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.
Study on the Safety and Immune Response of Investigational Vaccines for Respiratory Viruses
Study Overview
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.
Study Details
The duration of study participation will be approximately 6 months for each participant.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy Volunteers, Influenza Vaccination, Respiratory Syncytial Virus Vaccination, Parainfluenza Vaccination, Human Metapneumovirus Vaccination
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Age: 18 years - 49 years
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Gender: All
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.
This study investigates the safety and immune response of different investigational vaccines for respiratory viruses. The vaccines include formulations for trivalent influenza and a combined vaccine for respiratory syncytial virus, human metapneumovirus, and parainfluenza virus type 3. A lipid nanoparticle is used in the vaccines to help deliver the vaccine components into the body.
Participants in the study will receive a single injection of one of the vaccine formulations. They will keep a diary to report any reactions at the injection site, other health events, and their daily temperature. This helps the researchers gather comprehensive safety and immune response data.
- Who can participate: Healthy individuals aged 18 to 49 years can participate. Female participants must not be pregnant or breastfeeding and must agree to use effective contraception or abstain from sexual activity during the study period.
- Study details: Participants will receive one injection of an investigational vaccine. They will use a diary to record any reactions and their daily temperature. This information will help researchers understand the safety and immune response of the vaccines.
- Study Timelines: The study will last 6 months.
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