CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 801 enrolled
Drug / intervention
Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine +1 morebiological
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Healthy female and male adolescents aged 11-18 years
  • ✓In good health as determined by medical history, physical assessment, and clinical judgment of investigator
  • ✓Properly vaccinated against diphtheria, tetanus, and pertussis per local regulations, with any previous DTP-containing vaccination received at least 5 years before enrollment
  • ✓Any previous DTP vaccination must have been ≥5 years prior; no prior adolescent (11-18 years) DTP vaccines allowed
Key exclusion· 14
  • ✕Previous confirmed or suspected meningococcal disease
  • ✕Household contact or intimate exposure to culture-proven N. meningitidis infection within 60 days prior to enrollment
  • ✕Prior meningococcal vaccine or vaccine containing meningococcal antigen(s)
  • ✕Prior HPV vaccine

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01424644
NCT01424644Phase 4Completed
CompareCT.gov

A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine (Tdap, Boostrix®) and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine (Gardasil®) in Healthy Adolescents When Administered With MenACWY Conjugate Vaccine

Novartis·interventional·Posted Aug 29, 2011·Updated Feb 14, 2014

In Brief

A Phase 4 clinical trial evaluating Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine and MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine for Meningococcal Meningitis. Completed, enrolled 801 participants across 20 sites in 2 countries.

Detailed Summary

The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline, Boostrix®) and HPV vaccine (Merck \& Co., Inc., Gardasil®) when administered concomitantly with MenACWY are comparable to responses elicited by these vaccines when given alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Meningitis
CountriesItaly, United States
CollaboratorsNovartis Vaccines

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.8 years ago

Interventions

Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccinebiological

All three vaccines were administered concomitantly. Quadrivalent Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine is GARDASIL®. Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine(Tdap) is Boostrix®.

MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccinebiological

All three vaccines were administered concomitantly. MenACWY-CRM contains diphtheria-like toxoid as carrier for the capsular polysaccharides. Quadrivalent Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine is GARDASIL®. Reduced Diphtheria Toxoid,Acellular Pertussis Vaccine(Tdap) is Boostrix®.