Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00696917
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Biological: HBV-MPL vaccine 208129 Biological: Engerix™-B |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms [ Time Frame: Full course of vaccination ]
- Incidence of serious adverse events [ Time Frame: Study period ]
- Anti-HBs antibody concentrations [ Time Frame: At Month 7 ]
Secondary Outcome Measures:
- Occurrence and intensity of solicited local signs and symptoms [ Time Frame: 4-day after vaccination ]
- Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms [ Time Frame: 4-day after vaccination ]
- Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms [ Time Frame: 30 days after vaccination ]
- Occurrence and relationship to vaccination of SAEs [ Time Frame: During the study period ]
- Anti-HBs antibody concentrations [ Time Frame: At Months 1, 2, 6 and 7 ]
| Enrollment: | 1303 |
| Study Start Date: | April 1999 |
| Primary Completion Date: | February 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group A
Three doses according to 0, 1, 6-month schedule
|
Biological: Engerix™-B
3-dose intramuscular injection
|
|
Experimental: Group B
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
|
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
|
|
Experimental: Group C
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
|
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
|
|
Experimental: Group D
Two doses according to 0, 6-month schedule, with a placebo injection at Month 1
|
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
|
Detailed Description:
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the subject and/or from the parent or guardian of the subject.
- If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine (s) during the study period or within 30 days preceding the first dose of study vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B.
- History of non-response to previous hepatitis B vaccination.
- Known exposure to hepatitis B within the past 6 weeks.
- History of hepatitis B infection.
- Confirmed human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrollment.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
- Pregnant or lactating female
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696917
Locations
| Australia, Victoria | |
| GSK Clinical Trials Call Center | |
| Parkville, Victoria, Australia, 3052 | |
| Czech Republic | |
| GSK Clinical Trials Call Center | |
| Hradec Kralové, Czech Republic | |
| Germany | |
| GSK Clinical Trials Call Center | |
| München, Germany | |
| Italy | |
| GSK Clinical Trials Call Center | |
| Bari, Italy | |
| Netherlands | |
| GSK Clinical Trials Call Center | |
| Utrecht, Netherlands | |
| Switzerland | |
| GSK Clinical Trials Call Center | |
| Lausanne, Switzerland | |
| United Kingdom | |
| GSK Clinical Trials Call Center | |
| London, United Kingdom | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Isabelle Harpigny, GSK |
| ClinicalTrials.gov Identifier: | NCT00696917 History of Changes |
| Other Study ID Numbers: | 208129/031 |
| Study First Received: | June 11, 2008 |
| Last Updated: | June 11, 2008 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
Keywords provided by GlaxoSmithKline:
|
Hepatitis B Adjuvanted Hepatitis B vaccine Recombinant Hepatitis B vaccine |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on June 13, 2013