Clinical trial NCT06314724: Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines
Official title: Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines: a Randomized, Double-blind, Active-controlled Phase Ⅲ Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 642
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a Phase Ⅲ, randomized, double-blind, active-controlled study to assess the immunogenicity and safety of the varicella vaccine,Live (hereinafter referred to as "varicella vaccine")manufactured by Sinovac (Dalian) Vaccine Technology Co., LTD.(hereinafter referred to as "Sinovac").

Detailed description: A total of 642 healthy participants aged 12\~15 months will be enrolled. All participants will be randomized at a 1:1 ratio to receive a single dose of varicella vaccine either manufactured by Sinovac (Group A) or Merck Sharp \& Dohme (MSD, Group B).

Eligibility criteria: Inclusion Criteria:

* Healthy children aged 12\~15 months;
* Participants' legal guardians are able to understand and sign the informed consent 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 vaccination with any varicella containing vaccines;
* Prior history of VZV infection;
* Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
* Autoimmune diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, etc.) or immunodeficiency/immunosuppression (such as HIV infection, organ transplantation), asplenia;
* Receipt of blood products or immunoglobulins within the past 3 months before enrollment in this study, or scheduled to receive these treatments during the study period;
* Receipt of other investigational vaccines within 30 days prior to vaccination in this study;
* Receipt of attenuated live vaccines within 28 days prior to vaccination in this study;
* Receipt of inactivated or subunit vaccines within 7 days prior to vaccination in this study;
* Acute onset of various acute diseases or chronic diseases within 7 days prior to vaccination in this study;
* Has fever on the day of vaccination, with the axillary temperature \>37°C before vaccination;
* Is participating in or planning to participate in other vaccine or drug clinical trials;
* Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection;
* According to the investigator's judgment, the subject has any other factors that might interfere with the clinical trial results or pose additional risk to the participant due to participation in the study.

Primary outcomes:
measure: Seroresponse rate of varicella-zoster virus (VZV) antibody
timeFrame: Day 42 after vaccination
Secondary outcomes:
measure: Geometric mean concentrations (GMCs) of VZV antibody
timeFrame: Day 42 after vaccination after vaccination
measure: GMC of VZV antibody
timeFrame: Day 42 after vaccination
measure: seropositive rate
timeFrame: Day 42 after vaccination
measure: Geometric mean fold rise (GMFR) from before vaccination of VZV antibody
timeFrame: Day 42 after vaccination
measure: Incidence of adverse reactions within 0~42 days after vaccination
timeFrame: Within 0~42 days after vaccination
measure: Incidence of adverse reactions within 0~14 days after vaccination
timeFrame: Within 0~14 days after vaccination
measure: Incidence of serious adverse events (SAE) within 0~42 days after vaccination
timeFrame: Within 0~42 days after vaccination
Other outcomes:
Locations:
city: Pasay
country: Philippines
facility: San Juan de Dios Educational Foundation, lnc.
city: San Juan City
country: Philippines
facility: Cardinal Santos Medical Center
Study officials:
affiliation: Cardinal Santos Medical Center
name: Rommel Crisenio M. Lobo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Juan de Dios Educational Foundation, lnc.-Hospital
name: Nancy Nazaire Bermal, MD
role: PRINCIPAL_INVESTIGATOR
References: