Hepatitis APhase 4NCT01349829

A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children

A Phase 4 study testing HAVpur Junior and Havrix 720 Junior in people with Hepatitis A, run by Crucell Holland BV at 3 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides protection that is non-inferior to the protection afforded by vaccination with Havrix 720 Junior. Read more about this study

Who is it for?: Ages 18 to 47 monthsHealthy volunteers can take part
Conditions the study is for: Hepatitis A
What is being tested?: HAVpur Junior and Havrix 720 Junior
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 251 participants
Where: 3 sitesIndia
Study dates: Mar 2010to Apr 2011
Phase: Phase 4
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 18 to 47 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

A male or female between (and including) 18 months to 47 months of age.
Written informed consent obtained from the parent/legal guardian of the subject.
Free of obvious health problems as established by medical history and/or clinical examination before entering the study

Who cannot join

Seropositive for anti-HAV antibodies (>=10 mIU/ml).
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, such as prednisone, or equivalent, >=0.5 mg/kg/day.
Inhaled and local steroids are allowed.)
Planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine.
Previous vaccination against hepatitis A.

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Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment

Trial locations and contacts

3 sites in 1 country.

India3 sites

Medical College and Chacha Nehru Bal Chikitsalay
Indore, Madhya Pradesh, 452001
Christian Medical College and Hospital
Ludhiana, Punjab, 141008
Rajiv Ghandi Medical College
Thane, Maharashtra, 400 605

Other trials in India

About this study

Official title: A Phase IV Open, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of a Pediatric Presentation (0.25 ml) of the Virosomal Hepatitis A Virus (HAV) Vaccine HAVpur in Healthy Young Children Aged Between and Including 18 Months to 47 Months, Using a 0/6 Month Immunization Schedule

This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides protection that is non-inferior to the protection afforded by vaccination with Havrix 720 Junior.

Conditions: Hepatitis A
Being tested: HAVpur Junior, Havrix 720 Junior
Keywords: Hepatitis A, Vaccination, Immunity
Medical subject headings: Hepatitis A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HAVpur JuniorBiological
≥12 International Units (IU) hepatitis A antigen coupled to virosomes, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus)
Vaccination schedule: single doses at 0 and 6 months
Havrix 720 JuniorBiological
≥720 ELISA Units (EU) hepatitis A antigen adsorbed to aluminium hydroxide, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus)
Vaccination schedule: single doses at 0 and 6 months

Study groups in NCT01349829
Study group	Role	What they receive
HAVpur	Experimental	Not described Receives: Biological: HAVpur Junior
Havrix	Active comparator	Not described Receives: Biological: Havrix 720 Junior

What is being measured

The primary outcome is the main question the study is designed to answer.

Seroprotection at Month 1
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)
Measured: Month 1

Secondary outcomes (5)

Seroprotection at Month 6
Proportion of subjects seroprotected (>=10 mIU/ml)
Measured: Month 6
Seroprotection at Month 7
Proportion of subjects seroprotected (>=10 mIU/ml)
Measured: Month 7
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Measured: Month 1
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Measured: Month 6
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Measured: Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Apr 2011

First posted9 May 2011 (estimated)
Study startMar 2010
Primary completionApr 2011
Study completionApr 2011

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 AStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 251 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01349829
Sponsor's protocol ID: EPA-V-A008
Status last verified: Aug 2013
First submitted: 5 May 2011
Last updated: 17 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis A trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV Open, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of a Pediatric Presentation (0.25 ml) of the Virosomal Hepatitis A Virus (HAV) Vaccine HAVpur in Healthy Young Children Aged Between and Including 18 Months to 47 Months, Using a 0/6 Month Immunization Schedule
ClinicalTrials.gov ID: NCT01349829
Acronym / sponsor ID: EPA-V-A008
Conditions: Hepatitis A
Keywords: Hepatitis A, Vaccination, Immunity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 251 participants (actual)
Lead sponsor: Crucell Holland BVIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 9 May 2011 (estimated)
Results: Posted 17 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides protection that is non-inferior to the protection afforded by vaccination with Havrix 720 Junior.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
HAVpur	Experimental	Biological: HAVpur Junior
Havrix	Active comparator	Biological: Havrix 720 Junior

Who may qualify

Ages: 18 to 47 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

A male or female between (and including) 18 months to 47 months of age.
Written informed consent obtained from the parent/legal guardian of the subject.
Free of obvious health problems as established by medical history and/or clinical examination before entering the study

Key exclusion criteria (10 listed)

Seropositive for anti-HAV antibodies (>=10 mIU/ml).
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, such as prednisone, or equivalent, >=0.5 mg/kg/day.
Inhaled and local steroids are allowed.)
Planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine.

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
HAVpur Junior≥12 International Units (IU) hepatitis A antigen coupled to virosomes, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus) Vaccination schedule: single doses at 0 and 6 months	Biological	HAVpur
Havrix 720 Junior≥720 ELISA Units (EU) hepatitis A antigen adsorbed to aluminium hydroxide, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus) Vaccination schedule: single doses at 0 and 6 months	Biological	Havrix

Primary outcome

Seroprotection at Month 1
Time frame: Month 1
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)

5 secondary outcomes

Seroprotection at Month 6
Time frame: Month 6
Seroprotection at Month 7
Time frame: Month 7
Geometric Mean Concentrations (GMCs)
Time frame: Month 1
Geometric Mean Concentrations (GMCs)
Time frame: Month 6
Geometric Mean Concentrations (GMCs)
Time frame: Month 7

Results and safety

Results posted to the registry on 17 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HAVpur	126	117
Havrix	125	102

Primary outcome: Seroprotection at Month 1

Time frame: Month 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	HAVpur n = 122	Havrix n = 117
Value	95.9 (90.7 to 98.7)	96.6 (91.5 to 99.1)

Population analysed: Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HAVpur - First Vaccination	0 of 126 (0%)	24 of 126 (19%)	Not reported
Havrix - First Vaccination	1 of 125 (0.8%)	24 of 125 (19.2%)	Not reported
HAVPur - Second Vaccination	1 of 118 (0.8%)	4 of 118 (3.4%)	Not reported
Havrix - Second Vaccination	0 of 108 (0%)	6 of 108 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis A

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 2
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Not yet recruitingObservational study
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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.

Daljit Singh, MD principal investigator

Dayanad Medical College and Hospital

Tejinder Singh, MD principal investigator

Christian Medical College and Hospital

Hemant Jain, MD principal investigator

Medical College and Chacha Nehru Bal Chikitsalay

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing HAVpur Junior and Havrix 720 Junior in people with Hepatitis A, run by Crucell Holland BV at 3 sites in India.

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 3 inclusion and 10 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 17 Dec 2013. 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 India. 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.

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?

Yes. Results are posted in the registry (first posted 17 Dec 2013). 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?

Seroprotection at Month 1 (time frame: Month 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01349829.

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 17 Dec 2013.