A Prospective, Epidemiological Study to Assess the Disease Burden of Respiratory Syncytial Virus Associated, Suspected Lower Respiratory Tract Infections in Newborns, From 0 to 2 Years of Age and Risk of Development of Wheeze and Asthma From 0 to 6 Years of Age

Completed · Not applicable

Conditions studied: Respiratory Syncytial Virus

In brief

The purpose of this study is to assess the incidence and associated healthcare utilization of RSV-associated, suspected LRTI in a general population of infants from birth up to 2 years of age, and also to assess the accuracy of a newly developed LRTI case definition and severity scale compared to two existing definitions. The study will also assess the population attributable risk percent of RSV LRTI on the development of wheeze and asthma from 0 to 6 years of age.

Key facts

Study ID

NCT01995175

Run by

GlaxoSmithKline

People needed

2409

Starts

2013-12-12

Expected to finish

2021-11-03

Last updated by the study team

2022-11-29

Who can join

Age: any, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Before birth:
• Subject whose parent(s)/Legally Acceptable Representative(s) (LARs), in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent (including consent to obtain a cord blood sample at birth) obtained from the parent(s)/LAR(s) of the subject.
• After Birth:
• Subject for whom updated and re-signed informed consent and confirmation of eligibility is available not later than 5 working days after birth.
• Cord blood sample collection of at least 3 mL, at birth.
• For extension period:
• Subject is enrolled at a study site that is participating in the extension period follow-up.
• Subject whose parent(s)/LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent (or witnessed thumb printed consent in case of an illiterate subject) obtained from the parent(s)/LAR(s) of the subject.
• Previous participation in the primary study (from birth up to the age of 2 years).

You may not qualify if…

• Before birth:
• Subject expected to become Child in care
• Subjects whose parent(s)/LAR(s) are below the age of 18 or the legal consenting age of the respective country if this is higher.
• After Birth:
• Child in care
• Newborn with a gestational age of less than 28 weeks.
• Subjects with any congenital condition that will require an expected postnatal stay in hospital of more than 12 consecutive weeks.
• Subjects with major congenital defects or serious chronic illness limiting life expectancy to less than 5 years.
• Subjects with any confirmed or suspected immunosuppressive or immunodeficient condition (including positive infection with human immunodeficiency virus [HIV]), based on medical history, physical examination or positive test result.
• For extension period:
• Child in care.

Where it is running

• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — Santa Clara, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Syracuse, New York, United States
• GSK Investigational Site — Roy, Utah, United States
• GSK Investigational Site — Syracuse, Utah, United States
• GSK Investigational Site — Seattle, Washington, United States
• GSK Investigational Site — Ciudad de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — Río Cuarto, Argentina
• GSK Investigational Site — Dhaka, Bangladesh
• GSK Investigational Site — Halifax, Nova Scotia, Canada
• GSK Investigational Site — Kokkola, Finland
• GSK Investigational Site — Oulu, Finland
• GSK Investigational Site — Pori, Finland
• GSK Investigational Site — Seinäjoki, Finland
• GSK Investigational Site — San Pedro Sula, Honduras
• GSK Investigational Site — San Pedro Sula, Honduras
• GSK Investigational Site — Soweto, Gauteng, South Africa
• GSK Investigational Site — Bangkok, Thailand
• GSK Investigational Site — Khon Kaen, Thailand
• GSK Investigational Site — Pathum Thani, Thailand

Full record on ClinicalTrials.gov

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