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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

642 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-09-06

Brief Summary

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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").

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Detailed Description

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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).

Conditions

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Varicella

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Varicella vaccine group

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

Group Type EXPERIMENTAL

Varicella Vaccine

Intervention Type BIOLOGICAL

lyophilized powder,subcutaneous injection

Varivax

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

Group Type ACTIVE_COMPARATOR

Varivax

Intervention Type BIOLOGICAL

lyophilized powder,subcutaneous injection

Interventions

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Varicella Vaccine

lyophilized powder,subcutaneous injection

Intervention Type BIOLOGICAL

Varivax

lyophilized powder,subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes