Hepatitis APhase 4NCT03183492
Immunogenicity and Persistence of GlaxoSmithKline (GSK) Biologicals' Havrix® in Healthy Adult Subjects Vaccinated at Infancy Under the Hepatitis A Universal Mass Vaccination (UMV) Program in Israel
A Phase 4 study testing Havrix® in people with Hepatitis A, run by GlaxoSmithKline.
Trial summary
This study will evaluate the persistence, immunogenicity and safety of Havrix® (hepatitis A vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult vaccine. Read more about this study
- Who is it for?
- Ages 18 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Havrix®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2018to 28 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 19 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject prior to performing any study specific procedure
- A male or female subject aged 18 to 19 years at the time of enrolment (up to but excluding the 20th birthday)
- Documented administration of 2 doses of Havrix® Junior in the second year of life
- Healthy subjects as established by medical history and clinical examination before entering into the study
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to study vaccine administration, and has a negative pregnancy test on the day of vaccine administration, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study vaccine administration
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day 29 to Day1), or planned use during the study period
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
- Administration of long-acting immune-modifying drugs at any time during the study entry
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
- Administration of any hepatitis A vaccine dose, with the exception of the two doses of routine toddler vaccination for the subjects
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
- Planned enrolment in the Israel Defense Forces within 30 days of study enrolment or activity that would prohibit the subject to return for Visit 2
- Acute disease and/or fever at the time of enrolment Fever is defined as temperature ≥38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity Subjects with a minor illness without fever may be enrolled at the discretion of the investigator
- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive precautions
About this study
Official title: Long-term Persistence of Hepatitis A Immunity in Healthy Adults Vaccinated as Part of a Hepatitis A Universal Mass Vaccination Program
This study will evaluate the persistence, immunogenicity and safety of Havrix® (hepatitis A vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult vaccine. In the present study, the anamnestic response will be assessed 30 days after the challenge dose.
- Conditions
- Hepatitis A
- Being tested
- Havrix®
- Keywords
- Israel, Universal Mass Vaccination, Havrix®, Hepatitis A, Healthy adults, Long term persistence, Toddlers
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Havrix®Biological
Also called GSK Biologicals' inactivated hepatitis A vaccine
One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
| Study group | Role | What they receive |
|---|---|---|
| HAV Group | Experimental | Subjects who were vaccinated under UMV with 2 doses of Havrix® Junior at infancy and will receive a single challenge dose of Havrix Adult at Visit 1 (Day 1). Receives: Biological: Havrix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of immunity to hepatitis A in terms of anti-HAV (Antibodies against Hepatitis A virus) seropositivity status.
A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL.
Measured: At the pre-challenge time-point (Day 1)
Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations.
Immunogenicity will be assessed in terms of Geometric Mean Concentration (GMC) of anti-HAV antibody concentrations.
Measured: At the pre-challenge time-point (Day 1)
Secondary outcomes (6)
Evaluation of immunity to hepatitis A in terms of anti-HAV anamnestic response to hepatitis A vaccine challenge dose.
Anti-HAV anamnestic response to the challenge dose is defined as:
At least a 4-fold increase in anti-HAV antibody concentrations in subjects seropositive at the pre-challenge time-point.
Anti-HAV antibody concentrations at least 4 time the assay cut-off (i.e.60 mIU/mL) in subjects seronegative at the pre-challenge time-point.
Measured: 30 days (Day 31) after challenge dose
Evaluation of immunity to hepatitis A in terms of anti-HAV seropositivity status in response to hepatitis A vaccine challenge dose.
A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL .
Measured: 30 days (Day 31) after challenge dose
Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations in response to hepatitis A vaccine challenge dose.
Immunogenicity will be assessed in terms of GMC of anti-HAV antibody concentrations.
Measured: 30 days (Day 31) after challenge dose
Occurrence of solicited local and general symptoms.
The following local (injection-site) AEs will be solicited:
Pain at injection site, Redness at injection site, Swelling at injection site.
The following general AEs will be solicited:
Fatigue, Fever*, Gastrointestinal symptoms**, Headache.
*Fever is defined as temperature ≥38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
**Gastrointestinal symptoms include nausea, vomiting, diarrhea and/or abdominal pain.
The AEs will be categorized depending on their intensity into the following grades:
- (mild) = An AE which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities.
- (moderate) = An AE which is sufficiently discomforting to interfere with normal everyday activities.
- (severe) = An AE which prevents normal, everyday activities.
Measured: During the 4-day (Days 1-4) follow-up period after the challenge dose
Occurrence of unsolicited symptoms, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 31-day (Days 1-31) follow-up period after the challenge dose
Occurrence of Serious Adverse Events (SAEs).
SAEs to be assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.
Measured: After the challenge dose up to the study end (Days 1-31)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start7 May 2018 (estimated)
- Primary completion28 Jan 2019 (estimated)
- Study completion28 Jan 2019 (estimated)
Why it stopped: Sponsor cancelled the study as real life impact data has already shown the value of HepA vaccination \& as no critical need to gather additional data in Israel.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis AStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT03183492
- Sponsor's protocol ID
- 116762
- Status last verified
- Mar 2018
- First submitted
- 30 May 2017
- Last updated
- 2 Mar 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Persistence of Hepatitis A Immunity in Healthy Adults Vaccinated as Part of a Hepatitis A Universal Mass Vaccination Program
- ClinicalTrials.gov ID
- NCT03183492
- Acronym / sponsor ID
- 116762
- Conditions
- Hepatitis A
- Keywords
- Israel, Universal Mass Vaccination, Havrix®, Hepatitis A, Healthy adults, Long term persistence, Toddlers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor cancelled the study as real life impact data has already shown the value of HepA vaccination \& as no critical need to gather additional data in Israel.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 May 2018 (estimated)
- Primary completion
- 28 Jan 2019 (estimated)
- Study completion
- 28 Jan 2019 (estimated)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the persistence, immunogenicity and safety of Havrix® (hepatitis A vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult vaccine. In the present study, the anamnestic response will be assessed 30 days after the challenge dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAV Group | Experimental | Biological: Havrix®Subjects who were vaccinated under UMV with 2 doses of Havrix® Junior at infancy and will receive a single challenge dose of Havrix Adult at Visit 1 (Day 1). |
Who may qualify
- Ages
- 18 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject prior to performing any study specific procedure
- A male or female subject aged 18 to 19 years at the time of enrolment (up to but excluding the 20th birthday)
- Documented administration of 2 doses of Havrix® Junior in the second year of life
- Healthy subjects as established by medical history and clinical examination before entering into the study
Key exclusion criteria (12 listed)
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day 29 to Day1), or planned use during the study period
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
- Administration of long-acting immune-modifying drugs at any time during the study entry
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
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 |
|---|---|---|
| Havrix®Also: GSK Biologicals' inactivated hepatitis A vaccineOne challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm. | Biological | HAV Group |
Primary outcome
Evaluation of immunity to hepatitis A in terms of anti-HAV (Antibodies against Hepatitis A virus) seropositivity status.
Time frame: At the pre-challenge time-point (Day 1)
A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value of 15mIU/mL.
Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations.
Time frame: At the pre-challenge time-point (Day 1)
Immunogenicity will be assessed in terms of Geometric Mean Concentration (GMC) of anti-HAV antibody concentrations.
6 secondary outcomes
Evaluation of immunity to hepatitis A in terms of anti-HAV anamnestic response to hepatitis A vaccine challenge dose.
Time frame: 30 days (Day 31) after challenge dose
Evaluation of immunity to hepatitis A in terms of anti-HAV seropositivity status in response to hepatitis A vaccine challenge dose.
Time frame: 30 days (Day 31) after challenge dose
Evaluation of immunity to hepatitis A in terms of anti-HAV antibody concentrations in response to hepatitis A vaccine challenge dose.
Time frame: 30 days (Day 31) after challenge dose
Occurrence of solicited local and general symptoms.
Time frame: During the 4-day (Days 1-4) follow-up period after the challenge dose
Occurrence of unsolicited symptoms, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.
Time frame: During the 31-day (Days 1-31) follow-up period after the challenge dose
Occurrence of Serious Adverse Events (SAEs).
Time frame: After the challenge dose up to the study end (Days 1-31)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: Yes. 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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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Havrix® in people with Hepatitis A, run by GlaxoSmithKline.
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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of immunity to hepatitis A in terms of anti-HAV (Antibodies against Hepatitis A virus) seropositivity status. (time frame: At the pre-challenge time-point (Day 1)). 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 2 Mar 2018.