Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

Phase 3 Completed 500 enrolled GlaxoSmithKline

RandomizedParallel-groupPrevention

Summary

The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Timeline

Start: 2004-06-08
Primary completion: 2005-01-16
Completion: 2005-01-16

Publications

Kerdpanich A, Warachit B, Kosuwon P, Gatchalian SR, Watanaveeradej V, Borkird T, Kosalaraksa P, Han HH, Hutagalung Y, Boutriau D, Dobbelaere K. Primary vaccination with a new heptavalent DTPw-HBV/Hib-Neisseria meningitidis serogroups A and C combined vaccine is well tolerated. Int J Infect Dis. 2008 Jan;12(1):88-97. doi: 10.1016/j.ijid.2007.06.002. Epub 2007 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN	Vaccine	—	Intramuscular
Subject	Meningitec	Vaccine	—	Intramuscular
Background	Tritanrix-HepB	Vaccine	—	Intramuscular

Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

Summary

Timeline

Publications

Drugs

Indications