Trial intelligence / Profile preview

Nimenrix Booster Study in Toddlers

NCT00614614Phase 3

Key facts

Status: Completed
Start: Feb 2008
Primary completion: Jul 2009
Countries: 1
Sponsor: GSK
Modality: Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics

Drugs: meningococcal group A, C, W135 and Y conjugate vaccine
Conditions: meningococcal infection

Overview

Phase 3, randomised, open-label trial of meningococcal group A, C, W135 and Y conjugate vaccine in meningococcal infection (4 arms), sponsored by GSK. Primary endpoints: Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A, C, W-135, and Y at Month 14, Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY at Month 14 and 2 more. Started Feb 2008; status: completed.

Design

4 arms

Study design: RandomizedOpen-label

Nimenrix 1 Group
Menhibrix primary -> Nimenrix (12-15m) -> Infanrix (15-18m)
Menhibrix 2 Group
Menhibrix primary -> Menhibrix (12-15m) -> Infanrix (15-18m)
Nimenrix 2 Group
Menhibrix primary -> Nimenrix + Infanrix (15-18m)
ActHIB-Infanrix Group
ActHIB primary -> Infanrix (15-18m)

Who it enrols

Healthy male or female toddlers between 6 and 12 weeks of age at first vaccination, born after 36 weeks gestation. Exclusion criteria include previous vaccination against Neisseria meningitidis or Hib, history of allergic disease, major congenital defects, or chronic administration of immunosuppressants.

Endpoints

Primary

Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A, C, W-135, and YMonth 14
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenYMonth 14
Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody ConcentrationsMonth 14
Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRNMonth 14

Secondary

Solicited Local Adverse EventsDay 0-7 post-vaccination
Solicited General Adverse EventsDay 0-7 post-vaccination
Unsolicited Adverse EventsDay 0-30 post-vaccination
Serious Adverse EventsMonth 0 to Month 19-22
New Onset of Chronic Illness (NOCI)Month 0 to Month 19-22

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