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NCT01995175 · ClinicalTrials.gov registry record · NA
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
A NA study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- NA
- Development phase
- 2,409
- Enrollment target
NCT01995175: Completed NA study, sponsored by GlaxoSmithKline.
NCT01995175 is a NA study that has completed, run by GlaxoSmithKline. The registered enrollment target is 2,409 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01995175, a NA study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,409 participants
- Enrollment target
Study 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.
Primary Outcome
The incidence rate was calculated by dividing the number of subjects reporting first episode over the follow-up period, to the total person-years. Detection of the RSV-infection was performed by reverse transcription quantitative real time polymerase chain reaction (RT-qPCR ) assay on ribonucleic acids (RNA) extracted from nasal swabs. Number of suspected RSV RTI cases were tabulated.
Interventions
- PROCEDURE Blood sampling
- PROCEDURE Nasal swab sampling
- OTHER Diary cards
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,409 participants |
| Start Date | 2013-12-12 |
| Est. Completion | 2021-11-03 |
| Phase | NA |
What the finished NCT01995175 record still lists
NCT01995175 is an interventional study that assigns participants to a tested intervention. Its 2,409 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 3 interventions - of which Blood sampling is the first listed.
NCT01995175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01995175 about?
NCT01995175 is a clinical study titled "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". 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 tw...
What is the current status of trial NCT01995175?
This trial is currently completed. It is a NA study. The enrollment target is 2,409 participants. The study started on 2013-12-12. Estimated completion is 2021-11-03.
What interventions are being tested in trial NCT01995175?
The interventions under investigation include: Blood sampling (PROCEDURE), Nasal swab sampling (PROCEDURE), Diary cards (OTHER).
Who is sponsoring clinical trial NCT01995175?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01995175's enrollment target sits among peer trials
2,409 46th of 2000 higher than 1,955 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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