Healthy Volunteers, Human Metapneumovirus Vaccination, Influenza Vaccination, Parainfluenza Vaccination, Respiratory Syncytial Virus Vaccination
Conditions
Keywords
influenza, respiratory syncytial virus, parainfluenza, human metapneumovirus
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.
Interventions
BIOLOGICALTIV-HA Vaccine formulation 1 at low dose
Suspension for injection in a vial. Route of administration: IM injection
BIOLOGICALTIV-HA formulation 1 at high dose
Suspension for injection in a vial. Route of administration: IM injection
BIOLOGICALTIV-HA formulation 2 at low dose
Suspension for injection in a vial. Route of administration: IM injection
BIOLOGICALTIV-HA formulation 2 at high dose
Suspension for injection in a vial. Route of administration: IM injection
BIOLOGICALRSV/hMPV/PIV3 formulation 2 at low dose
Suspension for injection in a vial. Route of administration: IM injection
BIOLOGICALRSV/hMPV/PIV3 formulation 1 at high dose
Suspension for injection in a vial. Route of administration: IM injection
BIOLOGICALRSV/hMPV/PIV3 formulation 2 at high dose
Suspension for injection in a vial. Route of administration: IM injection
BIOLOGICALRSV/hMPV/PIV3 formulation 1 at low dose
Suspension for injection in a vial. Route of administration: IM injection
BIOLOGICALRIV4 (Supemtek®)
Solution for injection in a prefilled syringe. Route of administration: IM injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination | Within 30 minutes after each vaccination | Number of participants with unsolicited systemic AEs |
| 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 | Through 7 days after each vaccination | Number of participants with solicited injection site and systemic reactions |
| Presence of unsolicited AEs reported through 28 days after vaccination | Through 28 days after each vaccination | Number of participants with unsolicited AEs |
| Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study | Throughout study, approximately 6 months | : Number of participants with SAEs and AESIs |
| Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination | Through 7 days after vaccination | : Number of participants with out-of-range biological tests |
| Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29 | Day 1 and Day 29 | — |
| RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29 | Day 1 and Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| RSV B and hMPV A nAb titers at Day 1 and Day 29 | Day 1 and Day 29 |
| Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29 | Day 29 |
Countries
Australia
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Outcome results
None listed