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

PHASE3CompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

December 11, 2003

Primary Completion Date

October 23, 2004

Study Completion Date

October 23, 2004

Conditions
DiphtheriaHepatitis BWhole Cell PertussisHaemophilus Influenzae Type bTetanus
Interventions
BIOLOGICAL

Tritanrix-HepB/Meningitec conjugate vaccine

The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection

BIOLOGICAL

Tritanrix/Hiberix vaccine

The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.

Trial Locations (1)

1781

GSK Investigational Site, City of Muntinlupa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY