Persistence of Immune Response After Vaccination With MCC

Prevention of Meningococcal Infection Clinical Trial

Official title:

A Phase IV, Single Centre, Open-label Study to Evaluate the Persistence of Antibodies in Adolescents 14-16 Years of Age, Vaccinated With Chiron Meningococcal C Conjugate Vaccine During the 1999-2001 UK MenCC Immunization Campaign, at One Year After Either a Challenge Dose of Aventis Pasteur MSD Meningococcal A/C Polysaccharide Vaccine or a Booster Dose of MenC Vaccine, in Parallel to Subjects Aged 11-20 Evaluated at 4 Years After Vaccination During the 1999-2001 UK MenCC Immunization Campaign

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310687
• Other study ID #: M14P2E1
• Secondary ID: Impact N° 919
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2006
• Last updated: September 18, 2014
• Start date: October 2004
• Est. completion date: December 2005

Study information

• Verified date: September 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

Persistence of Immune response after vaccination with MCC

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1244
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 20 Years

Eligibility

Inclusion Criteria:

• healthy adolescents vaccinated with Meningococcal C Conjugate vaccine

Exclusion Criteria:

• ascertained or suspected disease caused by N. meningitidis

• household contact with individuals with proven N. meningitidis serogroup C infection

• significant acute or chronic infections

• any other serious disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Infections
• Prevention of Meningococcal Infection

Intervention

Procedure:
• BLOOD DRAW

Locations

Country	Name	City	State
United Kingdom	Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital	Headington	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	persistence of memory response to N. meningitidis serogroup C as measured by serum bactericidal activity at one year after either a challenge with 1/5 of a dose of Meningococcal A/C Polysaccharide vaccine or a booster dose of MenC Vaccine.
Secondary	Evaluation and comparison of the persistence of antibodies against N. meningitidis serogroup C as measured by hBCA
Secondary	Evaluation of the immunological response (ELISA) to N. meningitidis serogroup C