CompletedPhase 4

Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine

China120 participantsStarted 2017-07-16

Plain-language summary

The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination

Who can participate

Age range6 Months – 35 Months

SexALL

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Exclusion criteria

✕. Any serious adverse event that has a causal relationship with the investigated vaccine
✕. Severe allergic reactions or hypersensitivity after vaccination (including urticaria / rash appear within 30 minutes after vaccination
✕. Any confirmed or suspected autoimmune disease or immunodeficiency disease (e.g., HIV infection)
✕. Other reactions (including severe pain, severe swelling, severe activity limitation, persistent hyperthermia, severe headache or other systemic or local reactions)determined by the investigators
✕. Acute disease (moderate or severe disease with or without fever) in case of vaccination
✕. Axillary temperature \> 37.0 °C

What they're measuring

The seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination

Timeframe: 30 days

Trial details

NCT IDNCT03278132

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09-15

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