Trial Outcomes & Findings for HerpeVac Trial for Young Women (NCT NCT00057330)
NCT ID: NCT00057330
Last Updated: 2018-08-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
8323 participants
Primary outcome timeframe
Between Months 2 and 20
Results posted on
2018-08-27
Participant Flow
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).
Participant milestones
| Measure |
Herpes Simplex Virus Group
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.
|
Havrix Group
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 Study
STARTED
|
4577
|
3746
|
|
Overall Study
COMPLETED
|
3445
|
2826
|
|
Overall Study
NOT COMPLETED
|
1132
|
920
|
Reasons for withdrawal
| Measure |
Herpes Simplex Virus Group
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.
|
Havrix Group
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 Study
Adverse Event
|
9
|
12
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
115
|
84
|
|
Overall Study
Lost to Follow-up
|
745
|
617
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Other
|
260
|
206
|
Baseline Characteristics
HerpeVac Trial for Young Women
Baseline characteristics by cohort
| Measure |
Herpes Simplex Virus Group
n=4577 Participants
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.
|
Havrix Group
n=3746 Participants
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
n=8323 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.3 Years
STANDARD_DEVIATION 3.30 • n=5 Participants
|
22.3 Years
STANDARD_DEVIATION 3.23 • n=7 Participants
|
22.3 Years
STANDARD_DEVIATION 3.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4577 Participants
n=5 Participants
|
3746 Participants
n=7 Participants
|
8323 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between Months 2 and 20Population: 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.
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.
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=3798 Participants
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.
|
Havrix Group
n=3076 Participants
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.
|
|---|---|---|
|
Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2
|
35 Subjects
|
35 Subjects
|
SECONDARY outcome
Timeframe: Between Months 7 and 20Population: 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.
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.
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=3273 Participants
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.
|
Havrix Group
n=2622 Participants
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.
|
|---|---|---|
|
Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2
|
18 Subjects
|
22 Subjects
|
SECONDARY outcome
Timeframe: Between Months 2 and 20Population: 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.
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.
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=3798 Participants
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.
|
Havrix Group
n=3076 Participants
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.
|
|---|---|---|
|
Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion.
|
62 Subjects
|
46 Subjects
|
SECONDARY outcome
Timeframe: Between Months 7 and 20Population: 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.
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.
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=3273 Participants
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.
|
Havrix Group
n=2622 Participants
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.
|
|---|---|---|
|
Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion
|
40 Subjects
|
35 Subjects
|
SECONDARY outcome
Timeframe: At Months 0, 2, 6, 7, 12, 16 and 20Population: 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.
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
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=641 Participants
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.
|
Havrix Group
n=223 Participants
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.
|
|---|---|---|
|
Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.
Anti-gD GMCs at Month 0
|
21.52 EU/mL
Interval 20.77 to 22.29
|
20.62 EU/mL
Interval 19.94 to 21.32
|
|
Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.
Anti-gD GMCs at Month 2
|
3575 EU/mL
Interval 3256.0 to 3925.0
|
21.39 EU/mL
Interval 20.33 to 22.51
|
|
Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.
Anti-gD GMCs at Month 6
|
681.3 EU/mL
Interval 622.1 to 746.2
|
21.58 EU/mL
Interval 20.42 to 22.81
|
|
Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.
Anti-gD GMCs at Month 7
|
6809 EU/mL
Interval 6344.0 to 7309.0
|
21.50 EU/mL
Interval 20.36 to 22.71
|
|
Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.
Anti-gD GMCs at Month 12
|
1805 EU/mL
Interval 1667.0 to 1955.0
|
21.14 EU/mL
Interval 19.89 to 22.48
|
|
Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.
Anti-gD GMCs at Month 16
|
1025 EU/mL
Interval 941.9 to 1115.0
|
20.10 EU/mL
Interval 19.9 to 20.3
|
|
Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.
Anti-gD GMCs at Month 20
|
769.1 EU/mL
Interval 704.1 to 840.0
|
20.60 EU/mL
Interval 19.65 to 21.61
|
SECONDARY outcome
Timeframe: At Months 0, 2, 6, 7, 12, 16 and 20Population: 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.
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 .
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=641 Participants
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.
|
Havrix Group
n=223 Participants
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.
|
|---|---|---|
|
Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.
Anti-HSV GMTs at Month 0
|
2.09 ED
Interval 2.04 to 2.14
|
2.06 ED
Interval 2.0 to 2.12
|
|
Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.
Anti-HSV GMTs at Month 2
|
7.57 ED
Interval 6.86 to 8.34
|
NA ED
Antibody titers below the lowest level of quantification were not calculated.
|
|
Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.
Anti-HSV GMTs at Month 6
|
2.42 ED
Interval 2.31 to 2.54
|
NA ED
Antibody titers below the lowest level of quantification were not calculated.
|
|
Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.
Anti-HSV GMTs at Month 7
|
28.27 ED
Interval 26.59 to 30.06
|
2.10 ED
Interval 2.0 to 2.21
|
|
Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.
Anti-HSV GMTs at Month 12
|
8.40 ED
Interval 7.63 to 9.24
|
2.02 ED
Interval 1.99 to 2.05
|
|
Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.
Anti-HSV GMTs at Month 16
|
4.72 ED
Interval 4.32 to 5.16
|
2.03 ED
Interval 1.98 to 2.08
|
|
Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.
Anti-HSV GMTs at Month 20
|
3.65 ED
Interval 3.37 to 3.96
|
2.11 ED
Interval 2.01 to 2.22
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
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).
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=4488 Participants
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.
|
Havrix Group
n=3662 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Pain
|
3902 Subjects
|
2559 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Redness
|
1621 Subjects
|
702 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Swelling
|
1371 Subjects
|
438 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fatigue
|
2031 Subjects
|
1503 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Headache
|
1885 Subjects
|
1456 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Malaise
|
1459 Subjects
|
1003 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fever
|
400 Subjects
|
260 Subjects
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
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
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=4488 Participants
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.
|
Havrix Group
n=3662 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
307 Subjects
|
67 Subjects
|
|
Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
40 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
82 Subjects
|
4 Subjects
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
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
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=4488 Participants
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.
|
Havrix Group
n=3662 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
17 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
225 Subjects
|
146 Subjects
|
|
Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms
Fatigue related to vaccination
|
1776 Subjects
|
1286 Subjects
|
|
Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
175 Subjects
|
126 Subjects
|
|
Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms
Headache related to vaccination
|
1523 Subjects
|
1171 Subjects
|
|
Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms
Grade 3 Malaise
|
199 Subjects
|
121 Subjects
|
|
Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms
Malaise related to vaccination
|
1225 Subjects
|
816 Subjects
|
|
Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms
Fever related to vaccination
|
295 Subjects
|
198 Subjects
|
SECONDARY outcome
Timeframe: Within 31 days after vaccinationPopulation: The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
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.
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=4488 Participants
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.
|
Havrix Group
n=3662 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
2154 Subjects
|
1677 Subjects
|
SECONDARY outcome
Timeframe: Throughout the study (From Month 0 up to Month 20)Population: The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
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.
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=4488 Participants
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.
|
Havrix Group
n=3662 Participants
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.
|
|---|---|---|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
NOCDs/MSCs/SAEs
|
208 Subjects
|
182 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Asthma
|
14 Subjects
|
16 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Abortion spontaneous
|
24 Subjects
|
13 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Hypothyroidism
|
7 Subjects
|
11 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Appendicitis
|
5 Subjects
|
9 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Hypoesthesia
|
3 Subjects
|
6 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Suicide attempt
|
0 Subjects
|
7 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Ovarian cyst
|
0 Subjects
|
4 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Meningitis viral
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Dehydration
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Depression
|
6 Subjects
|
3 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Suicidal ideation
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Nephrolithaiasis
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Premature labor
|
0 Subjects
|
4 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Pyelonephritis
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Pyrexia
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Pneumonia
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Road traffic accident
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Skin laceration
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Abortion missed
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Abortion spontaneous complete
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Bipolar disorder
|
5 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Depression suicidal
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Crohn's disease
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Hyperemesis gravidarum
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)
Hyperthyroidism
|
0 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: Throughout the study (From Month 0 up to Month 20)Population: The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.
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.
Outcome measures
| Measure |
Herpes Simplex Virus Group
n=4488 Participants
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.
|
Havrix Group
n=3662 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
171 Subjects
|
132 Subjects
|
Adverse Events
Herpes Simplex Virus Group
Serious events: 171 serious events
Other events: 4133 other events
Deaths: 0 deaths
Havrix Group
Serious events: 132 serious events
Other events: 3061 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Herpes Simplex Virus Group
n=4488 participants at risk
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.
|
Havrix Group
n=3662 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Abortion spontaneous
|
0.53%
24/4488 • 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
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.
|
0.35%
13/3662 • 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
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.
|
|
Infections and infestations
Appendicitis
|
0.11%
5/4488 • 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
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.
|
0.25%
9/3662 • 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
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.
|
|
Psychiatric disorders
Depression
|
0.13%
6/4488 • 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
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.
|
0.08%
3/3662 • 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
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.
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
2/4488 • 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
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.
|
0.16%
6/3662 • 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
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.
|
|
Psychiatric disorders
Bipolar disorder
|
0.09%
4/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.09%
4/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.09%
4/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.09%
4/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.04%
2/4488 • 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
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.
|
0.08%
3/3662 • 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
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.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.02%
1/4488 • 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
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.
|
0.11%
4/3662 • 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
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.02%
1/4488 • 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
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.
|
0.08%
3/3662 • 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
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.
|
|
Infections and infestations
Infectious mononucleosis
|
0.04%
2/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Infections and infestations
Meningitis viral
|
0.02%
1/4488 • 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
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.
|
0.08%
3/3662 • 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
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.
|
|
Infections and infestations
Pneumonia
|
0.07%
3/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.02%
1/4488 • 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
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.
|
0.08%
3/3662 • 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
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.04%
2/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
General disorders
Pyrexia
|
0.07%
3/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
1/4488 • 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
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.
|
0.08%
3/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.02%
1/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Immune system disorders
Anaphylactic reaction
|
0.04%
2/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.04%
2/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Psychiatric disorders
Bipolar i disorder
|
0.04%
2/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.04%
2/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Psychiatric disorders
Depression suicidal
|
0.07%
3/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Immune system disorders
Drug hypersensitivity
|
0.04%
2/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.04%
2/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Nervous system disorders
Migraine
|
0.02%
1/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.04%
2/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4488 • 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
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.
|
0.08%
3/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.07%
3/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Appendicitis perforated
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Cellulitis
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
General disorders
Chest pain
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Fitz-hugh-curtis syndrome
|
0.00%
0/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Infections and infestations
Gastroenteritis
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Infections and infestations
Gastroenteritis viral
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Immune system disorders
Hypersensitivity
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Malaria
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Psychiatric disorders
Psychotic disorder
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Pyelonephritis acute
|
0.02%
1/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Infections and infestations
Tonsillitis
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4488 • 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
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.
|
0.05%
2/3662 • 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
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
2/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Accident
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Acute tonsillitis
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Psychiatric disorders
Agitation
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Psychiatric disorders
Anxiety
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Gastrointestinal disorders
Appendix disorder
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Congenital, familial and genetic disorders
Arnold-chiari malformation
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
General disorders
Asthenia
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Psychiatric disorders
Bipolar ii disorder
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Investigations
Blood pressure increased
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Nervous system disorders
Cerebral cyst
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Chlamydial cervicitis
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Chorioamnionitis
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Nervous system disorders
Complicated migraine
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Eye disorders
Conjunctivitis
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Corneal abscess
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
General disorders
Death neonatal
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Nervous system disorders
Dizziness
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Enterocolitis infectious
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Nervous system disorders
Epilepsy
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth retardation
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Renal and urinary disorders
Glomerulonephritis minimal lesion
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Nervous system disorders
Headache
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Vascular disorders
Hypotension
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Endocrine disorders
Hypothyroidic goitre
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Injury
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Localised infection
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Meningitis
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Renal and urinary disorders
Nephritis
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibrosarcoma recurrent
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Nervous system disorders
Ophthalmoplegic migraine
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Reproductive system and breast disorders
Ovarian haemorrhage
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Nervous system disorders
Paraesthesia
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Peritonsillar abscess
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Pharyngitis
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Pneumonia bacterial
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy induced hypertension
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Surgical and medical procedures
Prophylaxis against hiv infection
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Surgical and medical procedures
Removal of foreign body
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Eye disorders
Retinal detachment
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Sinusitis
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Staphylococcal infection
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Nervous system disorders
Stupor
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
General disorders
Sudden death
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Vascular disorders
Thrombosis
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Tick-borne fever
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Toxic shock syndrome
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Renal and urinary disorders
Ureteral polyp
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Infections and infestations
Vaginal abscess
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4488 • 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
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.
|
0.03%
1/3662 • 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
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Metabolism and nutrition disorders
Water intoxication
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
|
Infections and infestations
Wound infection
|
0.02%
1/4488 • 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
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.
|
0.00%
0/3662 • 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
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.
|
Other adverse events
| Measure |
Herpes Simplex Virus Group
n=4488 participants at risk
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.
|
Havrix Group
n=3662 participants at risk
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.
|
|---|---|---|
|
General disorders
Pain
|
86.9%
3902/4488 • 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
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.
|
69.9%
2559/3662 • 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
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.
|
|
General disorders
Redness
|
36.1%
1621/4488 • 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
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.
|
19.2%
702/3662 • 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
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.
|
|
General disorders
Swelling
|
30.5%
1371/4488 • 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
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.
|
12.0%
438/3662 • 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
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.
|
|
General disorders
Fatigue
|
45.3%
2031/4488 • 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
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.
|
41.0%
1503/3662 • 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
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.
|
|
General disorders
Headache
|
42.0%
1885/4488 • 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
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.
|
39.8%
1456/3662 • 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
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.
|
|
General disorders
Malaise
|
32.5%
1459/4488 • 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
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.
|
27.4%
1003/3662 • 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
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.
|
|
General disorders
Fever
|
8.9%
400/4488 • 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
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.
|
7.1%
260/3662 • 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
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
48.0%
2154/4488 • 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
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.
|
45.8%
1677/3662 • 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
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER