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NCT05805618
Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects
EARLY_PHASE1 trial testing Recombinant Norovirus Hexavalent Vaccine in Gastroenteritis in 60 participants. Status unknown.
1 November 2024
Quick facts
| Lead sponsor | Syneos Health |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | health services research |
| Enrollment | 60 |
| Start date | 1 July 2024 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 November 2024 |
Drugs / interventions tested
- Recombinant Norovirus Hexavalent Vaccine — full drug profile →
- Matching Placebo — full drug profile →
Conditions studied
- Gastroenteritis — all drugs for Gastroenteritis →
Sponsor
Syneos Health — full company profile →
Who can join
Adults 18 to 59, any sex, with Gastroenteritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety and immunogenicity of different dose levels of the Recombinant Norovirus Hexavalent Vaccine in healthy subjects aged 18-59 years given three doses of the vaccine at 28-day intervals.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Norovirus replication, host interactions and vaccine advances.
Prasad BVV, Atmar RL, Ramani S, Palzkill T, et al · · 2025 · cited 33× · PMID 39824927 · DOI 10.1038/s41579-024-01144-9 -
Vaccinia Virus Vector Bivalent Norovirus Vaccine.
Bai Y, Wu X, Shen Y, Wang L, et al · · 2025 · cited 1× · PMID 40006992 · DOI 10.3390/v17020237
Verify or expand the search:
- PubMed search for NCT05805618
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT04471493 — Pediatric and Ambulatory Research in Infectious Diseases · recruiting
Other Syneos Health trials
Trials by the same sponsor.
- NCT07497503 — A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants · Phase 1 · not yet recruiting
- NCT06435039 — A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers · Phase 1 · terminated
- NCT06170827 — Study to Evaluate the AIO-001 in Healthy Participants · Phase 1 · completed
- NCT05896969 — Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol · Phase 1 · completed
- NCT05715736 — Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3 · Phase 1 · 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 NCT05805618 (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 Syneos Health
- Last refreshed: 28 November 2023
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/NCT05805618.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing