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NCT02164110
A Randomized, Single Blind, Multicenter, Therapeutic Confirmatory Study to Assess the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
Phase 3 trial testing Euvichol in Prevention Harmful Effects in 3,632 participants. Completed in 1 October 2014.
1 September 2014
Quick facts
| Lead sponsor | EuBiologics Co.,Ltd |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 3,632 |
| Start date | 1 May 2014 |
| Primary completion | 1 September 2014 |
| Estimated completion | 1 October 2014 |
| Sites | 1 location across Philippines |
Drugs / interventions tested
Conditions studied
- Prevention Harmful Effects — all drugs for Prevention Harmful Effects →
Sponsor
EuBiologics Co.,Ltd — full company profile →
Who can join
Adults 1 to 40, any sex, with Prevention Harmful Effects. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Efficacy
Time frame: 14 days after second doses
Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline -
Safety
Time frame: From first shot to 14 days after second dose
Type and frequency of solicited adverse event type (Day 0 \~ 6), Type and frequency of unsolicited adverse event type (Day 0 \~ Day 28)
Sponsor's own description
The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02164110
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other EuBiologics Co.,Ltd trials
Trials by the same sponsor.
- NCT06409494 — Clinical Trial to Evaluate EuHZV in Healthy Adults Aged 50 to 69 Years · Phase 1 · active not recruiting
- NCT06216093 — Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 8 · Phase 1 · active not recruiting
- NCT05739292 — Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Year · Phase 1 · completed
- NCT05572879 — A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults · Phase 3 · completed
- NCT05603052 — A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older · Phase 3 · completed
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 NCT02164110 (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 EuBiologics Co.,Ltd
- Last refreshed: 4 December 2014
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/NCT02164110.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing