CompletedNot Applicable

Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children

Taiwan227 participantsStarted 2019-08-15

Plain-language summary

This study is designed to evaluate the long-term antibody titers of EV71 vaccine 4 and 5 years after first dose vaccination for subjects at the age of 2 to \< 6 years , and 3 to 5 years after first dose vaccination for subjects at the age of 2 months to \< 2 years

Who can participate

Age range2 Years – 9 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects who have completed participation in study CT-EV-21 part 2b, 2c, and 2d, and have received protocol specified doses of EV71 vaccine or Placebo (total of 2 doses in part 2b, and 3 doses for part 2c and 2d). * The subjects' guardians are able to understand and sign the informed consent form. Exclusion Criteria: * Subjects and/or guardians who refuse to comply with the study procedures

What they're measuring

Serum neutralizing antibody titer

Timeframe: Up to 5 years after first dose of EV71 vaccination

Trial details

NCT IDNCT04072276

SponsorMedigen Vaccine Biologics Corp.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-12-11

View on ClinicalTrials.gov More Enterovirus 71 Human trials