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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02712359
Recruitment Status : Completed
First Posted : March 18, 2016
Results First Posted : September 23, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Hepatitis A Vaccine
Intervention Other: Blood sample collection
Enrollment 1201
Recruitment Details 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.
Pre-assignment Details The design of the study included 2 epochs: Epoch 001 - Persistence at Year 8 and Epoch 002 - Persistence at Year 10.
Arm/Group Title Havrix 1 dose_Year 8 Group Havrix 2 doses_Year 8 Group Havrix 1 dose_Year 10 Group Havrix 2 doses_Year 10 Group
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Epoch 001: Persistence at Year 8
Started 300 300 0 0
Completed 300 300 0 0
Not Completed 0 0 0 0
Period Title: Epoch 002: Persistence at Year 10
Started 0 0 299 300
Completed 0 0 299 300
Not Completed 0 0 0 0
Arm/Group Title Havrix 1 dose_Year 8 Group Havrix 2 doses_Year 8 Group Havrix 1 dose_Year 10 Group Havrix 2 doses_Year 10 Group Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 300 300 299 300 1199
Hide Baseline Analysis Population Description
The demographic characteristics are presented separately for each study epoch (Epoch 001: Persistence at Year 8 and Epoch 002: Persistence at Year 10).
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 300 participants 300 participants 0 participants 0 participants 600 participants
10.5  (0.9) 10.0  (0.7) 10.2  (0.8)
[1]
Measure Description: Age continuous data for Epoch 001: Persistence at Year 8
[2]
Measure Analysis Population Description: The age continuous data in this baseline measure are reported for Havrix 1 dose_Year 8 and Havrix 2 doses_Year 8 Groups.
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 0 participants 299 participants 300 participants 599 participants
12.0  (0.5) 12.0  (0.4) 12.0  (0.5)
[1]
Measure Description: Age continuous data for Epoch 002: Persistence at Year 10
[2]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 300 participants 0 participants 0 participants 600 participants
Female
136
  45.3%
160
  53.3%
0 0
296
  49.3%
Male
164
  54.7%
140
  46.7%
0 0
304
  50.7%
[1]
Measure Description: Sex: Female, Male data for Epoch 001: Persistence at Year 8
[2]
Measure Analysis Population Description: The sex: female, male data in this baseline measure are reported for Havrix 1 dose_Year 8 and Havrix 2 doses_Year 8 Groups.
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 299 participants 300 participants 599 participants
Female 0 0
161
  53.8%
162
  54.0%
323
  53.9%
Male 0 0
138
  46.2%
138
  46.0%
276
  46.1%
[1]
Measure Description: Sex: female, male data for Epoch 002: Persistence at Year 10
[2]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic Ancestry Number Analyzed 300 participants 300 participants 0 participants 0 participants 600 participants
African Heritage / African American
13
   4.3%
6
   2.0%
0 0
19
   3.2%
White - Caucasian / European Heritage
1
   0.3%
0
   0.0%
0 0
1
   0.2%
Mixed Race
286
  95.3%
294
  98.0%
0 0
580
  96.7%
[1]
Measure Description: Race/Ethnicity data for Epoch 001: Persistence at Year 8
[2]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 0 participants 0 participants 299 participants 300 participants 599 participants
African Heritage / African American 0 0
5
   1.7%
6
   2.0%
11
   1.8%
American Indian or Alaskan Native 0 0
3
   1.0%
1
   0.3%
4
   0.7%
White - Caucasian / European Heritage 0 0
4
   1.3%
3
   1.0%
7
   1.2%
Mixed race 0 0
287
  96.0%
290
  96.7%
577
  96.3%
[1]
Measure Description: Race/ethnicity data for Epoch 002: Persistence at Year 10
[2]
Measure Analysis Population Description: The race/ethnicity data in this baseline measure are reported for Havrix 1 dose_Year 10 and Havrix 2 doses_Year 10 Groups.
1.Primary Outcome
Title Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose
Hide Description Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).
Time Frame At approximately 8 years after the last administered vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix 1 dose_Year 8 Group Havrix 2 doses_Year 8 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 300 300
Measure Type: Count of Participants
Unit of Measure: Participants
Seropositive
223
  74.3%
293
  97.7%
Seronegative
77
  25.7%
7
   2.3%
2.Primary Outcome
Title Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose
Hide Description Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Time Frame At approximately 10 years after the last administered vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix 1 dose_Year 10 Group Havrix 2 doses_Year 10 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 299 300
Measure Type: Count of Participants
Unit of Measure: Participants
Seropositive
215
  71.9%
289
  96.3%
Seronegative
84
  28.1%
11
   3.7%
3.Secondary Outcome
Title Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose
Hide Description 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.
Time Frame At approximately 8 years after the last administered vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix 1 dose_Year 8 Group Havrix 2 doses_Year 8 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 300 300
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
40.2
(34.2 to 47.4)
123.9
(111.5 to 137.7)
4.Secondary Outcome
Title Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose
Hide Description 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.
Time Frame At approximately 10 years after the last administered vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix 1 dose_Year 10 Group Havrix 2 doses_Year 10 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 299 300
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
26.0
(23.0 to 29.5)
82.1
(73.2 to 92.0)
5.Secondary Outcome
Title 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
Hide Description Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Time Frame At approximately 8 years after the last administered vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix 1 dose_Year 8 Group Havrix 2 doses_Year 8 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 300 300
Measure Type: Count of Participants
Unit of Measure: Participants
223
  74.3%
293
  97.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Havrix 1 dose_Year 8 Group, Havrix 2 doses_Year 8 Group
Comments Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose_Year 8 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses_Year 8 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 8 years after the administration of the last vaccine dose.
Type of Statistical Test Non-Inferiority
Comments The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose_Year 8 Group minus Havrix 2 doses_Year 8 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in seropositivity rate
Estimated Value -23.33
Confidence Interval (2-Sided) 95%
-28.78 to -18.29
Estimation Comments [Not Specified]
6.Secondary Outcome
Title 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
Hide Description Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Time Frame At approximately 10 years after the last administered vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix 1 dose_Year 10 Group Havrix 2 doses_Year 10 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 299 300
Measure Type: Count of Participants
Unit of Measure: Participants
215
  71.9%
289
  96.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Havrix 1 dose_Year 10 Group, Havrix 2 doses_Year 10 Group
Comments Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose_Year 10 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses_Year 10 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 10 years after the administration of the last vaccine dose.
Type of Statistical Test Non-Inferiority
Comments The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose_Year 10 Group minus Havrix 2 doses_Year 10 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in seropositivity rate
Estimated Value -24.43
Confidence Interval (2-Sided) 95%
-30.11 to -19.03
Estimation Comments [Not Specified]
Time Frame SAEs: Epoch 001: from Visit at Year 8 (the time of sample collection) up to study conclusion (i.e. during an approximate period of 15 months); Epoch 002: from Visit at Year 10 (the time of sample collection) up to study conclusion (i.e. during an approximate period of 8 months).
Adverse Event Reporting Description

Only SAEs related to study procedures were collected during the entire study period.

There were no other adverse events (AEs) data collected during the entire study period.

 
Arm/Group Title Havrix 1 dose_Year 8 Group Havrix 2 doses_Year 8 Group Havrix 1 dose_Year 10 Group Havrix 2 doses_Year 10 Group
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Havrix 1 dose_Year 8 Group Havrix 2 doses_Year 8 Group Havrix 1 dose_Year 10 Group Havrix 2 doses_Year 10 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/300 (0.00%)   0/300 (0.00%)   0/299 (0.00%)   0/300 (0.00%) 
Hide Serious Adverse Events
Havrix 1 dose_Year 8 Group Havrix 2 doses_Year 8 Group Havrix 1 dose_Year 10 Group Havrix 2 doses_Year 10 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/300 (0.00%)   0/300 (0.00%)   0/299 (0.00%)   0/300 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Havrix 1 dose_Year 8 Group Havrix 2 doses_Year 8 Group Havrix 1 dose_Year 10 Group Havrix 2 doses_Year 10 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02712359    
Other Study ID Numbers: 201630
First Submitted: March 7, 2016
First Posted: March 18, 2016
Results First Submitted: August 21, 2019
Results First Posted: September 23, 2019
Last Update Posted: November 19, 2019