NCT03283319

Panblok H7 Vaccine Adjuvanted With AS03 or MF59

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®

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Biomedical Advanced Research and Development Authority · Federal
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blinded, phase 2 study to assess safety and immunogenicity of Panblok H7 vaccine at three antigen dose levels (3.75, 7.5, and 15 μg) adjuvanted with AS03 or MF59. The main purpose of this study is to assess the safety and ability of the recombinant Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. The expected study duration is approximately 13.5 months per participant.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	3.75 ug Panblok H7	0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.
BIOLOGICAL	7.5 ug Panblok H7	Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.
BIOLOGICAL	15 ug Panblok H7	Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.
BIOLOGICAL	MF59	0.5 mL MF59 (39 mg squalene/mL ) adjuvant.
BIOLOGICAL	AS03	0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.

Timeline

• Start date: 2017-09-20
• Primary completion: 2017-12-15
• Completion: 2018-11-09
• First posted: 2017-09-14
• Last updated: 2020-05-06
• Results posted: 2019-09-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study