Influenza, Influenza Immunization
Conditions
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include: Study Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control. Visit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181
Detailed description
Approximately 6 months
Interventions
BIOLOGICALInfluenza Hemagglutinin mRNA vaccine
Pharmaceutical form:Solution for injection-Route of administration:IM injection
Pharmaceutical form:Solution for injection-Route of administration:IM injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Open label (Sponsor) Blinded (Sites, except for those preparing/administering study intervention)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Having given written informed consent prior to undertaking any study-related procedure.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: * Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection | Within 30 minutes after injection | Number of participants with unsolicited systemic immediate adverse events (AEs) |
| Presence of solicited injection site reactions (ie, pre listed in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection | Up to 7 days after injection | Number of participants with solicited injection site reactions |
| Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection | Up to 7 days after injection | Number of participants with solicited systemic reactions |
| Presence of unsolicited AEs reported up to 28 days after injection | Up to 28 days after injection | Number of participants with unsolicited AEs |
| Presence of medically attended AEs (MAAEs) reported up to 28 days after injection | Up to 28 days after injection | Number of participants with medically attended adverse events (MAAE)s |
| Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study | From baseline up to 6 months | Number of participants with serious adverse events (SAEs) |
| Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection | Up to 28 days after injection | Number of participants with out-of-range biological test results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181 | At Day 01, Day 29, D91 and D181 | — |
| Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181 | At Day 29, Day 91, and Day 181 | Antibody titers are expressed as Geometric Mean Titers (GMTs) |
| Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181 | At Day 01, Day 29, Day 91, and Day 181 | — |
| Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29 | From baseline up to 6 months | Ratios of antibody titers measured by HAI in each group before and after vaccination |
| HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181 | At Day 29, Day 91 and Day 181 | — |
| 2-fold and 4-fold rise in HAI titers from D01 to D91 and D01 to D181 | From Day 01 through Day 91 and Day 01 through Day 181 | — |
| Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181 | At Day 29, Day 91, and Day 181 | — |
| Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29 | From baseline up to 6 months | — |
| 2-fold and 4-fold rise in neutralizing titers from D01 to D91 and D01 to D181 | From Day 01 through Day 29 and Day 01 through Day 181 | — |
Countries
United States
Outcome results
None listed