Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-71
SponsorSinovac Biotech Co., Ltd
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy children aged 6~71 months when receiving the first dose of investigational EV71 vaccine;
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, be reachable by the investigator and must be able to contact the investigator throughout the study period.
Disqualifiers
Prior history of hand, foot and mouth disease (HFMD);
Have been exposed to a case with laboratory-confirmed (virological diagnosis, e.g., via PCR or virus isolation) HFMD at home, day care, or other settings within 2 weeks before enrollment;
Prior participated in clinical trial of EV71 vaccine and received any investigational EV71 vaccine;
Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
Trial design
Design model
Single group
Treatments tested in this trial
EV71 vaccine
Biological/VaccineInactivated 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.
Treatment groups
320 Participants
are divided into 1 treatment groupGroup A: EV71 Vaccine GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 vaccinationSecondary outcomes
1
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 vaccination2
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 vaccination3
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 vaccination4
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 vaccinationSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: