Respiratory Syncytial Virus InfectionsNCT05964582
Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers
An observational study of Respiratory Syncytial Virus Infections, run by Sanofi Pasteur, a Sanofi Company at 15 sites in 7 countries.
Trial summary
The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months. Read more about this study
- Who is it for?
- Ages 6 to 21 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- Type of treatment
- Vaccines
- How many people
- 344 participants
- Where
- 15 sitesin 7 countries
- Study dates
- 11 Jul 2023to 2 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy volunteers
Who may be able to join
- Aged 6 months to < 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month 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 are enrolled in the study
Who cannot join
- 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)
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved
- Member of a household that contains an immunocompromised individual, including, but not limited to:
- a person who is human immunodeficiency virus (HIV) infected
- a person who has received chemotherapy within the 12 months prior to study enrollment
Show all 16Show fewer
- 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
- Participant's mother previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding
- Receipt or planned receipt of any of the following vaccines:
- Any intranasal live attenuated vaccine within the 28 days prior to enrollment
- Any injectable live attenuated vaccine within the 28 days prior to and after enrollment
- Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin or RSV monoclonal antibody) less than 6 months before enrollment
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
Finland4 sites
Investigational Site Number : 2460002
Helsinki, 00100
Investigational Site Number : 2460001
Jarvenpaa, 04400
Investigational Site Number : 2460004
Kokkola, 67100
Investigational Site Number : 2460003
Tampere, 33100
United States2 sites
Senders Pediatrics Site Number : 8400002
Cleveland, Ohio, 44121-4243
Quality Clinical Research - 10040 Regency Cir - HyperCore - PPDS Site Number : 8400001
Omaha, Nebraska, 68114-3755
Ghana2 sites
Investigational Site Number : 2880002
Kintampo, 200
Investigational Site Number : 2880001
Navrongo, 114
Honduras2 sites
Investigational Site Number : 3400002
San Pedro Sula, 21104
Investigational Site Number : 3400001
Tegucigalpa, 11101
India2 sites
Investigational Site Number : 3560001
Mysuru, 570004
Investigational Site Number : 3560002
Pune, 412216
Thailand2 sites
Investigational Site Number : 7640001
Ratchathewi, 10400
Investigational Site Number : 7640002
Songkhla, 90110
About this study
Official title: A Multi-center, Multi-national, Prospective Surveillance Study of Respiratory Syncytial Virus Disease in Infants and Toddlers 6 to < 22 Months of Age
The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months. The 6-month follow-up will occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on enrollment timing and as per feasibility). A maximum of 1000 children from 6 to < 22 months of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting approximately 100 participants per country. The purpose of the study is to assess the seroprevalence and incidence of RSV disease during the study period in the targeted countries and sites for a Phase III vaccine study.
Read the detailed description
The duration of the study will be 6 months for each participant.
- Conditions
- Respiratory Syncytial Virus Infections
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children aged 6 months to < 22 months | No vaccine will be administered. All enrolled participants will have a blood sample collected at enrollment (visit 01) and a nasal swab collected each time they have an RSV-like illness visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSV A serum neutralizing antibody (Nab) titers
To assess RSV A serum Nab titers overall
Measured: At Day 1
RSV A serum neutralizing antibody (Nab) titers
To assess RSV A serum Nab titers by country
Measured: At Day 1
RSV B serum Nab titers
To assess RSV B serum Nab titers overall
Measured: At Day 1
RSV B serum Nab titers
To assess RSV B serum Nab titers overall by country
Measured: At Day 1
Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers
To assess Anti-F IgA and IgG ELISA titers overall
Measured: At Day 1
Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers
To assess Anti-F IgA and IgG ELISA titers by country
Measured: At Day 1
Baseline serostatus
To assess baseline serostatus overall
Measured: At Day 1
Baseline serostatus
To assess baseline serostatus by country
Measured: At Day 1
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of ARD confirmed by RT PCR overall
Measured: Throughout study, approximately 6 months
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of ARD confirmed by RT PCR by country
Measured: Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of LRTD confirmed by RT PCR overall
Measured: Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of LRTD confirmed by RT PCR by country
Measured: Throughout study, approximately 6 months
Secondary outcomes (21)
RSV A serum Nab titers
To assess RSV A serum Nab titers for each age group overall
Measured: At Day 1
RSV A serum Nab titers
To assess RSV A serum Nab titers for each age group by country
Measured: At Day 1
RSV B serum Nab antibody titers
To assess RSV B serum Nab titers for each age group overall
Measured: At Day 1
RSV B serum Nab antibody titers
To assess RSV B serum Nab titers for each age group by country
Measured: At Day 1
Anti-F IgA and IgG ELISA titers
To assess Anti-F IgA and IgG ELISA titers for each age group overall
Measured: At Day 1
Anti-F IgA and IgG ELISA titers
To assess Anti-F IgA and IgG ELISA titers for each age group by country
Measured: At Day 1
Baseline serostatus by age group
To assess baseline serostatus for each age group overall
Measured: At Day 1
Baseline serostatus by age group
To assess baseline serostatus for each age group by country
Measured: At Day 1
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of ARD confirmed by RT PCR for each age group overall
Measured: Throughout study, approximately 6 months
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of ARD confirmed by RT PCR for each age group by country
Measured: Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of LRTD confirmed by RT PCR for each age group overall
Measured: Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of LRTD confirmed by RT PCR for each age group by country
Measured: Throughout study, approximately 6 months
Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study
To assess to incidence of ARD confirmed by RT PCR for each strain overall
Measured: Throughout study, approximately 6 months
Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study
To assess to incidence of ARD confirmed by RT PCR for each strain by country
Measured: Throughout study, approximately 6 months
Occurrence of severe LRTD associated with any RT PCR confirmed RSV strain during the study
To assess the severity of LRTD confirmed by any RT PCR for each strain
Measured: Throughout study, approximately 6 months
Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study
To assess to incidence of LRTD confirmed by RT PCR for each strain overall
Measured: Throughout study, approximately 6 months
Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study
To assess to incidence of LRTD confirmed by RT PCR for each strain by country
Measured: Throughout study, approximately 6 months
Occurrence of clinically diagnosed RSV ARD according to routine practice (with or without RT-PCR RSV confirmation) during the study
Measured: Throughout study, approximately 6 months
Occurrence of clinically diagnosed RSV LRTD according to routine practice (with or without RT-PCR RSV confirmation) during the study
Measured: Throughout study, approximately 6 months
Occurrence of AOM episodes during the study
Measured: Throughout study, approximately 6 months
Occurrence of ARD and LRTD associated with any RT PCR confirmed RSV strain during the study, RSV A and RSV B serum neutralizing antibody titers, anti-F IgA and IgG ELISA antibody titers
To assess the association between RT-PCR confirmed RSV ARD and LRTD and RSV A, B, anti-G IgA an IgG ELISA antibodies at baseline
Measured: At Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start11 Jul 2023
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964582
- Sponsor's protocol ID
- VAD00019
- Other IDs
- U1111-1281-0204
- Status last verified
- Sep 2024
- First submitted
- 7 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Multi-national, Prospective Surveillance Study of Respiratory Syncytial Virus Disease in Infants and Toddlers 6 to < 22 Months of Age
- ClinicalTrials.gov ID
- NCT05964582
- Acronym / sponsor ID
- VAD00019
- Conditions
- Respiratory Syncytial Virus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months. The 6-month follow-up will occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on enrollment timing and as per feasibility). A maximum of 1000 children from 6 to < 22 months of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting approximately 100 participants per country. The purpose of the study is to assess the seroprevalence and incidence of RSV disease during the study period in the targeted countries and sites for a Phase III vaccine study.
Detailed description
The duration of the study will be 6 months for each participant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy children aged 6 months to < 22 months | – | –No vaccine will be administered. All enrolled participants will have a blood sample collected at enrollment (visit 01) and a nasal swab collected each time they have an RSV-like illness visit |
Who may qualify
- Ages
- 6 to 21 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Aged 6 months to < 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month 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 are enrolled in the study
Key exclusion criteria (16 listed)
- 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)
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved
- Member of a household that contains an immunocompromised individual, including, but not limited to:
- Participant's mother previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RSV A serum neutralizing antibody (Nab) titers
Time frame: At Day 1
To assess RSV A serum Nab titers overall
RSV A serum neutralizing antibody (Nab) titers
Time frame: At Day 1
To assess RSV A serum Nab titers by country
RSV B serum Nab titers
Time frame: At Day 1
To assess RSV B serum Nab titers overall
RSV B serum Nab titers
Time frame: At Day 1
To assess RSV B serum Nab titers overall by country
Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers
Time frame: At Day 1
To assess Anti-F IgA and IgG ELISA titers overall
Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers
Time frame: At Day 1
To assess Anti-F IgA and IgG ELISA titers by country
Baseline serostatus
Time frame: At Day 1
To assess baseline serostatus overall
Baseline serostatus
Time frame: At Day 1
To assess baseline serostatus by country
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
Time frame: Throughout study, approximately 6 months
To assess to incidence of ARD confirmed by RT PCR overall
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
Time frame: Throughout study, approximately 6 months
To assess to incidence of ARD confirmed by RT PCR by country
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
Time frame: Throughout study, approximately 6 months
To assess to incidence of LRTD confirmed by RT PCR overall
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
Time frame: Throughout study, approximately 6 months
To assess to incidence of LRTD confirmed by RT PCR by country
21 secondary outcomes
RSV A serum Nab titers
Time frame: At Day 1
RSV A serum Nab titers
Time frame: At Day 1
RSV B serum Nab antibody titers
Time frame: At Day 1
RSV B serum Nab antibody titers
Time frame: At Day 1
Anti-F IgA and IgG ELISA titers
Time frame: At Day 1
Anti-F IgA and IgG ELISA titers
Time frame: At Day 1
Baseline serostatus by age group
Time frame: At Day 1
Baseline serostatus by age group
Time frame: At Day 1
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
Time frame: Throughout study, approximately 6 months
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
Time frame: Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
Time frame: Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
Time frame: Throughout study, approximately 6 months
Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study
Time frame: Throughout study, approximately 6 months
Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study
Time frame: Throughout study, approximately 6 months
Occurrence of severe LRTD associated with any RT PCR confirmed RSV strain during the study
Time frame: Throughout study, approximately 6 months
Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study
Time frame: Throughout study, approximately 6 months
Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study
Time frame: Throughout study, approximately 6 months
Occurrence of clinically diagnosed RSV ARD according to routine practice (with or without RT-PCR RSV confirmation) during the study
Time frame: Throughout study, approximately 6 months
Occurrence of clinically diagnosed RSV LRTD according to routine practice (with or without RT-PCR RSV confirmation) during the study
Time frame: Throughout study, approximately 6 months
Occurrence of AOM episodes during the study
Time frame: Throughout study, approximately 6 months
Occurrence of ARD and LRTD associated with any RT PCR confirmed RSV strain during the study, RSV A and RSV B serum neutralizing antibody titers, anti-F IgA and IgG ELISA antibody titers
Time frame: At Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections, run by Sanofi Pasteur, a Sanofi Company at 15 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Finland, United States, Ghana, Honduras, India and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RSV A serum neutralizing antibody (Nab) titers (time frame: At Day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.