Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).

To Evaluate the Safety, Immunogenicity and Efficacy of GSK Biologicals' EBV Vaccine (268664) in Healthy Seronegative Adolescents/Adults When Injected Intramuscularly According to a 0-1-5 Month Schedule in Belgium.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00430534

Enrollment

200

Registered

2007-02-02

Start date

Unknown

Completion date

Unknown

Last updated

2007-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epstein Barr Virus (EBV) Infection

Keywords

Epstein Barr Virus, Belgium, Infectious mononucleosis

Brief summary

To evaluate the safety, immune-response and efficacy of GSK Biologicals' EBV vaccine in a population at risk of developing infectious mononucleosis. Each subject will receive three doses of vaccine or placebo during the study period.

Interventions

BIOLOGICALEBV vaccine (268664)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adolescent/adult subjects between and including 16 and 25 years of age at the time of screening. * Written informed consent obtained from the subject prior to enrolment. * Seronegative for EBV antibody.

Exclusion criteria

* Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period. * Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * Family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * History of intravenous drug abuse within the past 2 years. * Known or suspected allergy to any vaccine component.

Design outcomes

Primary

Measure	Time frame
Attack rates of infectious mononucleosis over 18 months after Dose 2	—

Secondary

Measure	Time frame
Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026