NCT00441012

Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)

A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus Influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 546 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 40 Days – 80 Days
• Healthy volunteers: Accepted

Summary

To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine

Conditions

• Haemophilus Influenzae Type B
• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Comparator: Modified Process Vaccine	Modified process vaccine HBsAg 5 ug/0.5 mL and PRP \[OMPC\] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 \& 12 months of age. Duration of treatment is 11 months.
BIOLOGICAL	Comparator: COMVAX™	COMVAX™ HBsAg 5 ug/0.5 mL and PRP \[OMPC\] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-02-27
• Last updated: 2015-03-19
• Results posted: 2009-07-10