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NCT03909074
Clinical Trial of Enterovirus 71（EV71） Inactivated Vaccine in Children Aged 36-71 Months
Phase 3 trial testing 36-71 months old children-experimental EV71 vaccine. in Hand, Foot and Mouth Disease in 900 participants. Completed in 13 November 2019.
17 June 2019
Quick facts
| Lead sponsor | Sinovac Biotech Co., Ltd |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 900 |
| Start date | 10 March 2019 |
| Primary completion | 17 June 2019 |
| Estimated completion | 13 November 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- 36-71 months old children-experimental EV71 vaccine. — full drug profile →
- 36-71 months old children-control EV71 vaccine. — full drug profile →
- 6-35 months old children-experimental EV71 vaccine. — full drug profile →
Conditions studied
- Hand, Foot and Mouth Disease — all drugs for Hand, Foot and Mouth Disease →
Sponsor
Sinovac Biotech Co., Ltd — full company profile →
Who can join
Adults 6 Months to 71 Months, any sex, with Hand, Foot and Mouth Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cross-Antigenicity between EV71 Sub-Genotypes: Implications for Vaccine Efficacy.
Liu P, Yuan Y, Cui B, Huo Y, et al · · 2021 · cited 8× · PMID 33919184 · DOI 10.3390/v13050720 -
Immunogenicity and Safety of Inactivated Enterovirus 71 Vaccine in Children Aged 36-71 Months: A Double-Blind, Randomized, Controlled, Non-inferiority Phase III Trial.
Zhang L, Gao F, Zeng G, Yang H, et al · · 2021 · cited 5× · PMID 33269798 · DOI 10.1093/jpids/piaa129
Verify or expand the search:
- PubMed search for NCT03909074
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hand, Foot and Mouth Disease
Currently open trials in the same condition.
- NCT06146088 — Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine · Phase 4 · recruiting
- 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 Sinovac Biotech Co., Ltd trials
Trials by the same sponsor.
- NCT07418229 — Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine · Phase 1 · not yet recruiting
- NCT07416110 — Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine · Phase 3 · not yet recruiting
- NCT07055295 — Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Pre-exposure Prophylaxis Regimen · Phase 3 · not yet recruiting
- NCT07055893 — Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen · Phase 3 · not yet recruiting
- NCT07400003 — Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine · Phase 1, PHASE2 · 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 NCT03909074 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sinovac Biotech Co., Ltd
- Last refreshed: 26 May 2022
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/NCT03909074.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing