Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

Sanofi Pasteur, a Sanofi Company385 enrolled

Overview

VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

385

Conditions

RSV Infection hMPV

Interventions

RSV/hMPV vaccine dose A1BIOLOGICAL

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose A2BIOLOGICAL

Suspension for injection. Route of administration: IM injection

RSV/hMPV vaccine dose A3BIOLOGICAL

Suspension for injection. Route of administration: IM injection

Eligibility

Sex: ALLMin age: 60 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 60 to 75 years on the day of inclusion * A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile Exclusion Criteria: * Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives. * The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (6)

Site # 0361004

Botany, New South Wales, Australia

Site # 031001

Brookvale, New South Wales, Australia

Site # 0361006

Miranda, New South Wales, Australia

Site # 0361002

Wollongong, New South Wales, Australia

Outcomes

Primary Outcomes

Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination

Time frame: On Day 1

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

Time frame: Day 1 through day 8

Presence of unsolicited AEs reported through 28 days after vaccination

Time frame: Day 1 through day 29

Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination

Time frame: SAE: Screening through day 181; AESI: Day 1 through day 181

Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination

Time frame: Screening through day 8

Secondary Outcomes

RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants

Time frame: At day 1 and day 29

hMPV A serum nAb titers at pre-vaccination and 28 days post-vaccination in all participants, except in those receiving the MV RSV vaccine

Time frame: At day 1 and day 28

RSV A and RSV B nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants

Time frame: At day 1, day 29, day 91, and day 181

RSV A serum anti-F IgG (immunoglobulin type G) Ab (Antibody) titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants

Data from ClinicalTrials.gov

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