Trial Outcomes & Findings for Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis (NCT NCT02282982)

NCT ID: NCT02282982

Last Updated: 2016-07-29

Results Overview

Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.

• Recruitment status: COMPLETED
• Target enrollment: 359 participants
• Primary outcome timeframe: Approximately 7 months
• Results posted on: 2016-07-29

Participant Flow

Participant milestones

Measure	Infants at High-risk of Serious RSV Illness Infants who received immunoprophylaxis during the RSV season
Overall Study STARTED	359
Overall Study Attended Visit 1	359
Overall Study Attended Visit 2	341
Overall Study Attended Visit 3	298
Overall Study Attended Visit 4	194
Overall Study Attended Visit 5	83
Overall Study Attended Follow-up Visit	349
Overall Study COMPLETED	153
Overall Study NOT COMPLETED	206

Reasons for withdrawal

Measure	Infants at High-risk of Serious RSV Illness Infants who received immunoprophylaxis during the RSV season
Overall Study Lost to Follow-up	15
Overall Study Withdrew consent	2
Overall Study Death	4
Overall Study Lack of product	156
Overall Study Palivizumab is ended	11
Overall Study Other, not specified	18

Baseline Characteristics

Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis

Baseline characteristics by cohort

Measure	Infants at High-risk of Serious RSV Illness n=359 Participants Infants who received immunoprophylaxis during the RSV season
Age, Continuous	3.4 months STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	179 Participants n=5 Participants
Sex: Female, Male Male	180 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 7 months

Population: Infants who received immunoprophylaxis during the RSV season

Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=359 Participants Infants who received immunoprophylaxis during the RSV season
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test	1 participants

PRIMARY outcome

Timeframe: Approximately 7 months

Population: Infants who received immunoprophylaxis during the RSV season

Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=359 Participants Infants who received immunoprophylaxis during the RSV season
Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection	0 participants

SECONDARY outcome

Timeframe: Approximately 7 months

Population: Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=1 Participants Infants who received immunoprophylaxis during the RSV season
Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test	46 days Only 1 participant was analyzed for this outcome.

SECONDARY outcome

Timeframe: Approximately 7 months

Population: Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

The number of hospitalized participants admitted to the Intensive Care Unit was documented.

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=1 Participants Infants who received immunoprophylaxis during the RSV season
Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants	1 participants

SECONDARY outcome

Timeframe: Approximately 7 months

Population: Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=1 Participants Infants who received immunoprophylaxis during the RSV season
Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)	35 days Only 1 participant was analyzed for this outcome.

SECONDARY outcome

Timeframe: Approximately 7 months

Population: Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

The proportion of participants who received supplemental oxygen while hospitalized was documented.

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=1 Participants Infants who received immunoprophylaxis during the RSV season
Proportion of Participants Who Received Supplemental Oxygen While Hospitalized	1 participants

SECONDARY outcome

Timeframe: Approximately 7 months

Population: Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

The proportion of participants who received mechanical ventilation while hospitalized was documented.

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=1 Participants Infants who received immunoprophylaxis during the RSV season
Proportion of Participants Who Received Mechanical Ventilation While Hospitalized	0 participants

SECONDARY outcome

Timeframe: Approximately 7 months

Population: Infants who received immunoprophylaxis during the RSV season

The proportion of participants with missed or delayed doses of palivizumab was documented.

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=359 Participants Infants who received immunoprophylaxis during the RSV season
Proportion of Participants With Missed Doses of Palivizumab 1 missed or delayed injection	61 participants
Proportion of Participants With Missed Doses of Palivizumab 2 or more missed or delayed injections	20 participants

SECONDARY outcome

Timeframe: Approximately 7 months

Population: Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=1 Participants Infants who received immunoprophylaxis during the RSV season
Proportion of Participants With Co-morbidities During Hospitalizations	1 participants

SECONDARY outcome

Timeframe: Approximately 7 months

Population: Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

The median duration of mechanical ventilation administration during hospitalizations was calculated.

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=1 Participants Infants who received immunoprophylaxis during the RSV season
Median Duration of Mechanical Ventilation Administration During Hospitalizations	0 days Only 1 participant was analyzed for this outcome.

SECONDARY outcome

Timeframe: Approximately 7 months

Population: Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test

The median duration of mechanical oxygen administration during hospitalizations was calculated.

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=1 Participants Infants who received immunoprophylaxis during the RSV season
Median Duration of Oxygen Administration During Hospitalizations	30 days Only 1 participant was analyzed for this outcome.

SECONDARY outcome

Timeframe: Approximately 7 months

Population: Infants who received immunoprophylaxis during the RSV season

The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).

Outcome measures

Measure	Infants at High-risk of Serious RSV Illness n=359 Participants Infants who received immunoprophylaxis during the RSV season
Proportion of Participants With a Particular Co-morbidity History of bronchopulmonary dysplasia	148 participants
Proportion of Participants With a Particular Co-morbidity History of congenital heart disease	45 participants

Adverse Events

Infants at High-risk of Serious RSV Illness

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Infants at High-risk of Serious RSV Illness n=359 participants at risk Infants who received immunoprophylaxis during the RSV season
Infections and infestations Respiratory tract infection viral	1.7% 6/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Bronchitis	1.4% 5/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Pneumonia	1.4% 5/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Bronchopneumonia	0.56% 2/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Otitis media acute	0.56% 2/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Pyelonephritis acute	0.56% 2/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Bacteraemia	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Conjunctivitis	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Infection	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Meningitis	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Osteomyelitis	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Infections and infestations Viral infection	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Gastrointestinal disorders Ascites	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Gastrointestinal disorders Enterocolitis	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Gastrointestinal disorders Intestinal obstruction	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Gastrointestinal disorders Pancreatitis necrotising	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Nervous system disorders Brain oedema	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Nervous system disorders Hydrocephalus	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Nervous system disorders Lethargy	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Nervous system disorders Periventricular leukomalacia	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary dysplasia	0.56% 2/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Blood and lymphatic system disorders Anaemia	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Blood and lymphatic system disorders Haemorrhagic disorder	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Cardiac disorders Myocarditis	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Cardiac disorders Pericardial effusion	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Hepatobiliary disorders Hepatitis	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Metabolism and nutrition disorders Decreased appetite	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.
Musculoskeletal and connective tissue disorders Connective tissue disorder	0.28% 1/359 • Treatment-emergent adverse events were collected from the time of the first dose of palivizumab until the last dose, up to 17 weeks. Serious adverse events were collected from the time of informed consent until 30 days following the last dose of palivizumab, up to 21 weeks.

Other adverse events

Adverse event data not reported

Additional Information

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