An observational study in Respiratory Syncytial Virus Infection, sponsored by AbbVie. Completed. Open to participants aged Up to 24 Months. Per ClinicalTrials.gov, last updated 2017-03-20.
Sponsored by AbbVie · Observational
This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014 and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and effectiveness of palivizumab for the prevention of serious lower respiratory tract infection caused by RSV in participants 24 months of age and under, who have an immunocompromised medical condition (e.g., combined immunodeficiency disease, antibody deficiency, or other types of immunodeficiency; HIV infection; recovering from organ or bone marrow transplantation; on chemotherapy; on high-dose corticosteroid therapy; on immunosuppressants) or who have Down syndrome.
Palivizumab was prescribed according to the local label and independently of the decision to enroll participants in the study. Palivizumab was administered monthly throughout the Respiratory Syncytial Virus (RSV) infection seasons via intramuscular injection at a dose of 15 mg/kg of body weight. Survey forms were collected after the observation period. The number of adverse events and the frequency of hospitalizations due to RSV infections in surveyed participants were assessed to evaluate the safety and effectiveness of palivizumab.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 312 is above the median of 240 across 2,136 observational studies indexed under Infections.
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Single-arm, Multi-center, Prospective Cohort
Newborns, infants, or young children 24 months of age and under who have an immunocompromised medical condition:
Exclusion criteria:
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Number of Participants With Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF).
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Number of Participants With Serious Adverse Events
A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF).
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Number of Participants With Adverse Drug Reactions
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: "Related", "Causality cannot be ruled out", or "Not assessable" as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: "Death", "Life-threatening condition", "Hospitalization or prolonged hospitalization", "Persistent or significant disability", or "Other medically important condition". Information about AEs and ADRs was documented on the case report form (CRF).
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection \[URI\]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF).
Time frame: From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks
Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection
Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF).
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection
The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Number of Hospitalized Participants Requiring Respiratory Support
The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF).
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Mean Duration of Respiratory Support
The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF).
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
| Milestone | Immunocompromised Children |
|---|---|
| Started | 312 |
| Treated | 312 |
| Safety analysis set (sas) | 304 |
| Completed | 288 |
| Not completed | 24 |
| Withdrew: Excluded from sas: enrollment violation | 2 |
| Withdrew: Excluded from sas: duplication | 2 |
| Withdrew: Excluded from sas: early treatment | 2 |
| Withdrew: Excluded from sas: ineligible for study | 2 |
| Withdrew: Did not meet inclusion criteria | 13 |
| Withdrew: Hospitalized for rsv at study start | 3 |
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF).
| Participants | Immunocompromised Children |
|---|---|
| Number of Participants With Adverse Events | 99 |
A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF).
| Participants | Immunocompromised Children |
|---|---|
| Number of Participants With Serious Adverse Events | 53 |
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: "Related", "Causality cannot be ruled out", or "Not assessable" as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: "Death", "Life-threatening condition", "Hospitalization or prolonged hospitalization", "Persistent or significant disability", or "Other medically important condition". Information about AEs and ADRs was documented on the case report form (CRF).
| Participants | Immunocompromised Children |
|---|---|
| Number of Participants With Adverse Drug Reactions | 25 |
The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection \[URI\]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF).
| units on a scale | Immunocompromised Children |
|---|---|
| 1 dose | 0.1 ± 0.6 |
| 2 doses | 0.1 ± 0.6 |
| 3 doses | 0.1 ± 0.6 |
| 4 doses | 0.1 ± 0.6 |
| 5 doses | 0.1 ± 0.4 |
| 6 doses | 0.1 ± 0.3 |
| 7 doses | 0.0 ± 0.2 |
| 8 doses | 0.1 ± 0.3 |
| 9 doses | 0.0 ± 0.0 |
Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF).
| Participants | Immunocompromised Children |
|---|---|
| Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection | 2 |
The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).
| days | Immunocompromised Children |
|---|---|
| Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection | 9.5 ± 2.1 |
The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF).
| Participants | Immunocompromised Children |
|---|---|
| Number of Hospitalized Participants Requiring Respiratory Support | 1 |
The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF).
| days | Immunocompromised Children |
|---|---|
| Mean Duration of Respiratory Support | 40.0 ± 62.4 |
Collected over All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immunocompromised Children | — | 53/304 (17.4%) | 67/304 (22%) |
| Event | Immunocompromised Children |
|---|---|
| PneumoniaInfections and infestations | 6/304 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 4/304 |
| BacteraemiaInfections and infestations | 3/304 |
| BronchitisInfections and infestations | 3/304 |
| GastroenteritisInfections and infestations | 3/304 |
| Bone marrow failureBlood and lymphatic system disorders | 3/304 |
| InfluenzaInfections and infestations | 2/304 |
| Lower respiratory tract infectionInfections and infestations | 2/304 |
| Pneumonia bacterialInfections and infestations | 2/304 |
| Respiratory syncytial virus infectionInfections and infestations | 2/304 |
| Event | Immunocompromised Children |
|---|---|
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 22/304 |
| Febrile neutropeniaBlood and lymphatic system disorders | 9/304 |
| DiarrhoeaGastrointestinal disorders | 6/304 |
| PyrexiaGeneral disorders | 4/304 |
| BronchitisInfections and infestations | 3/304 |
| ConjunctivitisInfections and infestations | 3/304 |
| Exanthema subitumInfections and infestations | 3/304 |
| GastroenteritisInfections and infestations | 3/304 |
| InfluenzaInfections and infestations | 3/304 |
| Catheter site infectionInfections and infestations | 3/304 |
Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.
| Age, Continuous(months) | Immunocompromised Children |
|---|---|
| Mean | 11.9 ± 7.5 |
| Sex: Female, Male(Participants) | Immunocompromised Children |
|---|---|
| Female | 117 |
| Male | 187 |
| Race/Ethnicity, Customized(Participants) | Immunocompromised Children |
|---|---|
| Japanese | 297 |
| Black | 0 |
| White | 0 |
| Asian | 3 |
| Others | 4 |
| Age at the start of treatment(Participants) | Immunocompromised Children |
|---|---|
| ≤ 1 month | 31 |
| > 1 and ≤ 3 months | 24 |
| > 3 and ≤ 6 months | 31 |
| > 6 and ≤ 12 months | 81 |
| > 12 and ≤ 24 months | 137 |
| > 24 months | 0 |
| Body weight at the start of treatment(Participants) | Immunocompromised Children |
|---|---|
| < 1000 grams | 0 |
| ≥ 1000 and < 1500 grams | 0 |
| ≥ 1500 and < 2500 grams | 1 |
| ≥ 2500 and < 5000 grams | 52 |
| ≥ 5000 and < 10000 grams | 202 |
| ≥ 10000 and < 15000 grams | 45 |
| ≥ 15000 grams | 1 |
| Not specified | 3 |
| Gestational age(Participants) | Immunocompromised Children |
|---|---|
| < 22 weeks | 0 |
| ≥ 22 and < 37 weeks | 56 |
| ≥ 37 and < 42 weeks | 237 |
| ≥ 42 weeks | 1 |
| Not specified | 10 |
| Body weight at birth(Participants) | Immunocompromised Children |
|---|---|
| < 1000 grams | 0 |
| ≥ 1000 and ≤ 1500 grams | 4 |
| ≥ 1500 and ≤ 2500 grams | 80 |
| ≥ 2500 and ≤ 4000 grams | 207 |
| ≥ 4000 grams | 2 |
| Not specified | 11 |
| Number of smokers in the household(Participants) | Immunocompromised Children |
|---|---|
| 0 smokers | 184 |
| ≥ 1 smokers | 40 |
| Not specified | 80 |
4 further baseline measures are reported on the registry.
No study locations are listed for this record.
Plan to share: No
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