Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00384462

Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants

Respiratory Syncytial Virus Infections Clinical Trial

Official title:
A Prospective, Non-Interventional Study to Evaluate the Incidence of Hospitalizations and Medically-Attended Lower Respiratory Tract Infection (MALRI) in Premature Infants 32 to 35 Weeks Gestational Age Who Are Not Recommended to Receive Prophylaxis for RSV

Clinical Trial Summary

The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections (MALRI) in 32-35 week gestational age (GA) premature infants who are less than 6 months of age and do not receive treatment.

Clinical Trial Description

The goals of this study are:

- To estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants who are:

- 32-35 weeks GA

- less than 6 months of age at the start of the RSV season

- not receiving palivizumab prophylaxis and not recommended to receive palivizumab according to the AAP guidelines

- To estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations and time periods (e.g., Cohort 2, Cohorts 1 and 2 combined, and subgroups based on chronological age at the start of the RSV season, GA, etc. within 150 days from enrollment and other time periods based on RSV activity, etc.)

- To estimate the incidence of RSV-associated MALRI in the study populations

- To characterize the incidence and type of clinical interventions for MALRI in the study populations ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00384462
Study type Observational
Source MedImmune LLC
Contact
Status Completed
Phase N/A
Start date October 2006
Completion date January 2008
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03698084 - RESCEU: Defining the Burden of RSV Disease
Completed NCT04090658 - A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults Phase 1
Completed NCT04231968 - A Study of AK0529 in Chinese Infants Hospitalized With RSV Phase 3
Completed NCT03227029 - Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age Phase 1
Withdrawn NCT02864628 - RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults. Phase 1
Completed NCT02873286 - RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults Phase 2
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Terminated NCT02948127 - Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants and Children 6 to 24 Months of Age Phase 1
Completed NCT02237209 - Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1
Completed NCT02040831 - Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1
Completed NCT02247726 - RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women. Phase 2
Completed NCT01915394 - Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial) N/A
Completed NCT01355016 - A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers Phase 1
Completed NCT00232635 - A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT Phase 2
Completed NCT01155193 - Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
Not yet recruiting NCT06083623 - A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Phase 2/Phase 3
Terminated NCT02890381 - Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants 6 to 24 Months of Age Phase 1
Active, not recruiting NCT03422237 - Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 6 to 24 Months of Age Phase 1
Completed NCT03674177 - A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women Phase 1
Completed NCT01968083 - Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1