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").
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
642
lyophilized powder,subcutaneous injection
lyophilized powder,subcutaneous injection
San Juan de Dios Educational Foundation, lnc.
Pasay, Philippines
Cardinal Santos Medical Center
San Juan City, Philippines
Seroresponse rate of varicella-zoster virus (VZV) antibody
The seroresponse rate of VZV antibodies on Day 42 after vaccination among susceptible population.
Time frame: Day 42 after vaccination
Geometric mean concentrations (GMCs) of VZV antibody
The GMC of VZV antibodies on Day 42 after vaccination among susceptible population.
Time frame: Day 42 after vaccination after vaccination
GMC of VZV antibody
The GMC of VZV antibodies on Day 42 after vaccination among among all participants.
Time frame: Day 42 after vaccination
seropositive rate
The seropositive rate of VZV antibodies on Day 42 after vaccination among all participants.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Within 0~14 days after vaccination
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Incidence of serious adverse events (SAE) within 0~42 days after vaccination
Incidence of SAE within 0\~42 days after vaccination among all participants.
Time frame: Within 0~42 days after vaccination