Hepatitis A VaccineNCT02712359
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
A study testing Blood sample collection in people with Hepatitis A Vaccine, run by GlaxoSmithKline at 3 sites in Panama.
Trial summary
The purpose of this study is to evaluate the persistence of hepatitis A antibodies, approximately 8 years and 10 years post vaccination with the complete series of Havrix (2 doses) and the partial series completion (1 dose). Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A Vaccine
- What is being tested?
- Blood sample collection
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,201 participants
- Where
- 3 sitesPanama
- Study dates
- 1 Jun 2016to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects whose parent(s)/ LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed assent/consent obtained from the subject or subject's parent(s)/ LAR(s) of the subject.
- Available HAV vaccination records.
- Children who have received either 1 or two doses of Havrix at selected health centres of Panama.
- Children with ≥ 7 years and < 10 years between last dose and Persistence Visit 1 (Year 8) and children ≥ 10 years and < 13 years between last dose and Persistence Visit 1' (Year 10).
Who cannot join
- Child in care.
- Subjects with history of vaccination with other hepatitis A vaccines other than Havrix.
- Subjects with known past history of hepatitis A infection, both without vaccination and after they received the last dose of Havrix (1 dose or the complete 2 dose schedule).
Trial locations and contacts
3 sites in 1 country.
Panama3 sites
GSK Investigational Site
Chiriquí
GSK Investigational Site
Juán Diaz
GSK Investigational Site
Panama City
About this study
Official title: Long Term Hepatitis A Virus (HAV) Antibody Persistence in Children Vaccinated With 1 Dose and Those Vaccinated With 2 Doses of Havrix in Panama
The purpose of this study is to evaluate the persistence of hepatitis A antibodies, approximately 8 years and 10 years post vaccination with the complete series of Havrix (2 doses) and the partial series completion (1 dose).
Read the detailed description
The study comprises of two independent cross-sectional surveys (Year 8 and Year 10). The first cross-sectional serosurvey will evaluate the long term persistence of immunity approximately 8 years post vaccine administration and the second cross-sectional study will evaluate long term persistence, approximately 10 years post vaccine administration.
- Conditions
- Hepatitis A Vaccine
- Being tested
- Blood sample collection
- Keywords
- Havrix, Cross-sectional seroprevalence survey, Panama, Long-term persistence, Hepatitis
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).
| Study group | Role | What they receive |
|---|---|---|
| Havrix 1 dose_Year 8 Group | Other | 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. Receives: Other: Blood sample collection |
| Havrix 2 doses_Year 8 Group | Other | 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. Receives: Other: Blood sample collection |
| Havrix 1 dose_Year 10 Group | Other | 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. Receives: Other: Blood sample collection |
| Havrix 2 doses_Year 10 Group | Other | 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. Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).
Measured: At approximately 8 years after the last administered vaccine dose
Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Measured: At approximately 10 years after the last administered vaccine dose
Secondary outcomes (4)
Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose
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.
Measured: At approximately 8 years after the last administered vaccine dose
Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose
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.
Measured: At approximately 10 years after the last administered vaccine dose
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
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Measured: At approximately 8 years after the last administered vaccine dose
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
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
Measured: At approximately 10 years after the last administered vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start1 Jun 2016
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis A VaccineStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712359
- Sponsor's protocol ID
- 201630
- Status last verified
- Nov 2019
- First submitted
- 7 Mar 2016
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Hepatitis A Virus (HAV) Antibody Persistence in Children Vaccinated With 1 Dose and Those Vaccinated With 2 Doses of Havrix in Panama
- ClinicalTrials.gov ID
- NCT02712359
- Acronym / sponsor ID
- 201630
- Conditions
- Hepatitis A Vaccine
- Keywords
- Havrix, Cross-sectional seroprevalence survey, Panama, Long-term persistence, Hepatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,201 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 23 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the persistence of hepatitis A antibodies, approximately 8 years and 10 years post vaccination with the complete series of Havrix (2 doses) and the partial series completion (1 dose).
Detailed description
The study comprises of two independent cross-sectional surveys (Year 8 and Year 10). The first cross-sectional serosurvey will evaluate the long term persistence of immunity approximately 8 years post vaccine administration and the second cross-sectional study will evaluate long term persistence, approximately 10 years post vaccine administration.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Havrix 1 dose_Year 8 Group | Other | Other: Blood sample collectionSubjects 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 | Other | Other: Blood sample collectionSubjects 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 | Other | Other: Blood sample collectionSubjects 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 | Other | Other: Blood sample collectionSubjects 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. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects whose parent(s)/ LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed assent/consent obtained from the subject or subject's parent(s)/ LAR(s) of the subject.
- Available HAV vaccination records.
- Children who have received either 1 or two doses of Havrix at selected health centres of Panama.
- Children with ≥ 7 years and < 10 years between last dose and Persistence Visit 1 (Year 8) and children ≥ 10 years and < 13 years between last dose and Persistence Visit 1' (Year 10).
Key exclusion criteria (3 listed)
- Child in care.
- Subjects with history of vaccination with other hepatitis A vaccines other than Havrix.
- Subjects with known past history of hepatitis A infection, both without vaccination and after they received the last dose of Havrix (1 dose or the complete 2 dose schedule).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionA blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10). | Other | Havrix 1 dose_Year 10 Group, Havrix 1 dose_Year 8 Group, Havrix 2 doses_Year 10 Group, Havrix 2 doses_Year 8 Group |
Primary outcome
Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose
Time frame: At approximately 8 years after the last administered vaccine dose
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).
Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose
Time frame: At approximately 10 years after the last administered vaccine dose
Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.
4 secondary outcomes
Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose
Time frame: At approximately 8 years after the last administered vaccine dose
Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose
Time frame: At approximately 10 years after the last administered vaccine dose
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
Time frame: At approximately 8 years after the last administered vaccine dose
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
Time frame: At approximately 10 years after the last administered vaccine dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site
Related trials for Hepatitis A Vaccine
Active, not recruitingPhase 4
Understanding Poor Vaccine Responses to Hepatitis B Vaccination
Vaccine Reaction
RecruitingObservational study
Study on the Long-Term Persistence of Immunity Induced by Inactivated Hepatitis A Vaccine
Hepatitis A
Recruiting
The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
Hepatitis B, Vaccination; Infection
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Not yet recruitingPhase 3
Study Interchangeability Hep-B Vaccine Administered at Birth Dose
Vaccination Adverse Event, Immunogenicity, Vaccine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection in people with Hepatitis A Vaccine, run by GlaxoSmithKline at 3 sites in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose (time frame: At approximately 8 years after the last administered vaccine dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.