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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат Varicella Vaccine
  Varicella vaccine manufactured by Sinovac

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Вьетнам · 1 центр

• Hanoi Medical University — Hanoi

Идентификаторы

NCT: NCT07473427 · PRO-VZV-4009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗