Health Trials

Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age

ConditionsRespiratory Syncytial Virus (RSV)Influenza A(H5N1)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-49
SponsorSanofi

About this trial

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of vaccines encoding the RSV monovalent antigen or the Flu hemagglutinin subtype 5 (H5) antigen in healthy participants aged 18 to 49 years.

The total duration of study participation for each participant varies by stage and treatment arm.

Stage 1:

* For Arm 1, Arm 2, and Arm 3 the duration of study participation will be approximately 7 months for each participant. * For Arm 4, Arm 5, and Arm 6 the duration of study participation will be approximately 6 months for each participant.

Stage 2: For all arms, the duration of study participation will be approximately 7 months for each participant.

Eligibility criteria

Qualifiers

Aged 18 to 49 years on the day of inclusion

Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR

Is of CBP (Child-Bearing Potential) and uses an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after the last study intervention administration.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • H5 Flu Investigational Medical Product (IMP) 1
  • H5 Flu IMP 2
  • H5 Flu IMP 3
  • RSV IMP 4
  • RSV IMP 5
  • RSV IMP 6
  • H5 Flu IMP 7
  • H5 Flu IMP 8
  • H5 Flu IMP 9
  • H5 Flu IMP 10
  • H5 Flu IMP 11
  • H5 Flu IMP 12

Treatment groups

570 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Sponsors and collaborators

Sanofi

Lead sponsor

Source ClinicalTrials.gov