CompletedPhase 3

Clinical Trial of Enterovirus 71（EV71） Inactivated Vaccine in Children Aged 36-71 Months

China900 participantsStarted 2019-03-10

Plain-language summary

The purpose of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, to evaluate the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months. The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd, and the control vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.

Who can participate

Age range6 Months – 71 Months

SexALL

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Exclusion criteria

✕. Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry
✕. Blood products within 2 months prior to study entry
✕. Any other investigational products (drug or vaccine）within 30 days prior to study entry
✕. Any live attenuated vaccine within 14 days prior to study entry
✕. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;

What they're measuring

The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8

Timeframe: 30 days after two doses

The Geometric mean titer (GMT) of the EV71 neutralizing antibody in the susceptible population

Timeframe: 30 days after two doses

Trial details

NCT IDNCT03909074

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-17

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