---
title: Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
nct_id: NCT00698087
overall_status: COMPLETED
phase: PHASE3
sponsor: GlaxoSmithKline
study_type: INTERVENTIONAL
primary_condition: Hepatitis B
countries: Austria
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00698087.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00698087"
ct_last_update_post_date: 2008-06-16
last_seen_at: "2026-05-12T07:26:11.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

**Official Title:** Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

**NCT ID:** [NCT00698087](https://clinicaltrials.gov/study/NCT00698087)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** GlaxoSmithKline
- **Conditions:** Hepatitis B
- **Start Date:** 1995-01
- **Completion Date:** 1996-02
- **CT.gov Last Update:** 2008-06-16

## Brief Summary

The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary

## Detailed Description

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 40 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Between 18 and 40 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

Exclusion Criteria:

* Pregnancy or lactation.
* Positive titres for anti hepatitis B antibodies
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL.
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Simultaneous administration of any other vaccine(s).
* Administration of any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial
```

## Arms

- **Group A** (EXPERIMENTAL)
- **Group B** (ACTIVE_COMPARATOR)
- **Group C** (EXPERIMENTAL)

## Interventions

- **MPL-Adjuvanted recombinant hepatitis B vaccine** (BIOLOGICAL) — Intramuscular injection, 2 or 3 doses, 2 different formulations
- **Engerix™-B** (BIOLOGICAL) — Intramuscular injection, 2 or 3 doses

## Primary Outcomes

- **Anti-HBs antibody concentrations** _(time frame: At M3 and M13)_
- **Occurrence of local and general solicited symptoms** _(time frame: 4-day follow-up after vaccination)_
- **Occurrence of unsolicited symptoms** _(time frame: 30-day follow-up after vaccination)_

## Secondary Outcomes

- **SAEs** _(time frame: Throughout the study up to 30 days after last vaccination)_
- **Anti-HBs antibody concentrations** _(time frame: Months 2, 3, 6, 9, 12, 13)_

## Locations (1)

- GSK Clinical Trials Call Center, Vienna, Austria

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.gsk clinical trials call center|vienna||austria` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00698087.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00698087*  
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