Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00224484
First received: September 21, 2005
Last updated: October 10, 2013
Last verified: April 2013
  Purpose

Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Hepatitis A
Biological: GSK208141
Biological: HavrixTM (investigational formulation)
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Herpes Simplex Candidate Vaccine (gD2‑AS04) in Healthy HSV Seronegative and Seropositive Female Subjects Aged 10-17 Years.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of Serious Adverse Events (SAEs). [ Time Frame: Up to Month 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of solicited general and local symptoms [ Time Frame: Within 7 days after each and any vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity, causal relationship to vaccination and resulting school or work absenteeism of unsolicited symptoms. [ Time Frame: Within 30 days after any vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of new onset chronic diseases and other medically significant conditions regardless of causal relationship to vaccination and intensity. [ Time Frame: Throughout the study period ] [ Designated as safety issue: Yes ]
  • Occurrence of abnormality in biochemical and haematological parameters assessed in a subset of study subjects. [ Time Frame: At months 0, 7 and 12 ] [ Designated as safety issue: Yes ]
  • Anti-gD antibody titres assessed in a subset of study subjects. [ Time Frame: At months 0, 7 and 12 ] [ Designated as safety issue: No ]
  • Anti-adjuvant antibody titres assessed in a subset of subjects. [ Time Frame: At months 0, 7 and 12 ] [ Designated as safety issue: No ]
  • Occurrence of SAEs, new onset chronic diseases and other medically significant conditions [ Time Frame: Up to month 18 ] [ Designated as safety issue: Yes ]

Enrollment: 5960
Study Start Date: April 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Herpes Simplex Biological: GSK208141
3 IM doses
Other Name: Herpes simplex vaccine
Active Comparator: Group Havrix Biological: HavrixTM (investigational formulation)
3 IM doses
Placebo Comparator: Group Saline Biological: Placebo
3 IM doses

Detailed Description:

Three groups of females (3000, 1500 and 1500 subjects, respectively) were injected 3 times (at months 0, 1 and 6) with the herpes simplex vaccine, the HavrixTM vaccine (control) and a Saline solution (placebo), respectively. Subjects were followed over 18 months.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study.
  • Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination.
  • Written informed assent obtained from the subject and written informed consent obtained from a parent or legal guardian of the subject prior to enrolment. If the subject is above the legal age of consent in her country, written informed consent will only be obtained from the subject.
  • Subjects must have a negative urine pregnancy test.
  • Subjects of childbearing potential at the time of study entry must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or likely to become pregnant during the first eight months of the study (months 0-8).
  • Any previous confirmed history of, or current clinical signs or symptoms of, oro labial herpes (cold sores), herpetic whitlow or genital herpes disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, dysuria or pain, burning, itching, tingling in the ano-genital area.
  • History of previous or planned vaccination against hepatitis A or a history of hepatitis A infection.
  • Previous vaccination against herpes.
  • History of herpetic keratitis.
  • History of multiform erythema.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of study vaccine with the following exceptions: administration of routine meningococcal, hepatitis B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before and 30 days after the first dose of study vaccine.
  • History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
  • History of a current acute or chronic autoimmune disease.
  • History of any neurological 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
  • Acute disease at the time of enrolment
  • Oral temperature >= 37.5°C (99.5°F) / axillary temperature >= 37.5°C (99.5°F) at the time of enrolment.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224484

  Show 152 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00224484     History of Changes
Other Study ID Numbers: 208141/040
Study First Received: September 21, 2005
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Herpes Simplex vaccine
Safety
Adolescents
Immunogenicity

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Herpes Simplex
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014