CompletedPhase 3

Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m

Thailand617 participantsStarted 2006-01-22

Plain-language summary

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.

Who can participate

Age range427 Days – 730 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Healthy male or female between and including 15 and 24 months of age * Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480) Exclusion criteria: * Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480). * History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition. * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.

What they're measuring

Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value

Timeframe: One month Post-Booster vaccination at 15-24 months of age

Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value

Timeframe: One Month Post-Booster vaccination at 15-24 months of age

Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value

Timeframe: One Month Post-Booster vaccination at 15-24 months of age

Trial details

NCT IDNCT00136604

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-04-23

Results submitted2017-04-13

View on ClinicalTrials.gov More Whole Cell Pertussis trials

Plain-language summary

Who can participate

Age range427 Days – 730 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value

Timeframe: One month Post-Booster vaccination at 15-24 months of age

Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value

Timeframe: One Month Post-Booster vaccination at 15-24 months of age

Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value

Timeframe: One Month Post-Booster vaccination at 15-24 months of age