- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03614676
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance (PEPNI)
A Prospective Epidemiological Study of Pregnancy Outcomes and of Events of Interest in Pregnant Women, Neonates and Infants (PEPNI)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Buenos Aires, Argentina, C1425EFD
- GSK Investigational Site
-
Ciudad Autónoma de Buenos Aires, Argentina, C1408INH
- GSK Investigational Site
-
Mendoza, Argentina, 5515
- GSK Investigational Site
-
Mendoza, Argentina, 6400
- GSK Investigational Site
-
Rio Cuarto, Argentina, 5800
- GSK Investigational Site
-
-
Mendoza
-
Villanueva- Guaymallen, Mendoza, Argentina, 5521
- GSK Investigational Site
-
-
-
-
-
Dhaka, Bangladesh
- GSK Investigational Site
-
Dhaka, Bangladesh, 1204
- GSK Investigational Site
-
-
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30130-100
- GSK Investigational Site
-
-
Rio Grande Do Sul
-
Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
- GSK Investigational Site
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazil, 14049-900
- GSK Investigational Site
-
-
-
-
-
Bogota, Colombia, 111411
- GSK Investigational Site
-
Cali, Colombia, 760042
- GSK Investigational Site
-
Medellin, Colombia, 50042
- GSK Investigational Site
-
Medellin, Colombia, 0500
- GSK Investigational Site
-
Santa Fe De Bogota, Colombia, 110111
- GSK Investigational Site
-
Villavicencio, Colombia, 660003
- GSK Investigational Site
-
-
-
-
-
Alor Setar, Malaysia, 05350
- GSK Investigational Site
-
Alor Setar, Malaysia, 05400
- GSK Investigational Site
-
Kota Kinabalu, Malaysia, 88996
- GSK Investigational Site
-
Kuala Lumpur, Malaysia, 68000
- GSK Investigational Site
-
Kuching, Malaysia, 93586
- GSK Investigational Site
-
-
-
-
-
Durango, Mexico, 34000
- GSK Investigational Site
-
Oaxaca, Mexico, 68000
- GSK Investigational Site
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico, 64460
- GSK Investigational Site
-
Monterrey, Nuevo León, Mexico, 64060
- GSK Investigational Site
-
-
-
-
-
Chiriquí, Panama, 0401
- GSK Investigational Site
-
Juán Diaz, Panama, 3449
- GSK Investigational Site
-
La Chorrera, Panama, 07079
- GSK Investigational Site
-
Panama City, Panama, 32401
- GSK Investigational Site
-
Panamá, Panama
- GSK Investigational Site
-
-
-
-
-
Cebu, Philippines, 6000
- GSK Investigational Site
-
Manila, Philippines, 1000
- GSK Investigational Site
-
Manila, Philippines, 1008
- GSK Investigational Site
-
-
-
-
-
Parow Valley, South Africa, 7505
- GSK Investigational Site
-
Soshanguve, South Africa, 0152
- GSK Investigational Site
-
-
Gauteng
-
Pretoria, Gauteng, South Africa, 0122
- GSK Investigational Site
-
-
-
-
-
Bangkok, Thailand, 10330
- GSK Investigational Site
-
Bangkok, Thailand, 10700
- GSK Investigational Site
-
Chiang Mai, Thailand, 50200
- GSK Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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,
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Pregnant Women/Mothers Group
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).
|
Venous blood samples will be collected from the maternal subjects at Day 1 and Day 56 of the study and at delivery.
Collection of cord blood samples from maternal subjects will occur, at delivery
Completion of Diary Card about health by pregnant woman/ mother, from enrolment through week 6 post delivery.
|
Other: Neonates/Infants Group
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.
|
Collection of nasal swabs from infants with potential LRTIs, from birth to 12 months of age.
Completion of Diary Card about health of infant from birth to 12 months of age.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From Day 1 up to Day 42 post delivery
|
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.
|
From Day 1 up to Day 42 post-delivery
|
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).
|
From birth up to Day 28 post-birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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).
|
From birth through Day 28 of life
|
Respiratory Syncytial Virus Type A (RSV-A) Neutralizing Antibody Titers in Maternal Blood
Time Frame: At delivery
|
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.
|
At delivery
|
RSV-A Neutralizing Antibodies Titers in Cord Blood
Time Frame: At delivery
|
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.
|
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
|
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.
|
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
|
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.
|
From birth up to 1 year of age
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 207636
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Syncytial Virus Infections
-
Sanofi Pasteur, a Sanofi CompanyRecruitingRespiratory Syncytial Virus ImmunizationPuerto Rico, United States, Australia, Honduras, Mexico
-
Vigonvita Life SciencesRecruitingRespiratory Syncytial Virus InfectionChina
-
AbbVie (prior sponsor, Abbott)CompletedRespiratory Syncytial Virus Infection
-
EuBiologics Co.,LtdNot yet recruitingRespiratory Syncytial Virus Infections | Respiratory Syncytial Virus (RSV)
-
Clover Biopharmaceuticals AUS Pty LtdRecruitingRespiratory Syncytial Virus InfectionAustralia
-
Sanofi Pasteur, a Sanofi CompanyRecruitingRespiratory Syncytial Virus InfectionUnited States, Puerto Rico
-
PfizerCompletedRespiratory Syncytial Virus InfectionChina
-
Sanofi Pasteur, a Sanofi CompanyCompletedRespiratory Syncytial Virus InfectionHonduras, United States, Chile
-
AbbVie (prior sponsor, Abbott)CompletedRespiratory Syncytial Virus InfectionJapan
-
Shanghai Ark Biopharmaceutical Co., Ltd.Ark Biosciences Pty Ltd.CompletedRESPIRATORY SYNCYTIAL VIRUS INFECTIONSAustralia, Hong Kong, Israel, Lebanon, Malaysia, Poland, Taiwan, Turkey
Clinical Trials on Blood sample collection
-
Poitiers University HospitalRecruitingPsoriasis | Psoriatic ArthritisFrance
-
Institut PasteurCentre Médical de l'Institut PasteurRecruiting
-
Emory UniversityMichael J. Fox Foundation for Parkinson's ResearchCompletedDefining a PD-specific Breath Fingerprint of Underlying Inflammatory and Neurodegenerative ProcessesParkinson's DiseaseUnited States
-
Masonic Cancer Center, University of MinnesotaCompletedAcute Leukemia | Chemotherapy-Induced Gut Barrier DamageUnited States
-
Masonic Cancer Center, University of MinnesotaCompletedAcute Myeloid LeukemiaUnited States
-
Benjamin GesundheitShaare Zedek Medical CenterRecruiting
-
Rennes University HospitalCompletedHistory of Exposure to Silica or Asbestosis | Positive Testing for ANA as a Marker of Systemic Autoimmune DiseasesFrance
-
Thomas Jefferson UniversityRecruitingBreast Cancer | Invasive Breast Cancer | Carcinoma in Situ of the BreastUnited States