Trial Outcomes & Findings for This Study Will Evaluate the Persistence of Hepatitis A Antibodies, 8 Years and 10 Years Later, in Children Who Had Received Havrix at Selected Health Centres of Panama (NCT NCT02712359)
NCT ID: NCT02712359
Last Updated: 2019-11-19
Results Overview
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1201 participants
Primary outcome timeframe
At approximately 8 years after the last administered vaccine dose
Results posted on
2019-11-19
Participant Flow
The study was conducted at 4 centers in Panama. Out of the 1201 subjects originally enrolled in the study, 2 subjects were eliminated from the ATP cohort for persistence, due to non-eligibility. Hence, 1199 subjects were included in the ATP cohort for persistence.
The design of the study included 2 epochs: Epoch 001 - Persistence at Year 8 and Epoch 002 - Persistence at Year 10.
Participant milestones
| Measure |
Havrix 1 dose_Year 8 Group
Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
Havrix 2 doses_Year 8 Group
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
Havrix 1 dose_Year 10 Group
Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
|
Havrix 2 doses_Year 10 Group
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
|
|---|---|---|---|---|
|
Epoch 001: Persistence at Year 8
STARTED
|
300
|
300
|
0
|
0
|
|
Epoch 001: Persistence at Year 8
COMPLETED
|
300
|
300
|
0
|
0
|
|
Epoch 001: Persistence at Year 8
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Epoch 002: Persistence at Year 10
STARTED
|
0
|
0
|
299
|
300
|
|
Epoch 002: Persistence at Year 10
COMPLETED
|
0
|
0
|
299
|
300
|
|
Epoch 002: Persistence at Year 10
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
Baseline characteristics by cohort
| Measure |
Havrix 1 dose_Year 8 Group
n=300 Participants
Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
Havrix 2 doses_Year 8 Group
n=300 Participants
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
Havrix 1 dose_Year 10 Group
n=299 Participants
Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
|
Havrix 2 doses_Year 10 Group
n=300 Participants
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (\<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey.
|
Total
n=1199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Geographic ancestry · American Indian or Alaskan Native
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
3 Participants
n=299 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
1 Participants
n=300 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
4 Participants
n=599 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
|
Age, Continuous
|
10.5 Years
STANDARD_DEVIATION 0.9 • n=300 Participants • The age continuous data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
10.0 Years
STANDARD_DEVIATION 0.7 • n=300 Participants • The age continuous data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
12.0 Years
STANDARD_DEVIATION 0.5 • n=299 Participants • The age continuous data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
12.0 Years
STANDARD_DEVIATION 0.4 • n=300 Participants • The age continuous data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
12.0 Years
STANDARD_DEVIATION 0.5 • n=599 Participants • The age continuous data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
|
Sex: Female, Male
Female
|
0 Participants
The sex: female, male data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
0 Participants
The sex: female, male data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
161 Participants
n=299 Participants • The sex: female, male data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
162 Participants
n=300 Participants • The sex: female, male data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
323 Participants
n=599 Participants • The sex: female, male data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
|
Sex: Female, Male
Male
|
0 Participants
The sex: female, male data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
0 Participants
The sex: female, male data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
138 Participants
n=299 Participants • The sex: female, male data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
138 Participants
n=300 Participants • The sex: female, male data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
276 Participants
n=599 Participants • The sex: female, male data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
|
Race/Ethnicity, Customized
Geographic Ancestry · African Heritage / African American
|
13 Participants
n=300 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
6 Participants
n=300 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
19 Participants
n=600 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
|
Race/Ethnicity, Customized
Geographic Ancestry · White - Caucasian / European Heritage
|
1 Participants
n=300 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
0 Participants
n=300 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
1 Participants
n=600 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
|
Race/Ethnicity, Customized
Geographic Ancestry · Mixed Race
|
286 Participants
n=300 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
294 Participants
n=300 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
580 Participants
n=600 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 8 and Havrix 2 doses\_Year 8 Groups.
|
|
Race/Ethnicity, Customized
Geographic ancestry · African Heritage / African American
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
5 Participants
n=299 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
6 Participants
n=300 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
11 Participants
n=599 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian / European Heritage
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
4 Participants
n=299 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
3 Participants
n=300 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
7 Participants
n=599 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
|
Race/Ethnicity, Customized
Geographic ancestry · Mixed race
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
0 Participants
The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
287 Participants
n=299 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
290 Participants
n=300 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
577 Participants
n=599 Participants • The race/ethnicity data in this baseline measure are reported for Havrix 1 dose\_Year 10 and Havrix 2 doses\_Year 10 Groups.
|
PRIMARY outcome
Timeframe: At approximately 8 years after the last administered vaccine dosePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).
Outcome measures
| Measure |
Havrix 1 dose_Year 8 Group
n=300 Participants
Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
Havrix 2 doses_Year 8 Group
n=300 Participants
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
|---|---|---|
|
Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose
Seropositive
|
223 Participants
|
293 Participants
|
|
Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose
Seronegative
|
77 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: At approximately 10 years after the last administered vaccine dosePopulation: The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Outcome measures
| Measure |
Havrix 1 dose_Year 8 Group
n=299 Participants
Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
Havrix 2 doses_Year 8 Group
n=300 Participants
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
|---|---|---|
|
Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose
Seropositive
|
215 Participants
|
289 Participants
|
|
Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose
Seronegative
|
84 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: At approximately 8 years after the last administered vaccine dosePopulation: The analysis was performed on the ATP cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.
Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL.
Outcome measures
| Measure |
Havrix 1 dose_Year 8 Group
n=300 Participants
Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
Havrix 2 doses_Year 8 Group
n=300 Participants
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
|---|---|---|
|
Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose
|
40.2 mIU/mL
Interval 34.2 to 47.4
|
123.9 mIU/mL
Interval 111.5 to 137.7
|
SECONDARY outcome
Timeframe: At approximately 10 years after the last administered vaccine dosePopulation: The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.
Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL.
Outcome measures
| Measure |
Havrix 1 dose_Year 8 Group
n=299 Participants
Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
Havrix 2 doses_Year 8 Group
n=300 Participants
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
|---|---|---|
|
Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose
|
26.0 mIU/mL
Interval 23.0 to 29.5
|
82.1 mIU/mL
Interval 73.2 to 92.0
|
SECONDARY outcome
Timeframe: At approximately 8 years after the last administered vaccine dosePopulation: The analysis was performed on the ATP cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Outcome measures
| Measure |
Havrix 1 dose_Year 8 Group
n=300 Participants
Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
Havrix 2 doses_Year 8 Group
n=300 Participants
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
|---|---|---|
|
Number of Subjects With Anti-HAV Antibody Concentration ≥ 15 mIU/mL at Approximately 8 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix
|
223 Participants
|
293 Participants
|
SECONDARY outcome
Timeframe: At approximately 10 years after the last administered vaccine dosePopulation: The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Outcome measures
| Measure |
Havrix 1 dose_Year 8 Group
n=299 Participants
Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
Havrix 2 doses_Year 8 Group
n=300 Participants
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (\<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey.
|
|---|---|---|
|
Number of Subjects With Anti-HAV Antibody Concentrations ≥ 15 mIU/mL at Approximately 10 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix
|
215 Participants
|
289 Participants
|
Adverse Events
Havrix 1 dose_Year 8 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Havrix 2 doses_Year 8 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Havrix 1 dose_Year 10 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Havrix 2 doses_Year 10 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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