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

Last updated: January 23, 2025
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Chickenpox (Varicella Zoster Infection)

Shingles

Herpes Simplex Infections

Treatment

Varivax

Varicella Vaccine

Clinical Study ID

NCT06314724
PRO-VZV-4006
  • Ages 12-15
  • All Genders
  • Accepts Healthy Volunteers

Study 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").

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy children aged 12~15 months;

  • Participants' legal guardians are able to understand and sign the informed consentvoluntarily;

  • Participants are able to comply with the study procedures based on the assessment ofthe investigator;

  • Participants should provide verifiable identification, to be contacted, and tocontact the investigator during the study period.

Exclusion

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 tovaccines, such as urticaria, dyspnea, angioneurotic edema;

  • Autoimmune diseases (including but not limited to systemic lupus erythematosus,rheumatoid arthritis, etc.) or immunodeficiency/immunosuppression (such as HIVinfection, organ transplantation), asplenia;

  • Receipt of blood products or immunoglobulins within the past 3 months beforeenrollment in this study, or scheduled to receive these treatments during the studyperiod;

  • Receipt of other investigational vaccines within 30 days prior to vaccination inthis study;

  • Receipt of attenuated live vaccines within 28 days prior to vaccination in thisstudy;

  • Receipt of inactivated or subunit vaccines within 7 days prior to vaccination inthis study;

  • Acute onset of various acute diseases or chronic diseases within 7 days prior tovaccination in this study;

  • Has fever on the day of vaccination, with the axillary temperature >37°C beforevaccination;

  • Is participating in or planning to participate in other vaccine or drug clinicaltrials;

  • Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection;

  • According to the investigator's judgment, the subject has any other factors thatmight interfere with the clinical trial results or pose additional risk to theparticipant due to participation in the study.

Study Design

Total Participants: 642
Treatment Group(s): 2
Primary Treatment: Varivax
Phase: 3
Study Start date:
February 29, 2024
Estimated Completion Date:
September 06, 2024

Study 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).

Connect with a study center

  • San Juan de Dios Educational Foundation, lnc.

    Pasay, 1300
    Philippines

    Site Not Available

  • Cardinal Santos Medical Center

    San Juan City, 1502
    Philippines

    Site Not Available

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