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NCT04035278
A Phase 1 Safety Study of Dengusiil in Healthy Adults
Phase 1 trial testing Dengusiil in Prevention of Dengue Fever in 60 participants. Completed in 11 June 2021.
11 June 2021
Quick facts
| Lead sponsor | Serum Institute of India Pvt. Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 17 December 2019 |
| Primary completion | 11 June 2021 |
| Estimated completion | 11 June 2021 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Dengusiil — full drug profile →
- Placebo
Conditions studied
- Prevention of Dengue Fever — all drugs for Prevention of Dengue Fever →
Sponsor
Serum Institute of India Pvt. Ltd. — full company profile →
Who can join
Adults 18 to 45, any sex, with Prevention of Dengue Fever. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1 study to assess safety and tolerability of a single subcutaneous dose of Dengusiil in healthy adults of 18 to 45 years of age. In this study, immune response to Dengusiil will also be assessed over a period of 6 months and vaccine viremia will also be assessed over a period of 12 days after administration of vaccine.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a tetravalent live attenuated dengue vaccine in adults.
Gunale B, Farinola N, Yeolekar L, Shrivastava S, et al · · 2023 · cited 3× · PMID 37532611 · DOI 10.1016/j.vaccine.2023.07.045
Verify or expand the search:
- PubMed search for NCT04035278
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Serum Institute of India Pvt. Ltd. trials
Trials by the same sponsor.
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- NCT06507605 — Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults · Phase 1 · completed
- NCT06413121 — Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV · Phase 3 · recruiting
- NCT05421611 — A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL · Phase 3 · completed
- NCT05447377 — A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants · Phase 3 · 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 NCT04035278 (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 Serum Institute of India Pvt. Ltd.
- 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/NCT04035278.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing