A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance

NACompletedINTERVENTIONAL
Enrollment

4,493

Participants

Timeline

Start Date

May 30, 2019

Primary Completion Date

July 27, 2021

Study Completion Date

July 27, 2021

Conditions
Respiratory Syncytial Virus Infections
Interventions
PROCEDURE

Blood sample collection

Venous blood samples will be collected from the maternal subjects at Day 1 and Day 56 of the study and at delivery.

PROCEDURE

Cord blood sample collection

Collection of cord blood samples from maternal subjects will occur, at delivery

OTHER

Maternal Diary Card

Completion of Diary Card about health by pregnant woman/ mother, from enrolment through week 6 post delivery.

PROCEDURE

Nasal Swab collection

Collection of nasal swabs from infants with potential LRTIs, from birth to 12 months of age.

OTHER

Infant Diary Card

Completion of Diary Card about health of infant from birth to 12 months of age.

Trial Locations (40)

1000

GSK Investigational Site, Manila

1008

GSK Investigational Site, Manila

1204

GSK Investigational Site, Dhaka

3449

GSK Investigational Site, Juán Diaz

5515

GSK Investigational Site, Mendoza

5521

GSK Investigational Site, Villanueva- Guaymallen

5800

GSK Investigational Site, Río Cuarto

6000

GSK Investigational Site, Cebu

6400

GSK Investigational Site, Mendoza

7505

GSK Investigational Site, Parow Valley

10330

GSK Investigational Site, Bangkok

10700

GSK Investigational Site, Bangkok

32401

GSK Investigational Site, Panama City

34000

GSK Investigational Site, Durango

50042

GSK Investigational Site, Medellín

50200

GSK Investigational Site, Chiang Mai

64060

GSK Investigational Site, Monterrey

64460

GSK Investigational Site, Monterrey

68000

GSK Investigational Site, Kuala Lumpur

GSK Investigational Site, Oaxaca City

88996

GSK Investigational Site, Kota Kinabalu

93586

GSK Investigational Site, Kuching

110111

GSK Investigational Site, Bogotá

111411

GSK Investigational Site, Bogotá

660003

GSK Investigational Site, Villavicencio

760042

GSK Investigational Site, Santiago de Cali

C1408INH

GSK Investigational Site, Buenos Aires

C1425EFD

GSK Investigational Site, Buenos Aires

Unknown

GSK Investigational Site, Dhaka

GSK Investigational Site, Panama City

30130-100

GSK Investigational Site, Belo Horizonte

97105-900

GSK Investigational Site, Santa Maria

14049-900

GSK Investigational Site, Ribeirão Preto

0500

GSK Investigational Site, Medellín

05350

GSK Investigational Site, Alor Star

05400

GSK Investigational Site, Alor Star

0401

GSK Investigational Site, Chiriquí

07079

GSK Investigational Site, La Chorrera

0122

GSK Investigational Site, Pretoria

0152

GSK Investigational Site, Soshanguve

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03614676 - A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance | Biotech Hunter | Biotech Hunter