Clinical trial
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
Name
VAV00018
Description
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
Trial arms
Trial start
2022-04-11
Estimated PCD
2023-02-17
Trial end
2023-02-17
Status
Completed
Phase
Early phase I
Treatment
Influenza Hemagglutinin mRNA vaccine
Pharmaceutical form:Solution for injection-Route of administration:IM injection
Arms:
main cohort 1, main cohort 2, main cohort 3, sentinel cohort 1, sentinel cohort 2, sentinel cohort 3
Quadrivalent Recombinant Influenza Vaccine
Pharmaceutical form:Solution for injection-Route of administration:IM injection
Arms:
main cohort 1, main cohort 2, main cohort 3, sentinel cohort 1, sentinel cohort 2, sentinel cohort 3
Other names:
RIV4, Flublok Quadrivalent®
Size
388
Primary endpoint
Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection
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
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
Up to 7 days after injection
Presence of unsolicited AEs reported up to 28 days after injection
Up to 28 days after injection
Presence of medically attended AEs (MAAEs) reported up to 28 days after injection
Up to 28 days after injection
Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
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
Up to 28 days after injection
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Open label (Sponsor) Blinded (Sites, except for those preparing/administering study intervention)', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 388, 'type': 'ACTUAL'}}
Updated at
2023-11-07
1 organization
2 products
2 indications
Indication
InfluenzaIndication
Influenza ImmunizationOrganization
Sanofi Pasteur