## Protocol Section
### Identification Module
**NCT ID:** NCT05687279

**Brief Title:** Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)

**Official Title:** Phase II, Randomized, Observer-blind, Placebo-controlled, Multi-center Study of a Live Attenuated Respiratory Syncytial Virus Vaccine to Assess the Vaccine Virus' Transmissibility in Household or Daycare Center Settings, Shedding, and Genetic Stability, and to Describe the Immunogenicity and Safety of the Vaccine in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)

#### Organization Study ID Info
**ID:** VAD00014
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**Domain:** ICTRP
**ID:** U1111-1278-3910
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2025-05-21

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2025-05-21

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-02-06

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2023-01-18
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-06
**Study First Submit QC Date:** 2023-01-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sanofi Pasteur, a Sanofi Company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to \< 24 months of age.

**Detailed Description:** The duration of each participant's participation is up to 8 months, including the 6 months safety follow-up phone call after the second study intervention administration for the pediatric participants The treatment administration for the pediatric participants will be on D01 and D57 (1 intranasal administration each).

### Conditions Module

**Conditions:**

- Respiratory Syncytial Virus Infection

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Masking Description:** Observer-blind:

* Blinding for vaccine group assignment: participants, parents or legally acceptable representative (LAR), outcome assessors, investigators, laboratory personnel, Sponsor study staff
* No blinding for study staff who prepare and administer the study interventions

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 2 intranasal administrations (56 days apart) of the RSVt vaccine at D01 and D57

**Intervention Names:**

- Biological: RSVt Vaccine

**Label:** RSVt Vaccine Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 2 intranasal administrations (56 days apart) of the placebo at D01 and D57

**Intervention Names:**

- Other: Control Group

**Label:** Control Group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- RSVt Vaccine Group

**Description:** Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal

**Name:** RSVt Vaccine

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Control Group

**Description:** Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal

**Name:** Control Group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Proportion of vaccinees infected with vaccine virus in the placebo group, defined as vaccine virus shedding, detected by quantitative reverse transcription polymerase chain reaction (qRT-PCR)

**Measure:** Presence of vaccine virus

**Time Frame:** Day 1 through Day 22

**Description:** Titer of vaccine virus shedding in nasal swabs, quantified by qRT-PCR Assay in all pediatric participants

**Measure:** Change in the Geometric Mean Titers (GMTs) of vaccine virus shedding

**Time Frame:** Day 1 through Day 71

**Description:** Number of differences detected in genetic sequence of NS2 segment of the vaccine virus compared to the reference strain vaccine virus isolates in the vaccine virus positive swabs from pediatric participants receiving placebo and ad hoc close contact participants

**Measure:** Number of differences detected in genetic sequence of NS2 segment

**Time Frame:** Approximately Day 1 through Day 85

#### Secondary Outcomes

**Description:** RSV A serum Nab titers

**Measure:** Geometric Mean Titers (GMTs) of RSV A serum neutralizing antibody (nAb) titers

**Time Frame:** Day 1, Day 57 and Day 85

**Description:** RSV serum anti-F IgG ELISA antibody titers

**Measure:** GMTs of RSV serum anti-F Immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) antibody titers up to 28 days after the second administration (D01, D57, and D85)

**Time Frame:** Day 1, Day 57 and Day 85

**Description:** Number of participants experiencing immediate unsolicited systemic AEs

**Measure:** Presence of immediate unsolicited systemic Adverse Events (AEs)

**Time Frame:** Within 30 minutes after each vaccination administration

**Description:** Number of participants reporting:

* injection site reactions: pain, erythema and swelling
* systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills

**Measure:** Presence of solicited injection site or systemic reactions

**Time Frame:** Within 21 days after each vaccination administration

**Description:** Number of participants experiencing unsolicited AEs

**Measure:** Presence of unsolicited AEs

**Time Frame:** Within 28 days after each vaccination administration

**Description:** Number of participants experiencing AESIs

**Measure:** Presence of adverse events of special interest (AESIs)

**Time Frame:** Within 28 days after each vaccination administration

**Description:** Number of participants experiencing MAAEs

**Measure:** Presence of medically attended adverse events (MAAEs)

**Time Frame:** Within 28 days after each vaccination administration

**Description:** Number of participants experiencing SAEs

**Measure:** Presence of serious adverse events (SAEs)

**Time Frame:** From Day 1 until the end of the study (approximately 8 months)

**Description:** Proportion of vaccinees infected with vaccine virus in the placebo group, defined as vaccine virus shedding, detected by quantitative reverse transcription polymerase chain reaction (qRT-PCR)

**Measure:** Presence of vaccine virus at Day 64 through Day 71

**Time Frame:** Day 64 through Day 71

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged 6 months to \< 24 months on the day of inclusion (from the day of the 6 months after birth to the day before the 2nd birthday)
* Participants who are healthy as determined by medical evaluation including medical history.
* Born at full term of pregnancy (≥ 37 weeks) or born after a gestation period of 27 through 36 weeks 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
* Attends a daycare facility at least 3 days per week and 4 hours per day at which the participant would be in a contact group/playroom of at least one other child 6 to \< 24 months of age who will participate in this study or is a member of a household, which includes at least one other child 6 to \< 24 months of age who will participate in this study

Exclusion Criteria:

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
* Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Probable or confirmed ongoing case of COVID-19 at the time of enrollment
* Member of a household that contains an immunocompromised individual, including, but not limited to:

  * a person who is HIV infected
  * a person who has received chemotherapy within the 12 months prior to study enrollment
  * a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents
  * a person living with a solid organ or bone marrow transplant
* Member of a household that includes, or will include, an infant who is less than 6 months of age at the time of enrollment
* Attends a daycare facility and shares a daycare room with infants less than 6 months of age, and parent/legally acceptable representative is unable or unwilling to suspend attendance at the daycare facility for 28 days following study intervention administration
* Any need of supplemental oxygen therapy in a home or hospital setting at the time of enrollment.
* Participant's mother previous receipt or planned administration of an investigational RSV vaccine or any monoclonal antibody (such as Infliximab) during pregnancy and/or breastfeeding.
* Receipt or planned receipt of any of the following vaccines prior to or after the first study intervention administration:

  * any influenza vaccine within 7 days prior to and after, or any COVID-19 or inactivated vaccine or live-attenuated rotavirus vaccine within 14 days prior to and after, or
  * any live vaccine, other than rotavirus vaccine, within 28 days prior to and after
* Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV Immunoglobulin (IG) or RSV monoclonal antibody) at the time of enrollment.
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
* Receipt at the time of enrollment or previous receipt of salicylate (aspirin) or salicylate-containing products
* Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
* Deprived of freedom in an emergency setting, or hospitalized involuntarily
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

**Healthy Volunteers:** True

**Maximum Age:** 23 Months

**Minimum Age:** 6 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Norfolk

**Country:** United States

**Facility:** Meridian Clinical Research Norfolk Site Number : 8400003

**State:** Nebraska

**Zip:** 68701

**Location 2:**

**City:** Omaha

**Country:** United States

**Facility:** Velocity Clinical Research, Omaha Site Number : 8400001

**State:** Nebraska

**Zip:** 68134

**Location 3:**

**City:** Bayamón

**Country:** Puerto Rico

**Facility:** Investigational Site Number : 6300004

**Zip:** 00960

**Location 4:**

**City:** Carolina

**Country:** Puerto Rico

**Facility:** Investigational Site Number : 6300002

**Zip:** 984

**Location 5:**

**City:** Guayama

**Country:** Puerto Rico

**Facility:** Investigational Site Number : 6300003

**Zip:** 00784

**Location 6:**

**City:** San Juan

**Country:** Puerto Rico

**Facility:** Investigational Site Number : 6300001

**Zip:** 00918

#### Overall Officials

**Official 1:**

**Affiliation:** Sanofi Pasteur, a Sanofi Company

**Name:** Clinical Sciences & Operations

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** 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

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000018186

- Term: Pneumovirus Infections

- ID: D000018184

- Term: Paramyxoviridae Infections

- ID: D000018701

- Term: Mononegavirales Infections

- ID: D000012327

- Term: RNA Virus Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20494

- Name: Respiratory Syncytial Virus Infections

- Relevance: HIGH

- As Found: Respiratory Syncytial Virus Infections

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20330

- Name: Paramyxoviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20778

- Name: Mononegavirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018357

- Term: Respiratory Syncytial Virus Infections

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
