Respiratory Syncytial Virus InfectionsPEPNINCT03614676

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

A study testing Blood sample collection, Cord blood sample collection and Maternal Diary Card in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 40 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus Infections
What is being tested?: Blood sample collection, Cord blood sample collection and Maternal Diary Card
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,493 participants
Where: 40 sitesin 10 countries
Study dates: 30 May 2019to 27 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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;

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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,
primary cytomegalovirus infection,
varicella infection,
Zika infection,
Active tuberculosis infection,
Incompetent cervix or cerclage
Individuals who have any underlying condition or infection that would predispose them to increased risk for a serious obstetrical complication that is not mentioned above
Individuals who have behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study;
Individuals who have known or suspected impairment of the immune system, an active autoimmune disorder that is not well-controlled, or who are receiving systemic immunosuppressive therapy;
Individuals participating in any concurrent clinical trial during the current pregnancy;
Individuals pregnant with a fetus with a confirmed or suspected major congenital anomaly at the time of enrolment.
Child in care

Trial locations and contacts

40 sites in 10 countries.

Country

City, postcode or hospital

40 sites in 10 countries

Argentina6 sites

GSK Investigational Site
Buenos Aires, C1408INH
GSK Investigational Site
Buenos Aires, C1425EFD
GSK Investigational Site
Mendoza, 5515
GSK Investigational Site
Mendoza, 6400
GSK Investigational Site
Río Cuarto, 5800
GSK Investigational Site
Villanueva- Guaymallen, Mendoza Province, 5521

Other trials in Argentina

Colombia6 sites

GSK Investigational Site
Bogotá, 110111
GSK Investigational Site
Bogotá, 111411
GSK Investigational Site
Cali, 760042
GSK Investigational Site
Medellín, 0500
GSK Investigational Site
Medellín, 50042
GSK Investigational Site
Villavicencio, 660003

Other trials in Colombia

Malaysia5 sites

GSK Investigational Site
Alor Star, 05350
GSK Investigational Site
Alor Star, 05400
GSK Investigational Site
Kota Kinabalu, 88996
GSK Investigational Site
Kuala Lumpur, 68000
GSK Investigational Site
Kuching, 93586

Other trials in Malaysia

Panama5 sites

GSK Investigational Site
Chiriquí, 0401
GSK Investigational Site
Juán Diaz, 3449
GSK Investigational Site
La Chorrera, 07079
GSK Investigational Site
Panama City, 32401
GSK Investigational Site
Panama City

Other trials in Panama

Mexico4 sites

GSK Investigational Site
Durango, 34000
GSK Investigational Site
Monterrey, Nuevo León, 64060
GSK Investigational Site
Monterrey, Nuevo León, 64460
GSK Investigational Site
Oaxaca City, 68000

Other trials in Mexico

Brazil3 sites

GSK Investigational Site
Belo Horizonte, Minas Gerais, 30130-100
GSK Investigational Site
Ribeirão Preto, São Paulo, 14049-900
GSK Investigational Site
Santa Maria, Rio Grande do Sul, 97105-900

Other trials in Brazil

Philippines3 sites

GSK Investigational Site
Cebu, 6000
GSK Investigational Site
Manila, 1000
GSK Investigational Site
Manila, 1008

Other trials in Philippines

South Africa3 sites

GSK Investigational Site
Parow Valley, 7505
GSK Investigational Site
Pretoria, Gauteng, 0122
GSK Investigational Site
Soshanguve, 0152

Other trials in South Africa

Thailand3 sites

GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Bangkok, 10700
GSK Investigational Site
Chiang Mai, 50200

Other trials in Thailand

Bangladesh2 sites

GSK Investigational Site
Dhaka, 1204
GSK Investigational Site
Dhaka

Other trials in Bangladesh

About this study

Official title: A Prospective Epidemiological Study of Pregnancy Outcomes and of Events of Interest in Pregnant Women, Neonates and Infants (PEPNI)

Conditions: Respiratory Syncytial Virus Infections
Being tested: Blood sample collection, Cord blood sample collection, Maternal Diary Card, Nasal Swab collection, Infant Diary Card
Keywords: third trimester, Respiratory Syncytial Virus (RSV) illness, Pregnancy, Maternal Immunization, Pregnant Women, Neonates, Respiratory Tract Illness
Medical subject headings: Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood sample collectionProcedure or surgery
Venous blood samples will be collected from the maternal subjects at Day 1 and Day 56 of the study and at delivery.
Cord blood sample collectionProcedure or surgery
Collection of cord blood samples from maternal subjects will occur, at delivery
Maternal Diary CardOther
Completion of Diary Card about health by pregnant woman/ mother, from enrolment through week 6 post delivery.
Nasal Swab collectionProcedure or surgery
Collection of nasal swabs from infants with potential LRTIs, from birth to 12 months of age.
Infant Diary CardOther
Completion of Diary Card about health of infant from birth to 12 months of age.

Study groups in NCT03614676
Study group	Role	What they receive
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). Receives: 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. Receives: Procedure: Nasal Swab collection; Other: Infant Diary Card

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 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
Pregnancy related events of interest by GAIA level (Lv.) of diagnostic certainty (where applicable/feasible) range from Level 1 to Level 2 or 3 (Highest level of diagnostic certainty (1) to lowest level of diagnostic certainty (2 or 3)): 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, Cesarean 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.
Measured: 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
Neonatal events of interest by GAIA level (Lv.) of diagnostic certainty, range from Level 1 to Level 4 or 5 (Highest level of diagnostic certainty (1) to lowest level of diagnostic certainty (4 or 5 based on the neonatal events)): 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 ≥ 28 to <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).
Measured: From birth through Day 28 of life
Respiratory Syncytial Virus Type A (RSV-A) Neutralizing Antibody Titers in Maternal Blood
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed Geometric Mean Titers (GMT) with 95% Confidence Interval (CI) in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated maternal subjects.
Measured: At delivery
RSV-A Neutralizing Antibodies Titers in Cord Blood
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were presented as GMTs, expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery.
Measured: 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
The incidence rate was calculated by dividing the number of infant subjects reporting first episodes over the follow-up period, to the total person-years. LRTI Case definition by WHO (Modjarrad, 2016): LRTI is diagnosed when infant has history of cough OR difficulty in breathing AND SpO2 < 95%, OR RR increase AND Confirmed RSV infection. Severe LRTI is diagnosed when an infant with RSV LRTI has oxygen saturation <93% or lower chest wall drawing. Very severe LRTI is diagnosed when an infant with RSV LRTI has oxygen saturation <90%, OR inability to feed OR failure to respond / unconscious.
Measured: From birth up to 1 year of age
Incidence Rates of Infant Subjects With RSV Hospitalizations
The incidence rate was calculated by dividing the number of subjects reporting first episodes over the follow-up period to the total person-years. RSV hospitalizations definition by WHO (Modjarrad, 2015): Infant has confirmed RSV infection AND hospitalized for acute medical condition.
Measured: From birth up to 1 year of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 201927 Jul 2021

First posted3 Aug 2018
Study start30 May 2019
Primary completion27 Jul 2021
Study completion27 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 4,493 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03614676
Sponsor's protocol ID: 207636
Acronym: PEPNI
Status last verified: Jul 2023
First submitted: 30 Jul 2018
Last updated: 14 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized data sets Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

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;26(1):679. doi: 10.1186/s12884-025-08012-1.
PubMed 41535781
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.
PubMed 38088983

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Epidemiological Study of Pregnancy Outcomes and of Events of Interest in Pregnant Women, Neonates and Infants (PEPNI)
ClinicalTrials.gov ID: NCT03614676
Acronym / sponsor ID: PEPNI / 207636
Conditions: Respiratory Syncytial Virus Infections
Keywords: third trimester, Respiratory Syncytial Virus (RSV) illness, Pregnancy, Maternal Immunization, Pregnant Women, Neonates, Respiratory Tract Illness
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,493 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 May 2019 (actual)
Primary completion: 27 Jul 2021 (actual)
Study completion: 27 Jul 2021 (actual)
First posted: 3 Aug 2018 (actual)
Results: Posted 14 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Pregnant Women/Mothers Group	Other	Procedure: Blood sample collection, Procedure: Cord blood sample collection, Other: Maternal Diary CardSubjects, 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).
Neonates/Infants Group	Other	Procedure: Nasal Swab collection, Other: Infant Diary CardInfants 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.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

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.

Key exclusion criteria (26 listed)

Individuals determined to have one of the following conditions associated with increased risk for a serious obstetrical complication
Individuals determined to have (during the current pregnancy) one of the following infections or conditions associated with risk of adverse outcome:
Individuals who have any underlying condition or infection that would predispose them to increased risk for a serious obstetrical complication that is not mentioned above
Individuals who have behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study;
Individuals who have known or suspected impairment of the immune system, an active autoimmune disorder that is not well-controlled, or who are receiving systemic immunosuppressive therapy;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood sample collectionVenous blood samples will be collected from the maternal subjects at Day 1 and Day 56 of the study and at delivery.	Procedure or surgery	Pregnant Women/Mothers Group
Cord blood sample collectionCollection of cord blood samples from maternal subjects will occur, at delivery	Procedure or surgery	Pregnant Women/Mothers Group
Maternal Diary CardCompletion of Diary Card about health by pregnant woman/ mother, from enrolment through week 6 post delivery.	Other	Pregnant Women/Mothers Group
Nasal Swab collectionCollection of nasal swabs from infants with potential LRTIs, from birth to 12 months of age.	Procedure or surgery	Neonates/Infants Group
Infant Diary CardCompletion of Diary Card about health of infant from birth to 12 months of age.	Other	Neonates/Infants Group

Primary outcome

Number of Maternal Subjects With Pregnancy Outcomes
Time frame: From Day 1 up to Day 42 post delivery
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.
Number of Maternal Subjects With Pregnancy Related Events of Interest
Time frame: From Day 1 up to Day 42 post-delivery
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.
Number of Infant Subjects With Neonatal Events of Interest
Time frame: From birth up to Day 28 post-birth
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).

6 secondary outcomes

Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty
Time frame: 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
Time frame: From birth through Day 28 of life
Respiratory Syncytial Virus Type A (RSV-A) Neutralizing Antibody Titers in Maternal Blood
Time frame: At delivery
RSV-A Neutralizing Antibodies Titers in Cord Blood
Time frame: 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
Time frame: From birth up to 1 year of age
Incidence Rates of Infant Subjects With RSV Hospitalizations
Time frame: From birth up to 1 year of age

Results and safety

Results posted to the registry on 14 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregnant Women/Mothers Group	2,311	2,195
Neonates/Infants Group	2,181	2,017

Primary outcome: Number of Maternal Subjects With Pregnancy Outcomes

Time frame: From Day 1 up to Day 42 post delivery. Count of participants. Unit: Participants

Measure	Pregnant Women/Mothers Group n = 2222
Live birth with no congenital anomalies	2088
Live birth with congenital anomalies	18
Antepartum fetal death/still birth with no congenital anomalies	8
Intrapartum fetal death/still birth with no congenital anomalies	5
Antepartum fetal death/still birth with congenital anomalies	0
Intrapartum fetal death/still birth with congenital anomalies	1
Elective/therapeutic termination with no congenital anomalies	11
Elective/therapeutic termination with congenital anomalies	1

Population analysed: The analysis was performed on the maternal Per Protocol Set (PPS) which included all pregnant women (mothers) meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).

Primary outcome: Number of Maternal Subjects With Pregnancy Related Events of Interest

Time frame: From Day 1 up to Day 42 post-delivery. Count of participants. Unit: Participants

Measure	Pregnant Women/Mothers Group n = 2222
Maternal death	1
Gestational hypertension	72
Pre-eclampsia	37
Pre-eclampsia with severe features	16
Morbidly adherent placenta	1
Placental abruption	10
Caesarean scar pregnancy	0
Uterine rupture	0

Population analysed: The analysis was performed on the maternal PPS which included all pregnant women (mothers) meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).

Primary outcome: Number of Infant Subjects With Neonatal Events of Interest

Time frame: From birth up to Day 28 post-birth. Count of participants. Unit: Participants

Measure	Neonates/Infants Group n = 2094
Small for gestational age	111
Low birth weight including very low birth weight	156
Neonatal encephalopathy	6
Congenital microcephaly-Postnatally diagnosed	16
Congenital microcephaly-Prenatally diagnosed	1
CA -Major external structural defects	38
CA -Internal structural defects	46
CA -Functional defects	19

Population analysed: The analysis was performed on the infant PPS which included all neonates/infants who born to pregnant women in the maternal PPS, meeting all eligibility criteria up to the time of their censoring, either at study completion or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up), who have at least one time point evaluation.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: No AEs or SAEs were reported in this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregnant Women/Mothers Group	0 of 0	0 of 0	1 of 2,311
Neonates/Infants Group	0 of 0	0 of 0	23 of 2,181

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41535781Tullio 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;26(1):679. doi: 10.1186/s12884-025-08012-1.
Derived from this study: PubMed 38088983Fry 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.
Individual participant dataSharing planned: Yes. Anonymized data sets Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

40 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Argentina, Colombia, Malaysia, Panama, Mexico and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Maternal Subjects With Pregnancy Outcomes (time frame: From Day 1 up to Day 42 post delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03614676, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.