NCT03369808 is a Phase 1, PHASE2 clinical trial of 7.5μg H7N9 Vaccine in H7N9 Influenza, sponsored by Shanghai Institute Of Biological Products.

Who is sponsoring NCT03369808?

NCT03369808 is sponsored by Shanghai Institute Of Biological Products.

What drugs are being tested in NCT03369808?

Interventions in NCT03369808: 7.5μg H7N9 Vaccine, Phosphate Buffer Solution, Aluminum Hydroxide Adjuvant, 15μg H7N9 Vaccine, 30μg H7N9 Vaccine.

What condition does NCT03369808 study?

NCT03369808 studies H7N9 Influenza.

Is NCT03369808 still recruiting?

NCT03369808 is currently completed. Last updated 15 October 2024.

Last reviewed 2024-10-15 · How we verify

NCT03369808

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine

Completed Phase 1, PHASE2 Last updated 15 October 2024

What this trial tests

Phase 1, PHASE2 trial testing 7.5μg H7N9 Vaccine in H7N9 Influenza in 360 participants. Completed in 15 November 2019.

Timeline

29 December 2017

Primary endpoint
29 August 2018

15 November 2019

Quick facts

Lead sponsor	Shanghai Institute Of Biological Products
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	360
Start date	29 December 2017
Primary completion	29 August 2018
Estimated completion	15 November 2019
Sites	1 location across China

Drugs / interventions tested

7.5μg H7N9 Vaccine — full drug profile →
Phosphate Buffer Solution
Aluminum Hydroxide Adjuvant — full drug profile →
15μg H7N9 Vaccine — full drug profile →
30μg H7N9 Vaccine — full drug profile →

Conditions studied

H7N9 Influenza — all drugs for H7N9 Influenza →

Sponsor

Shanghai Institute Of Biological Products

Who can join

12 and older, any sex, with H7N9 Influenza. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults. The investigators will test the vaccine in participants aged 12-60 years, for a randomized, blind, placebo-controlled, age-stratified clinical study. The investigators designed three dosage groups: 7.5 μg,15 μg and 30 μg of hemagglutinin antigen. According to the age of the subjects, Each group was divided into different age subgroups. Phosphate buffer solution and Aluminum hydroxide adjuvant as placebo controls were both set up in the subgroups.Participants will receive 2 doses of vaccine at 21-day intervals.Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination were determined.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pandemic preparedness through vaccine development for avian influenza viruses.
Cargnin Faccin F, Perez DR. · · 2024 · cited 34× · PMID 38807261 · DOI 10.1080/21645515.2024.2347019

Verify or expand the search:

Other Shanghai Institute Of Biological Products trials

Trials by the same sponsor.

NCT07363837 — Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants · Phase 1, PHASE2 · not yet recruiting
NCT07327398 — Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 2 · not yet recruiting
NCT07253675 — Evaluate the Safety and Immunogenicity of the MVA-SIBP Vaccine in the Democratic Republic of the Congo · Phase 2 · not yet recruiting
NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
NCT07205198 — A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects. · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03369808 (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 Shanghai Institute Of Biological Products
Last refreshed: 15 October 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/NCT03369808.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing