Trial intelligence / Profile preview

Tritanrix-HepB/Hib-MenAC vaccine immunogenicity and safety in infants

NCT00290303Phase 3

Key facts

Status: Completed
Start: May 2004
Primary completion: Mar 2005
Countries: 1
Sponsor: GSK
Modality: Split/Subunit Vaccines

Drugs: Tritanrix-HepB/Hib-MenAC
Conditions: diphtheriaTetanuspertussishepatitis B (HBV)Haemophilus influenzae type b infection (Hib)

Overview

Phase 3, randomised trial of Tritanrix-HepB/Hib-MenAC in diphtheria, Tetanus, pertussis and 3 more (4 arms), sponsored by GSK. Primary endpoints: Serum bactericidal antibody titers against meningococcal serogroup A, Serum bactericidal antibody titers against meningococcal serogroup C and 5 more. Started May 2004; status: completed.

Design

4 arms

Study design: Randomized

Arm 1 (HBsAg- mothers)
Tritanrix-HepB/Hib-MenAC + HepB at birth
Arm 2 (HBsAg- mothers)
Tritanrix-HepB/Hib-MenAC
Arm 3 (HBsAg- mothers, Control)
Tritanrix-HepB/Hiberix
Arm 4 (HBsAg+ mothers)
Tritanrix-HepB/Hib-MenAC + HepB at birth

Who it enrols

Healthy infants aged 3 days or less, born after 36-42 weeks of gestation, whose mothers have a known Hepatitis B status. Excludes infants with immunodeficiencies, major congenital defects, neurologic disorders, or recent receipt of blood products.

Endpoints

Primary

Serum bactericidal antibody titers against meningococcal serogroup AOne month post-dose 3
Serum bactericidal antibody titers against meningococcal serogroup COne month post-dose 3
Anti-polyribosylribitol phosphate antibody concentrationsOne month post-dose 3
Anti-hepatitis B surface antigen antibody concentrationsOne month post-dose 3
Anti-diphtheria antibody concentrationsOne month post-dose 3

Secondary

Solicited local and general adverse eventsDays 0-3 post-vaccination
Unsolicited adverse eventsDays 0-30 post-vaccination
Serious Adverse EventsEntire study

Beyond the preview

Go deeper on NCT00290303.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00290303.