Persistence of Antibodies and Kinetics of B Cell Response in Healthy Children After Vaccination With MCC Vaccine

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 C Saccharide Component of Chiron's Meningococcal C Conjugate Vaccine Administered to Healthy Children at Least 12 Months of Age After Priming With a Commercially Available Men ACWY Conjugate Vaccine at 2, 3 and 4 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310713
• Other study ID #: M14P5E1
• Secondary ID: Impact N° 1637
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2006
• Last updated: September 18, 2014
• Start date: April 2006
• Est. completion date: August 2006

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 antibodies and kinetics of B cell response in healthy children after vaccination with MCC vaccine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 13 Months

Eligibility

Inclusion Criteria:

• Healthy children

Exclusion Criteria:

• Known hypersensitivity to any vaccine products

• Any immunodeficiency, genetic anomaly or severe acute or chronic illness

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
Group 1: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 3 post immunization) Group 2: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 5 post immunization) Group 3: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 7 post immunization) Group 4: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 9 post immunization) Group 5: Meningococcal C conjugate vaccine dose boost on Visit 6 (day 0), blood sample on Visit 7 (day 10 post immunization)

Locations

Country	Name	City	State
United Kingdom	Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road	Headington	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Blanchard Rohner G, Snape MD, Kelly DF, John T, Morant A, Yu LM, Borkowski A, Ceddia F, Borrow R, Siegrist CA, Pollard AJ. The magnitude of the antibody and memory B cell responses during priming with a protein-polysaccharide conjugate vaccine in human infants is associated with the persistence of antibody and the intensity of booster response. J Immunol. 2008 Feb 15;180(4):2165-73. Erratum in: J Immunol. 2011 May 15;186(10):6064. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence of memory B cells in the blood at least one year after primary immunisation with MenC Vaccine at 2, 3 and 4 months of age, as determined by meningococcal C specific B-cell ELISPot assay or limiting dilution
Secondary	Immune Response measured 4 weeks after the booster immunisation.
Secondary	establish at which day CRM -197 specific B cells are detectable in the blood after booster immunisation, as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.