The purpose of this study is to evaluate the immunogenicity and safety of an inactivated Enterovirus Type 71 (EV71) vaccine, manufactured by Sinovac, in healthy Vietnamese children aged 6 to 71 months. Hand, Foot, and Mouth Disease (HFMD) is a common infectious disease in children, and EV71 is a major cause of severe complications and outbreaks in the Asia-Pacific region, including Vietnam. While this vaccine has demonstrated high efficacy and a favorable safety profile in previous clinical trials conducted in China, this study aims to generate specific bridging data for the Vietnamese pediatric population. This is a single-armed bridging clinical trial that plans to enroll approximately 320 healthy participants. Each participant will receive two doses of the EV71 vaccine administered intramuscularly on a 0 and 30-day schedule. The primary objective is to assess the seroconversion rate of neutralizing antibodies 30 days after the second dose. Safety will be assessed by monitoring the incidence of adverse reactions and serious adverse events (SAEs) throughout the study duration (approximately 2 months).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
320
Inactivated Enterovirus Type 71 Vaccine (Vero Cell), 0.5 mL per dose. Each dose contains no less than 3.0 EU of inactivated EV71 antigen adsorbed onto aluminum hydroxide. The vaccine is supplied as a milky white suspension in a pre-filled syringe. Participants will receive two intramuscular (IM) injections into the deltoid region of the upper arm, administered on a 0 and 30-day schedule.
Pasteur Institute
Ho Chi Minh City, Vietnam
Seroconversion rate of Enterovirus Type 71 (EV71) neutralizing antibodies
Seroconversion is defined as: (1) a post-vaccination neutralizing antibody titer of ≥ 1:8 in participants with a pre-vaccination titer of \< 1:8; or (2) at least a four-fold increase in neutralizing antibody titer in participants with a pre-vaccination titer of ≥ 1:8.
Time frame: 30 days after the second dose of vaccination
Seropositive rate of Enterovirus Type 71 (EV71) neutralizing antibodies
The percentage of participants with a neutralizing antibody titer ≥ 1:8 against EV71.
Time frame: 30 days after the second dose of vaccination
GMT of Enterovirus Type 71 (EV71) neutralizing antibodies
The geometric mean of neutralizing antibody titers against EV71.
Time frame: 30 days after the second dose of vaccination
GMFR of Enterovirus Type 71 (EV71) neutralizing antibodies
The geometric mean of the ratio of post-vaccination neutralizing antibody titer to pre-vaccination titer.
Time frame: 30 days after the second dose of vaccination
Incidence of adverse reactions within 30 days
Incidence of adverse reactions within 30 days after each dose vaccination.
Time frame: 30 days after each dose vaccination
Incidence of adverse reactions within 7 days
Incidence of adverse reactions within 7 days after each dose vaccination.
Time frame: 7 days after each dose vaccination
Incidence of SAE
Incidence of serious adverse events (SAE) from the first dose vaccination until 30 days after the second dose vaccination.
Time frame: From the first dose vaccination until 30 days after the second dose vaccination
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