Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children

Official title

Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children Aged 1~12 Years: A Single-armed Bridging Clinical Trial

Overview

This is a single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled. All participants will receive a single dose of varicella vaccine manufactured by Sinovac.

Interventions

• Biological Varicella Vaccine
  Varicella vaccine manufactured by Sinovac

Primary outcome measures

• The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history [Time frame: 42 days after vaccination]

Secondary outcome measures (7)

• The Geometric Mean Concentration(GMC) of VZV antibodies among susceptible population without varicella immunization history [Time frame: 42 days after vaccination]
• The Geometric Mean Concentration(GMC) of VZV antibodies in total population [Time frame: 42 days after vaccination]
• The seropositive rate of VZV antibodies in total population [Time frame: 42 days after vaccination]
• The geometric mean fold rise (GMFR) of VZV antibodies in total population [Time frame: 42 days after vaccination]
• The geometric mean fold rise (GMFR) of VZV antibodies among population with varicella immunization history [Time frame: 42 days after vaccination]
• The geometric mean concentration (GMC) of VZV antibodies among population with varicella immunization history [Time frame: 42 days after vaccination]
• The seropositive rate of VZV antibodies among population with varicella immunization history [Time frame: 42 days after vaccination]

Eligibility criteria

Inclusion criteria

• Healthy children aged 1-12 years;
• Vaccination history:

• Participants aged 1 year old: no vaccination history with any varicella containing vaccine;
• Participants aged 2\~12 years old: no vaccination history with any varicella containing vaccine, or have received 1 dose of varicella vaccine at least 3 months before enrollment;
• Participants and/or their legal guardians are able to understand and sign the informed consent/assent voluntarily;
• Participants are able to comply with the study procedures based on the assessment of the investigator;
• Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.

Exclusion criteria

• Prior history of VZV infection;
• Have been exposed to VZV at home, day care, school, etc. within 4 weeks before enrollment;
• Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
• Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
• Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
• Poorly controlled chronic illnesses or history of severe diseases that, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, and a history of major organ transplantation;
• Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection;
• Current or history of severe neurological diseases (epilepsy, convulsions or seizures \[excluding history of febrile seizures\]) or psychiatric disorders, or presence of a family history of psychiatric disorders;
• Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥20mg/day, or prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment during the trial;
• Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the trial;
• Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
• Receipt of attenuated live vaccines or nucleic acid vaccines within 28 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
• Fever on vaccination day, with axillary temperature >37.2°C pre-vaccination, or vital signs outside normal range, or failure to pass physical examination;
• Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with drug administration or observation of local reactions;
• Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
• Any other factors considered by the investigator to make the participant unsuitable for participation in the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Vietnam · 1 center

• Hanoi Medical University — Hanoi

Identifiers

NCT: NCT07473427 · PRO-VZV-4009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗