InfluenzaPhase 1NCT06118151
Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older
A Phase 1 study testing Influenza Hemagglutinin mRNA vaccine and Quadrivalent Recombinant Influenza Vaccine in people with Influenza and Influenza Immunization, run by Sanofi Pasteur, a Sanofi Company at 20 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza Immunization
- What is being tested?
- Influenza Hemagglutinin mRNA vaccine and Quadrivalent Recombinant Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 20 sitesUnited States
- Study dates
- 11 Apr 2022to 17 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Elligo Health Research, Inc. Site Number : 8400035
Austin, Texas, 78704
Benchmark Research - Austin Site Number : 8400006
Austin, Texas, 78705
AES Austin Site Number : 8400021
Austin, Texas, 78744
AMR Coral Gables/Miami, Formerly Clinical Research of South Florida, an AMR company (Clinic) Site Number : 8400004
Coral Gables, Florida, 33134
AMR El Dorado Site Number : 8400009
El Dorado, Kansas, 67042
Research Centers of America Site Number : 8400003
Hollywood, Florida, 33024
AMR Knoxville Site Number : 8400027
Knoxville, Tennessee, 37920
AMR Lexington Site Number : 8400014
Lexington, Kentucky, 40509
Benchmark Research Site Number : 8400010
Metairie, Louisiana, 70006
AMR - Newton Site Number : 8400005
Newton, Kansas, 67114
Coastal Carolina Research Center - N Charleston Site Number : 8400008
North Charleston, South Carolina, 29405
Quality Clinical Research Site Number : 8400018
Omaha, Nebraska, 68112
Velocity Clinical Research, Omaha Site Number : 8400007
Omaha, Nebraska, 68134
AES Peoria Site Number : 8400017
Peoria, Illinois, 61614
Peninsula Research Associates Site Number : 8400013
Rolling Hills Estates, California, 90274
Clinical Trials of Texas, Inc. Site Number : 8400012
San Antonio, Texas, 78229
Optimal Research Site Number : 8400026
San Diego, California, 92108
Meridian Clinical Research, LLC Site Number : 8400016
Savannah, Georgia, 31406
Velocity Clinical Research Vestal Site Number : 8400033
Vestal, New York, 13850
AMR Wichita West Site Number : 8400030
Wichita, Kansas, 67205
About this study
Official title: A Phase I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adults 18 Years of Age and Older
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
Read the detailed description
Approximately 6 months
- Conditions
- Influenza, Influenza Immunization
- Being tested
- Influenza Hemagglutinin mRNA vaccine, Quadrivalent Recombinant Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Hemagglutinin mRNA vaccineBiological
Pharmaceutical form:Solution for injection-Route of administration:IM injection
Quadrivalent Recombinant Influenza VaccineBiological
Also called RIV4, Flublok Quadrivalent®
Pharmaceutical form:Solution for injection-Route of administration:IM injection
| Study group | Role | What they receive |
|---|---|---|
| sentinel cohort 1 | Experimental | 20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control Receives: Biological: Influenza Hemagglutinin mRNA vaccine; Biological: Quadrivalent Recombinant Influenza Vaccine |
| sentinel cohort 2 | Experimental | 20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control Receives: Biological: Influenza Hemagglutinin mRNA vaccine; Biological: Quadrivalent Recombinant Influenza Vaccine |
| sentinel cohort 3 | Experimental | 10 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5 with half of the participants in each age group also receiving the RIV4 control Receives: Biological: Influenza Hemagglutinin mRNA vaccine; Biological: Quadrivalent Recombinant Influenza Vaccine |
| main cohort 1 | Experimental | 40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control Receives: Biological: Influenza Hemagglutinin mRNA vaccine; Biological: Quadrivalent Recombinant Influenza Vaccine |
| main cohort 2 | Experimental | 40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control Receives: Biological: Influenza Hemagglutinin mRNA vaccine; Biological: Quadrivalent Recombinant Influenza Vaccine |
| main cohort 3 | Experimental | 20 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5, and half number of the participants in each age group also receiving the RIV4 control Receives: Biological: Influenza Hemagglutinin mRNA vaccine; Biological: Quadrivalent Recombinant Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection
Number of participants with unsolicited systemic immediate adverse events (AEs)
Measured: Within 30 minutes after injection
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
Number of participants with solicited injection site reactions
Measured: Up to 7 days after injection
Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection
Number of participants with solicited systemic reactions
Measured: Up to 7 days after injection
Presence of unsolicited AEs reported up to 28 days after injection
Number of participants with unsolicited AEs
Measured: Up to 28 days after injection
Presence of medically attended AEs (MAAEs) reported up to 28 days after injection
Number of participants with medically attended adverse events (MAAE)s
Measured: Up to 28 days after injection
Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
Number of participants with serious adverse events (SAEs)
Measured: From baseline up to 6 months
Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection
Number of participants with out-of-range biological test results
Measured: Up to 28 days after injection
Secondary outcomes (9)
Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181
Antibody titers are expressed as Geometric Mean Titers (GMTs)
Measured: At Day 29, Day 91, and Day 181
Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29
Ratios of antibody titers measured by HAI in each group before and after vaccination
Measured: From baseline up to 6 months
HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181
Measured: 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
Measured: From Day 01 through Day 91 and Day 01 through Day 181
Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181
Measured: At Day 29, Day 91, and Day 181
Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29
Measured: From baseline up to 6 months
2-fold and 4-fold rise in neutralizing titers from D01 to D91 and D01 to D181
Measured: From Day 01 through Day 29 and Day 01 through Day 181
HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181
Measured: At Day 01, Day 29, D91 and D181
Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181
Measured: At Day 01, Day 29, Day 91, and Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start11 Apr 2022
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118151
- Sponsor's protocol ID
- VAV00018
- Other IDs
- U1111-1271-2001
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adults 18 Years of Age and Older
- ClinicalTrials.gov ID
- NCT06118151
- Acronym / sponsor ID
- VAV00018
- Conditions
- Influenza, Influenza Immunization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| sentinel cohort 1 | Experimental | Biological: Influenza Hemagglutinin mRNA vaccine, Biological: Quadrivalent Recombinant Influenza Vaccine20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control |
| sentinel cohort 2 | Experimental | Biological: Influenza Hemagglutinin mRNA vaccine, Biological: Quadrivalent Recombinant Influenza Vaccine20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control |
| sentinel cohort 3 | Experimental | Biological: Influenza Hemagglutinin mRNA vaccine, Biological: Quadrivalent Recombinant Influenza Vaccine10 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5 with half of the participants in each age group also receiving the RIV4 control |
| main cohort 1 | Experimental | Biological: Influenza Hemagglutinin mRNA vaccine, Biological: Quadrivalent Recombinant Influenza Vaccine40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control |
| main cohort 2 | Experimental | Biological: Influenza Hemagglutinin mRNA vaccine, Biological: Quadrivalent Recombinant Influenza Vaccine40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control |
| main cohort 3 | Experimental | Biological: Influenza Hemagglutinin mRNA vaccine, Biological: Quadrivalent Recombinant Influenza Vaccine20 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5, and half number of the participants in each age group also receiving the RIV4 control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza Hemagglutinin mRNA vaccinePharmaceutical form:Solution for injection-Route of administration:IM injection | Biological | main cohort 1, main cohort 2, main cohort 3, sentinel cohort 1, sentinel cohort 2, sentinel cohort 3 |
| Quadrivalent Recombinant Influenza VaccineAlso: RIV4, Flublok Quadrivalent®Pharmaceutical form:Solution for injection-Route of administration:IM injection | Biological | main cohort 1, main cohort 2, main cohort 3, sentinel cohort 1, sentinel cohort 2, sentinel cohort 3 |
Primary outcome
Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection
Time frame: 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
Time frame: 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
Time frame: Up to 7 days after injection
Number of participants with solicited systemic reactions
Presence of unsolicited AEs reported up to 28 days after injection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 28 days after injection
Number of participants with out-of-range biological test results
9 secondary outcomes
Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181
Time frame: At Day 29, Day 91, and Day 181
Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29
Time frame: From baseline up to 6 months
HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181
Time frame: 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
Time frame: From Day 01 through Day 91 and Day 01 through Day 181
Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181
Time frame: At Day 29, Day 91, and Day 181
Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29
Time frame: From baseline up to 6 months
2-fold and 4-fold rise in neutralizing titers from D01 to D91 and D01 to D181
Time frame: From Day 01 through Day 29 and Day 01 through Day 181
HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181
Time frame: At Day 01, Day 29, D91 and D181
Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181
Time frame: At Day 01, Day 29, Day 91, and Day 181
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Influenza Hemagglutinin mRNA vaccine and Quadrivalent Recombinant Influenza Vaccine in people with Influenza and Influenza Immunization, run by Sanofi Pasteur, a Sanofi Company at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection (time frame: Within 30 minutes after injection). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.