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Hepatitis APhase 4HAVNCT01949857

The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

A Phase 4 study testing Attenuated HAV Vaccine, H2 Strain, Attenuated HAV Vaccine, L-A-1 Strain and Inactivated HAV Vaccine, Lu8 Strain in people with Hepatitis A, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.

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

The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine. Read more about this study

Who is it for?
Ages 18 months to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis A
What is being tested?
Attenuated HAV Vaccine, H2 Strain, Attenuated HAV Vaccine, L-A-1 Strain and Inactivated HAV Vaccine, Lu8 Strain
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35,000 participants
Where
1 siteChina
Study dates
Sep 2013to Jun 2016
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 months to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Only subjects fulfilling all of the following criteria will be eligible for the study:
  • People aged from 18 months to 65 years old.
  • The subjects or subjects' guardians are able to understand and sign the informed consent
  • The subjects or subjects' guardians allow to comply with the requirements of the protocol
  • Subjects with temperature <=37.0°C on axillary setting
  • The subjects have signed informed consent already

Who cannot join

  • Subjects will not be eligible for the study if any of the following criteria is met:
  • Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
  • Have a history of neurological symptoms or signs
  • Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
  • Suffering from serious chronic diseases
  • Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
Show all 17Show fewer
  • Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
  • Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
  • Any prior diseases including human immunodeficiency virus infection or related
  • Bleeding constitution or prolong bleeding time situation
  • Accept hepatitis A vaccination within a month
  • Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
  • People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
  • Caught a fever with axillary temperature 38°C or higher in past 3 days
  • Take part in another clinical researchers
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
  • Pregnancy test result is positive

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute of Medical Biology -Chinese Academy of Medical Sciences

    Kunming, Yunnan, 650118

Other trials in China

About this study

Official title: Phase 4 Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine

The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.

Read the detailed description

Hepatitis A refers to liver inflammation caused by infection with the hepatitis A virus. HAV is is one of the most common hepatitis viruses that can cause hepatitis in China. The data from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese people.

Conditions
Hepatitis A
Being tested
Attenuated HAV Vaccine, H2 Strain, Attenuated HAV Vaccine, L-A-1 Strain, Inactivated HAV Vaccine, Lu8 Strain, Inactivated HAV Vaccine, TZ84 Strain
Keywords
Hepatitis A, Vaccine, Safety, efficacy
Medical subject headings
Hepatitis A

What participants receive

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

  • Attenuated HAV Vaccine, H2 StrainBiological

    Also called Hepatitis A (Live) Vaccine, Freeze-dried

    6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).

  • Attenuated HAV Vaccine, L-A-1 StrainBiological

    Also called Hepatitis A Vaccine

    6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).

  • Inactivated HAV Vaccine, Lu8 StrainBiological

    Also called Hepatitis A Vaccine, Inactivated

    320EU/Vial in babies aged 18-35 months\320EU/Vial in children aged 3-15 years \640EU/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose

  • Inactivated HAV Vaccine, TZ84 StrainBiological

    Also called Hepatitis A Vaccine, Inactivated

    250U/Vial in babies aged 18-35 months\250U/Vial in children aged 3-15 years \500U/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose.

Study groups in NCT01949857
Study groupRoleWhat they receive
Attenuated HAV Vaccine, H2 StrainExperimental6.50 lgCCID50/ml in babies aged 18-35 months\6.50 lgCCID50/ml in children aged 3-15 years \6.50 lgCCID50/ml in adults aged 16 up to 65 years old
Receives: Biological: Attenuated HAV Vaccine, H2 Strain
Attenuated HAV Vaccine, L-A-1 StrainExperimental6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).
Receives: Biological: Attenuated HAV Vaccine, L-A-1 Strain
Inactivated HAV Vaccine, Lu8 StrainExperimental320EU/Vial in babies aged 18-35 months\320EU/Vial in children aged 3-15 years \640EU/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose
Receives: Biological: Inactivated HAV Vaccine, Lu8 Strain
Inactivated HAV Vaccine, TZ84 StrainExperimental250U/Vial in babies aged 18-35 months\250U/Vial in children aged 3-15 years \500U/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose
Receives: Biological: Inactivated HAV Vaccine, TZ84 Strain

What is being measured

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

  1. changes of hepatitis A antibody concentration

    1. Changes of anti-HAV antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.

    Measured: up to 43 months

Secondary outcomes (1)

  1. The frequency of all the adverse events in vaccine group and placebo group

    compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group.

    Measured: up to 43 months

Timeline

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

  1. First posted25 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2015
  4. Study completionJun 2016

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
35,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949857
Sponsor's protocol ID
qiangmingsun123456!
Acronym
HAV
Status last verified
Oct 2023
First submitted
28 Aug 2013
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Attenuated HAV Vaccine, H2 Strain, Attenuated HAV Vaccine, L-A-1 Strain and Inactivated HAV Vaccine, Lu8 Strain in people with Hepatitis A, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.

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 6 inclusion and 17 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

changes of hepatitis A antibody concentration (time frame: up to 43 months). 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 NCT01949857.

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 10 Oct 2023.

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