Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine
A Phase III, Double-blind, Randomized, Study to Compare: 1) the Immunogenicity and Safety of 3 Commercial Scale Consistency Lots of GlaxoSmithKline (GSK) Biologicals' Herpes Simplex Candidate Vaccine in Healthy HSV-1 and -2 Seronegative (HSV 1-/2-) Female Subjects Aged 10 - 17 Years, and 2) Vaccine Immunogenicity in Healthy HSV 1-/2- Females Aged 10 - 17 Years With Healthy HSV 1-/2- Adult Females
1 other identifier
interventional
671
3 countries
13
Brief Summary
Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2003
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 21, 2005
CompletedFirst Posted
Study publicly available on registry
September 23, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedSeptember 21, 2016
September 1, 2016
1.8 years
September 21, 2005
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-gD antibody titre in the entire cohort (10-17 yrs)
At month 7
Secondary Outcomes (10)
Anti-gD antibody titre
At months 2 and 12
Anti-HSV neutralizing antibodies
At months 2, 7 and 12
Occurrence and intensity of solicited local symptoms. Resulting school absenteeism will also be evaluated.
Within 7 days after each vaccination
Occurrence, intensity, relationship to vaccination and resulting school absenteeism of solicited general symptoms
Within 7 days after each vaccination
Occurrence, intensity, relationship to vaccination and resulting school absenteeism of unsolicited adverse events
Within 30 days after any vaccination
- +5 more secondary outcomes
Study Arms (3)
Group A
EXPERIMENTALGroup B
EXPERIMENTALGroup C
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination.
- Seronegative for HSV-1 and HSV-2 at screening
- 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.
- Subject must have a negative urine pregnancy test.
- Subject must be of non-childbearing potential, i.e. pre-menarcheal, or if of childbearing potential she must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination, have a negative urine pregnancy test 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.
- A subject who (or whose parents/guardian) the investigator believes can and will comply with the requirements of the protocol
You may not qualify if:
- Pregnant or lactating female.
- Female planning to become pregnant during the first eight months of the study
- Any previous history of, or current clinical signs or symptoms of oro-labial (cold sores), genital or non-genital HSV disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, pain, burning, itching, tingling, or dysuria.
- Previous vaccination against herpes.
- History of erythema multiforme.
- Use of any investigational or non-registered 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.
- Planned administration/administration of a non-study vaccine within 30 days before and 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 the first dose of study vaccine is allowed.
- 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, including human immunodeficiency virus (HIV) infection.
- History of a current acute or chronic autoimmune disease.
- 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 medical history or physical examination.
- Acute disease at the time of enrolment
- Oral temperature ≥99.5°F (\> 37.5°C) / axillary temperature ≥99.5°F (\> 37.5°C) 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 or planned use during the study period
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (13)
GSK Investigational Site
Mesa, Arizona, 85201, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Golden, Colorado, 80401, United States
GSK Investigational Site
Cincinnati, Ohio, 45229, United States
GSK Investigational Site
Charleston, South Carolina, 29403, United States
GSK Investigational Site
Galveston, Texas, 77555-0188, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
Seattle, Washington, 98105, United States
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Edmonton, Alberta, T6G 2C8, Canada
GSK Investigational Site
Vancouver, British Columbia, V6H 3N1, Canada
GSK Investigational Site
Beauport, Quebec, G1E 7G9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2005
First Posted
September 23, 2005
Study Start
December 1, 2003
Primary Completion
September 1, 2005
Study Completion
January 1, 2006
Last Updated
September 21, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.