Respiratory syncytial virus (RSV) is a highly contagious virus that causes infection of the airways and lungs. RSV infections are typically mild in adults, but may cause serious health issues such as bronchitis or pneumonia in infants and children. Infants under 6 months of age are at highest risk for RSV, as immune protection acquired from their mothers declines over the first few months of life and their own immune systems remain underdeveloped. In the UK, an estimated 33,500 infants are hospitalised for RSV-related infections every year. Due to the high impact of RSV in the UK and globally, there is a need to develop a vaccine to protect infants. To address this need, GSK is developing an RSV maternal vaccine. This vaccine is intended to be given to pregnant women to boost their immune response to RSV, thereby allowing newborns to fight the virus more effectively using the immune response passed on by their mothers. The primary purpose of this study is to provide up-to-date information on the outcomes of pregnant women (including those receiving the influenza vaccine) and their infants in England. As well as providing important information on the health outcomes of pregnant women and their children, the information from this study will provide researchers with a benchmark with which to assess the impact of any subsequent changes in the clinical care of mothers, for instance the introduction of a RSV vaccine.
Respiratory syncytial virus (RSV) is the most common cause of upper and lower respiratory tract infections in
infants and children worldwide. There is a significant public health need to develop a maternal vaccine that can
protect neonates from RSV. Prior to initiating trials of an investigational vaccine in pregnant women, it is first
important to understand background rates of pregnancy-related outcomes and events of interest (EIs) in the
population that will be enrolled in future vaccine clinical trials. The current study uses a cohort design to estimate
the incidence proportion of specific pregnancy outcomes, pregnancy-related EIs, and infant EIs in pregnant women
and their infants. Endpoints will be identified in the Clinical Practice Research Datalink (CPRD), Hospital Episode
Statistics, and Office of National Statistics, and women will be linked to their infants using the CPRD Mother Baby
Link. A cohort of low-risk pregnant women similar to those who may be enrolled in clinical trials will be identified,
and the incidence proportion of influenza vaccination in pregnant women enrolled in the study will also be
investigated. Statistical analyses will be descriptive and the results of this study will be used to help interpret safety
data in future RSV maternal clinical trials.
The incidence proportion of the following endpoints will be estimated:
Pregnancy outcomes:
Foetal death or still birth
Live birth
Preterm birth
Terminations of pregnancies (elective or therapeutic)
Pregnancy related EIs:
Maternal death
Maternal sepsis
Vaginal or intrauterine haemorrhage
Premature labour
Labour protraction and arrest disorders
Pre-eclampsia and eclampsia
Pregnancy-related hypertension
Preterm premature rupture of membranes (PPROM)
Oligohydramnios
Polyhydramnios
Intrauterine growth restriction or poor foetal growth
Gestational diabetes mellitus
Biliary and liver disease
Foetal/perinatal distress or asphyxia
Small for gestational age
Large for gestational age
Infant EIs :
Neonatal death within 28 days
Infant death
Sepsis
Very low birth weight (<1000g)
Low birth weight (1000-2499g)
Macrosomia (>4000g)
Congenital anomalies
Gael Dos-Santos - Chief Investigator - GlaxoSmithKline - UK
Sophie Graham - Corresponding Applicant - Evidera, Inc
Deborah Covington - Collaborator - Evidera, Inc
Dimitra Lambrelli - Collaborator - Evidera, Inc
Emmanuel ARIS - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Huajun Wang - Collaborator - GSK
Jenna Collins - Collaborator - Evidera, Inc
Kastoori Thakuri - Collaborator - GSK
Nadia Tullio - Collaborator - GSK
Nicola Sawalhi-Leckenby - Collaborator - Evidera, Inc
Robert Carroll - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Sharon MacLachlan - Collaborator - Evidera, Inc
Sonia Stoszek - Collaborator - GSK
Wendolyn Lopez - Collaborator - GSK
Yves BRABANT - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Padmaja Patnaik - Chief Investigator - GSK
Sonia Stoszek - Chief Investigator - GSK
Alexander Schmidt - Collaborator - GSK
Andrew Hastie - Collaborator - GSK
Brooke Hanscom - Collaborator - GSK
Chanbin Kim - Collaborator - GSK
Dominique Rosillon - Collaborator - GlaxoSmithKline - USA
Emad Yanni - Collaborator - GSK Vaccines
John Logie - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
Megan Riley - Collaborator - GSK Vaccines
Ouzama Henry - Collaborator - GSK
Robert Donaldson - Collaborator - Evidera Ltd - UK
Veronique Bianco - Collaborator - GSK
Vishvesh Shende - Collaborator - GSK
CPRD Mother-Baby Link;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Pregnancy Register