Influenza A(H5N1), Respiratory Syncytial Virus (RSV)
Conditions
Keywords
RSV, RSV Infection, RSV Vaccine, Flu, Flu Infection, Flu Vaccine
Brief summary
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.
Interventions
BIOLOGICALH5 Flu Investigational Medical Product (IMP) 1
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALH5 Flu IMP 2
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALH5 Flu IMP 3
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALRSV IMP 4
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALRSV IMP 5
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALRSV IMP 6
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALH5 Flu IMP 7
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALH5 Flu IMP 8
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALH5 Flu IMP 9
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALH5 Flu IMP 10
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALH5 Flu IMP 11
Suspension for injection. Route of administration: Intramuscular (IM) injection
BIOLOGICALH5 Flu IMP 12
Suspension for injection. Route of administration: Intramuscular (IM) injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Modified double-blind design for Sentinel and Main Cohorts. * Blinded to formulation: Participants; Investigators; Sponsor study staff (except biostatistician); Sponsor laboratory personnel (during interim analysis); Sponsor SMT for Main Cohorts only * Unblinded to formulation: Staff preparing and administering study vaccines (at group level); Study biostatistician (throughout study); Sponsor SMT for Sentinel Cohorts, including ESDRs; SMT may receive unblinded data in case of identified safety concern evaluate the potential safety signal. * Blinded to antigen assignment (RSV vs. Flu H5): None * Unblinded to antigen assignment (RSV vs. Flu H5): Investigators; Participants; Sponsor study staff; Sponsor laboratory personnel (for immunogenicity assays); Study biostatistician; SMT
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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 of the following conditions applies: * 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination | On Day 1 | — |
| 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 | Day 1 through day 8 | — |
| 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 | Day 1 through day 8 | — |
| Presence of unsolicited AEs reported through 20 days after the first vaccination and after the second vaccination for IMPs with the Flu H5 antigen | Day 1 through day 21 | — |
| Presence of unsolicited AEs reported through 28 days after vaccination for IMPs with the RSV antigen | 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) | SAE: Screening day through day 202 (IMPs containing Flu H5 antigen), Screening day through day 181 (IMPs containing RSV antigen); AESI: Day 1 through day 202 (IMPs containing Flu H5 antigen), Day 1 through day 181 (IMPs containing RSV antigen) | — |
| Presence of out-of-range biological test results (including shift from baseline values) through 7 days after each vaccination | Screening through day 8 | — |
| Presence of AEs leading to study discontinuation throughout the study (ie, through 6 months after vaccination) | Screening through day 202 (IMPs containing Flu H5 antigen), Screening through day 181 (IMPs containing RSV antigen) | — |
| RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants receiving IMPs with the RSV antigen | Day 1 and day 29 | — |
| Flu H5 antibody (Ab) titer measured by hemagglutination inhibition (HAI) at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22 and day 43 | — |
| Hemagglutination Inhibition (HAI) geometric mean titer ratio at 21 and 42 days post-vaccination relative to pre-vaccination for all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22 and day 43 | Ratio of post-vaccination to pre-vaccination hemagglutination inhibition (HAI) antibody titers, calculated as Day 22/Day 1 and Day 43/Day 1. |
| Seroconversion rate based on Hemagglutination inhibition (HAI) antibody titers at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22 and day 43 | — |
| Proportion of participants with Hemagglutination Inhibition (HAI) antibody titer ≥40 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22, and day 43 | — |
| Proportion of participants with detectable HAI antibody titer ≥10 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22, and day 43 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1, day 22, and day 43 | — |
| Neutralizing antibody titer ratio at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22, and day 43 | 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. |
| 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 | Day 1, day 22, and day 43 | — |
| 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 | Day 1, day 22, and day 43 | — |
| Proportion of participants with ≥2-fold and ≥4-fold increase in neutralizing antibody titers at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen | Day 1, day 22, and day 43 | — |
Countries
Australia
Contacts
CONTACTSanofi Trial Transparency Email Recommended (Toll free for US and Canada)
Outcome results
None listed