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NCT02547792
Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults
Phase 1 trial testing VXA-BYW.10 (Low Dose) Oral Vaccine in Seasonal Influenza B in 54 participants. Completed in 21 November 2016.
21 November 2016
Quick facts
| Lead sponsor | Vaxart |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 54 |
| Start date | 20 October 2015 |
| Primary completion | 21 November 2016 |
| Estimated completion | 21 November 2016 |
| Sites | 1 location across New Zealand |
Drugs / interventions tested
- VXA-BYW.10 (Low Dose) Oral Vaccine — full drug profile →
- VXA-BYW.10 (High Dose) Oral Vaccine — full drug profile →
- Placebo Tablets — full drug profile →
Conditions studied
- Seasonal Influenza B — all drugs for Seasonal Influenza B →
Sponsor
Vaxart — full company profile →
Who can join
Adults 18 to 49, any sex, with Seasonal Influenza B. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27 subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated through 1 year post vaccination.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Noninvasive vaccination against infectious diseases.
Zheng Z, Diaz-Arévalo D, Guan H, Zeng M. · · 2018 · cited 46× · PMID 29624470 · DOI 10.1080/21645515.2018.1461296 -
Ebola virus disease candidate vaccines under evaluation in clinical trials.
Martins KA, Jahrling PB, Bavari S, Kuhn JH. · · 2016 · cited 37× · PMID 27160784 · DOI 10.1080/14760584.2016.1187566 -
Blades and barriers: Oral vaccines for conquering cancers and warding off infectious diseases.
Yang K, Liu J, Zhao Y, Xu H, et al · · 2025 · PMID 40893667 · DOI 10.1016/j.apsb.2025.05.038
Verify or expand the search:
- PubMed search for NCT02547792
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Vaxart trials
Trials by the same sponsor.
- NCT06944717 — A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years · Phase 1 · active not recruiting
- NCT07254728 — A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing I · Phase 1 · completed
- NCT05626803 — A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers · Phase 2 · completed
- NCT05213728 — A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-v · Phase 1 · completed
- NCT05212168 — Norovirus Challenge Study · Phase 1, PHASE2 · 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 NCT02547792 (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 Vaxart
- Last refreshed: 31 May 2018
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/NCT02547792.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing