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NCT06146088
Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine
Phase 4 trial testing EV71 Vaccine in Hand, Foot and Mouth Disease in 1,500 participants. Currently enrolling.
31 March 2024
Quick facts
| Lead sponsor | Institute of Medical Biology, Chinese Academy of Medical Sciences |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 1,500 |
| Start date | 25 November 2023 |
| Primary completion | 31 March 2024 |
| Estimated completion | 15 July 2026 |
| Sites | 4 locations across China |
Drugs / interventions tested
- EV71 Vaccine — full drug profile →
Conditions studied
- Hand, Foot and Mouth Disease — all drugs for Hand, Foot and Mouth Disease →
Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Who can join
Adults 6 Months to 35 Months, any sex, with Hand, Foot and Mouth Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06146088
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of EV71 Vaccine
Trials testing the same drug.
- NCT07026500 — Clinical Trial for Batch Consistency of EV71 Vaccine · Phase 4 · completed
Other recruiting trials for Hand, Foot and Mouth Disease
Currently open trials in the same condition.
- NCT06063057 — Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial · Phase 1, PHASE2 · active not recruiting
- NCT06263439 — Surveillance of HFMD in Pediatric Outpatients · recruiting
Other Institute of Medical Biology, Chinese Academy of Medical Sciences trials
Trials by the same sponsor.
- NCT07418372 — Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine · Phase 1, PHASE2 · not yet recruiting
- NCT07326878 — Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine · Phase 1 · not yet recruiting
- NCT07144202 — Study on the Persistence of Immunity Following EV71 Vaccination · enrolling by invitation
- NCT06920069 — Study of Concomitant Administration of the sIPV and DTaP or MMR · Phase 4 · not yet recruiting
- NCT06800950 — Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06146088 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Medical Biology, Chinese Academy of Medical Sciences
- Last refreshed: 3 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06146088.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing