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.

Sanofi

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Influenza Vaccination; Human Metapneumovirus Vaccination; Parainfluenza Vaccination; Respiratory Syncytial Virus Vaccination

Treatments: Biological: TIV-HA formulation 2 at low dose; Biological: RSV/hMPV/PIV3 formulation 2 at high dose; Biological: RSV/hMPV/PIV3 formulation 1 at low dose; Biological: RSV/hMPV/PIV3 formulation 1 at high dose; Biological: RSV/hMPV/PIV3 formulation 2 at low dose; Biological: TIV-HA formulation 1 at high dose; Biological: RIV4 (Supemtek®); Biological: TIV-HA formulation 2 at high dose; Biological: TIV-HA Vaccine formulation 1 at low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06850051

VAV00030

U1111-1311-1743 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 270 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 9 patient groups

Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose

Experimental group

Description:

Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.

Treatment:

Biological: TIV-HA formulation 1 at high dose

Group 2 TIV-HA formulation 2 at high dose

Experimental group

Description:

Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.

Treatment:

Biological: TIV-HA formulation 2 at high dose

Group 3 TIV-HA formulation 1 at low dose

Experimental group

Description:

Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.

Treatment:

Biological: TIV-HA Vaccine formulation 1 at low dose

Group 4 TIV-HA formulation 2 at low dose

Experimental group

Description:

Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.

Treatment:

Biological: TIV-HA formulation 2 at low dose

Group 5 RSV/hMPV/PIV3 formulation 1 at high dose

Experimental group

Description:

Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV/PIV3 formulation 1 at high dose

Group 6 RSV/hMPV/PIV3 formulation 2 at high dose

Experimental group

Description:

Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV/PIV3 formulation 2 at high dose

Group 7 RSV/hMPV/PIV3 formulation 1 at low dose

Experimental group

Description:

Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV/PIV3 formulation 1 at low dose

Group 8 RSV/hMPV/PIV3 formulation 2 at low dose

Experimental group

Description:

Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.

Treatment:

Biological: RSV/hMPV/PIV3 formulation 2 at low dose

Group 9 recombinant influenza vaccine quadrivalent (RIV4)

Active Comparator group

Description:

Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule.

Treatment:

Biological: RIV4 (Supemtek®)