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

NCT03614676 | Completed Results

• 1 other identifier: 207636
• Study Type: interventional
• Target: 4,493
• Locations: 10 countries
• Sites: 40

Brief Summary

The purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal events of interest in healthy pregnant women and their new-borns. The study will also determine incidence of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in the new-borns during their first year of life.

Conditions

Respiratory Syncytial Virus Infections

Keywords

third trimester; Respiratory Syncytial Virus (RSV) illness; Pregnancy; Maternal Immunization; Pregnant Women; Neonates; Respiratory Tract Illness

Outcome Measures

Primary Outcomes (3)

• Number of Maternal Subjects With Pregnancy Outcomes

  Pregnancy outcomes included: live birth with no congenital anomalies, live birth with congenital anomalies, fetal death/stillbirth loss at or after 22 weeks of gestation (antepartum stillbirth, Intrapartum stillbirth) with no congenital anomalies, fetal death/still birth loss at or after 22 weeks of gestation (antepartum stillbirth, Intrapartum stillbirth) with congenital anomalies, elective/therapeutic termination with no congenital anomalies, elective/therapeutic termination with congenital anomalies.

  From Day 1 up to Day 42 post delivery

• Number of Maternal Subjects With Pregnancy Related Events of Interest

  Pregnancy related events of interest included: maternal death, hypertensive disorders of pregnancy including gestational hypertension, pre-eclampsia and pre-eclampsia with severe features (including eclampsia), antenatal bleeding (morbidly adherent placenta, placental abruption, Caesarean scar pregnancy, uterine rupture), postpartum haemorrhage, fetal growth restriction, dysfunctional labor (first stage of labor, second stage of labor), gestational diabetes mellitus, non-reassuring fetal status, pathways to preterm birth including premature preterm rupture of membranes, preterm labour, and provider initiated preterm birth, chorioamnionitis, oligohydramnios, polyhydramnios, gestational liver disease (intrahepatic cholestasis of pregnancy \[ICP\], acute fatty liver of pregnancy), and maternal sepsis.

  From Day 1 up to Day 42 post-delivery

• Number of Infant Subjects With Neonatal Events of Interest

  Neonatal events of interest included: small for gestational age, low birth weight including very low birth weight, neonatal encephalopathy, congenital microcephaly (postnatally diagnosed, prenatally diagnosed), congenital anomalies \[CA\] (major external structural defects, internal structural defects, functional defects), neonatal death (neonatal death in a preterm live birth \[gestational age greater than or equal to (≥) 28 to less than (\<) 37 weeks\], neonatal death in a term live birth), neonatal infections, (blood stream infections, meningitis, respiratory infection), respiratory distress in the neonate, preterm birth, failure to thrive, large for gestational age, macrosomia, any other neonatal event considered by the investigator to be of concern (e.g. neurodevelopmental delay).

  From birth up to Day 28 post-birth

Secondary Outcomes (6)

• Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty

  From Day 1 up to Day 42 post-delivery

• Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty

  From birth through Day 28 of life

• Respiratory Syncytial Virus Type A (RSV-A) Neutralizing Antibody Titers in Maternal Blood

  At delivery

• RSV-A Neutralizing Antibodies Titers in Cord Blood

  At delivery

• Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition

  From birth up to 1 year of age

Study Arms (2)

Pregnant Women/Mothers Group

OTHER

Subjects, 18 to 45 years of age enrolled in the study in view of determining pregnancy outcomes and related events of interest, as well as the occurrence of lower respiratory tract illness (LRTI) associated with respiratory syncytial virus (RSV).

Procedure: Blood sample collection; Procedure: Cord blood sample collection; Other: Maternal Diary Card

Neonates/Infants Group

OTHER

Infants born to mothers aged 18-45 years old, enrolled for the collection of infant events of interest, nasal swabs and the incidence of RSV LRTI and RSV hospitalization.

Procedure: Nasal Swab collection; Other: Infant Diary Card

Interventions

Blood sample collection PROCEDURE

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

Pregnant Women/Mothers Group

Cord blood sample collection PROCEDURE

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

Pregnant Women/Mothers Group

Maternal Diary Card OTHER

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

Pregnant Women/Mothers Group

Nasal Swab collection PROCEDURE

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

Neonates/Infants Group

Infant Diary Card OTHER

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

Neonates/Infants Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women 18-45years of age who are ≥ 24 0/7 weeks GA at screening and ≤ 27 6/7 weeks GA at Visit 1, as established by ultrasound examination and/or last menstrual period (LMP) date
• Women with pre-pregnancy body mass index (BMI) ≥18.5 and ≤ 39.9 kg/m2.
• Women whose pregnancy is considered low risk, based on medical history, obstetric history, and clinical findings during the current pregnancy
• Women who had no significant findings (such as abnormal fetal morphology, amniotic fluid levels, placenta, or umbilical cord) observed during a Level 2 ultrasound (fetal morphology assessment).
• Human Immunodeficiency Virus (HIV) uninfected women who have been tested within the past year and have documented HIV negative test results.
• Individuals who give written or witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements.
• The informed consent given at screening should either include consent for both the mother's participation and participation of the infant after the infant's birth (if consistent with local regulations/guidelines), or consent for the mother's participation and expressed willingness to consider permitting the infant to take part after the infant has been born (if local regulations/guidelines require parent(s) to provide an additional informed consent after the infant's birth).
• Both mother and father should consent if local regulations/guidelines require it.
• Individuals who consent to have cord blood collected at delivery for the purpose of the study;
• Individuals who plan to reside in the study area for at least one year after delivery.
• Individuals who are in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
• Individuals who, in the opinion of the investigator can and will comprehend and comply with all study procedures
• Infants who were in utero at the time maternal (and paternal, if required) informed consent was given, and who are live-born.
• If local law requires it: Written or witnessed/thumb printed informed consent for study participation of the infant obtained from parent(s)/Legally Accepted Representative \[LAR(s)\] within 21 days of birth.

You may not qualify if:

• Individuals determined to have one of the following conditions associated with increased risk for a serious obstetrical complication
• Gestational hypertension;
• Gestational diabetes uncontrolled by diet and exercise;
• Pre-eclampsia or eclampsia;
• Multiple pregnancy;
• Intrauterine growth restriction;
• Placenta previa;
• Polyhydramnios;
• Oligohydramnios;
• Individuals determined to have (during the current pregnancy) one of the following infections or conditions associated with risk of adverse outcome:
• Known or suspected:
• Syphilis infection,
• Parvovirus B19,
• Rubella infection,
• primary herpes simplex infection,

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (40)

GSK Investigational Site

Villanueva- Guaymallen, Mendoza Province, 5521, Argentina

Location

GSK Investigational Site

Buenos Aires, C1408INH, Argentina

Location

GSK Investigational Site

Buenos Aires, C1425EFD, Argentina

Location

GSK Investigational Site

Mendoza, 5515, Argentina

Location

GSK Investigational Site

Mendoza, 6400, Argentina

Location

GSK Investigational Site

Río Cuarto, 5800, Argentina

Location

GSK Investigational Site

Dhaka, 1204, Bangladesh

Location

GSK Investigational Site

Dhaka, Bangladesh

Location

GSK Investigational Site

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

GSK Investigational Site

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

GSK Investigational Site

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

GSK Investigational Site

Bogotá, 110111, Colombia

Location

GSK Investigational Site

Bogotá, 111411, Colombia

Location

GSK Investigational Site

Cali, 760042, Colombia

Location

GSK Investigational Site

Medellín, 0500, Colombia

Location

GSK Investigational Site

Medellín, 50042, Colombia

Location

GSK Investigational Site

Villavicencio, 660003, Colombia

Location

GSK Investigational Site

Alor Star, 05350, Malaysia

Location

GSK Investigational Site

Alor Star, 05400, Malaysia

Location

GSK Investigational Site

Kota Kinabalu, 88996, Malaysia

Location

GSK Investigational Site

Kuala Lumpur, 68000, Malaysia

Location

GSK Investigational Site

Kuching, 93586, Malaysia

Location

GSK Investigational Site

Monterrey, Nuevo León, 64060, Mexico

Location

GSK Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

GSK Investigational Site

Durango, 34000, Mexico

Location

GSK Investigational Site

Oaxaca City, 68000, Mexico

Location

GSK Investigational Site

Chiriquí, 0401, Panama

Location

GSK Investigational Site

Juán Diaz, 3449, Panama

Location

GSK Investigational Site

La Chorrera, 07079, Panama

Location

GSK Investigational Site

Panama City, 32401, Panama

Location

GSK Investigational Site

Panama City, Panama

Location

GSK Investigational Site

Cebu, 6000, Philippines

Location

GSK Investigational Site

Manila, 1000, Philippines

Location

GSK Investigational Site

Manila, 1008, Philippines

Location

GSK Investigational Site

Pretoria, Gauteng, 0122, South Africa

Location

GSK Investigational Site

Parow Valley, 7505, South Africa

Location

GSK Investigational Site

Soshanguve, 0152, South Africa

Location

GSK Investigational Site

Bangkok, 10330, Thailand

Location

GSK Investigational Site

Bangkok, 10700, Thailand

Location

GSK Investigational Site

Chiang Mai, 50200, Thailand

Location

Related Publications (2)

• Tullio AN, Yanni E, Coutinho CM, Sivapatham L, Lee CMF, Pallem S, Pu Y, Akawung A, Kim JH, Henry O, Mussi-Pinhata MM, Ahmed K, Del Carmen Flores Acosta C, Reyes O, Abadia de Regalado I, Arias Fernandez DA, Aurpibul L, Taher SW, Caccavo J, Ceballos A, Pichailuck C, D'Andrea Nores U, De Leon T, De Bernardi M, Dieser P, D'Silva EC, Falaschi A, Fry S, Gentile A, Teo IH, Kotze S, Lopez-Medina E, Luca R, Lucion MF, Mantaring JBIV, Marin B, Moelo M, Pinto J, Puthanakit T, Roa MF, Rodriguez Brieschke MT, Rodriguez CE, Rodriguez Nino JN, Schwarzbold AV, Sierra Garcia A, Soon R, Tinoco JC, Velasquez Penagos JA, Zaman K, Dos Santos G. A multicountry study to establish rates for pregnancy and neonatal outcomes in low- and middle-income regions. BMC Pregnancy Childbirth. 2026 Jan 14. doi: 10.1186/s12884-025-08012-1. Online ahead of print.

  PMID: 41535781 DERIVED

• Fry S, Chokephaibulkit K, Pallem S, Henry O, Pu Y, Akawung A, Kim JH, Yanni E, Tullio AN, Aurpibul L, Lee CMF, Ceballos A, Zaman K, Abadia de Regalado I, Ahmed K, Arias Fernandez DA, Taher SW, Caccavo J, Coutinho CM, D'Andrea Nores U, De Leon T, D'Silva EC, De Bernardi M, Dieser P, Falaschi A, Flores Acosta CDC, Gentile A, Teo IH, Kotze S, Lopez-Medina E, Luca R, Lucion MF, Mantaring JBIV, Marin B, Moelo M, Mussi-Pinhata MM, Pinto J, Puthanakit T, Reyes O, Roa MF, Rodriguez Brieschke MT, Rodriguez CE, Rodriguez Nino JN, Schwarzbold AV, Sierra Garcia A, Sivapatham L, Soon R, Tinoco JC, Velasquez Penagos JA, Dos Santos G. Incidence of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Illness in Infants in Low- and Middle-Income Regions During the Coronavirus Disease 2019 Pandemic. Open Forum Infect Dis. 2023 Dec 1;10(12):ofad553. doi: 10.1093/ofid/ofad553. eCollection 2023 Dec.

  PMID: 38088983 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

The study period partly overlapped with COVID-19 pandemic. RSV LRTI findings might not reflect a standard RSV season due to low virus circulation, social distancing, travel restriction and other actions to control COVID-19 spreading. GAIA classification is not used as care standard in participating sites. Some sites might face challenges into classify the outcomes of interest. Background rates for less frequent events were difficult to estimate due to the relatively limited size.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment is selected because this is a low-interventional, epidemiological study. As such, the study does not have multiple groups/treatment arms that will be compared against one another statistically in the way two study arms would be compared against each other in a clinical trial. Instead, the study will longitudinally follow pregnant women through a 42-day post-delivery period and will also follow the infants born to these women. It should be noted that these are the two populations listed in the protocol, but these are not two groups that will compared against one another. Statistical analyses will be conducted within each group and some analyses will be done across the two groups. However, these two groups should not be considered equivalent to two study arms. This explains why a single group assignment is appropriate while two study groups (mothers and infants) will be examined.

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: May 30, 2019
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

MY (5); CO (6); PH (3); AR (6); ZA (3); TH (3); PA (5); BA (2); BR (3); ME (4)