Study to Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15

NCT00697775 Phase 2 COMPLETED

In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	COMPLETED
Enrolment	200
Start date	1998-03

Conditions

• Hepatitis B

Interventions

• HBV-MPL vaccine Formulation A
• HBV-MPL vaccine Formulation B
• Engerix™-B

Primary outcomes

• Occurrence of Serious adverse experiences (SAE) — During the study period
• Occurrence, intensity and relationship to vaccination of solicited local and general symptoms — During the 8-day follow-up period after vaccination
• Occurrence, intensity and causal relationship of unsolicited adverse events — 31-day follow-up period after vaccination

Countries

Germany