Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

November 7, 2022

Primary Completion Date

April 20, 2023

Study Completion Date

October 3, 2023

Conditions
Morbid ObesitySevere Obesity
Interventions
BIOLOGICAL

Supemtek®

"Quadrivalent recombinant high-dose influenza vaccine containing 45 µg of hemagglutinin (HA) for each of the 4 strains included (2 strains A and 2 strains B).~Solution for injection is sterile liquid supplied in 0.5mL single dose pre-filled syringe. Vaccine is injected intra-muscularly in the non-dominant arm at Day 0."

BIOLOGICAL

Vaxigriptetra®

Quadrivalent inactivated influenza vaccine containing 15 µg of hemagglutinin (HA) for each of the 4 strains included. Suspension for injection is sterile liquid supplied in 0.5mL single dose pre-filled syringe. Vaccine is injected intra-muscularly in the non-dominant arm at Day 0.

Trial Locations (1)

75013

Pitie-Salpêtrière hospital APHP, Paris

All Listed Sponsors
collaborator

Sanofi Pasteur, a Sanofi Company

INDUSTRY

collaborator

Hospices Civils de Lyon

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER