Who is sponsoring NCT00317174?

NCT00317174 is sponsored by GlaxoSmithKline.

What condition does NCT00317174 study?

NCT00317174 studies Haemophilus Influenzae Type b, Tetanus, Whole Cell Pertussis, Hepatitis B, Diphtheria.

What drugs are being tested in NCT00317174?

Interventions: DTPw-HBV/Hib-MenAC conjugate vaccine.

What is the status of NCT00317174?

NCT00317174 is currently COMPLETED.

Last reviewed 2016-09-08 · How we verify

Assess Immune Persistence & Memory by Giving Plain PRP,PSA & PSC (10 Mths Age), & Immunogenicity & Safety of a Tritanrix™-HBV/Hib-MenAC/ Tritanrix™-HBV/Hib2.5 Booster (15-18 Mths Age) in Previously Primed Subjects

NCT00317174 Phase 2 COMPLETED

The purpose of the study is as follows: * To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001) by giving unconjugated PRP, PSA and PSC at 10 months age to one subset of subjects. * To evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to Tritanrix™-HepB/Hib2.5 vaccine or Tritanrix™-HepB/Hib-MenAC vaccine at 15-18 months age in the other subset of subjects.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	COMPLETED
Enrolment	450
Start date	2003-07
Completion	2004-04

Conditions

Haemophilus Influenzae Type b
Tetanus
Whole Cell Pertussis
Hepatitis B
Diphtheria

Interventions

DTPw-HBV/Hib-MenAC conjugate vaccine

Primary outcomes

Pre & 1M post-plain PS, antibody levels & bactericidal titers (meningococcal serogroups A & C). Pre & 1M post-DTP booster, antibody levels for all vaccine antigens.

Countries

Philippines