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NCT00316654 Clinical Trial

Persistence of Antibody Response to N. Meningitidis Group C in Children

Prevention of Meningococcal Infection Clinical Trial

Official title:
A Phase IV,Multi-Center,Open-Label,Unrandomized Study to Evaluate the Persistence of Antibody Response to N.Meningitidis Group C,Before & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00316654
Other study ID # V14P38E1
Secondary ID 2004-001522-24
Status Completed
Phase Phase 4
First received April 19, 2006
Last updated July 21, 2017
Start date February 2005
Est. completion date October 2005

Study information
Verified date July 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Persistence of Antibody Response to N. meningitidis Group C in Children

Recruitment information / eligibility
Status Completed
Enrollment 489
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Months and older
Eligibility Inclusion Criteria:

- healthy children

Exclusion Criteria:

- previous ascertained or suspected disease caused by N. meningitidis

- previous significant acute or chronic infections

- any other serious disease

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Meningococcal C conjugate vaccine

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Novartis Vaccines GlaxoSmithKline

Countries where clinical trial is conducted

Poland,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
Secondary Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
Secondary safety and tolerability
See also
  Status Clinical Trial Phase
Completed NCT00310674 - Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of Age Phase 3
Completed NCT00311415 - Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children Phase 3
Completed NCT00310687 - Persistence of Immune Response After Vaccination With MCC Phase 4
Completed NCT00310700 - Kinetics of B Cell Response in Infants Menjugate Vaccination Phase 4
Completed NCT00310713 - Persistence of Antibodies and Kinetics of B Cell Response in Healthy Children After Vaccination With MCC Vaccine Phase 4