CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,104 enrolled
Drug / intervention
MenHibrix (Hib-MenCY-TT) +7 morebiological
Likely dose
MenHibrix (Hib-MenCY-TT): one intramuscular dose at 2, 4, and 6 months of age, and one intramuscular dose at 12 to 15 months of ageAI-extracted
Key inclusion· 4
  • ✓Male or female infant aged 6–12 weeks at first vaccination
  • ✓Born after a gestation period of 36–42 weeks
  • ✓Free of obvious health problems on medical history and clinical examination
  • ✓Parent/guardian able and willing to comply with protocol requirements
Key exclusion· 11
  • ✕Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, or Streptococcus pneumoniae; more than one prior hepatitis B dose
  • ✕Any confirmed or suspected immunosuppressive or immunodeficient condition
  • ✕History of invasive disease from Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae, or varicella
  • ✕History of allergic disease or reactions likely to be exacerbated by vaccine components including natural latex rubber, tetanus toxoid, diphtheria toxoid, neomycin, or polymyxin

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

Search/NCT00134719
NCT00134719Phase 2Completed
CompareCT.gov

A Multicentre Primary & Booster Vaccination Study of GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine When Given According to the 2-4-6 Month Schedule to Healthy Infants With Booster Dose at 12 to 15 Months

GlaxoSmithKline·interventional·Posted Aug 25, 2005·Updated Jul 19, 2018

In Brief

A Phase 2 clinical trial evaluating MenHibrix (Hib-MenCY-TT), Infanrix® Penta, and 6 other interventions for Neisseria Meningitidis and Haemophilus Influenzae Type b. Completed, enrolled 1,104 participants across 3 sites.

Detailed Summary

This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeisseria Meningitidis, Haemophilus Influenzae Type b
CountriesAustralia
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 25, 2005
Enrollment StartApr 11, 2005
Primary CompletionJul 24, 2006
Study CompletionFeb 21, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.9 years ago

Interventions

MenHibrix (Hib-MenCY-TT)biological

One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B)

Infanrix® Pentabiological

One intramuscular dose at 2, 4 and 6 months of age

Prevenar®biological

One intramuscular dose at 2, 4 and 6 months of age

ActHIB®biological

One intramuscular dose at 2, 4 and 6 months of age

Meningitec®biological

One intramuscular dose at 2, 4 and 6 months of age

M-M-R®IIbiological

One subcutaneous dose at 12-15 months of age

Varivax®biological

One subcutaneous dose at 12 to 15 months of age

PedvaxHIB®biological

One intramuscular dose at 12 to 15 months of age