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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00316654
Enrollment
489
Registered
2006-04-21
Start date
2005-02-28
Completion date
2005-10-31
Last updated
2017-07-25

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, child, antibody persistence

Brief summary

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

Interventions

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
Novartis Vaccines
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Months to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA

Secondary

MeasureTime frame
Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
safety and tolerability

Countries

Poland, Spain

Outcome results

None listed

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