A Phase III, open, randomized, controlled, multicenter study to assess the immunogenicity and reactogenicity of GSK Biologicals' meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT) administered alone as compared to MenACWY-TT co-administered with a licensed viral vaccine or co-administered with a licensed viral vaccine and GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) (Boostrix) in female adolescents and young adults at 9-25 years of age.
Phase of Trial: Phase III
Latest Information Update: 11 Jul 2018
At a glance
- Drugs DTaP vaccine (Primary) ; Human papillomavirus vaccine recombinant bivalent Japan Vaccine/MedImmune (Primary) ; Meningococcal vaccine groups A C Y W-135 conjugate (Primary)
- Indications Cervical cancer; Diphtheria; Human papillomavirus infections; Meningococcal infections; Pertussis; Tetanus
- Focus Registrational; Therapeutic Use
- Acronyms MenACWY-TT-054
- Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals
- 29 May 2018 According to EudraCT record this trial was also planned in Brazil.
- 19 May 2018 Primary endpoint (Non-inferiority of MenACWY-TT coadministered with AS04-HPV16/18 compared to MenACWY-TT ) has been met, as per the results published in Vaccine.
- 19 May 2018 Primary endpoint (Non-inferiority of AS04-HPV16/18 coadministered with MenACWY-TT and Tdap compared to AS04-HPV16/18 co-administered with Tdap) has been met, as per the results published in Vaccine.