NCT00127855

Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 409 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Haemophilus Influenzae Type b
• Neisseria Meningitidis

Interventions

Type	Name	Description
BIOLOGICAL	Hib-MenCY-TT vaccine (MenHibrix)	Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
BIOLOGICAL	Meningitec®	Three doses were administered IM in right lower thigh at Months 0,2 and 4.
BIOLOGICAL	ActHIB®	Three doses were administered IM in left thigh at Months 0,2 and 4.
BIOLOGICAL	Infanrix® Penta	Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
BIOLOGICAL	Prevenar®	Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
BIOLOGICAL	Mencevax® ACWY	One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
BIOLOGICAL	PRP (Polyribosyl Ribitol Phosphate)	One dose was administered IM in deltoid region of left arm at Month 10 as booster.

Timeline

• Start date: 2003-03-01
• Primary completion: 2004-02-01
• Completion: 2004-02-12
• First posted: 2005-08-09
• Last updated: 2018-08-27
• Results posted: 2012-07-23

Locations

3 sites across 1 country: Australia