CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 366 enrolled
Drug / intervention
3.75 ug Panblok H7 +4 morebiological
Likely dose
3.75 ug Panblok H7 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03283319
NCT03283319Phase 2Completed
CompareCT.gov

Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Panblok H7 Vaccine at Three Antigen Dose Levels Adjuvanted With AS03® or MF59®

Biomedical Advanced Research and Development Authority·interventional·Posted Sep 14, 2017·Updated May 6, 2020

In Brief

A Phase 2 clinical trial evaluating 3.75 ug Panblok H7, 7.5 ug Panblok H7, and 3 other interventions for Influenza, Human. Completed, enrolled 366 participants across 4 sites.

Detailed Summary

The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days. Three different antigen dose levels of Panblok H7 will be tested.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesUnited States
CollaboratorsRho, Inc.

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 14, 2017
Enrollment StartSep 20, 2017
Primary CompletionDec 15, 2017
Study CompletionNov 9, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.8 years ago

Interventions

3.75 ug Panblok H7biological

0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.

7.5 ug Panblok H7biological

Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.

15 ug Panblok H7biological

Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.

MF59biological

0.5 mL MF59 (39 mg squalene/mL ) adjuvant.

AS03biological

0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.