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VaricellaPhase 3NCT05150392

An Open-labelled Clinical Trial of Live Attenuated Varicella Vaccines to Evaluate the Immunity Persistence After Primary Immunization and Safety and Immunogenicity After the Booster Immunization

A Phase 3 study testing Investigational live attenuated varicella 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
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Trial summary

This is an open-labelled clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunity persistence of the single-dose primary immunization of live attenuated varicella vaccine on different time points ,and the… Read more about this study

Who is it for?
Ages 2 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Varicella
What is being tested?
Investigational live attenuated varicella vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,193 participants
Where
1 siteChina
Study dates
11 Jul 2018to 14 Aug 2020
Phase
Phase 3
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 2 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Received one dose live attenuated varicella vaccine in the phase Ⅲ lot-consistency clinical trial;
  • Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.

Who cannot join

  • Received one dose live attenuated varicella vaccine at the end of the phase Ⅲ lot-consistency clinical trial;
  • 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

  • Xiangfu County Center for Disease Control and Prevention

    Kaifeng, Henan, 461700

Other trials in China

About this study

Official title: An Open-labelled Clinical Trial,to Evaluate the Immunity Persistence of the Single-dose Primary Immunization of Live Attenuated Varicella Vaccine on Different Time Points,and the Safety and Immunogenicity After the Booster Immunization

This is an open-labelled clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunity persistence of the single-dose primary immunization of live attenuated varicella vaccine on different time points ,and the safety and immunogenicity after the booster immunization

Read the detailed description

This study is an open-labelled phase Ⅲ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.A total of 1195 subjects who received vaccine in the phase Ⅲ lot-consistency clinical trial were be enrolled .All subjects except C0243 and C0556 were divided into 3 groups according to the order of study number.Subjects in 3 groups received a booster immunization of live attenuated varicella vaccines 1 year,2 years and 3 years after primary immunization,respectively.About 3.0ml of venous blood was collected from each enrolled subject at pre-booster immunization,30 days after booster immunization and the serum was separated for neutralizing antibody detection.The antibody levels were used to evaluate the immunity persistence and immunogenicity after booster immunization of live attenuated varicella vaccines .

Conditions
Varicella
Being tested
Investigational live attenuated varicella vaccine
Medical subject headings
Chickenpox

What participants receive

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

  • Investigational live attenuated varicella vaccineBiological

    The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.And the 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

Study groups in NCT05150392
Study groupRoleWhat they receive
Booster immunization 1 year after primary immunizationExperimentalSubjects C0001-C0400 except C0243 received 1 dose of booster immunization 1 year after primary immunization.
Receives: Biological: Investigational live attenuated varicella vaccine
Booster immunization 2 year after primary immunizationExperimentalSubjects C0401-C0800 except C0556 received 1 dose of booster immunization 2 years after primary immunization.
Receives: Biological: Investigational live attenuated varicella vaccine
Booster immunization 3 year after primary immunizationExperimentalSubjects C0801-C1197 received 1 dose of booster immunization 3 years after primary immunization.
Receives: Biological: Investigational live attenuated varicella vaccine

What is being measured

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

  1. Immunogenicity index-seroconversion rate of antibody

    seroconversion rates of antibody 1 year after primary immunization

    Measured: 1 year after primary immunization

  2. Immunogenicity index-seroconversion rate of antibody

    seroconversion rates of antibody 2 years after primary immunization

    Measured: 2 years after primary immunization

  3. Immunogenicity index-seroconversion rate of antibody

    seroconversion rates of antibody 3 years after primary immunization

    Measured: 3 years after primary immunization

  4. Immunogenicity index-Seroconversion rate of antibody

    Seroconversion rate of the neutralizing antibody 30 days after booster immunization

    Measured: 30 days after booster immunization

  5. Immunogenicity index-seropositivity rate of antibody

    Seropositivity rate of antibody 30 days after booster immunization

    Measured: 30 days after booster immunization

Secondary outcomes (7)

  1. Immunogenicity index-Seropositivity rate of antibody

    Seropositivity rate of antibody before booster immunization

    Measured: Before the booster dose immunization

  2. Immunogenicity index-GMT of the antibody

    GMT of the antibody before booster immunization

    Measured: Before the booster dose immunization

  3. Immunogenicity index- GMT of the antibody

    GMT of the antibody 30 days after booster immunization

    Measured: 30 days after booster immunization

  4. Immunogenicity index- GMI of the antibody

    GMI of the antibody 30 days after booster immunization

    Measured: 30 days after booster immunization

  5. Safety index-Incidence of solicited local or systemic AE

    Incidence of solicited local or systemic AE within 14 days after vaccination

    Measured: within 14 days after vaccination

  6. Safety index-Incidence of local or systemic AE

    Incidence of local or systemic AE within 30 days after vaccination

    Measured: within 30 days after vaccination

  7. Safety index-Incidence of SAE

    Incidence of SAE within 30 days after vaccination

    Measured: within 30 days after vaccination

Timeline

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

  1. First posted9 Dec 2021
  2. Study start11 Jul 2018
  3. Primary completion11 Aug 2018
  4. Study completion14 Aug 2020

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 3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05150392
Sponsor's protocol ID
PRO-VZV-3002-1
Status last verified
Nov 2021
First submitted
22 Nov 2021
Last updated
9 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Investigational live attenuated varicella 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 2 inclusion and 2 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 9 Dec 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Immunogenicity index-seroconversion rate of antibody (time frame: 1 year after primary immunization). The study lists 5 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 NCT05150392.

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 9 Dec 2021.

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