a dose of Chiron Meningococcal C conjugate vaccine.
time frame:

Secondary Outcomes

To assess the immunological response to N. meningitidis serogroup C in those challenged with meningococcal A/C polysaccharide vaccine and in those who received a dose of Chiron Meningococcal C conjugate vaccine.
time frame:

Eligibility Criteria

Male or female participants from 13 years up to 15 years old.

Inclusion Criteria: - Healthy adolescents between and including 13-15 years of age, who provide written informed consent and who received one immunization with Chiron Meningococcal C Conjugate vaccine (Menjugate) during the UK immunization campaign and for which documentation can be provided. Exclusion Criteria: - Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

Additional Information

Official title A Phase IV, Single Center, Open-Label, Controlled, Randomized Study to Evaluate the Memory Response of Children Previously Vaccinated With Chiron Meningococcal C Conjugate Vaccine, Menjugate® and Describe the Kinetic of the Antibody Response and Maturation on Days 2-7 and 28 After Challenge With Pasteur Merieux Meningococcal A/C Polysaccharide Vaccine or Menjugate®
Principal investigator Andrew J. Pollard, MBBS, FRCPCH, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2005.
Information provided to ClinicalTrials.gov by Chiron Corporation.