CompletedPhase 3

Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China

China800 participantsStarted 2021-11-24

Plain-language summary

The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China

Age range0 Years – 1 Year

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
✕. Known renal impairment

Incidence of medically attended LRTI due to RT-PCR-confirmed RSV

Timeframe: Day 1 to Day 151

NCT IDNCT05110261

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-24

Who can participate

Age range0 Years – 1 Year

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
✕. Known renal impairment