Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
Study Details
Study Description
Brief Summary
The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.
This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.
No additional subjects will be recruited during this long-term follow-up.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations.
If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Months 138, 150, 162, 174,186, 198, 210, 222, 234 and 246), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to extend the follow up until Year 20.
The study has 10 phases: 100571, 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, 110681.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Havrix Group Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Biological: Havrix™
2 doses at 12 months interval
|
Outcome Measures
Primary Outcome Measures
- Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration [At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246]
Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
- Number of Seropositive Subjects Against Hepatitis A Virus [At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246]
A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
Secondary Outcome Measures
- Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration [Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination]
Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. Please note that value 14.9 means <15.
- Number of Subjects Reporting Solicited Local Symptoms [During the 4-day (Days 0-3) follow-up period after additional vaccination]
Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.
- Number of Subjects Reporting Solicited General Symptoms [During the 4-day (Days 0-3) follow-up period after additional vaccination]
Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
- Number of Subjects Reporting Unsolicited Adverse Events (AE) [During the 30-day follow-up period after additional vaccination]
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 4 subjects received additional vaccination at Month 186 and 1 at Month 198.
- Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy [At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246]
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above
- Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination [During the 30-day follow-up period after additional vaccination]
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. 4 subjects received additional vaccination at Month 186 and 1 at Month 198.
- Number of Subjects Reporting Pregnancies After Additional Vaccination [At Months 186 and 198]
The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects who had received at least one dose of the study vaccine in the primary study
-
Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | GSK Investigational Site | Wilrijk | Belgium | 2610 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Van Herck K, Crasta PD, Messier M, Hardt K, Van Damme P. Seventeen-year antibody persistence in adults primed with two doses of an inactivated hepatitis A vaccine. Hum Vaccin Immunother. 2012 Mar;8(3):323-7. doi: 10.4161/hv.18617. Epub 2012 Feb 13.
- Van Herck K, Jacquet JM, Van Damme P. Antibody persistence and immune memory in healthy adults following vaccination with a two-dose inactivated hepatitis A vaccine: long-term follow-up at 15 years. J Med Virol. 2011 Nov;83(11):1885-91. doi: 10.1002/jmv.22200. Epub 2011 Aug 23.
- 100571 (M138)
- 100572 (M150)
- 100573 (M162)
- 100574 (M174)
- 100575 (M186)
- 110677 (M198)
- 110678 (M210)
- 110679
- 110680
- 110681
Study Results
Participant Flow
Recruitment Details | Participant Flow and Baseline Measures are given for each of the follow-up time points- Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246. Note that not all subjects returned and participated in each of the intermediate follow-up time points. |
---|---|
Pre-assignment Detail | The Long-Term (LT) Total Cohort included all subjects who returned for the follow-up and who belonged to the Total Cohort in the primary study. The Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity included subjects who returned for the follow-up and who were included in the ATP cohort for immunogenicity of the primary study. |
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Period Title: Month 138 | |
STARTED | 107 |
COMPLETED | 107 |
NOT COMPLETED | 0 |
Period Title: Month 138 | |
STARTED | 117 |
COMPLETED | 117 |
NOT COMPLETED | 0 |
Period Title: Month 138 | |
STARTED | 127 |
COMPLETED | 127 |
NOT COMPLETED | 0 |
Period Title: Month 138 | |
STARTED | 127 |
COMPLETED | 127 |
NOT COMPLETED | 0 |
Period Title: Month 138 | |
STARTED | 129 |
COMPLETED | 129 |
NOT COMPLETED | 0 |
Period Title: Month 138 | |
STARTED | 135 |
COMPLETED | 135 |
NOT COMPLETED | 0 |
Period Title: Month 138 | |
STARTED | 124 |
COMPLETED | 124 |
NOT COMPLETED | 0 |
Period Title: Month 138 | |
STARTED | 114 |
COMPLETED | 114 |
NOT COMPLETED | 0 |
Period Title: Month 138 | |
STARTED | 110 |
COMPLETED | 110 |
NOT COMPLETED | 0 |
Period Title: Month 138 | |
STARTED | 116 |
COMPLETED | 116 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Overall Participants | 135 |
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
42.2
(5.44)
|
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
42.9
(5.35)
|
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
43.4
(5.34)
|
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
44.5
(5.37)
|
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
45.4
(5.39)
|
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
46.3
(5.35)
|
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
47.6
(5.39)
|
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
48.5
(5.39)
|
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
49.6
(5.42)
|
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
50.8
(5.34)
|
Sex: Female, Male (Count of Participants) | |
Female |
77
57%
|
Male |
30
22.2%
|
Sex: Female, Male (Count of Participants) | |
Female |
87
64.4%
|
Male |
30
22.2%
|
Sex: Female, Male (Count of Participants) | |
Female |
93
68.9%
|
Male |
34
25.2%
|
Sex: Female, Male (Count of Participants) | |
Female |
94
69.6%
|
Male |
33
24.4%
|
Sex: Female, Male (Count of Participants) | |
Female |
98
72.6%
|
Male |
31
23%
|
Sex: Female, Male (Count of Participants) | |
Female |
103
76.3%
|
Male |
32
23.7%
|
Sex: Female, Male (Count of Participants) | |
Female |
93
68.9%
|
Male |
31
23%
|
Sex: Female, Male (Count of Participants) | |
Female |
83
61.5%
|
Male |
31
23%
|
Sex: Female, Male (Count of Participants) | |
Female |
81
60%
|
Male |
29
21.5%
|
Sex: Female, Male (Count of Participants) | |
Female |
86
63.7%
|
Male |
30
22.2%
|
Outcome Measures
Title | Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration |
---|---|
Description | Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246. |
Time Frame | At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint. * The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging. |
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Measure Participants | 102 |
Month 138 (N=79) |
748.1
|
Month 138 (N=85)* |
378.6
|
Month 150 (N=93) |
419.3
|
Month 162 (N=101) |
342.2
|
Month 174 (N=102) |
318.9
|
Month 186 (N=98) |
353.1
|
Month 198 (N=101) |
339.9
|
Month 210 (N=91) |
369.3
|
Month 222 (N=86) |
340.1
|
Month 234 (N=79)** |
283.3
|
Month 246 (N=85)$ |
317.3
|
Title | Number of Seropositive Subjects Against Hepatitis A Virus |
---|---|
Description | A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246. |
Time Frame | At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint. *The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging. |
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Measure Participants | 102 |
Month 138 (N=79) |
77
|
Month 138 (N=85)* |
82
|
Month 150 (N=93) |
90
|
Month 162 (N=101) |
98
|
Month 174 (N=102) |
100
|
Month 186 (N=98) |
95
|
Month 198 (N=101) |
97
|
Month 210 (N=91) |
88
|
Month 222 (N=86) |
86
|
Month 234 (N=79)** |
79
|
Month 246 (N=85)$ |
85
|
Title | Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration |
---|---|
Description | Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. Please note that value 14.9 means <15. |
Time Frame | Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose. |
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Measure Participants | 5 |
Subject 1 Month 186 before |
14.9
|
Subject 1 Month 186 day 14 |
15
|
Subject 1 Month 186 day 30 |
26
|
Subject 2 Month 186 before |
14.9
|
Subject 2 Month 186 day 14 |
453
|
Subject 2 Month 186 day 30 |
787
|
Subject 3 Month 186 before |
15
|
Subject 3 Month 186 day 14 |
3102
|
Subject 3 Month 186 day 30 |
3819
|
Subject 4 Month 186 before |
16
|
Subject 4 Month 186 day 14 |
1636
|
Subject 4 Month 186 day 30 |
2051
|
Subject 5 Month 198 before |
16
|
Subject 5 Month 198 day 14 |
3222
|
Subject 5 Month 198 day 30 |
4894
|
Title | Number of Subjects Reporting Solicited Local Symptoms |
---|---|
Description | Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint. |
Time Frame | During the 4-day (Days 0-3) follow-up period after additional vaccination |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose. |
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Measure Participants | 5 |
Pain Month 186 (N=4) |
2
|
Redness Month 186 (N=4) |
0
|
Swelling Month 186 (N=4) |
0
|
Pain Month 198 (N=1) |
1
|
Redness Month 198 (N=1) |
0
|
Swelling Month 198 (N=1) |
0
|
Title | Number of Subjects Reporting Solicited General Symptoms |
---|---|
Description | Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. |
Time Frame | During the 4-day (Days 0-3) follow-up period after additional vaccination |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose. |
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Measure Participants | 5 |
Fatigue Month 186 (N=4) |
2
|
Fever Month 186 (N=4) |
0
|
Gastrointestinal Month 186 (N=4) |
1
|
Headache Month 186 (N=4) |
1
|
Fatigue Month 198 (N=1) |
0
|
Fever Month 198 (N=1) |
0
|
Gastrointestinal Month 198 (N=1) |
0
|
Headache Month 198 (N=1) |
0
|
Title | Number of Subjects Reporting Unsolicited Adverse Events (AE) |
---|---|
Description | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 4 subjects received additional vaccination at Month 186 and 1 at Month 198. |
Time Frame | During the 30-day follow-up period after additional vaccination |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose. |
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Measure Participants | 5 |
Month 186 (N=4) |
0
|
Month 198 (N=1) |
0
|
Title | Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy |
---|---|
Description | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above |
Time Frame | At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on the Long Term Total cohort, on subjects with available data for the defined timepoint. |
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Measure Participants | 135 |
Month 138 (N=107) |
0
|
Month 150 (N=117) |
0
|
Month 162 (N=127) |
0
|
Month 174 (N=127) |
0
|
Month 186 (N=129) |
0
|
Month 198 (N=135) |
0
|
Month 210 (N=124) |
0
|
Month 222 (N=114) |
0
|
Month 234 (N=110) |
0
|
Month 246 (N=116) |
0
|
Title | Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination |
---|---|
Description | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. 4 subjects received additional vaccination at Month 186 and 1 at Month 198. |
Time Frame | During the 30-day follow-up period after additional vaccination |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose. |
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Measure Participants | 5 |
Month 186 (N=4) |
0
|
Month 198 (N=1) |
0
|
Title | Number of Subjects Reporting Pregnancies After Additional Vaccination |
---|---|
Description | The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. |
Time Frame | At Months 186 and 198 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose. |
Arm/Group Title | Havrix Group |
---|---|
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Measure Participants | 5 |
Subjects with pregnancy - At Month 186 (N=4) |
0
|
Subjects with pregnancy - At Month 198 (N=1) |
0
|
Adverse Events
Time Frame | SAEs: At Months 138, 150, 162, 174, 186, 198, 210, 222 234 and 246. Other adverse events: within the 4-day periods after additional vaccination (at Month 186 or 198), only in subjects who received additional vaccination at the specified time point. | |
---|---|---|
Adverse Event Reporting Description | Analyses were performed on the Long-Term (LT) Total Cohort which included all subjects who returned for the follow-up and who belonged to the Total Cohort in the primary study. Maximum amount of subjects which participated at Month 198 has been taken as the number of subjects at risk for SAEs. | |
Arm/Group Title | Havrix Group | |
Arm/Group Description | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. | |
All Cause Mortality |
||
Havrix Group | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Havrix Group | ||
Affected / at Risk (%) | # Events | |
Total | 0/135 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Havrix Group | ||
Affected / at Risk (%) | # Events | |
Total | 2/5 (40%) | |
General disorders | ||
Pain | 2/4 (50%) | |
Pain | 1/1 (100%) | |
Fatigue | 2/4 (50%) | |
Gastrointestinal | 1/4 (25%) | |
Headache | 1/4 (25%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title | GSK Response Center |
---|---|
Organization | GlaxoSmithKline |
Phone | 866-435-7343 |
- 100571 (M138)
- 100572 (M150)
- 100573 (M162)
- 100574 (M174)
- 100575 (M186)
- 110677 (M198)
- 110678 (M210)
- 110679
- 110680
- 110681