CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 461 enrolled
Drug / intervention
Conjugated meningococcal ACWY-TT (vaccine) +4 morebiological
Likely dose
Conjugated meningococcal ACWY-TT vaccine — one intramuscular dose during primary vaccination; MenC-CRM197 or Mencevax ACWY — one dose (subcutaneous or intramuscular depending on age and study phase)AI-extracted
Key inclusion· 3
  • ✓Male or female aged 12-14 months or 3-5 years at first vaccination
  • ✓Completed routine childhood vaccinations; children 12-14 months must have received acellular pertussis vaccine
  • ✓Free of obvious health problems on medical history and clinical examination
Key exclusion· 12
  • ✕Prior vaccination against meningococcal serogroups A, C, W-135, or Y
  • ✕History of or known exposure to meningococcal serogroup A, C, W-135, or Y disease within previous year
  • ✕Immunosuppressive or immunodeficient condition including HIV infection
  • ✕Family history of congenital or hereditary immunodeficiency

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

Search/NCT00196976
NCT00196976Phase 2Completed
CompareCT.gov

Evaluate the Immunogenicity, Reactogenicity, Safety of 4 Different Formulations of GSK Biologicals' Conjugate Vaccine (MenACWY) vs 1 Dose of MenC-CRM197 or Mencevax™ ACWY in Children Aged 12-14 Months & 3-5 Years

GlaxoSmithKline·interventional·Posted Sep 20, 2005·Updated Jun 8, 2018

In Brief

A Phase 2 clinical trial evaluating Conjugated meningococcal ACWY-TT (vaccine), DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), and 3 other interventions for Infections, Meningococcal. Completed, enrolled 461 participants across 17 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesAustria, Greece
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartMar 24, 2005
Primary CompletionMar 1, 2006
Study CompletionMar 3, 2006
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 20.8 years ago

Interventions

Conjugated meningococcal ACWY-TT (vaccine)biological

One intramuscular dose during the primary vaccination

DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)biological

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)biological

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

Meningitec™biological

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age

Mencevax™ACWYbiological

One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)