NCT00129116

3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 388 (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 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.

Detailed description

Primary \& booster vaccination study to evaluate the immuno,reacto \& safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C \& Y-conjugate vaccine \& one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule

Conditions

• Haemophilus Influenzae Type b
• Neisseria Meningitidis

Interventions

Type	Name	Description
BIOLOGICAL	Hib-MenCY-TT vaccine	Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
BIOLOGICAL	Hib-MenC-TT vaccine	Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
BIOLOGICAL	Menjugate ®	Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
BIOLOGICAL	Infanrix penta ®	Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
BIOLOGICAL	Infanrix hexa ®	Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Timeline

• Start date: 2003-03-01
• Primary completion: 2003-12-01
• Completion: 2003-12-16
• First posted: 2005-08-11
• Last updated: 2018-08-27
• Results posted: 2012-07-23

Locations

26 sites across 2 countries: Belgium, Germany