Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age
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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
H5 Flu Investigational Medical Product (IMP) 1
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 2
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 3
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
RSV IMP 4
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
RSV IMP 5
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
RSV IMP 6
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 7
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 8
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 9
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 10
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 11
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 12
Biological/VaccineSuspension for injection. Route of administration: Intramuscular (IM) injection
Treatment groups
570 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Group A: Stage 1, Arm 1Experimental treatment 1 intervention
Group B: Stage 1, Arm 2Experimental treatment 1 intervention
Group C: Stage 1, Arm 3Experimental treatment 1 intervention
Group D: Stage 1, Arm 4Experimental treatment 1 intervention
Group E: Stage 1, Arm 5Experimental treatment 1 intervention
Group F: Stage 1, Arm 6Experimental treatment 1 intervention
Group G: Stage 2, Arm 1Experimental treatment 1 intervention
Group H: Stage 2, Arm 2Experimental treatment 1 intervention
Group I: Stage 2, Arm 3Experimental treatment 1 intervention
Group J: Stage 2, Arm 4Experimental treatment 1 intervention
Group K: Stage 2, Arm 5Experimental treatment 1 intervention
Group L: Stage 2, Arm 6Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Time frame
On Day 12
Presence of solicited injection site reactions (ie, injection site pain, injection site erythema, injection site swelling, pre-listed in participant's diary and in the eCRF (electronic case report form)) occurring through 7 days after each vaccination
Time frame
Day 1 through day 83
Presence of solicited systemic reactions (ie, fever, headache, and only new or worsened fatigue, myalgia, arthralgia, and chills pre-listed in the participant's diary and in the eCRF) occurring through 7 days after each vaccination
Time frame
Day 1 through day 84
Presence of unsolicited AEs reported through 20 days after the first vaccination and after the second vaccination for IMPs with the Flu H5 antigen
Time frame
Day 1 through day 21Secondary outcomes
1
Geometric mean neutralizing antibody titers measured by Neutralization Assay (NT) at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen
Time frame
Day 1, day 22, and day 432
Neutralizing antibody titer ratio at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen
Ratio of post-vaccination to pre-vaccination neutralizing antibody titers, calculated as Day 22/Day 1 and Day 43/Day 1 using a validated neutralization (NT) assay.
Time frame
Day 1, day 22, and day 433
Proportion of participants with neutralizing antibody titers ≥20, ≥40, and ≥80 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen
Time frame
Day 1, day 22, and day 434
Proportion of participants with detectable neutralizing antibody titers ≥10 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen
Time frame
Day 1, day 22, and day 43 Source ClinicalTrials.gov