A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.
NCT ID: NCT06850051
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
270 participants
INTERVENTIONAL
2025-03-19
2026-01-31
Brief Summary
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Overall, the study is designed to:
* Assess the safety profile of the candidate formulations
* Describe the immunogenicity profile of the candidate formulations
* Eligible participants will be randomized to receive a single intramuscular injection of either one of the vaccine formulations.
Participants will be provided with a diary to solicit reporting of injection site reactions and systemic reactions, unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest AESIs).
Participants will also be required to record their daily temperature on the diary.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
TIV-HA formulation 1 at high dose
Suspension for injection in a vial. Route of administration: IM injection
Group 2 TIV-HA formulation 2 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
TIV-HA formulation 2 at high dose
Suspension for injection in a vial. Route of administration: IM injection
Group 3 TIV-HA formulation 1 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
TIV-HA Vaccine formulation 1 at low dose
Suspension for injection in a vial. Route of administration: IM injection
Group 4 TIV-HA formulation 2 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
TIV-HA formulation 2 at low dose
Suspension for injection in a vial. Route of administration: IM injection
Group 5 RSV/hMPV/PIV3 formulation 1 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
RSV/hMPV/PIV3 formulation 1 at high dose
Suspension for injection in a vial. Route of administration: IM injection
Group 6 RSV/hMPV/PIV3 formulation 2 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
RSV/hMPV/PIV3 formulation 2 at high dose
Suspension for injection in a vial. Route of administration: IM injection
Group 7 RSV/hMPV/PIV3 formulation 1 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
RSV/hMPV/PIV3 formulation 1 at low dose
Suspension for injection in a vial. Route of administration: IM injection
Group 8 RSV/hMPV/PIV3 formulation 2 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
RSV/hMPV/PIV3 formulation 2 at low dose
Suspension for injection in a vial. Route of administration: IM injection
Group 9 recombinant influenza vaccine quadrivalent (RIV4)
Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule.
RIV4 (Supemtek®)
Solution for injection in a prefilled syringe. Route of administration: IM injection
Interventions
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TIV-HA Vaccine formulation 1 at low dose
Suspension for injection in a vial. Route of administration: IM injection
TIV-HA formulation 1 at high dose
Suspension for injection in a vial. Route of administration: IM injection
TIV-HA formulation 2 at low dose
Suspension for injection in a vial. Route of administration: IM injection
TIV-HA formulation 2 at high dose
Suspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 2 at low dose
Suspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 1 at high dose
Suspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 2 at high dose
Suspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 1 at low dose
Suspension for injection in a vial. Route of administration: IM injection
RIV4 (Supemtek®)
Solution for injection in a prefilled syringe. Route of administration: IM injection
Eligibility Criteria
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Inclusion Criteria
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile OR
* Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
Exclusion Criteria
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18 Years
49 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Paratus Clinical
Blacktown, New South Wales, Australia
Paratus Clinical
Herston, Queensland, Australia
University of Sunshine Coast Clinical Trials
Morayfield, Queensland, Australia
University of Sunshine Coast Clinical Trials
South Brisbane, Queensland, Australia
Griffith University
Southport, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
Countries
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Other Identifiers
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VAV00030
Identifier Type: -
Identifier Source: org_study_id
U1111-1311-1743
Identifier Type: OTHER
Identifier Source: secondary_id