NCT06314724

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 642 (actual)
• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

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).

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Varicella Vaccine	lyophilized powder,subcutaneous injection
BIOLOGICAL	Varivax	lyophilized powder,subcutaneous injection

Timeline

• Start date: 2024-02-29
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2024-03-18
• Last updated: 2025-01-27

Locations

2 sites across 1 country: Philippines