Skip to content

Kinetics of B Cell Response in Infants Menjugate Vaccination

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00310700
Enrollment
75
Registered
2006-04-04
Start date
2005-05-31
Completion date
2005-11-30
Last updated
2014-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Meningococcal Infection

Keywords

Prevention of Meningococcal Meningitis, vaccines, conjugate, immunology, infant, antibody persistence

Brief summary

Kinetics of B cell response in infants Menjugate vaccination

Interventions

Sponsors

Novartis Vaccines
CollaboratorINDUSTRY
Novartis
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Weeks to 11 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To establish how long the B cells persist in the blood
To note the difference between plasma cell response following the first and third MenC vaccination.
To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026