Kinetic of Immune Memory Response After Re-Vaccination With Meningococcal Vaccine

Meningococcal Disease; Meningococcal Meningitis Clinical Trial

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®

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00262015
• Other study ID #: M14P2
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 2, 2005
• Last updated: December 2, 2005
• Start date: September 2003

Study information

• Verified date: December 2005
• Source: Chiron Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 264
• Gender: Both
• Age group: 13 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis, Meningococcal
• Meningococcal Disease; Meningococcal Meningitis
• Meningococcal Infections

Intervention

Biological:
• · Meningococcal C conjugate vaccine; Meningococcal A/C Polysaccharide vaccine (partial dose)

Locations

Country	Name	City	State
United Kingdom	University of Oxford, The Oxford Vaccine Group	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Chiron Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.