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NCT02889497
Safety, Three Batches Consistency and Immunity Duration of the Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months
Phase 4 trial testing the first batch vaccine in Hand Foot and Mouth Disease in 20,900 participants. Status unknown.
1 March 2019
Quick facts
| Lead sponsor | Beijing Chaoyang District Centre for Disease Control and Prevention |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 20,900 |
| Start date | 1 September 2016 |
| Primary completion | 1 March 2019 |
| Estimated completion | 1 September 2019 |
Drugs / interventions tested
- the first batch vaccine — full drug profile →
- the second batch vaccine — full drug profile →
- the third batch vaccine — full drug profile →
Conditions studied
- Hand Foot and Mouth Disease — all drugs for Hand Foot and Mouth Disease →
Sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention — full company profile →
Who can join
Adults 6 Months to 71 Months, any sex, with Hand Foot and Mouth Disease. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Evaluate the Rate of Adverse reactions of Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months.
Time frame: 24 months
Adverse reactions associated with vaccine will be observed in Children Aged 6-71 Months after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy. -
Evaluate the seroconversion rate of EV71 antibodies in serum after vaccination.
Time frame: 56 days
The seroconversion rate of EV71 antibodies will be evaluated in serum at days 0 and 56.
Sponsor's own description
This study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group and immunogenicity observation group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2 epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02889497
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other Beijing Chaoyang District Centre for Disease Control and Prevention trials
Trials by the same sponsor.
- NCT03659110 — Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice · unknown
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 NCT02889497 (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 Beijing Chaoyang District Centre for Disease Control and Prevention
- Last refreshed: 6 September 2016
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/NCT02889497.
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