CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 756 enrolled
Drug / intervention
GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine +4 morebiological
Likely dose
GSK HibMenCYTT: 3 IM doses in primary phase, 1 IM dose booster; ActHIB: 3 IM doses in primary phase, 1 IM dose booster; Pediarix: 3 IM doses; Prevnar: 3 IM doses in primary phase, 1 IM dose booster; Menomune: 1 SC dose (Group C)AI-extracted
Key inclusion· 5
  • ✓Healthy male or female infants aged 6-12 weeks at first vaccination (Groups A and B)
  • ✓Born after gestation period of 36-42 weeks (Groups A and B)
  • ✓Free of obvious health problems on medical history and clinical examination (Groups A and B)
  • ✓Healthy male or female aged 3-5 years at vaccination (Group C)
Key exclusion· 11
  • ✕Any confirmed or suspected immunosuppressive or immunodeficient condition on history and examination (Groups A, B, and C)
  • ✕History of allergic disease or reactions likely to be exacerbated by vaccine components, including latex (Groups A, B, and C)
  • ✕Major congenital defects or serious chronic illness (Groups A, B, and C)
  • ✕History of neurologic disorders or seizures (Groups A and B)

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

Search/NCT00129129
NCT00129129Phase 2Completed
CompareCT.gov

Evaluate Immuno and Safety of GSKBiologicals' HibMenCYTT vs Licensed Hib Conjugate Vaccine, Each Coadministered With Pediarix® and Prevnar®, in Healthy Infants. An Exploratory Control Group Will Receive Licensed Menomune® at 3 to 5 Years

GlaxoSmithKline·interventional·Posted Aug 11, 2005·Updated Aug 24, 2018

In Brief

A Phase 2 clinical trial evaluating GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine, ActHIB, and 3 other interventions for Haemophilus Influenzae Type b and Neisseria Meningitidis. Completed, enrolled 756 participants across 27 sites.

Detailed Summary

This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age. The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHaemophilus Influenzae Type b, Neisseria Meningitidis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2005
Enrollment StartAug 1, 2004
Primary CompletionSep 15, 2005
Study CompletionMar 29, 2006
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.9 years ago

Interventions

GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccinebiological

Primary phase: 3 IM doses Booster phase: 1 IM dose

ActHIBbiological

Primary phase: 3 IM doses Booster phase: 1 IM dose

Pediarixbiological

Primary phase: 3 IM doses

Prevnarbiological

Primary phase: 3 IM doses Booster phase: 1 IM dose

Menomunebiological

Primary phase: 1 SC dose