NCT00134719

Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,104 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

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.

Detailed description

The study will be conducted in 2 stages: a 3-dose primary vaccination at 2, 4 and 6 months of age and a booster vaccination at 12 to 15 months of age. All subjects will have 3 blood samples taken. Half of the subjects of each group will have a blood sample taken just prior to the administration of the third dose of the primary vaccination and the other half of the subjects of each group will have a blood sample taken at one month after the third vaccine dose of the primary vaccination phase. In addition, all subjects of all groups will have a blood sample taken before and 42 days after administration of the booster dose.

Conditions

• Neisseria Meningitidis
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	MenHibrix (Hib-MenCY-TT)	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)
BIOLOGICAL	Infanrix® Penta	One intramuscular dose at 2, 4 and 6 months of age
BIOLOGICAL	Prevenar®	One intramuscular dose at 2, 4 and 6 months of age
BIOLOGICAL	ActHIB®	One intramuscular dose at 2, 4 and 6 months of age
BIOLOGICAL	Meningitec®	One intramuscular dose at 2, 4 and 6 months of age
BIOLOGICAL	M-M-R®II	One subcutaneous dose at 12-15 months of age
BIOLOGICAL	Varivax®	One subcutaneous dose at 12 to 15 months of age
BIOLOGICAL	PedvaxHIB®	One intramuscular dose at 12 to 15 months of age

Timeline

• Start date: 2005-04-11
• Primary completion: 2006-07-24
• Completion: 2007-02-21
• First posted: 2005-08-25
• Last updated: 2018-07-19
• Results posted: 2012-07-20

Locations

3 sites across 1 country: Australia