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

NCT06583031
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Phase
Phase 1
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Recruitment status
Completed
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Participants
385
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Start date
2024-10-09
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Number of sites
6
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Summary
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.
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Short title
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
clinicaltrials.gov
Official title
A Phase 1, Randomized, Modified Double-blind, Multi-center, Parallel Group, Multi-arm Study to Investigate the Safety and Immunogenicity of an RSV/hMPV Vaccine Candidate in Adult Participants Aged 60 to 75 Years
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-10-09
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First posted
2024-09-03
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Registry last updated
2025-11-20
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Primary completion date
2025-10-09
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Start date
2024-10-09
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Actual participants
385
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Participants
385
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
6
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06583031
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ClinicalTrials.gov ID
NCT06583031
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masking description
Modified double-blinded for the sentinel and main cohorts. * Blinding for vaccine group assignment: participants, outcome assessors, Investigators, laboratory personnel (for both sentinel and main cohort); Sponsor study staff (except biostatistician) and Sponsor SMT (Safety Management Team) for main cohort * No blinding for vaccine group assignment: those preparing and administering the study interventions; Sponsor study staff and Sponsor SMT for sentinel cohorts
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

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

    Timeframe: On Day 1

  2. 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

    Timeframe: Day 1 through day 8

  3. Presence of unsolicited AEs reported through 28 days after vaccination

    Timeframe: Day 1 through day 29

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

    Timeframe: SAE: Screening through day 181; AESI: Day 1 through day 181

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

    Timeframe: Screening through day 8

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

    Timeframe: At day 1 and day 29

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

    Timeframe: At day 1 and day 28

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

    Timeframe: At day 1, day 29, day 91, and day 181

  4. 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

    Timeframe: At day 1, day 29, day 91, and day 181

  5. hMPV A nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine

    Timeframe: At day 1, day 29, day 91, and day 181

  6. hMPV serum anti-F IgG Ab titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine

    Timeframe: At day 1, day 29, day 91, and day 181

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
60 Years
Maximum age
75 Years
Healthy volunteers
Yes

  • 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

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Site # 0361004Botany, Australia
  • Site # 031001Brookvale, Australia
  • Site # 0361006Miranda, Australia
  • Site # 0361002Wollongong, Australia
  • Site # 0361003Herston, Australia
  • Site # 0361005South Brisbane, Australia
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1308-3615
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)