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

NCT06314724 | Completed Phase 3

• 1 other identifier: PRO-VZV-4006
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 2

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").

Conditions

Varicella

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Geometric mean concentrations (GMCs) of VZV antibody

  Day 42 after vaccination after vaccination

• GMC of VZV antibody

  Day 42 after vaccination

• seropositive rate

  Day 42 after vaccination

• Geometric mean fold rise (GMFR) from before vaccination of VZV antibody

  Day 42 after vaccination

• Incidence of adverse reactions within 0~42 days after vaccination

  Within 0~42 days after vaccination

Study Arms (2)

Varicella vaccine group

EXPERIMENTAL

Participants will receive a single dose of investigational varicella vaccine on Day 0.

Biological: Varicella Vaccine

Varivax

ACTIVE COMPARATOR

Participants will receive a single dose of Varivax on Day 0.

Biological: Varivax

Interventions

Varicella Vaccine BIOLOGICAL

lyophilized powder,subcutaneous injection

Varicella vaccine group

Varivax BIOLOGICAL

lyophilized powder,subcutaneous injection

Varivax

Eligibility Criteria

• Age: 12 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinovac (Dalian) Vaccine Technology Co., Ltd.: lead

Study Sites (2)

San Juan de Dios Educational Foundation, lnc.

Pasay, 1300, Philippines

Location

Cardinal Santos Medical Center

San Juan City, 1502, Philippines

Location

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Rommel Crisenio M. Lobo, MD

  Cardinal Santos Medical Center

  PRINCIPAL INVESTIGATOR

• Nancy Nazaire Bermal, MD

  San Juan de Dios Educational Foundation, lnc.-Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 18, 2024
• Study Start: February 29, 2024
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

PH (2)