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| ID | Type | Description | Link |
|---|---|---|---|
| 100572 (M150) | Other Identifier | GSK | |
| 100573 (M162) | Other Identifier | GSK | |
| 100574 (M174) | Other Identifier | GSK | |
| 100575 (M186) | Other Identifier | GSK | |
| 110677 (M198) | Other Identifier | GSK | |
| 110678 (M210) | Other Identifier | GSK | |
| 110679 | Other Identifier | GSK | |
| 110680 | Other Identifier | GSK | |
| 110681 | Other Identifier | GSK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Havrix Group | Experimental | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Havrix™ | Biological | 2 doses at 12 months interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration | 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. | At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246 |
| Number of Seropositive Subjects Against Hepatitis A Virus | 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. | At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration | 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. | Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21915861 | Background | 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. | |
| 22327499 | Background | 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. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 100571 (M138) | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Havrix Group | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 138 |
| |||||||||||||
| Month 150 |
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| Month 162 |
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| Month 174 |
| |||||||||||||
| Month 186 |
| |||||||||||||
| Month 198 |
| |||||||||||||
| Month 210 |
| |||||||||||||
| Month 222 |
| |||||||||||||
| Month 234 |
| |||||||||||||
| Month 246 |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Havrix Group | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The baseline measure data here corresponds to Month 138 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246 |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Havrix Group | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment | Occurrence of the specified adverse event collected 4-days after additional dose reported among the 4 subjects receiving vaccination at Month 186 |
For 5 subjects at Month 234, serum sample tubes were broken. Due to risk of contamination, anti-HAV concentrations analyses were not performed for these subjects, who were excluded in the LT-ATP cohort for immunogenicity analysis at Month 234.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Number of Subjects Reporting Solicited Local Symptoms |
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. |
| During the 4-day (Days 0-3) follow-up period after additional vaccination |
| Number of Subjects Reporting Solicited General Symptoms | 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. | During the 4-day (Days 0-3) follow-up period after additional vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | 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. | During the 30-day follow-up period after additional vaccination |
| Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy | 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 | At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246 |
| Number of Subjects Reporting Serious Adverse Events (SAE) 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. | During the 30-day follow-up period after additional vaccination |
| Number of Subjects Reporting Pregnancies After Additional Vaccination | 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. | At Months 186 and 198 |
| 32710245 | Derived | Agrawal A, Kolhapure S, Andani A, Ota MOC, Badur S, Karkada N, Mitra M. Long-Term Persistence of Antibody Response with Two Doses of Inactivated Hepatitis A Vaccine in Children. Infect Dis Ther. 2020 Dec;9(4):785-796. doi: 10.1007/s40121-020-00311-8. Epub 2020 Jul 24. |
| 26190091 | Derived | Theeten H, Van Herck K, Van Der Meeren O, Crasta P, Van Damme P, Hens N. Long-term antibody persistence after vaccination with a 2-dose Havrix (inactivated hepatitis A vaccine): 20 years of observed data, and long-term model-based predictions. Vaccine. 2015 Oct 13;33(42):5723-5727. doi: 10.1016/j.vaccine.2015.07.008. Epub 2015 Jul 16. |
| 24508042 | Derived | Hens N, Habteab Ghebretinsae A, Hardt K, Van Damme P, Van Herck K. Model based estimates of long-term persistence of inactivated hepatitis A vaccine-induced antibodies in adults. Vaccine. 2014 Mar 14;32(13):1507-13. doi: 10.1016/j.vaccine.2013.10.088. Epub 2014 Feb 7. |
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100571 are summarised with studies 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, and 110681 on the GSK Clinical Study |
| 100571 (M138) | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100571 (M138) | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100571 (M138) | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100571 (M138) | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100571 (M138) | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Note that not all subjects returned and participated in each of the intermediate follow-up time points.
| Mean |
| Standard Deviation |
| Years |
|
| Age, Continuous | The baseline measure data here corresponds to Month 150 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Month 162 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Month 174 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Month 186 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Month 198 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Month 210 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Month 222 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Month 234 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Month 246 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | The baseline measure data here corresponds to Month 138 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Month 150 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Month 162 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Month 174 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Month 186 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Month 198 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Month 210 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Month 222 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Month 234 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Month 246 | Note that not all subjects returned and participated in each of the intermediate follow-up time points. | Count of Participants | Participants |
|
| OG000 | Havrix Group | Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12. |
|
|
| Primary | Number of Seropositive Subjects Against Hepatitis A Virus | 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. | 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. | Posted | Number | Subjects | At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246 |
|
|
|
| Secondary | Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration | 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. | 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. | Posted | Number | mIU/mL | Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Solicited Local Symptoms | 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. | 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. | Posted | Number | subjects | During the 4-day (Days 0-3) follow-up period after additional vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Solicited General Symptoms | 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. | 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. | Posted | Number | subjects | During the 4-day (Days 0-3) follow-up period after additional vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 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. | 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. | Posted | Number | subjects | During the 30-day follow-up period after additional vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy | 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 | Analysis was performed on the Long Term Total cohort, on subjects with available data for the defined timepoint. | Posted | Number | Subjects | At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246 |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) 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. | 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. | Posted | Number | subjects | During the 30-day follow-up period after additional vaccination |
|
|
|
| Secondary | Number of Subjects Reporting Pregnancies After Additional Vaccination | 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. | 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. | Posted | Number | Subject | At Months 186 and 198 |
|
|
|
| 0 |
| 135 |
| 2 |
| 5 |
|
| Pain | General disorders | Systematic Assessment | Occurrence of the specified adverse event collected 4-days after additional dose reported by the 1 subject receiving vaccination at Month 198 |
|
| Fatigue | General disorders | Occurrence of the specified adverse event collected 4-days after additional dose reported among the 4 subjects receiving vaccination at Month 186 |
|
| Gastrointestinal | General disorders | Systematic Assessment | Occurrence of the specified adverse event collected 4-days after additional dose reported among the 4 subjects receiving vaccination at Month 186 |
|
| Headache | General disorders | Systematic Assessment | Occurrence of the specified adverse event collected 4-days after additional dose reported among the 4 subjects receiving vaccination at Month 186 |
|
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.
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |
| Title | Measurements |
|---|---|
|
| Month 162 (N=101) |
|
| Month 174 (N=102) |
|
| Month 186 (N=98) |
|
| Month 198 (N=101) |
|
| Month 210 (N=91) |
|
| Month 222 (N=86) |
|
| Month 234 (N=79)** |
|
| Month 246 (N=85)$ |
|
| Title | Measurements |
|---|---|
|
| Subject 2 Month 186 before |
|
| Subject 2 Month 186 day 14 |
|
| Subject 2 Month 186 day 30 |
|
| Subject 3 Month 186 before |
|
| Subject 3 Month 186 day 14 |
|
| Subject 3 Month 186 day 30 |
|
| Subject 4 Month 186 before |
|
| Subject 4 Month 186 day 14 |
|
| Subject 4 Month 186 day 30 |
|
| Subject 5 Month 198 before |
|
| Subject 5 Month 198 day 14 |
|
| Subject 5 Month 198 day 30 |
|
| Title | Measurements |
|---|---|
|
| Pain Month 198 (N=1) |
|
| Redness Month 198 (N=1) |
|
| Swelling Month 198 (N=1) |
|
| Title | Measurements |
|---|---|
|
| Headache Month 186 (N=4) |
|
| Fatigue Month 198 (N=1) |
|
| Fever Month 198 (N=1) |
|
| Gastrointestinal Month 198 (N=1) |
|
| Headache Month 198 (N=1) |
|
| Title | Measurements |
|---|---|
|
| Month 174 (N=127) |
|
| Month 186 (N=129) |
|
| Month 198 (N=135) |
|
| Month 210 (N=124) |
|
| Month 222 (N=114) |
|
| Month 234 (N=110) |
|
| Month 246 (N=116) |
|