VaricellaPhase 3NCT05839301
A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age
A Phase 3 study testing Investigational live attenuated varicella vaccine (lot 1), Investigational live attenuated varicella vaccine (lot 2) and Investigational live attenuated varicella vaccine (lot 3) in people with Varicella, run by China National Biotec Group Company Limited at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the lot-to-lot consistency, immunogenicity, and safety of 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 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- Investigational live attenuated varicella vaccine (lot 1), Investigational live attenuated varicella vaccine (lot 2) and Investigational live attenuated varicella vaccine (lot 3)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2023to 30 Apr 2024
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 1 to 12 years on the day of enrollment ,male or female, and able to provide legal identity certificate.
- Subjects and/or guardians have the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent form.
- Axillary temperature ≤ 37.0 ° C on the day of enrollment.
Who cannot join
- Previous vaccination against varicella (eg, varicella vaccine, measles + varicella vaccine).
- History of varicella or herpes zoster infection, or exposure to varicella/herpes zoster within 30 days of enrollment or suspected varicella/herpes zoster;
- Current use of salicylates (including salicylic acid, aspirin, diflunisal, p-aminosalicylic acid (sodium), salsalsalate, benorilate, etc.), or planned long-term use during the study.
- Febrile illness (axillary temperature ≥ 38.5 ° C) or use of antipyretic, analgesic, and anti-allergic drugs (eg, acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination.
- History of allergy to vaccine ingredients and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria.
- History of epilepsy, convulsions, or convulsions, or a family history of psychosis.
Show all 16Show fewer
- Impaired immune function or has been 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.
- Patients suffering from serious congenital malformations, genetic diseases, serious cardiovascular diseases, serious liver/kidney diseases, diabetes with complications, malignant tumors, severe malnutrition.
- Immunosuppressant therapy such as chronic oral or injectable glucocorticoid therapy (≥ 14 days at doses ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalent prednisone dose) within 3 months prior to administration of trial vaccine or planned 30 days following administration, but not limited by topical use (eg, ointment, eye drops, inhalers, or nasal sprays).
- Receiving blood/blood-related products or immunoglobulins 3 months before vaccination or planning to use such products 30 days after vaccination.
- Vaccination with a live attenuated vaccine within 30 days or any vaccine within 14 days prior to vaccination.
- Absence of spleen or splenectomy due to any condition such as splenectomy.
- Patients with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection.
- Infectious, suppurative and allergic skin diseases.
- Participating in other investigational or non-registered product (drug, vaccine or device, etc.) clinical trials, or planning to participate in other clinical trials before the end of this clinical trial.
- Subject has any other factor that, in the judgment of the investigator, would make the subject unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinyi Center for Disease Control and Prevention
Xuzhou, Jiangsu, 221600
About this study
Official title: A Single-center, Randomized, Double-blind Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age
The goal of this clinical trial is to evaluate the lot-to-lot consistency, immunogenicity, and safety of 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 lot-to-lot consistency, immunogenicity, and safety of live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy people 1 to 12 years of age.1200 healthy subjects aged 1-12 years were enrolled after their guardians passed the informed consent, inclusion and exclusion criteria screening in turn. Three batches were randomized in a 1:1: 1 ratio, with 400 subjects in each batch.All subjects received 1 dose of trial vaccine (Batch 1 or Batch 2 or Batch 3) and all were collected Blood samples were collected from subjects before vaccination, on Day 30 after vaccination for serum neutralizing antibody testing to evaluate immunogenicity, and Safety observations were performed until 6 months post-vaccination in all subjects.
- Conditions
- Varicella
- Being tested
- Investigational live attenuated varicella vaccine (lot 1), Investigational live attenuated varicella vaccine (lot 2), Investigational live attenuated varicella vaccine (lot 3)
- Keywords
- varicella vaccine, safety, immunogenicity, lot-to-lot consistency
- 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 vaccine (lot 1)Biological
0.5ml/vial
Investigational live attenuated varicella vaccine (lot 2)Biological
0.5ml/vial
Investigational live attenuated varicella vaccine (lot 3)Biological
0.5ml/vial
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group1 | Experimental | Single subcutaneous injection of the investigational vaccine (0.5ml) Receives: Biological: Investigational live attenuated varicella vaccine (lot 1) |
| Experimental Group2 | Experimental | Single subcutaneous injection of the investigational vaccine (0.5ml) Receives: Biological: Investigational live attenuated varicella vaccine (lot 2) |
| Experimental Group3 | Experimental | Single subcutaneous injection of the investigational vaccine (0.5ml) Receives: Biological: Investigational live attenuated varicella vaccine (lot 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization
Measured: 30 days after vaccination
Secondary outcomes (4)
Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies
Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization
Measured: 30 days after vaccination
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies 30 days after vaccination in the whole population
Measured: 30 days after vaccination
The incidences of adverse events (AEs)
AEs occurred witnin 30 days after vaccination will be collected
Measured: 30 days after vaccination
The incidences of serious adverse events (SAEs) and Adverse Event of Special Interest(AESI)
SAEs and AESI occurred witnin 6 months after vaccination will be collected
Measured: 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start27 Apr 2023
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricellaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Institute of Biological Products Co Ltd., Jiangsu Province Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Hongxing Pan, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839301
- Sponsor's protocol ID
- CNBG-BIBP-VZV-08
- Status last verified
- Jun 2023
- First submitted
- 20 Apr 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age
- ClinicalTrials.gov ID
- NCT05839301
- Acronym / sponsor ID
- CNBG-BIBP-VZV-08
- Conditions
- Varicella
- Keywords
- varicella vaccine, safety, immunogenicity, lot-to-lot consistency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Institute of Biological Products Co Ltd., Jiangsu Province Centers for Disease Control and Prevention
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the lot-to-lot consistency, immunogenicity, and safety of live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.
Detailed description
This trial is aim to evaluate the lot-to-lot consistency, immunogenicity, and safety of live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy people 1 to 12 years of age.1200 healthy subjects aged 1-12 years were enrolled after their guardians passed the informed consent, inclusion and exclusion criteria screening in turn. Three batches were randomized in a 1:1: 1 ratio, with 400 subjects in each batch.All subjects received 1 dose of trial vaccine (Batch 1 or Batch 2 or Batch 3) and all were collected Blood samples were collected from subjects before vaccination, on Day 30 after vaccination for serum neutralizing antibody testing to evaluate immunogenicity, and Safety observations were performed until 6 months post-vaccination in all subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group1 | Experimental | Biological: Investigational live attenuated varicella vaccine (lot 1)Single subcutaneous injection of the investigational vaccine (0.5ml) |
| Experimental Group2 | Experimental | Biological: Investigational live attenuated varicella vaccine (lot 2)Single subcutaneous injection of the investigational vaccine (0.5ml) |
| Experimental Group3 | Experimental | Biological: Investigational live attenuated varicella vaccine (lot 3)Single subcutaneous injection of the investigational vaccine (0.5ml) |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1 to 12 years on the day of enrollment ,male or female, and able to provide legal identity certificate.
- Subjects and/or guardians have the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent form.
- Axillary temperature ≤ 37.0 ° C on the day of enrollment.
Key exclusion criteria (16 listed)
- Previous vaccination against varicella (eg, varicella vaccine, measles + varicella vaccine).
- History of varicella or herpes zoster infection, or exposure to varicella/herpes zoster within 30 days of enrollment or suspected varicella/herpes zoster;
- Current use of salicylates (including salicylic acid, aspirin, diflunisal, p-aminosalicylic acid (sodium), salsalsalate, benorilate, etc.), or planned long-term use during the study.
- Febrile illness (axillary temperature ≥ 38.5 ° C) or use of antipyretic, analgesic, and anti-allergic drugs (eg, acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination.
- History of allergy to vaccine ingredients and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria.
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 |
|---|---|---|
| Investigational live attenuated varicella vaccine (lot 1)0.5ml/vial | Biological | Experimental Group1 |
| Investigational live attenuated varicella vaccine (lot 2)0.5ml/vial | Biological | Experimental Group2 |
| Investigational live attenuated varicella vaccine (lot 3)0.5ml/vial | Biological | Experimental Group3 |
Primary outcome
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies
Time frame: 30 days after vaccination
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization
4 secondary outcomes
Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies
Time frame: 30 days after vaccination
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies
Time frame: 30 days after vaccination
The incidences of adverse events (AEs)
Time frame: 30 days after vaccination
The incidences of serious adverse events (SAEs) and Adverse Event of Special Interest(AESI)
Time frame: 6 months after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Varicella
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
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.
Hongxing Pan principal investigator
Jiangsu Province Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational live attenuated varicella vaccine (lot 1), Investigational live attenuated varicella vaccine (lot 2) and Investigational live attenuated varicella vaccine (lot 3) in people with Varicella, run by China National Biotec Group Company Limited 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: 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 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?
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?
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies (time frame: 30 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.