AzTrials
AzTrials

VaricellaPhase 4NCT05526820

A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine

A Phase 4 study testing The live attenuated varicella vaccine and the inactivated hepatitis A vaccine in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. 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
Search all trials

Trial summary

This study is a randomized and controlled Phase IV clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of combined immunization with live attenuated varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months. Read more about this study

Who is it for?
Ages 12 to 15 monthsHealthy volunteers can take part
Conditions the study is for
Varicella
What is being tested?
The live attenuated varicella vaccine and the inactivated hepatitis A vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteChina
Study dates
8 Apr 2021to 27 Feb 2022
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 12 to 15 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy child aged 1 year old (12-15 months old);
  • Proven legal identity;
  • The subjects'guardians should be capable of understanding the informed consent form, and such form should be signed prior to enrolment.

Who cannot join

  • History of vaccination of varicella vaccine or hepatitis A vaccine.
  • Previous history of varicella infection or hepatitis A infection;
  • History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
  • Thyroid disease or history of thyroidectomy, asplenia,functional asplenia,asplenia or splenectomy resulting from any condition;
  • Suffering from serious chronic diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, etc;
Show all 16Show fewer
  • Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before enrollment;
  • Receipt of blood products within the past 3 months;
  • Receipt of other investigational vaccines or drugs within 28 days prior to receiving the investigational vaccine;
  • Receipt of attenuated live vaccines in the past 28 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Onset of various acute or chronic diseases within 7 days prior to the study;
  • Armpit temperature in subjects with fever prior to vaccination with the investigational vaccine. 37.4 ℃;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Feicheng Center for Disease Control and Prevention

    Tai’an, Shandong

Other trials in China

About this study

Official title: A Randomized, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Inactivated Hepatitis A Vaccine

This study is a randomized and controlled Phase IV clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of combined immunization with live attenuated varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months.

Read the detailed description

This study is a randomized and controlled phase IV clinical trial in children aged 1 year old (12-15 months).The purpose of this study is to evaluate the immunogenicity and safety of live attenuated varicella vaccine co-administration with inactivated hepatitis A vaccine .The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 450 subjects aged 1 year old (12-15 months) were be enrolled.Subjects were be randomly divided into 2 groups in a ratio of 1:1.Subjects in the combined immunization group received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.Subjects in the Non-combined immunization group received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.

Conditions
Varicella
Being tested
The live attenuated varicella vaccine and the inactivated hepatitis A vaccine
Medical subject headings
Chickenpox

What participants receive

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

  • The live attenuated varicella vaccine and the inactivated hepatitis A vaccineBiological

    The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.

    The live attenuated varicella vaccine:live varicella-zoster virus in 0.5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection.

    The inactivated hepatitis A vaccine:250 U inactivated virus in 0.5mL of aluminium hydroxide solution per injection.

    All subjects received hepatitis A vaccine in the upper left arm and varicella vaccine in the upper right arm.

Study groups in NCT05526820
Study groupRoleWhat they receive
The combined immunization groupExperimental225 participants received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.
Receives: Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine
The Non-combined immunization groupActive comparator225 participants received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.
Receives: Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine

What is being measured

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

  1. Seroconversion rates of the varicella antibody

    Seroconversion rate of varicella antibody 42 days after immunization of live attenuated varicella vaccine.

    Measured: 42 days after immunization of live attenuated varicella vaccine

  2. Seroconversion rates of anti-HAV antibody

    Seroconversion rate of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.

    Measured: 30 days after full immunization with hepatitis A vaccine

Secondary outcomes (9)

  1. Seropositive rates of varicella antibody

    Seropositive rates of varicella antibody 42 days after immunization of live attenuated varicella vaccine.

    Measured: 42 days after immunization of live attenuated varicella vaccine

  2. GMT of varicella antibody

    GMT of varicella antibody 42 days after immunization of live attenuated varicella vaccine.

    Measured: 42 days after immunization of live attenuated varicella vaccine

  3. GMI of varicella antibody

    GMI of varicella antibody 42 days after immunization of live attenuated varicella vaccine.

    Measured: 42 days after immunization of live attenuated varicella vaccine

  4. Seropositive rates of anti-HAV antibody

    Seropositive rates of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.

    Measured: 30 days after full immunization with hepatitis A vaccine

  5. GMC of anti-HAV antibody

    GMC of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.

    Measured: 30 days after full immunization with hepatitis A vaccine

  6. GMI of anti-HAV antibody

    GMI of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.

    Measured: 30 days after full immunization with hepatitis A vaccine

  7. The incidence of adverse events

    Incidence of adverse events within 0-42 days (or 0-30 days) after each dose of vaccine.

    Measured: within 0-42 days (or 0-30 days) after each dose of vaccine

  8. The incidence of local and systemic solicitation adverse reactions

    The incidence of local and systemic solicitation adverse reactions within 0-14 days (or 0-7 days) after each dose of vaccine.

    Measured: Within 0-14 days (or 0-7 days) after each dose of vaccine

  9. The incidence of serious adverse events (SAE)

    The incidence of serious adverse events (SAE) within 42 days (or 30 days) after administration of each dose of vaccine.

    Measured: Within 42 days (or 30 days) after administration of each dose of vaccine

Timeline

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

  1. First posted2 Sep 2022
  2. Study start8 Apr 2021
  3. Primary completion8 Apr 2021
  4. Study completion27 Feb 2022

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
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05526820
Sponsor's protocol ID
PRO-VZV-4001
Status last verified
Aug 2022
First submitted
31 Aug 2022
Last updated
2 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sun D, Yu D, Du Z, Jia N, Liu X, Sun J, Xu Q, Sun Z, Luan C, Lv J, Xiong P, Zhang L, Sha X, Gao Y, Kang D. Immunogenicity and safety of a live attenuated varicella vaccine co-administered with inactive hepatitis A vaccine: A phase 4, single-center, randomized, controlled trial. Hum Vaccin Immunother. 2023 Dec 31;19(1):2161789. doi: 10.1080/21645515.2022.2161789. Epub 2023 Jan 2.

    PubMed 36593652

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing The live attenuated varicella vaccine and the inactivated hepatitis A vaccine in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. 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 3 inclusion and 16 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 2 Sep 2022. 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?

Seroconversion rates of the varicella antibody (time frame: 42 days after immunization of live attenuated varicella vaccine). 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?

On the ClinicalTrials.gov record for NCT05526820, which also lists 1 linked publication.

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 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in