At a glance
ClinicalIndex Comparison Record- ✓Male or female infants aged 6–12 weeks (42–90 days) at first vaccination
- ✓Free of obvious health problems on medical history and clinical examination
- ✓Born after gestation period of 36–42 weeks
- ✓Vaccinated against hepatitis B at birth
- ✕Chronic immunosuppressants or immune-modifying drugs since birth
- ✕Any chronic drug therapy to be continued during study
- ✕Any confirmed or suspected 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.
A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity (Including Immune Memory), Reactogenicity and Safety of Three Different Formulations of the GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups CY Conjugate Vaccine Given Concomitantly With Infanrix® Penta and Prevenar®, Versus ActHIB® and Meningitec® Given Concomitantly With Infanrix® Penta and Versus ActHIB® Given Concomitantly With Infanrix® Penta and Prevenar® in Infants According to a 2-4-6 Month Schedule.
In Brief
A Phase 2 clinical trial evaluating Hib-MenCY-TT vaccine (MenHibrix), Meningitec®, and 5 other interventions for Haemophilus Influenzae Type b and Neisseria Meningitidis. Completed, enrolled 409 participants across 3 sites.
Detailed Summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.
Study Details
Timeline
Interventions
Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Three doses were administered IM in right lower thigh at Months 0,2 and 4.
Three doses were administered IM in left thigh at Months 0,2 and 4.
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
One dose was administered IM in deltoid region of left arm at Month 10 as booster.