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VaricellaPhase 3NCT05669625

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine

A Phase 3 study testing Investigational live attenuated varicella vaccine in people with Varicella, run by China National Biotec Group Company Limited at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children. Read more about this study

Who is it for?
Ages 1 year to 59 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?
Yes, some participants may receive a placebo
How many people
12,440 participants
Where
13 sitesChina
Study dates
26 Dec 2022to 14 Sep 2026
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 1 year to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy volunteer between 13 - 59 years old for Stage 1, 1-12 years old for Stage 2, and be able to provide legal identification ;
  • Subject and/or guardian has the ability to understand study requirements and processes, consent to participate in clinical trials, and sign informed consent forms;
  • Consent to use effective contraception during study participation, no pregnancy and no family planning (for women of childbearing potential or their spouses);
  • Axillary temperature ≤ 37.0 °C on the day of enrollment;

Who cannot join

  • Has received any varicella vaccine before ( Not applicable to Stage 1）;
  • Has history of varicella or herpes zoster infection, or contact with varicella/shingles patients or suspected varicella/shingles patients within 30 days before enrollment ( Not applicable to Stage 1）;
  • Currently using salicylates (including salicylic acid, aspirin, diflunisalin, p-aminosalicylate (sodium), dicalicylate, benoxate, etc.), or plan to use it for a long time during the study；
  • Have had febrile illness (axillary temperature ≥ 38.5 °C) or used antipyretic, analgesic, anti-allergic drugs (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination；
  • Have a history of allergy to vaccine components and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, local allergic necrosis (Arthus) reaction, severe urticaria, etc；
  • Have a history of epilepsy, convulsions or convulsions, and have a family history of severe neurological disease or psychosis
Show all 16Show fewer
  • Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases；
  • With severe congenital malformations, hereditary diseases, serious cardiovascular diseases, serious liver/kidney diseases, complicated diabetes, malignant tumors, and severe malnutrition
  • Immunosuppressant therapy, such as long-term oral or injectable glucocorticoid therapy (≥ 14 days, dose ≥2 mg/kg/day or ≥20 mg/day or equivalent to prednisone), within 3 months prior to enrollment or planned within 30 days of vaccination, but topical medications (e.g., ointments, eye drops, inhalers, or nasal sprays) are not restricted
  • Have received blood/blood-related products or immunoglobulins 3 months prior to vaccination, or plan to use such products 30 days after vaccination；
  • Have received a live attenuated vaccine within 30 days prior to the trial vaccine, or any vaccine within 14 days prior to vaccination;
  • Asplenectomy or splenectomy due to any condition (e.g. splenectomy);
  • Those with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection;
  • Suffering from various infectious, purulent or allergic skin diseases;
  • Are participating in other investigational or unregistered clinical trials of products (drugs, vaccines or devices, etc.), or have plans to participate in other clinical trials before the end of this clinical trial;
  • Has any other factors that are not suitable for participation in the clinical trial in the judgment of the investigator

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Qi County Center for Disease Control and Prevention

    Hebi, Henan

  • Wuzhi County Center for Disease Control and Prevention

    Jiaozuo, Henan

  • Wuyang County Center for Disease Control and Prevention

    Luohe, Henan

  • Mianyang Anzhou District Center for Disease Control and Prevention

    Mianyang, Sichuan

  • Southern County Center for Disease Control and Prevention

    Nanchong, Sichuan

  • Neijiang City Center for Disease Control and Prevention

    Neijiang, Sichuan

  • Lancang Lahu Autonomous County Center for Disease Control and Prevention

    Pu'er, Yunnan

  • Sinan County Center for Disease Control and Prevention

    Tongren, Guizhou

  • Songtao Miao Autonomous County Center for Disease Control and Prevention

    Tongren, Guizhou

  • Yuping Dong Autonomous County Center for Disease Control and Prevention

    Tongren, Guizhou

  • Yanshan County Center for Disease Control and Prevention

    Wenshan, Yunnan

  • Pei County Center for Disease Control and Prevention

    Xuzhou, Jiangsu, 221600

  • Huaiyin District Center for Disease Control and Prevention

    Xuzhou, Jiangsu, 223300

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Live Attenuated Varicella Vaccine in Healthy People

The goal of this clinical trial is to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.

Read the detailed description

This trial is aim to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children aged 1-12 years old.

This study will be conducted in two stage. the stage 1 adopts an open design, and 20 subjects aged 18~59 and 13~17 years old (18~59 years old→ 13~17 years old, sequentially enrolled) are enrolled, and 1 dose of the trial vaccine is administered to explore safety.

The stage 2 adopts a randomized, blinded, placebo-controlled design, 12400 healthy participants aged 1-12 years old will be randomly assigned into experimental group or control group with the ratio 1:1.

Conditions
Varicella
Being tested
Investigational live attenuated varicella vaccine, Placebo of live attenuated varicella vaccine
Keywords
vaccine efficacy, varicella vaccine, safety, immunogenicity
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

    0.5 ml/vial

  • Placebo of live attenuated varicella vaccineBiological

    0.5 ml/vial

Study groups in NCT05669625
Study groupRoleWhat they receive
Experimental GroupExperimentalSingle subcutaneous injection of the investigational vaccine (0.5 ml)
Receives: Biological: Investigational live attenuated varicella vaccine
Placebo GroupPlacebo comparatorSingle subcutaneous injection of the investigational placebo (0.5 ml)
Receives: Biological: Placebo of live attenuated varicella vaccine

What is being measured

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

  1. The incidences of varicella in each group

    The first 24 cases of varicella occurred 30 days after injection will be collected

    Measured: number of cases reported 30 days after vaccination

  2. The efficacy of the live attenuated varicella vaccine

    The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination

    Measured: number of cases reported 30 days after vaccination

Secondary outcomes (8)

  1. The vaccine efficacy against laboratory-confirmed cases of moderate and severe varicella

    The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination

    Measured: number of cases reported 30 days after vaccination

  2. The vaccine efficacy against clinical-confirmed cases

    calculated based on the reported cases occurred 30 days after vaccination

    Measured: number of cases reported 30 days after vaccination

  3. The incidences of adverse events (AEs)

    AEs occurred within 30 days after injection will be collected

    Measured: within 30 days after vaccination

  4. The incidences of serious adverse events (SAEs)

    SAEs occurred within 6 months after vaccination will be collected

    Measured: at least 6 months after vaccination

  5. The geometric mean titer (GMT) in the immunogenicity subgroup

    Geometric mean titer (GMT) will be measured before and 30 days after vaccination

    Measured: 30 days after vaccination

  6. The seroconversion rate of the immunogenicity subgroup

    The seroconversion rate will be calculated before and 30 days after vaccination

    Measured: 30 days after vaccination

  7. The geometric mean fold increase (GMI) of the immunogenicity subgroup

    Geometric mean fold increase (GMI) of the immunogenicity group will be calculated based on the geometric mean titer

    Measured: 30 days after vaccination

  8. The immune persistence of the immunogenicity subgroup

    Geometric mean titer (GMT) will be measured

    Measured: 1 year, 2 years, and 3 years 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 posted3 Jan 2023
  2. Study start26 Dec 2022
  3. Primary completion14 Apr 2024 (estimated)
  4. Study completion14 Sep 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
12,440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05669625
Sponsor's protocol ID
CNBG-BIBP-VZV-07
Status last verified
Jun 2023
First submitted
20 Dec 2022
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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 China National Biotec Group Company Limited at 13 sites 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 4 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

The incidences of varicella in each group (time frame: number of cases reported 30 days after vaccination). 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 NCT05669625.

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 18 Jun 2023.

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