Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines

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

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").

Study Overview

• Status: Completed
• Conditions: Varicella
• Intervention / Treatment: Biological: Varicella Vaccine; Biological: Varivax

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).

• Study Type: Interventional
• Enrollment (Actual): 642
• Phase: Phase 3

Contacts and Locations

Study Locations

• Philippines
  • Pasay, Philippines, 1300
    • San Juan de Dios Educational Foundation, lnc.
  • San Juan City, Philippines, 1502
    • Cardinal Santos Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varicella vaccine group; Participants will receive a single dose of investigational varicella vaccine on Day 0.	Biological: Varicella Vaccine; lyophilized powder,subcutaneous injection
Active Comparator: Varivax; Participants will receive a single dose of Varivax on Day 0.	Biological: Varivax; lyophilized powder,subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroresponse rate of varicella-zoster virus (VZV) antibody	The seroresponse rate of VZV antibodies on Day 42 after vaccination among susceptible population.	Day 42 after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean concentrations (GMCs) of VZV antibody	The GMC of VZV antibodies on Day 42 after vaccination among susceptible population.	Day 42 after vaccination after vaccination
GMC of VZV antibody	The GMC of VZV antibodies on Day 42 after vaccination among among all participants.	Day 42 after vaccination
seropositive rate	The seropositive rate of VZV antibodies on Day 42 after vaccination among all participants.	Day 42 after vaccination
Geometric mean fold rise (GMFR) from before vaccination of VZV antibody	The GMFR from before vaccination of VZV antibodies on Day 42 after vaccination among all participants.	Day 42 after vaccination
Incidence of adverse reactions within 0~42 days after vaccination	Incidence of adverse reactions within 0~42 days after vaccination among all participants	Within 0~42 days after vaccination
Incidence of adverse reactions within 0~14 days after vaccination	Incidence of adverse reactions within 0~14 days after vaccination among all participants	Within 0~14 days after vaccination
Incidence of serious adverse events (SAE) within 0~42 days after vaccination	Incidence of SAE within 0~42 days after vaccination among all participants.	Within 0~42 days after vaccination

Collaborators and Investigators

• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Investigators: Principal Investigator: Rommel Crisenio M. Lobo, MD, Cardinal Santos Medical Center; Principal Investigator: Nancy Nazaire Bermal, MD, San Juan de Dios Educational Foundation, lnc.-Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Actual): September 6, 2024
• Study Completion (Actual): September 6, 2024

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Zoster; Chickenpox
• Other Study ID Numbers: PRO-VZV-4006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No