Kinetics of B Cell Response in Infants Menjugate Vaccination

Prevention of Meningococcal Infection Clinical Trial

Official title:

A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the First and the Third Immunization With Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Infants at 2, 3 and 4 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310700
• Other study ID #: M14P5
• Secondary ID: Impact N° 145720
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2006
• Last updated: September 18, 2014
• Start date: May 2005
• Est. completion date: November 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

Kinetics of B cell response in infants Menjugate vaccination

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Weeks to 11 Weeks

Eligibility

Inclusion Criteria:

• healthy infants

Exclusion Criteria:

• previously ascertained or suspected disease caused by N. meningitidis

• previous household contact with an individual with a positive culture of N. meningitidis serogroup C

Study Design

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

Related Conditions & MeSH terms

• Meningococcal Infections
• Prevention of Meningococcal Infection

Intervention

Biological:
• Meningococcal C conjugate vaccine

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Kelly DF, Snape MD, Perrett KP, Clutterbuck EA, Lewis S, Blanchard Rohner G, Jones M, Yu LM, Pollard AJ. Plasma and memory B-cell kinetics in infants following a primary schedule of CRM 197-conjugated serogroup C meningococcal polysaccharide vaccine. Immunology. 2009 May;127(1):134-43. doi: 10.1111/j.1365-2567.2008.02934.x. Erratum in: Immunology. 2011 Apr;132(4):589. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.
Secondary	To establish how long the B cells persist in the blood
Secondary	To note the difference between plasma cell response following the first and third MenC vaccination.
Secondary	To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation