Lower Respiratory Tract InfectionPhase 3CHIMESNCT05110261
Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China
A Phase 3 study testing Nirsevimab in people with Lower Respiratory Tract Infection, run by AstraZeneca at 30 sites in China.
Trial summary
The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China Read more about this study
- Who is it for?
- Ages 0 years to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Lower Respiratory Tract Infection
- What is being tested?
- Nirsevimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 30 sitesChina
- Study dates
- 24 Nov 2021to 24 Nov 2025
- Phase
- Phase 3
- 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 0 years to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Chinese preterm and term infants in their first year of life and born ≥ 29 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis or Down syndrome with no other risk factors are eligible)
- Infants who are entering their first RSV season at the time of screening
- Written informed consent and any locally required authorization obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations
- Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up visits as judged by the Investigator
- Subject is available to complete the follow up period, which will be approximately 1 year after receipt of investigational product
Who cannot join
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to investigational product administration
- Any history of LRTI or active LRTI prior to, or at the time of, randomization
- Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
- Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt during the study with the exception of: a) multivitamins and iron; b) infrequent use of over-the-counter (OTC) medications for the systemic treatment of common childhood symptoms (eg, pain relievers) that may be permitted according to the judgment of the Investigator
- Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the Investigator)
- History of receipt of blood products, or immunoglobulin products, or expected receipt through the duration of the study
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- Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
- Known renal impairment
- Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
- History of CLD/bronchopulmonary dysplasia
- Clinically significant congenital anomaly of the respiratory tract
- CHD, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect)
- Chronic seizure, or evolving or unstable neurologic disorder
- Prior history of a suspected or actual acute life-threatening event
- Known immunodeficiency, including human immunodeficiency virus (HIV)
- Mother with HIV infection (unless the child has been proven to be not infected)
- Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins, or history of allergic reaction
- Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
- Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, IV immunoglobulin) or anticipated use during the study
- Receipt of any investigational product
- Concurrent enrollment in another interventional study
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of study results
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites
Research Site
Beijing, 100191
Research Site
Changde, 415000
Research Site
Changsha, 410005
Research Site
Changsha, 410008
Research Site
Chengdu, 610000
Research Site
Chengdu, 610041
Research Site
Guangzhou, 510120
Research Site
Guangzhou, 510150
Research Site
Guangzhou, 510280
Research Site
Hangzhou, 310006
Research Site
Hangzhou, 310013
Research Site
Jiaxing, 314000
Research Site
Kunming, 650101
Research Site
Langfang, 065000
Research Site
Linfen, 041099
Research Site
Linfen, 41081
Research Site
Nanjing, 210009
Research Site
Ningbo, 315012
Research Site
Sanmenxia, 472000
Research Site
Sanya, 572000
Research Site
Shantou, 515041
Research Site
Shaoxing, 311800
Research Site
Shenzhen, 518106
Research Site
Suzhou, 215002
Research Site
Tangshan, 63003
Research Site
Tianjin, 300201
Research Site
Wenzhou, 325027
Research Site
Xinxiang, 453000
Research Site
Zhengzhou, 450018
Research Site
Zhongshan, 528400
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Nirsevimab, a Monoclonal Antibody With Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm and Term Infants in China
The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China
Read the detailed description
This is a Phase 3 randomized, double-blind, placebo-controlled, single-dose study to determine if nirsevimab will prevent medically attended RSV-confirmed LRTI in healthy preterm and term infants entering their first RSV season. The population to be enrolled is healthy preterm and term infants > 29 weeks 0 days GA entering their first RSV season, who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local or national guidelines. Approximately 800 subjects will be randomized 2:1 to receive a single IM dose of nirsevimab 50 mg (if weight < 5 kg) or 100 mg (if weight ≥ 5 kg) (N = 530) or placebo (N = 270). Randomization will be stratified by subject age at the time of randomization (≤ 3 months, > 3 to ≤ 6 months, > 6 months), and by GA (< 35 weeks GA, ≥ 35 weeks GA). Enrollment of infants > 6 months of age will be limited to approximately 100. All subjects will be followed through 1 year after dose administration. An independent data monitoring committee will review safety data regularly and make recommendations regarding further study conduct. Around 40 investigational study centres participate in the study.
- Conditions
- Lower Respiratory Tract Infection
- Being tested
- Nirsevimab, Placebo
- Keywords
- Respiratory Syncytial Viral (RSV), Efficacy, Safety, Nirsevimab, healthy Chinese preterm and term infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NirsevimabDrug
Also called MEDI8897
Drug: injection, 100 mg/mL, a single fixed IM dose of 50 mg (if weight < 5 kg) or 100 mg (if weight ≥ 5 kg)on day 1 only.
PlaceboDrug
Commercially available 0.9% (w/v) saline (sterile for human use) fixed IM dose of 0.5 mL (if weight <5 kg) or 1.0 mL (if weight >=5 kg)
| Study group | Role | What they receive |
|---|---|---|
| Nirsevimab | Experimental | Subjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo. Receives: Drug: Nirsevimab |
| Placebo | Placebo comparator | Subjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of medically attended LRTI due to RT-PCR-confirmed RSV
Incidence of all medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after dosing (ie, during a typical 5-month RSV season)
Measured: Day 1 to Day 151
Secondary outcomes (5)
Incidence of LRTI hospitalization due to RT-PCR confirmed RSV
To assess the efficacy of nirsevimab in reducing hospitalizations due to protocol-defined LRTI caused by RT-PCR-confirmed RSV, compared to placebo
Measured: Day 1 to Day 151
Incidence of medically attended LRTI (protocol defined) due to RT-PCR-confirmed RSV
To assess the efficacy of nirsevimab in reducing protocol-defined LRTI caused by RT-PCR-confirmed RSV, compared to placebo
Measured: Day 1 to Day 151
Safety and tolerability
Safety and tolerability of nirsevimab as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE) Other safety assessments will include the occurrence of Adverse Event of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs).
Measured: Day 1 to Day 361
Summary of nirsevimab serum concentrations
To evaluate serum concentrations of nirsevimab.
Measured: Day 1, Day 15, Day 151 & Day 361
Incidence of ADA to nirsevimab in serum
To evaluate ADA responses to nirsevimab in serum.
Measured: Day 1, Day 151 & Day 361
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start24 Nov 2021
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110261
- Sponsor's protocol ID
- D5290C00006
- Other IDs
- 2021-005075-38
- Acronym
- CHIMES
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Nirsevimab, a Monoclonal Antibody With Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm and Term Infants in China
- ClinicalTrials.gov ID
- NCT05110261
- Acronym / sponsor ID
- CHIMES / D5290C00006
- Conditions
- Lower Respiratory Tract Infection
- Keywords
- Respiratory Syncytial Viral (RSV), Efficacy, Safety, Nirsevimab, healthy Chinese preterm and term infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc.
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 5 Nov 2021 (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 purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China
Detailed description
This is a Phase 3 randomized, double-blind, placebo-controlled, single-dose study to determine if nirsevimab will prevent medically attended RSV-confirmed LRTI in healthy preterm and term infants entering their first RSV season. The population to be enrolled is healthy preterm and term infants > 29 weeks 0 days GA entering their first RSV season, who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local or national guidelines. Approximately 800 subjects will be randomized 2:1 to receive a single IM dose of nirsevimab 50 mg (if weight < 5 kg) or 100 mg (if weight ≥ 5 kg) (N = 530) or placebo (N = 270). Randomization will be stratified by subject age at the time of randomization (≤ 3 months, > 3 to ≤ 6 months, > 6 months), and by GA (< 35 weeks GA, ≥ 35 weeks GA). Enrollment of infants > 6 months of age will be limited to approximately 100. All subjects will be followed through 1 year after dose administration. An independent data monitoring committee will review safety data regularly and make recommendations regarding further study conduct. Around 40 investigational study centres participate in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nirsevimab | Experimental | Drug: NirsevimabSubjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo. |
Who may qualify
- Ages
- 0 years to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy Chinese preterm and term infants in their first year of life and born ≥ 29 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis or Down syndrome with no other risk factors are eligible)
- Infants who are entering their first RSV season at the time of screening
- Written informed consent and any locally required authorization obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations
- Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up visits as judged by the Investigator
- Subject is available to complete the follow up period, which will be approximately 1 year after receipt of investigational product
Key exclusion criteria (23 listed)
- Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to investigational product administration
- Any history of LRTI or active LRTI prior to, or at the time of, randomization
- Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
- Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt during the study with the exception of: a) multivitamins and iron; b) infrequent use of over-the-counter (OTC) medications for the systemic treatment of common childhood symptoms (eg, pain relievers) that may be permitted according to the judgment of the Investigator
- Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the Investigator)
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 |
|---|---|---|
| NirsevimabAlso: MEDI8897Drug: injection, 100 mg/mL, a single fixed IM dose of 50 mg (if weight < 5 kg) or 100 mg (if weight ≥ 5 kg)on day 1 only. | Drug | Nirsevimab |
| PlaceboCommercially available 0.9% (w/v) saline (sterile for human use) fixed IM dose of 0.5 mL (if weight <5 kg) or 1.0 mL (if weight >=5 kg) | Drug | Placebo |
Primary outcome
Incidence of medically attended LRTI due to RT-PCR-confirmed RSV
Time frame: Day 1 to Day 151
Incidence of all medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after dosing (ie, during a typical 5-month RSV season)
5 secondary outcomes
Incidence of LRTI hospitalization due to RT-PCR confirmed RSV
Time frame: Day 1 to Day 151
Incidence of medically attended LRTI (protocol defined) due to RT-PCR-confirmed RSV
Time frame: Day 1 to Day 151
Safety and tolerability
Time frame: Day 1 to Day 361
Summary of nirsevimab serum concentrations
Time frame: Day 1, Day 15, Day 151 & Day 361
Incidence of ADA to nirsevimab in serum
Time frame: Day 1, Day 151 & Day 361
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 15 Oct 2026.
- CSR Synopsis RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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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.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nirsevimab in people with Lower Respiratory Tract Infection, run by AstraZeneca at 30 sites in China.
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 23 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of medically attended LRTI due to RT-PCR-confirmed RSV (time frame: Day 1 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 15 Oct 2026.