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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 November 2021 |
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Main ID: |
NCT01995175 |
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Date of registration:
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07/11/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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December 12, 2013 |
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Target sample size:
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2409 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01995175 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Argentina
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Bangladesh
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Canada
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Finland
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Honduras
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South Africa
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Thailand
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
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).
Exclusion Criteria:
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.
Age minimum:
N/A
Age maximum:
6 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Respiratory Syncytial Virus
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Intervention(s)
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Procedure: Nasal swab sampling
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Procedure: Blood sampling
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Other: Diary cards
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Primary Outcome(s)
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Incidence Rates of First Episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI)
[Time Frame: From birth up to 2 years of age]
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Number of RSV LRTI or Severe LRTI Episodes as Defined by the GlaxoSmithKline (GSK) LRTI Case Definition
[Time Frame: From birth up to 2 years of age]
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Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI as Defined by the LRTI Case Definition and Severity Scale
[Time Frame: From birth up to 2 years of age]
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Number of Subjects Hospitalized for RSV
[Time Frame: From birth up to 2 years of age]
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Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (Nokes et al.)
[Time Frame: From birth up to 2 years of age]
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Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (WHO [Modjarrad 2015])
[Time Frame: From birth up to 2 years of age]
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Secondary Outcome(s)
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GMTs of RSV A and B Neutralizing Antibodies in the Cord Blood by Subjects Classified According to Non-overlapping Disease Severity Categories
[Time Frame: At month 0]
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Number of Subjects With Medication Prescription for Wheeze or Asthma
[Time Frame: From 2 years of age up to 6 years of age.]
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Levels of RSV-A and B Neutralizing Antibodies in the Cord Blood
[Time Frame: At birth (Month 0)]
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Number of Subjects With Medically Attended Wheeze
[Time Frame: From 2 years of age up to 6 years of age.]
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Number of WHO Severe LRTI Cases by Age Categories
[Time Frame: From birth up to 2 years of life]
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GMTs of RSV A and B Neutralizing Antibodies by Subjects Classified According to Non-overlapping Disease Severity Categories
[Time Frame: During the first 6 months of life]
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Number of Subjects With Wheeze or Asthma Requiring Admission
[Time Frame: From 2 years of age up to 6 years of age.]
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Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum
[Time Frame: At 2, 4, 6, 12, 18 and 24 months of age.]
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Number of WHO LRTI Episodes by Age Categories
[Time Frame: From birth up to 2 years of life]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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