At a glance
ClinicalIndex Comparison Record- ✓Healthy infants without major congenital illness, immunosuppression, or chronic disease
- ✓Born at 36 to 42 weeks of gestation
- ✓Between 6 and 12 weeks of age at enrollment
- ✓Vaccinated against hepatitis B at birth
- ✕Prior receipt of investigational drug or vaccine
- ✕Prior receipt of chronic immunosuppressants
- ✕Prior receipt of immunoglobulin or blood products
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Three Different Formulations of GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals' Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta, Versus MeningitecTM, Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule
In Brief
A Phase 2 clinical trial evaluating Hib-MenCY-TT vaccine, Hib-MenC-TT vaccine, and 3 other interventions for Haemophilus Influenzae Type b and Neisseria Meningitidis. Completed, enrolled 388 participants across 26 sites in 2 countries.
Detailed Summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
Study Details
Timeline
Interventions
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.