A Phase 3 interventional study of Low Dose (LD) RSVt vaccine and Standard Dose (SD) RSVt vaccine in RSV Immunisation and Healthy Volunteers, sponsored by Sanofi Pasteur, a Sanofi Company. Terminated at 3 sites in Honduras. Open to participants aged 6 Months to 21 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention
This study was a Phase III, parallel group, randomized, observer blind, placebo controlled, multi-national, multi-center, multi-arm study conducted in 42 healthy children enrolled at 6 months to \<22 months of age. The purpose of the study was to evaluate the non-inferiority of the immune response of the lower dose (LD) when compared to the standard dose (SD) respiratory syncytial virus infant and toddler (RSVt) vaccine and the safety of the LD, SD and high dose (HD) vaccine in preterm born children and of the HD vaccine in full term born children administered by intranasal route and compared to placebo.
The study duration was approximately 8 months for each participant, including the 6 months safety follow-up phone call after the second study intervention administration.
For Cohort 1 and Cohort 2 (contingent upon satisfactory safety profile of the RSVt vaccine in Cohort 1):
--Participant born 28 through 36 weeks of gestation and medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention.
For Cohort 2:
Exclusion Criteria:
Participants were excluded from the study if any of the following criteria apply:
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
Member of a household that contains an immunocompromised individual, including, but not limited to:
Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration:
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Participants received 2 intranasal administrations of SD RSVt vaccine
Biological: Standard Dose (SD) RSVt vaccine
Participants received 2 intranasal administrations of placebo
Biological: Placebo
Participants received 2 intranasal administrations of HD RSVt vaccine
Biological: High Dose (HD) RSVt vaccine
Participants received 2 intranasal administrations of placebo
Biological: Placebo
Participants received 2 intranasal administrations of LD RSVt vaccine
Biological: Low Dose (LD) RSVt vaccine
Participants received 2 intranasal administrations of SD RSVt vaccine
Biological: Standard Dose (SD) RSVt vaccine
Participants received 2 intranasal administrations of HD RSVt vaccine
Biological: High Dose (HD) RSVt vaccine
Participants received 2 intranasal administrations of placebo
Biological: Placebo
Pharmaceutical form: Liquid for nasal spray Route of administration: Intranasal
Also known as: 534
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Also known as: 534
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Also known as: 534
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Cohort 2: Geometric Mean Titers (GMT) of RSV A Serum Neutralizing Antibodies at Day 85 (Post-Dose 2)
Serum samples were planned to be collected at specified timepoints for immunogenicity assessments. RSV A serum neutralizing antibody titers were planned to be determined using a validated plaque reduction neutralization test (PRNT).
Time frame: Day 85 (28 days post-vaccination 2)
Cohort 2: Geometric Mean Titers of RSV B Serum Neutralizing Antibodies at Day 85 (Post-Dose 2)
Serum samples were planned to be collected at specified timepoints for immunogenicity assessments. RSV B serum neutralizing antibody titers were planned to be determined using a validated PRNT.
Time frame: Day 85 (28 days post-vaccination 2)
Cohorts 1 and 2: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after each vaccination and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs.
Time frame: Up to 30 minutes after each vaccination (post-dose on Day 1)
Cohorts 1 and 2: Number of Participants With Solicited Administration Site Reactions
A solicited injection/administration site reactions were adverse reactions (AR) at and around the injection/administration site of the study vaccine observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as related to the study vaccine administered.
Time frame: Up to 21 days after each vaccination (post-dose on Day 1)
Cohorts 1 and 2: Number of Participants With Solicited Systemic Reactions
A solicited reaction was an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as related to the study vaccine administered.
Time frame: Up to 21 days after each vaccination (post-dose on Day 1)
Cohorts 1 and 2: Number of Participants With Unsolicited Adverse Events
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Time frame: Up to 28 days after each vaccination (post-dose on Day 1)
Cohorts 1 and 2: Number of Participants With Medically Attended Adverse Events (MAAEs)
An MAAE was defined as a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department.
Time frame: From first dose of study vaccine administration (Day 1) to 198 days
Cohorts 1 and 2: Number of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any AE that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was other medically important event.
Time frame: From first dose of study vaccine administration (Day 1) to 198 days
Cohorts 1 and 2: Number of Participants With Adverse Events of Special Interest (AESIs)
An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was appropriate. Acute wheeze and anaphylaxis were collected as AESI.
Time frame: From first dose of study vaccine administration (Day 1) to 198 days
Cohort 1: Geometric Mean Titers of RSV A and B Serum Neutralizing Antibodies at Baseline (Day 1) and Day 85
Serum samples were planned to be collected at specified timepoints for immunogenicity assessments. RSV A and RSV B serum neutralizing antibody titers were planned to be determined using a validated PRNT.
Time frame: Baseline (Day 1) and Day 85
Cohorts 1 and 2: Mean Titers of RSV Serum Anti-F Immunoglobulin (Ig) A and IgG Antibodies at Baseline (Day 1) and Day 85
Serum samples were collected at specified timepoints for immunogenicity assessments. Antibodies to RSV F antigen were measured using the anti-RSV serum anti-F IgA and IgG using electrochemiluminescence method. Log10 titer values are reported.
Time frame: Baseline (Day 1) and Day 85
Cohorts 1 and 2: Percentage of Participants With Quantified Shedding >=3.37 Lower Limit of Quantitation (LLOQ)
Nasal swabs were collected to assess shedding of the attenuated RSV vaccine strain at specified timepoints. Quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay was developed to detect and quantify RSV ΔNS2 candidate in nasal swab samples. Percentages rounded off to tenth decimal place.
Time frame: Day 8 and Day 64
Cohorts 1 and 2: Percentage of Participants With Detectable Shedding >=2.08 Limit of Detection
Nasal swabs were collected to assess shedding of the attenuated RSV vaccine strain at specified timepoints. qRT-PCR assay was developed to detect and quantify RSV ΔNS2 candidate in nasal swab samples. Percentages rounded off to tenth decimal place.
Time frame: Day 8 and Day 64
Cohorts 1 and 2: Titer of Vaccine Virus Shedding in Participants Detected in Nasal Samples Quantified by Quantitative Real Time-Polymerase Chain Reaction
Nasal swabs were collected to assess shedding of the attenuated RSV vaccine strain at specified timepoints. qRT-PCR assay was developed to detect and quantify RSV ΔNS2 candidate in nasal swab samples. Quantified virus shedding was defined as vaccine virus shedding \>=lower limit of quantification (LLOQ=3.37 log10 copies/mL).
Time frame: Day 8 and Day 64
Study was conducted at 1 center in a single country from 25 November 2024 to 13 December 2024. 42 healthy infants/toddlers aged 6 to\<22 months were randomized to 2 cohorts: preterm born children(Cohort1:randomized to receive either placebo or standard dose of live-attenuated respiratory syncytial virus delta\[Δ\] non-structural \[NS\]2/Δ1313/I1314L vaccine \[RSVt vaccine\]) and full term born children (Cohort2:randomized to receive either low dose, standard dose or high dose RSVt vaccine or placebo).
| Milestone | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Started | 2 | 3 | 10 | 10 | 12 | 5 |
| Completed | 2 | 3 | 10 | 10 | 12 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Serum samples were planned to be collected at specified timepoints for immunogenicity assessments. RSV A serum neutralizing antibody titers were planned to be determined using a validated plaque reduction neutralization test (PRNT).
No measurements were reported for this outcome.
Serum samples were planned to be collected at specified timepoints for immunogenicity assessments. RSV B serum neutralizing antibody titers were planned to be determined using a validated PRNT.
No measurements were reported for this outcome.
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after each vaccination and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs.
| Participants | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Cohorts 1 and 2: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 | 0 | 0 | 0 | 0 | 0 |
A solicited injection/administration site reactions were adverse reactions (AR) at and around the injection/administration site of the study vaccine observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as related to the study vaccine administered.
| Participants | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Cohorts 1 and 2: Number of Participants With Solicited Administration Site Reactions | 0 | 2 | 6 | 8 | 4 | 3 |
A solicited reaction was an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as related to the study vaccine administered.
| Participants | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Cohorts 1 and 2: Number of Participants With Solicited Systemic Reactions | 0 | 2 | 4 | 6 | 6 | 4 |
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
| Participants | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Cohorts 1 and 2: Number of Participants With Unsolicited Adverse Events | 0 | 0 | 0 | 1 | 0 | 0 |
An MAAE was defined as a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department.
| Participants | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Cohorts 1 and 2: Number of Participants With Medically Attended Adverse Events (MAAEs) | 1 | 1 | 2 | 0 | 2 | 0 |
An SAE was defined as any AE that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was other medically important event.
| Participants | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Cohorts 1 and 2: Number of Participants With Serious Adverse Events (SAEs) | 0 | 1 | 0 | 0 | 0 | 0 |
An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was appropriate. Acute wheeze and anaphylaxis were collected as AESI.
| Participants | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Cohorts 1 and 2: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 | 0 | 0 | 0 | 0 | 0 |
Serum samples were planned to be collected at specified timepoints for immunogenicity assessments. RSV A and RSV B serum neutralizing antibody titers were planned to be determined using a validated PRNT.
No measurements were reported for this outcome.
Serum samples were collected at specified timepoints for immunogenicity assessments. Antibodies to RSV F antigen were measured using the anti-RSV serum anti-F IgA and IgG using electrochemiluminescence method. Log10 titer values are reported.
| titer | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Baseline (Day 1): IgA | 1.20 ± 0.622 | 1.45 ± 1.52 | 1.35 ± 0.881 | 0.502 ± 0.364 | 1.56 ± 0.953 | 0.921 ± 0.863 |
| Baseline (Day 1): IgG | 0.709 ± 1.14 | 1.79 ± 1.87 | 2.55 ± 0.878 | 0.935 ± 0.798 | 2.55 ± 0.911 | 1.57 ± 1.22 |
Nasal swabs were collected to assess shedding of the attenuated RSV vaccine strain at specified timepoints. Quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay was developed to detect and quantify RSV ΔNS2 candidate in nasal swab samples. Percentages rounded off to tenth decimal place.
| percentage of participants | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Day 8 | 0 (0 to 84.2) | 0 (0 to 70.8) | 0 (0 to 30.8) | 40.0 (12.2 to 73.8) | 25.0 (5.5 to 57.2) | 0 (0 to 52.2) |
Nasal swabs were collected to assess shedding of the attenuated RSV vaccine strain at specified timepoints. qRT-PCR assay was developed to detect and quantify RSV ΔNS2 candidate in nasal swab samples. Percentages rounded off to tenth decimal place.
| percentage of participants | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Day 8 | 0 (0 to 84.2) | 0 (0 to 70.8) | 0 (0 to 30.8) | 50.0 (18.7 to 81.3) | 33.3 (9.9 to 65.1) | 0 (0 to 52.2) |
Nasal swabs were collected to assess shedding of the attenuated RSV vaccine strain at specified timepoints. qRT-PCR assay was developed to detect and quantify RSV ΔNS2 candidate in nasal swab samples. Quantified virus shedding was defined as vaccine virus shedding \>=lower limit of quantification (LLOQ=3.37 log10 copies/mL).
| log10 copies/mL | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| Day 8 | — | — | — | 5.20 ± 1.02 | 4.91 ± 1.33 | — |
Collected over Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: Group 1: Standard Dose RSVt | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Cohort 1: Group 2: Placebo | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Cohort 2: Group 1: Low Dose RSVt | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Cohort 2: Group 2: Standard Dose RSVt | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| Cohort 2: Group 3: High Dose RSVt | 0/12 (0%) | 0/12 (0%) | 7/12 (58.3%) |
| Cohort 2: Group 4: Placebo | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| Event | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 0/2 | 1/3 | 0/10 | 0/10 | 0/12 | 0/5 |
| Event | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo |
|---|---|---|---|---|---|---|
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/2 | 2/3 | 6/10 | 8/10 | 4/12 | 2/5 |
| Nasal CongestionRespiratory, thoracic and mediastinal disorders | 0/2 | 1/3 | 3/10 | 7/10 | 1/12 | 3/5 |
| Decreased AppetiteMetabolism and nutrition disorders | 0/2 | 0/3 | 2/10 | 5/10 | 2/12 | 3/5 |
| CryingGeneral disorders | 0/2 | 0/3 | 2/10 | 4/10 | 3/12 | 1/5 |
| SomnolenceNervous system disorders | 0/2 | 1/3 | 1/10 | 2/10 | 2/12 | 1/5 |
| VomitingGastrointestinal disorders | 0/2 | 1/3 | 2/10 | 3/10 | 2/12 | 1/5 |
| IrritabilityPsychiatric disorders | 0/2 | 0/3 | 1/10 | 3/10 | 2/12 | 1/5 |
| PyrexiaGeneral disorders | 0/2 | 0/3 | 0/10 | 1/10 | 2/12 | 0/5 |
| NasopharyngitisInfections and infestations | 0/2 | 0/3 | 0/10 | 1/10 | 0/12 | 0/5 |
Randomized analysis set consisted of participants for whom a study vaccine group had been allocated.
| Age, Continuous(months) | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Mean | 16.5 ± 0.707 | 14.0 ± 5.20 | 13.0 ± 3.71 | 10.9 ± 2.69 | 11.8 ± 3.38 | 10.0 ± 2.12 | 12.0 ± 3.43 |
| Sex: Female, Male(Participants) | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo | Total |
|---|---|---|---|---|---|---|---|
| Female | 1 | 1 | 3 | 4 | 7 | 1 | 17 |
| Male | 1 | 2 | 7 | 6 | 5 | 4 | 25 |
| Race (NIH/OMB)(Participants) | Cohort 1: Group 1: Standard Dose RSVt | Cohort 1: Group 2: Placebo | Cohort 2: Group 1: Low Dose RSVt | Cohort 2: Group 2: Standard Dose RSVt | Cohort 2: Group 3: High Dose RSVt | Cohort 2: Group 4: Placebo | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 10 | 10 | 12 | 5 | 42 |
| White | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi Pasteur, a Sanofi Company