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

NACompletedINTERVENTIONAL
Enrollment

2,409

Participants

Timeline

Start Date

December 12, 2013

Primary Completion Date

October 3, 2017

Study Completion Date

November 3, 2021

Conditions
Respiratory Syncytial Virus
Interventions
PROCEDURE

Nasal swab sampling

Nasal swab samples will be collected from subjects at each examination visit, if they develop respiratory tract infection symptoms with difficulty in breathing and are called for an examination visit in the study.

PROCEDURE

Blood sampling

A single blood sample will be collected from a sub-cohort consisting of the first 2000 enrolled subjects when they are either 2, 4, 6, 12, 18 or 24 months old.

OTHER

Diary cards

Diary cards will be provided to parents or LARs of the subjects to record RTI/LRTI, wheeze and asthma symptoms.

Trial Locations (23)

1000

GSK Investigational Site, Dhaka

2013

GSK Investigational Site, Soweto

5800

GSK Investigational Site, Río Cuarto

10330

GSK Investigational Site, Bangkok

12120

GSK Investigational Site, Pathum Thani

13210

GSK Investigational Site, Syracuse

21101

GSK Investigational Site, San Pedro Sula

21102

GSK Investigational Site, San Pedro Sula

28100

GSK Investigational Site, Pori

40002

GSK Investigational Site, Khon Kaen

60100

GSK Investigational Site, Seinäjoki

67100

GSK Investigational Site, Kokkola

84067

GSK Investigational Site, Roy

84075

GSK Investigational Site, Syracuse

90220

GSK Investigational Site, Oulu

94596

GSK Investigational Site, Walnut Creek

94611

GSK Investigational Site, Oakland

95051

GSK Investigational Site, Santa Clara

95815

GSK Investigational Site, Sacramento

95823

GSK Investigational Site, Sacramento

98105

GSK Investigational Site, Seattle

C1431FWO

GSK Investigational Site, Ciudad de Buenos Aires

B3K 6R8

GSK Investigational Site, Halifax

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY