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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00224484




Registration number
NCT00224484
Ethics application status
Date submitted
21/09/2005
Date registered
23/09/2005
Date last updated
7/01/2019

Titles & IDs
Public title
Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
Scientific 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.
Secondary ID [1] 0 0
208141/040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Simplex 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - GSK208141
Other interventions - Havrix (investigational formulation)
Other interventions - Placebo

Experimental: GD2-AS04 GROUP - Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.

Active Comparator: HAVRIX GROUP - Female subjects aged 10-17 years, who received 3 doses of Havrix, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.

Placebo Comparator: SALINE GROUP - Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.


Other interventions: GSK208141
3 intramuscular doses

Other interventions: Havrix (investigational formulation)
3 intramuscular doses

Other interventions: Placebo
3 intramuscular doses

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Serious Adverse Events (SAEs) - Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Timepoint [1] 0 0
From Month 0 to Month 12
Secondary outcome [1] 0 0
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = greater than (>) 30mm diameter and persisting more than 24 hours.
Timepoint [1] 0 0
Within 7 days (Days 0-6) after each and any vaccination
Secondary outcome [2] 0 0
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Assessed solicited general symptoms were arthralgia, fatigue, headache, malaise, rash, temperature [defined as oral temperature equal to or above (=) 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 arthralgia, fatigue, headache, malaise, rash = general symptom that prevented normal activity. Grade 3 temperature = greater than 39 degrees Celsius (°C). Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = general symptom assessed by the investigator as causally related to the study vaccination.
Timepoint [2] 0 0
Within 7 days (Days 0-6) after each and any vaccination
Secondary outcome [3] 0 0
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) - An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = event which prevented normal, everyday activities. In adults/ adolescents, such an AE would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy. Related = event assessed by the investigator as causally related to study vaccination.
Timepoint [3] 0 0
Within 30 days (Day 0-29) after any vaccination
Secondary outcome [4] 0 0
Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits - An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. A medically attended visit is an event which prompted the subject to seek medical advice.
Timepoint [4] 0 0
Within the 30 Day (Day 0-29) post-vaccination period
Secondary outcome [5] 0 0
Number of Subjects With New Onset Chronic Diseases (NOCD) - NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Timepoint [5] 0 0
During the active phase (up to Month 12)
Secondary outcome [6] 0 0
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed - Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents ALT results.
Timepoint [6] 0 0
At months 7 and 12
Secondary outcome [7] 0 0
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed - Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents CREA results.
Timepoint [7] 0 0
At months 7 and 12
Secondary outcome [8] 0 0
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed - Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents Hct results.
Timepoint [8] 0 0
At months 7 and 12
Secondary outcome [9] 0 0
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed - Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents PLA results.
Timepoint [9] 0 0
At months 7 and 12
Secondary outcome [10] 0 0
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed - Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents RBC results.
Timepoint [10] 0 0
At months 7 and 12
Secondary outcome [11] 0 0
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed - Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents UREA results.
Timepoint [11] 0 0
At months 7 and 12
Secondary outcome [12] 0 0
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed - Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents WBC results.
Timepoint [12] 0 0
At months 7 and 12
Secondary outcome [13] 0 0
Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits - An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. A medically attended visit is an event which prompted the subject to seek medical advice.
Timepoint [13] 0 0
Starting from Day 30 until the end of study (Month 18)
Secondary outcome [14] 0 0
Number of Subjects With Medically Significant Conditions (MSC) - MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.
Timepoint [14] 0 0
During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)
Secondary outcome [15] 0 0
Number of Subjects With New Onset Chronic Diseases (NOCD) - NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.
Timepoint [15] 0 0
During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)
Secondary outcome [16] 0 0
Number of Subjects With Serious Adverse Events (SAEs) - Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.
Timepoint [16] 0 0
Up to month 18 (during active phase and ESFU period)
Secondary outcome [17] 0 0
Anti-glycoprotein D (Anti-gD) Antibody Concentrations - Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL). Analysis was based on an immunogenicity subset, stratified by initial serostatus: HSV seronegative (-)/ seropositive (+), this included gD2-AS04 vaccine recipients, as follows: HSV 1 and HSV 2 seronegative (HSV1-/2-) and HSV 1 seropositive and HSV 2 seronegative (HSV1+/2-)
Timepoint [17] 0 0
At months 0, 7 and 12
Secondary outcome [18] 0 0
Anti-deacylated Monophosphoryl Lipid A (Anti-MPL) Antibody Concentrations - Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL). The subset of subjects used for this analysis was 50% of the pre-defined subset of subjects that underwent assessment of biochemical and hematological parameters.
Timepoint [18] 0 0
At months 0, 7 and 12

Eligibility
Key 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.
Minimum age
10 Years
Maximum age
17 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [4] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [5] 0 0
GSK Investigational Site - Carlton
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
- Hobart
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
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United States of America
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Missouri
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
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United States of America
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Oregon
Country [18] 0 0
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Wisconsin
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Belgium
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Gent
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Belgium
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Wilrijk
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Aarhus N
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Château Renault
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France
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Derval
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France
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Evreux
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France
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Haute Goulaine
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France
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La Chapelle sur Erdre
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France
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Le Temple De Bretagne
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France
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Luynes
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France
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Nantes
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France
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Nort sur Erdre
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France
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Paris
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France
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Pont de L'Arche
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France
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Saint Aubin des Chateaux
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France
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Saint Avertin
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France
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Saint Sebastien sur Loire
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France
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Tours
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Greece
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Athens
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Greece
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Komotini
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Greece
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Thessaloniki
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Hungary
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Bordány
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Hungary
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Budapest
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Hungary
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Gyor
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Hungary
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Hódmezovásárhely
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Hungary
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Szeged
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Zsombó
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Gardabaer
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Iceland
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Kopavogur
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Iceland
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Reykjavik
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Lithuania
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Kaunas
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Lithuania
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Panevezys
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Lithuania
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Vilnius
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Netherlands
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Rotterdam
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New Zealand
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Christchurch
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Norway
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Bergen
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Norway
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Oslo
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Romania
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Bucharest
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Romania
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Bucuresti
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Spain
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Blanes
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Spain
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Castellon
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Spain
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Madrid
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Spain
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Montgat/Barcelona
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Spain
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Valencia
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Sweden
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Göteborg
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Sweden
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Karlskrona
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Sweden
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Linköping
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Sweden
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Malmö
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Sweden
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Umeå
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Sweden
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Örebro
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United Kingdom
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Hampshire
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United Kingdom
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Lancashire
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United Kingdom
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Warwickshire
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United Kingdom
State/province [83] 0 0
West Midlands
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Bradford
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Doncaster
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United Kingdom
State/province [86] 0 0
Leeds
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United Kingdom
State/province [87] 0 0
London
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00224484
Trial related presentations / publications
Tavares F, Cheuvart B, Heineman T, Arellano F, Dubin G. Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit herpes simplex virus vaccine. Vaccine. 2013 Mar 25;31(13):1759-64. doi: 10.1016/j.vaccine.2013.01.002. Epub 2013 Jan 10.
HSV-040 Study Group, Abu-Elyazeed RR, Heineman T, Dubin G, Fourneau M, Leroux-Roels I, Leroux-Roels G, Richardus JH, Ostergaard L, Diez-Domingo J, Poder A, Van Damme P, Romanowski B, Blatter M, Silfverdal SA, Berglund J, Josefsson A, Cunningham AL, Flodmark CE, Tragiannidis A, Dobson S, Olafsson J, Puig-Barbera J, Mendez M, Barton S, Bernstein D, Mares J, Ratner P. Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age: results from a randomised, controlled, double-blind trial. Vaccine. 2013 Dec 9;31(51):6136-43. doi: 10.1016/j.vaccine.2013.06.081. Epub 2013 Jul 9.
Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications