Clinical trial NCT06850051: 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.
Official title: A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different Formulations of Multivalent Influenza and Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV)/Parainfluenza Virus Type 3 (PIV3) Vaccines in Healthy Participants 18 to 49 Years of Age.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Influenza Vaccination
Respiratory Syncytial Virus Vaccination
Parainfluenza Vaccination
Human Metapneumovirus Vaccination
Keywords: influenza
respiratory syncytial virus
parainfluenza
human metapneumovirus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-02-27
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. A lipid nanoparticle will be used in this study.

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: The duration of study participation will be approximately 6 months for each participant.

Eligibility criteria: Inclusion Criteria:

* Aged 18 to 49 years on the day of inclusion
* 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:

- Any medical condition or circumstance which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
timeFrame: Within 30 minutes after each vaccination
measure: Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
timeFrame: Through 7 days after each vaccination
measure: Presence of unsolicited AEs reported through 28 days after vaccination
timeFrame: Through 28 days after each vaccination
measure: Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study
timeFrame: Throughout study, approximately 6 months
measure: Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
timeFrame: Through 7 days after vaccination
measure: Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29
timeFrame: Day 1 and Day 29
measure: RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29
timeFrame: Day 1 and Day 29
Secondary outcomes:
measure: RSV B and hMPV A nAb titers at Day 1 and Day 29
timeFrame: Day 1 and Day 29
measure: Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29
timeFrame: Day 29
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Paratus Clinical
state: New South Wales
city: Herston
country: Australia
facility: Paratus Clinical
state: Queensland
city: Morayfield
country: Australia
facility: University of Sunshine Coast Clinical Trials
state: Queensland
city: South Brisbane
country: Australia
facility: University of Sunshine Coast Clinical Trials
state: Queensland
city: Southport
country: Australia
facility: Griffith University
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
Study officials:
References: