Last updated: 11/02/2022 12:14:25
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A prospective, epidemiological study to assess the disease burden of RSV associated, suspected LRTIs from 0 to 2 years and population attributable risk percent of RSV LRTI on the development of recurrent wheeze and asthma from 0 to 6 years
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Incidence rates of first episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI) [Period 1]
Timeframe: From birth up to 2 years of age
Number of subjects hospitalized for RSV [Period 1]
Timeframe: From birth up to 2 years of age
Incidence rates of RSV Lower Respiratory Tract Infection (LRTI) or severe LRTI as defined by the LRTI case definition and severity scale [Period 1]
Timeframe: From birth up to 2 years of age
Number of RSV LRTI or severe LRTI episodes as defined by the GlaxoSmithKline (GSK) LRTI case definition [Period 1]
Timeframe: From birth up to 2 years of age
Number of RSV LRTI or severe LRTI episodes as defined by the existing comparator LRTI case definition (WHO [Modjarrad 2015]) [Period 1]
Timeframe: From birth up to 2 years of age
Number of RSV LRTI or severe LRTI episodes as defined by the existing comparator LRTI case definition (Nokes et al.) [Period 1]
Timeframe: From birth up to 2 years of age
Secondary outcomes:
Levels of RSV-A and B neutralizing antibodies in the cord blood [Period 1]
Timeframe: At birth (Month 0)
Levels of RSV-A and B neutralizing antibodies in the blood serum [Period 1]
Timeframe: At 2, 4, 6, 12, 18 and 24 months of age
GMTs of RSV A and B neutralizing antibodies in the cord blood by subjects classified according to non-overlapping disease severity categories [Period 1]
Timeframe: At Month 0
GMTs of RSV A and B neutralizing antibodies by subjects classified according to non-overlapping disease severity categories [Period 1]
Timeframe: During the first 6 months of life
Number of WHO LRTI episodes by age categories [Period 1]
Timeframe: From birth up to 2 years of life
Number of WHO severe LRTI cases by age categories [Period 1]
Timeframe: From birth up to 2 years of life
Incidence rates of first episode of medically attended wheeze [Period 2]
Timeframe: From 2 years of age up to 6 years of age
Incidence rates of first episode of wheeze or asthma requiring hospital admission [Period 2]
Timeframe: From 2 years of age up to 6 years of age
Incidence rates of first episode of reported wheeze with use of any medication [Period 2]
Timeframe: From 2 years of age up to 6 years of age
Interventions:
Procedure/surgery: Nasal swab sampling
Procedure/surgery: Blood sampling
Other: Diary cards
Enrollment:
2409
Observational study model:
Not applicable
Primary completion date:
2017-03-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus
Product
GSK2647160A, GSK3389245A
Collaborators
Not applicable
Study date(s)
December 2013 to November 2021
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable - 6 Years
Accepts healthy volunteers
Yes
- 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.
- Before birth:
- Subject expected to become Child in care
Inclusion and exclusion criteria
Inclusion criteria:
- 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).
Before birth:
Exclusion criteria:
- 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.
Before birth:
Trial location(s)
Location
GSK Investigational Site
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1431FWO
Status
Study Complete
Location
GSK Investigational Site
Oakland, California, United States, 94611
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95815
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95823
Status
Study Complete
Location
GSK Investigational Site
Santa Clara, California, United States, 95051
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98105
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94596
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2017-03-10
Actual study completion date
2021-03-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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