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Trial record 58 of 126 for:    HSV-2

HerpeVac Trial for Young Women

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ClinicalTrials.gov Identifier: NCT00057330
Recruitment Status : Completed
First Posted : April 1, 2003
Results First Posted : November 3, 2011
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition Herpes Simplex Infection
Interventions Biological: HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine
Biological: Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine
Enrollment 8323
Recruitment Details 8323 subjects were enrolled and vaccinated (4577 in the Herpes Simplex Virus Group and 3746 in the Havrix Group). Out of these, 7850 subjects were followed throughout the entire study, e. a. for safety and adverse event assessment (4488 in the Herpes Simplex Virus Group and 3662 in the Havrix Group).
Pre-assignment Details  
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule. Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Period Title: Overall Study
Started 4577 3746
Completed 3445 2826
Not Completed 1132 920
Reason Not Completed
Adverse Event             9             12
Death             1             0
Protocol Violation             1             1
Withdrawal by Subject             115             84
Lost to Follow-up             745             617
Physician Decision             1             0
Other             260             206
Arm/Group Title Herpes Simplex Virus Group Havrix Group Total
Hide Arm/Group Description Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule. Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule. Total of all reporting groups
Overall Number of Baseline Participants 4577 3746 8323
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4577 participants 3746 participants 8323 participants
22.3  (3.30) 22.3  (3.23) 22.3  (3.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4577 participants 3746 participants 8323 participants
Female
4577
 100.0%
3746
 100.0%
8323
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2
Hide Description Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.
Time Frame Between Months 2 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol cohort for analysis of efficacy (Months 2-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 2 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 3798 3076
Measure Type: Number
Unit of Measure: Subjects
35 35
2.Secondary Outcome
Title Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2
Hide Description Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.
Time Frame Between Months 7 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol cohort for analysis of efficacy (Months 7-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 3 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 3273 2622
Measure Type: Number
Unit of Measure: Subjects
18 22
3.Secondary Outcome
Title Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion.
Hide Description The number of subjects with newly acquired HSV-2 infection confirmed by either virus culture or HSV-2 seroconversion was tabulated. Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.
Time Frame Between Months 2 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol cohort for analysis of efficacy (Months 2-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 2 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 3798 3076
Measure Type: Number
Unit of Measure: Subjects
62 46
4.Secondary Outcome
Title Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion
Hide Description The number of subjects with newly acquired HSV-2 infection confirmed by either virus culture or HSV-2 seroconversion was tabulated. Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.
Time Frame Between Months 7 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol cohort for analysis of efficacy (Months 7-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 3 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 3273 2622
Measure Type: Number
Unit of Measure: Subjects
40 35
5.Secondary Outcome
Title Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.
Hide Description Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EU/mL). The seroprotection cut-off of the assay was 40 EU/mL
Time Frame At Months 0, 2, 6, 7, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (meeting eligibility criteria, complying with protocol-defined procedures and not meeting either the infection or disease criteria on or prior to Month 7) for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 641 223
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Anti-gD GMCs at Month 0
21.52
(20.77 to 22.29)
20.62
(19.94 to 21.32)
Anti-gD GMCs at Month 2
3575
(3256 to 3925)
21.39
(20.33 to 22.51)
Anti-gD GMCs at Month 6
681.3
(622.1 to 746.2)
21.58
(20.42 to 22.81)
Anti-gD GMCs at Month 7
6809
(6344 to 7309)
21.50
(20.36 to 22.71)
Anti-gD GMCs at Month 12
1805
(1667 to 1955)
21.14
(19.89 to 22.48)
Anti-gD GMCs at Month 16
1025
(941.9 to 1115)
20.10
(19.90 to 20.30)
Anti-gD GMCs at Month 20
769.1
(704.1 to 840.0)
20.60
(19.65 to 21.61)
6.Secondary Outcome
Title Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.
Hide Description Titers for Anti-HSV neutralizing antibodies are presented as Geometric Mean Titers (GMTs), and are expressed in Estimated Doses (ED), that is, the reciprocal of the dilution necessary to achieve neutralization. Antibody titers below the lowest level of quantification were not calculated .
Time Frame At Months 0, 2, 6, 7, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (meeting eligibility criteria, complying with protocol-defined procedures and not meeting either the infection or disease criteria on or prior to Month 7) for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 641 223
Geometric Mean (95% Confidence Interval)
Unit of Measure: ED
Anti-HSV GMTs at Month 0
2.09
(2.04 to 2.14)
2.06
(2.00 to 2.12)
Anti-HSV GMTs at Month 2
7.57
(6.86 to 8.34)
NA [1] 
(NA to NA)
Anti-HSV GMTs at Month 6
2.42
(2.31 to 2.54)
NA [1] 
(NA to NA)
Anti-HSV GMTs at Month 7
28.27
(26.59 to 30.06)
2.10
(2.00 to 2.21)
Anti-HSV GMTs at Month 12
8.40
(7.63 to 9.24)
2.02
(1.99 to 2.05)
Anti-HSV GMTs at Month 16
4.72
(4.32 to 5.16)
2.03
(1.98 to 2.08)
Anti-HSV GMTs at Month 20
3.65
(3.37 to 3.96)
2.11
(2.01 to 2.22)
[1]
Antibody titers below the lowest level of quantification were not calculated.
7.Secondary Outcome
Title Number of Subjects Reporting Solicited Local and General Symptoms
Hide Description

Solicited local symptoms assessed were pain, redness and swelling.

Solicited general symptoms assessed were fatigue, headache, malaise and fever (defined as oral/axillary/tympanic temperature equal to or above 37.5 degrees Celsius).

Time Frame Within 7 days (Days 0-6) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 4488 3662
Measure Type: Number
Unit of Measure: Subjects
Pain 3902 2559
Redness 1621 702
Swelling 1371 438
Fatigue 2031 1503
Headache 1885 1456
Malaise 1459 1003
Fever 400 260
8.Secondary Outcome
Title Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Hide Description

Solicited local symptoms assessed were pain, redness and swelling.

Grade 3 pain = pain that prevented normal activities.

Grade 3 redness/swelling = redness/swelling above 30 mm and persisting for more than 24 hours

Time Frame Within 7 days (Days 0-6) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 4488 3662
Measure Type: Number
Unit of Measure: Subjects
Grade 3 Pain 307 67
Grade 3 Redness 40 2
Grade 3 Swelling 82 4
9.Secondary Outcome
Title Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms
Hide Description

Solicited general symptoms assessed were fatigue, headache, malaise and fever (oral/axillary/tympanic).

Grade 3 headache, fatigue, malaise = symptom that prevented normal activities.

Grade 3 fever = temperature above 39.0 degrees Celsius.

Related = symptom assessed by the investigator as causally related to the vaccination

Time Frame Within 7 days (Days 0-6) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 4488 3662
Measure Type: Number
Unit of Measure: Subjects
Grade 3 Fatigue 225 146
Fatigue related to vaccination 1776 1286
Grade 3 Headache 175 126
Headache related to vaccination 1523 1171
Grade 3 Malaise 199 121
Malaise related to vaccination 1225 816
Grade 3 Fever 17 7
Fever related to vaccination 295 198
10.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Hide Description Unsolicited AEs have been tabulated for a 31-day period. An unsolicited AE was any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Time Frame Within 31 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 4488 3662
Measure Type: Number
Unit of Measure: Subjects
2154 1677
11.Secondary Outcome
Title Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Hide Description NOCDs included adverse events (AEs) as autoimmune disorders, asthma, type I diabetes, allergies. MSCs included AEs prompting emergency room or physician visits unrelated to common diseases or routine visits for physical examination or vaccination, or SAEs unrelated to common diseases. SAEs included medical occurrences either life-threatening, requiring hospitalization, or resulting in death, disability/incapacity or congenital anomaly/birth defect in a subject’s offspring. Common diseases included upper respiratory infections (URIs), sinusitis, pharyngitis, gastroenteritis, urinary tract infection, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. The following were not reported if not considered as SAEs and occurring more than 30 days post vaccination: URIs, sinusitis, pharyngitis, gastroenteritis, injury, or visits for routine physical examination or vaccination. AEs are described, using Medical Dictionary for Regulatory Activities’ preferred terms.
Time Frame Throughout the study (From Month 0 up to Month 20)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 4488 3662
Measure Type: Number
Unit of Measure: Subjects
NOCDs/MSCs/SAEs 208 182
Asthma 14 16
Abortion spontaneous 24 13
Hypothyroidism 7 11
Appendicitis 5 9
Hypoesthesia 3 6
Suicide attempt 0 7
Ovarian cyst 0 4
Meningitis viral 0 3
Dehydration 0 3
Depression 6 3
Suicidal ideation 0 3
Nephrolithaiasis 0 3
Premature labor 0 4
Pyelonephritis 0 3
Pyrexia 3 0
Pneumonia 3 0
Road traffic accident 4 0
Skin laceration 3 0
Abortion missed 4 0
Abortion spontaneous complete 4 0
Bipolar disorder 5 0
Depression suicidal 3 0
Crohn's disease 0 3
Hyperemesis gravidarum 0 3
Hyperthyroidism 0 3
12.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in a subject’s offspring.
Time Frame Throughout the study (From Month 0 up to Month 20)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description:
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 4488 3662
Measure Type: Number
Unit of Measure: Subjects
171 132
Time Frame Solicited local and general symptoms: during the 7-day (Day 0-6) follow-up period after vaccination. Unsolicited adverse events: during the 31 days following vaccination period. Serious adverse events: from Month 0 up to Month 20
Adverse Event Reporting Description Related SAEs were reported for 6 and 5 subjects in the Herpes Simplex Virus and Havrix groups, respectively. 1 fatal SAE was reported for 1 subject in the Herpes Simplex Virus Group, and assessed by the investigator as not related to vaccination.
 
Arm/Group Title Herpes Simplex Virus Group Havrix Group
Hide Arm/Group Description Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule. Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
All-Cause Mortality
Herpes Simplex Virus Group Havrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Herpes Simplex Virus Group Havrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   171/4488 (3.81%)   132/3662 (3.60%) 
Blood and lymphatic system disorders     
Idiopathic thrombocytopenic purpura * 1 [1]  0/4488 (0.00%)  2/3662 (0.05%) 
Anaemia * 1 [1]  0/4488 (0.00%)  1/3662 (0.03%) 
Cardiac disorders     
Tachycardia * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Congenital, familial and genetic disorders     
Arnold-chiari malformation * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Heart disease congenital * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Endocrine disorders     
Hypothyroidic goitre * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Eye disorders     
Conjunctivitis * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Retinal detachment * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Retinal vein occlusion * 1 [1]  0/4488 (0.00%)  1/3662 (0.03%) 
Visual impairment * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Gastrointestinal disorders     
Gastrooesophageal reflux disease * 1  0/4488 (0.00%)  2/3662 (0.05%) 
Vomiting * 1 [2]  2/4488 (0.04%)  0/3662 (0.00%) 
Abdominal adhesions * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Abdominal pain * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Abdominal pain lower * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Appendix disorder * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Crohn’s disease * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Gastric ulcer * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Nausea * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Pancreatitis * 1  0/4488 (0.00%)  1/3662 (0.03%) 
General disorders     
Pyrexia * 1  3/4488 (0.07%)  1/3662 (0.03%) 
Chest pain * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Asthenia * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Death neonatal * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Sudden death * 1 [3]  1/4488 (0.02%)  0/3662 (0.00%) 
Hepatobiliary disorders     
Bile duct stone * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Cholecystitis * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Cholecystitis acute * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Cholelithiasis * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Gallbladder disorder * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Hyperbilirubinaemia * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Immune system disorders     
Anaphylactic reaction * 1  2/4488 (0.04%)  1/3662 (0.03%) 
Drug hypersensitivity * 1  2/4488 (0.04%)  1/3662 (0.03%) 
Hypersensitivity * 1 [1]  1/4488 (0.02%)  1/3662 (0.03%) 
Infections and infestations     
Appendicitis * 1  5/4488 (0.11%)  9/3662 (0.25%) 
Infectious mononucleosis * 1 [1]  2/4488 (0.04%)  2/3662 (0.05%) 
Meningitis viral * 1  1/4488 (0.02%)  3/3662 (0.08%) 
Pneumonia * 1  3/4488 (0.07%)  1/3662 (0.03%) 
Pyelonephritis * 1  0/4488 (0.00%)  3/3662 (0.08%) 
Appendicitis perforated * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Cellulitis * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Fitz-hugh-curtis syndrome * 1  0/4488 (0.00%)  2/3662 (0.05%) 
Gastroenteritis * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Gastroenteritis salmonella * 1  0/4488 (0.00%)  2/3662 (0.05%) 
Gastroenteritis viral * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Malaria * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Pyelonephritis acute * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Tonsillitis * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Urinary tract infection * 1  0/4488 (0.00%)  2/3662 (0.05%) 
Acute tonsillitis * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Chlamydial cervicitis * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Chorioamnionitis * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Clostridium difficile colitis * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Corneal abscess * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Enterocolitis infectious * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Kidney infection * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Localised infection * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Meningitis * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Pelvic inflammatory disease * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Peritonsillar abscess * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Pharyngitis * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Pharyngitis streptococcal * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Pneumococcal bacteraemia * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Pneumonia bacterial * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Pneumonia pneumococcal * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Sinusitis * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Staphylococcal infection * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Staphylococcal sepsis * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Tick-borne fever * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Toxic shock syndrome * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Upper respiratory tract infection * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Vaginal abscess * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Wound infection * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Injury, poisoning and procedural complications     
Road traffic accident * 1  4/4488 (0.09%)  2/3662 (0.05%) 
Ankle fracture * 1  2/4488 (0.04%)  1/3662 (0.03%) 
Skin laceration * 1  3/4488 (0.07%)  0/3662 (0.00%) 
Concussion * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Multiple injuries * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Overdose * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Spinal fracture * 1  0/4488 (0.00%)  2/3662 (0.05%) 
Accident * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Acetabulum fracture * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Alcohol poisoning * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Contusion * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Facial bones fracture * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Fibula fracture * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Foot fracture * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Hand fracture * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Head injury * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Injury * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Joint dislocation * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Joint sprain * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Lower limb fracture * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Multiple fractures * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Patella fracture * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Post procedural haemorrhage * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Respiratory fume inhalation disorder * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Rib fracture * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Spinal compression fracture * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Splenic rupture * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Tendon rupture * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Traumatic liver injury * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Upper limb fracture * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Wound dehiscence * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Investigations     
Blood pressure increased * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Hepatic enzyme increased * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/4488 (0.02%)  3/3662 (0.08%) 
Hypokalaemia * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Hyponatraemia * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Hypovolaemia * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Water intoxication * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Compartment syndrome * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Systemic lupus erythematosus * 1 [2]  1/4488 (0.02%)  0/3662 (0.00%) 
Tendonitis * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma * 1  2/4488 (0.04%)  1/3662 (0.03%) 
Acute myeloid leukaemia * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Basal cell carcinoma * 1  0/4488 (0.00%)  2/3662 (0.05%) 
Adenocarcinoma of the cervix * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Breast cancer * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Neoplasm malignant * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Neurofibrosarcoma recurrent * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Pituitary tumour benign * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Teratoma * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Thyroid cancer * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Uterine leiomyoma * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Vulval cancer * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Nervous system disorders     
Abortion spontaneous * 1 [4]  24/4488 (0.53%)  13/3662 (0.35%) 
Migraine * 1  1/4488 (0.02%)  2/3662 (0.05%) 
Convulsion * 1  0/4488 (0.00%)  2/3662 (0.05%) 
Cerebral cyst * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Complicated migraine * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Dizziness * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Epilepsy * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Headache * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Loss of consciousness * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Nerve compression * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Ophthalmoplegic migraine * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Paraesthesia * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Stupor * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Syncope * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Transient ischaemic attack * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Tremor * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Pregnancy, puerperium and perinatal conditions     
Abortion missed * 1  4/4488 (0.09%)  1/3662 (0.03%) 
Abortion spontaneous complete * 1  4/4488 (0.09%)  1/3662 (0.03%) 
Premature labour * 1  1/4488 (0.02%)  3/3662 (0.08%) 
Abortion spontaneous incomplete * 1 [2]  1/4488 (0.02%)  2/3662 (0.05%) 
Hyperemesis gravidarum * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Pre-eclampsia * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Premature separation of placenta * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Abortion threatened * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Ectopic pregnancy * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Foetal growth retardation * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Oligohydramnios * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Pregnancy induced hypertension * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Stillbirth * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Psychiatric disorders     
Depression * 1  6/4488 (0.13%)  3/3662 (0.08%) 
Suicide attempt * 1  2/4488 (0.04%)  6/3662 (0.16%) 
Bipolar disorder * 1  4/4488 (0.09%)  2/3662 (0.05%) 
Suicidal ideation * 1  1/4488 (0.02%)  3/3662 (0.08%) 
Bipolar i disorder * 1  2/4488 (0.04%)  1/3662 (0.03%) 
Depression suicidal * 1  3/4488 (0.07%)  0/3662 (0.00%) 
Psychotic disorder * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Agitation * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Anxiety * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Bipolar ii disorder * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Drug dependence * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Mental status changes * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Schizophrenia * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Renal and urinary disorders     
Nephrolithiasis * 1  2/4488 (0.04%)  3/3662 (0.08%) 
Calculus urinary * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Glomerulonephritis minimal lesion * 1 [2]  1/4488 (0.02%)  0/3662 (0.00%) 
Nephritis * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Nephropathy * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Renal failure acute * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Renal haemorrhage * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Ureteral polyp * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Ureteric obstruction * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Reproductive system and breast disorders     
Ovarian cyst * 1  1/4488 (0.02%)  4/3662 (0.11%) 
Ovarian cyst ruptured * 1  2/4488 (0.04%)  1/3662 (0.03%) 
Endometriosis * 1  2/4488 (0.04%)  0/3662 (0.00%) 
Haemorrhagic ovarian cyst * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Menorrhagia * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Ovarian haemorrhage * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Pelvic pain * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Vaginal haemorrhage * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  2/4488 (0.04%)  2/3662 (0.05%) 
Asthma * 1  1/4488 (0.02%)  1/3662 (0.03%) 
Dyspnoea * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Dyspnoea exertional * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Hypoventilation * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Pneumothorax * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Skin and subcutaneous tissue disorders     
Lichen sclerosus * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Surgical and medical procedures     
Prophylaxis against hiv infection * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Removal of foreign body * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Vascular disorders     
Deep vein thrombosis * 1  2/4488 (0.04%)  1/3662 (0.03%) 
Hypertension * 1  0/4488 (0.00%)  2/3662 (0.05%) 
Hypotension * 1  1/4488 (0.02%)  0/3662 (0.00%) 
Phlebitis * 1  0/4488 (0.00%)  1/3662 (0.03%) 
Thrombosis * 1  1/4488 (0.02%)  0/3662 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
This SAE was assessed the investigators as related to study vaccination for one subject in the Havrix Group.
[2]
This SAE was assessed the investigators as related to study vaccination for one subject in the Herpes Simplex Virus Group.
[3]
This SAE was fatal and assessed by the investigators as not related to study vaccination.
[4]
This SAE was assessed the investigators as related to vaccination for 2 and one subjects in the Herpes Simplex Virus and Havrix groups, respectively.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Herpes Simplex Virus Group Havrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4133/4488 (92.09%)   3061/3662 (83.59%) 
General disorders     
Pain  1  3902/4488 (86.94%)  2559/3662 (69.88%) 
Redness  1  1621/4488 (36.12%)  702/3662 (19.17%) 
Swelling  1  1371/4488 (30.55%)  438/3662 (11.96%) 
Fatigue  1  2031/4488 (45.25%)  1503/3662 (41.04%) 
Headache  1  1885/4488 (42.00%)  1456/3662 (39.76%) 
Malaise  1  1459/4488 (32.51%)  1003/3662 (27.39%) 
Fever  1  400/4488 (8.91%)  260/3662 (7.10%) 
Infections and infestations     
Upper respiratory tract infection * 1  2154/4488 (47.99%)  1677/3662 (45.79%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Out of the 8323 subjects enrolled and vaccinated, 7850 subjects were followed throughout the study, e. a. for safety and adverse event assessment (4488 in the Herpes Simplex Virus Group and 3662 in the Havrix Group).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00057330     History of Changes
Other Study ID Numbers: 208141/039
208141/039 ( Other Identifier: GSK )
First Submitted: March 31, 2003
First Posted: April 1, 2003
Results First Submitted: September 29, 2011
Results First Posted: November 3, 2011
Last Update Posted: August 27, 2018