NCT06146088

Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine

To Evaluate the Lot-to-lot Consistency of Immunogenicity, Safety, and Immune Persistence of Three Consecutive Commercial Manufacturing Batches of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell) in Children Aged 6-35 Months in a Randomized, Blinded Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in 1500 children aged 6-35 months. The primary immunogenicity endpoint is the anti-EV71 neutralizing antibody geometric mean titer (GMT) 30 days after the final dose. The secondary immunogenicity endpoints are the geometric mean fold increases and seroconversion rates of anti-EV71 neutralizing antibodies 30 days after the final dose. The immune persistence endpoints are the seropositive rates as well as GMT of anti-EV71 neutralizing antibodies 12 and 24 months after the final dose. The safety endpoints are the number of adverse events/reactions within 30 minutes after each dose, the number of solicited adverse events/reactions within 7 days after each dose, the number of unsolicited adverse events/reactions within 30 days after each dose, and the number of serious adverse events (SAE) from the first dose to 6 months post the final dose.

Detailed description

This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in children aged 6-35 months. The study is conducted to enroll 1500 healthy participants, including 600 infants aged 6-11 months, 600 toddlers aged 12-23 months, and 300 children aged 24-35 months. Eligibility will be assessed through medical history and physical examination. Participants from each age group will be randomly assigned to three different batch groups in a ratio of 1:1:1, that is, 500 participants in total will be in each lot arm, respectively. All participants will receive an injection of the EV71 vaccine in the anterolateral midthigh or deltoid muscle of the upper arm on Day 0 and Day 30, respectively. The duration of interventions for each participant is approximately 1 month, thus, the duration of the immune persistence study for each participant is approximately 25 months. For immunogenicity and immune persistence assessment, neutralizing antibodies against EV71 of all participants will be assessed on the first day (Day 0) before administration, 30 days after the final dose, and 12 and 24 months after the final dose, respectively. For safety assessment, observation of adverse events (AE) from Day 0 to Day 30 after each dose of vaccination will be evaluated by diary or contact cards. Simultaneously, the serious adverse event (SAE) between the first dose of the vaccine to 6 months after the final dose will be evaluated by diary or contact cards, active reports, investigators' phone calls, or on-site visits. Meanwhile, participants will be observed at clinical sites for at least 30 minutes.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
BIOLOGICAL	EV71 Vaccine	Inactivated enterovirus 71 vaccine (human diploid cell) of 3.0EU/0.5mL on Day 0,30

Timeline

• Start date: 2023-11-25
• Primary completion: 2024-03-31
• Completion: 2026-07-15
• First posted: 2023-11-24
• Last updated: 2024-01-03

Locations

4 sites across 1 country: China