N/A
N=2,401
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
Respiratory Syncytial Virus
Bottom Line
View on ClinicalTrials.gov: NCT01995175 ↗Enrolled (actual)
2,401
Serious AEs
—
Results posted
Feb 2019
Primary outcome: Primary: Incidence Rates of First Episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI) [Period 1] — 7.93 Cases per 100 person-years
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasal swab sampling (Procedure); Blood sampling (Procedure); Diary cards (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rates of First Episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI) [Period 1] |
7.93 | — |
| PRIMARY Number of Subjects Hospitalized for RSV [Period 1] |
31 | — |
| PRIMARY Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI as Defined by the LRTI Case Definition and Severity Scale [Period 1] |
4.75; 1.53 | — |
| PRIMARY Number of RSV LRTI or Severe LRTI Episodes as Defined by the GlaxoSmithKline (GSK) LRTI Case Definition [Period 1] |
227; 145 | — |
| PRIMARY Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (WHO [Modjarrad 2015]) [Period 1] |
227; 73 | — |
| PRIMARY Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (Nokes et al.) [Period 1] |
226; 67 | — |
| SECONDARY Levels of RSV-A and B Neutralizing Antibodies in the Cord Blood [Period 1] |
251.21; 327.05 | — |
| SECONDARY Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1] |
77.92; 31.25; 13.91; 14.30; 22.41; 46.32 | — |
| SECONDARY GMTs of RSV A and B Neutralizing Antibodies in the Cord Blood by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1] |
252.47; 213.24; 165.80; 328.18; 259.18; 279.69 | — |
| SECONDARY GMTs of RSV A and B Neutralizing Antibodies by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1] |
254.08; 193.34; 174.09; 327.83; 276.52; 349.53 | — |
| SECONDARY Number of WHO LRTI Episodes by Age Categories [Period 1] |
110; 210; 276; 416 | — |
| SECONDARY Number of WHO Severe LRTI Cases by Age Categories [Period 1] |
45; 67; 62; 85 | — |
| SECONDARY Incidence Rates of First Episode of Medically Attended Wheeze [Period 2] |
3.79; 3.28; 9.82 | — |
| SECONDARY Incidence Rates of First Episode of Wheeze or Asthma Requiring Hospital Admission [Period 2] |
0.35; 0.30; 0.82 | — |
| SECONDARY Incidence Rates of First Episode of Reported Wheeze With Use of Any Medication [Period 2] |
3.63; 3.13; 9.44 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01995175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.