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.

  • STATUS
    Recruiting
  • End date
    Oct 31, 2025
  • participants needed
    270
  • sponsor
    Sanofi
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Updated on 8 May 2025
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Accepts healthy volunteers

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.

Description

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

Details
Condition Healthy Volunteers, Influenza Vaccination, Respiratory Syncytial Virus Vaccination, Parainfluenza Vaccination, Human Metapneumovirus Vaccination
Age 18years - 49years
Clinical Study IdentifierNCT06850051
SponsorSanofi
Last Modified on8 May 2025

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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