A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age

NCT05839301 | Unknown Phase 3

• 1 other identifier: CNBG-BIBP-VZV-08
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Varicella

Keywords

varicella vaccine; safety; immunogenicity; lot-to-lot consistency

Outcome Measures

Primary Outcomes (1)

• 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

  30 days after vaccination

Secondary Outcomes (4)

• Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies

  30 days after vaccination

• Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies

  30 days after vaccination

• The incidences of adverse events (AEs)

  30 days after vaccination

• The incidences of serious adverse events (SAEs) and Adverse Event of Special Interest(AESI)

  6 months after vaccination

Study Arms (3)

Experimental Group1

EXPERIMENTAL

Single subcutaneous injection of the investigational vaccine (0.5ml)

Biological: Investigational live attenuated varicella vaccine (lot 1)

Experimental Group2

EXPERIMENTAL

Single subcutaneous injection of the investigational vaccine (0.5ml)

Biological: Investigational live attenuated varicella vaccine (lot 2)

Experimental Group3

EXPERIMENTAL

Single subcutaneous injection of the investigational vaccine (0.5ml)

Biological: Investigational live attenuated varicella vaccine (lot 3)

Interventions

Investigational live attenuated varicella vaccine (lot 1) BIOLOGICAL

0.5ml/vial

Experimental Group1

Investigational live attenuated varicella vaccine (lot 2) BIOLOGICAL

0.5ml/vial

Experimental Group2

Investigational live attenuated varicella vaccine (lot 3) BIOLOGICAL

0.5ml/vial

Experimental Group3

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Beijing Institute of Biological Products Co Ltd.: collaborator
• Jiangsu Province Center for Disease Control and Prevention: collaborator

Study Sites (1)

Xinyi Center for Disease Control and Prevention

Xuzhou, Jiangsu, 221600, China

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Hongxing Pan

  Jiangsu Province Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: April 27, 2023
• Primary Completion: July 30, 2023
• Study Completion: April 30, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)