Respiratory Syncytial Virus (RSV)SynagisNCT06851806
Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
A study testing Palivizumab 15 mg/kg in people with Respiratory Syncytial Virus (RSV), run by AstraZeneca at 9 sites in India.
Trial summary
This is a Phase IV, prospective, open-label, multicentre study to evaluate the safety of palivizumab IM injection for the prevention of severe LRTD in Indian infants and children who are at high-risk of RSV disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- Palivizumab 15 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 9 sitesIndia
- Study dates
- 10 Dec 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants at risk of severe RSV disease defined as fulfilling at least one of the following:
- Infants born ≤ 35 wGA and are < 6 months of age at enrolment.
- Children < 24 months of age at enrolment and requiring treatment for BPD within the last 6 months.
- Children < 24 months of age and with haemodynamically significant CHD.
- Written informed consent obtained from the participant's parent(s)/legal guardian and the participant's parent(s)/legal guardian is able to understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Hospitalisation at the time of enrolment, unless the discharge is expected within 30 days of the time of enrolment
- Required mechanical ventilation (including continuous positive airway pressure) or other mechanical respiratory or cardiac support at the time of enrolment.
- Anticipated cardiac surgery within 2 weeks after enrolment.
- Anticipated survival of < 6 months after enrolment in the trial.
- Active LRTD, including RSV infection at the time of enrolment and/or study intervention administration.
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- Any fever (≥ 38.0°C) or acute illness within 7 days prior to investigational product administration.
- Known history of evolving or unstable neurologic disorder.
- Known history of unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated.
- Known allergy, including to immunoglobulin products, or history of allergic reaction.
- Receipt of palivizumab or other RSV monoclonal antibodies or any RSV vaccine, including maternal RSV vaccination.
- Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study.
- Concurrent enrolment in another interventional study.
- Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- Judgment by the investigator that the participant should not participate in the study if the participant or the participant's parent/legal guardian is unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
Research Site
Hyderabad, 500084
Research Site
Jhānsi, 284128
Research Site
Kanpur, 208011
Research Site
Kolkata, 700073
Research Site
Mysore, 570001
Research Site
Nagpur, 440012
Research Site
Nagpur, 441108
Research Site
Pune, 411006
Research Site
Vidyanagar, Hubballi, 580022
About this study
Official title: A Multicentre, Interventional, Phase IV, Open-label, Study to Evaluate the Safety of Palivizumab in Children Less Than 24 Months of Age With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
This is a Phase IV, prospective, open-label, multicentre study to evaluate the safety of palivizumab IM injection for the prevention of severe LRTD in Indian infants and children who are at high-risk of RSV disease. All enrolled participants will receive palivizumab 15 mg/kg IM injection once a month for up to 5 injections during the study. Children who undergo cardiac surgery with cardiopulmonary bypass during the study should receive an additional dose of study intervention immediately after surgery, when medically stable for IM injection as determined by the physician. Prior to each study intervention administration, all participants will undergo safety assessments. A follow-up visit will be performed telephonically with the parent(s) or legal guardian(s) of all participants 30 days after their last injection of palivizumab.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- Palivizumab 15 mg/kg
- Keywords
- Phase IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palivizumab 15 mg/kgDrug
Single-dose liquid solution vials, 50 mg/0.5 mL, IM injection
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | All the eligible participants will receive palivizumab 15 mg/kg on Days 1, 31, 61, 91, and 121. Receives: Drug: Palivizumab 15 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of palivizumab prophylaxis when administered to preterm infants (≤ 35 wGA), children with BPD (< 24 months) and/or children with haemodynamically significant CHD (< 24 months).
- To determine percentage of participants with AEs and SAEs. 2) To assess nature, incidence, and severity of all AEs including unexpected adverse drug reactions 2)To determine percentage of participants with AEs that lead to study intervention discontinuation.
Measured: screening to day 151
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start10 Dec 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851806
- Sponsor's protocol ID
- D4800L00014
- Other IDs
- 2025-000041-13, 2025
- Acronym
- Synagis
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Interventional, Phase IV, Open-label, Study to Evaluate the Safety of Palivizumab in Children Less Than 24 Months of Age With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
- ClinicalTrials.gov ID
- NCT06851806
- Acronym / sponsor ID
- Synagis / D4800L00014
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- Phase IV
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 28 Feb 2025 (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.
This is a Phase IV, prospective, open-label, multicentre study to evaluate the safety of palivizumab IM injection for the prevention of severe LRTD in Indian infants and children who are at high-risk of RSV disease. All enrolled participants will receive palivizumab 15 mg/kg IM injection once a month for up to 5 injections during the study. Children who undergo cardiac surgery with cardiopulmonary bypass during the study should receive an additional dose of study intervention immediately after surgery, when medically stable for IM injection as determined by the physician. Prior to each study intervention administration, all participants will undergo safety assessments. A follow-up visit will be performed telephonically with the parent(s) or legal guardian(s) of all participants 30 days after their last injection of palivizumab.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Drug: Palivizumab 15 mg/kgAll the eligible participants will receive palivizumab 15 mg/kg on Days 1, 31, 61, 91, and 121. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Participants at risk of severe RSV disease defined as fulfilling at least one of the following:
- Written informed consent obtained from the participant's parent(s)/legal guardian and the participant's parent(s)/legal guardian is able to understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator.
Key exclusion criteria (15 listed)
- Hospitalisation at the time of enrolment, unless the discharge is expected within 30 days of the time of enrolment
- Required mechanical ventilation (including continuous positive airway pressure) or other mechanical respiratory or cardiac support at the time of enrolment.
- Anticipated cardiac surgery within 2 weeks after enrolment.
- Anticipated survival of < 6 months after enrolment in the trial.
- Active LRTD, including RSV infection at the time of enrolment and/or study intervention administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palivizumab 15 mg/kgSingle-dose liquid solution vials, 50 mg/0.5 mL, IM injection | Drug | Study Arm |
Primary outcome
To assess the safety of palivizumab prophylaxis when administered to preterm infants (≤ 35 wGA), children with BPD (< 24 months) and/or children with haemodynamically significant CHD (< 24 months).
Time frame: screening to day 151
1) To determine percentage of participants with AEs and SAEs. 2) To assess nature, incidence, and severity of all AEs including unexpected adverse drug reactions 2)To determine percentage of participants with AEs that lead to study intervention discontinuation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palivizumab 15 mg/kg in people with Respiratory Syncytial Virus (RSV), run by AstraZeneca at 9 sites in India.
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 5 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. 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?
This study is still under way. Results are not available in the source record yet.
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?
To assess the safety of palivizumab prophylaxis when administered to preterm infants (≤ 35 wGA), children with BPD (< 24 months) and/or children with haemodynamically significant CHD (< 24 months). (time frame: screening to day 151). 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 9 Sep 2026.