Clinical trial NCT03614676: A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
Official title: A Prospective Epidemiological Study of Pregnancy Outcomes and of Events of Interest in Pregnant Women, Neonates and Infants (PEPNI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Syncytial Virus Infections
Keywords: third trimester
Respiratory Syncytial Virus (RSV) illness
Pregnancy
Maternal Immunization
Pregnant Women
Neonates
Respiratory Tract Illness
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 4493
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Maternal Subjects With Pregnancy Outcomes
timeFrame: From Day 1 up to Day 42 post delivery
measure: Number of Maternal Subjects With Pregnancy Related Events of Interest
timeFrame: From Day 1 up to Day 42 post-delivery
measure: Number of Infant Subjects With Neonatal Events of Interest
timeFrame: From birth up to Day 28 post-birth
Secondary outcomes:
measure: Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty
timeFrame: From Day 1 up to Day 42 post-delivery
measure: Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty
timeFrame: From birth through Day 28 of life
measure: Respiratory Syncytial Virus Type A (RSV-A) Neutralizing Antibody Titers in Maternal Blood
timeFrame: At delivery
measure: RSV-A Neutralizing Antibodies Titers in Cord Blood
timeFrame: At delivery
measure: 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
timeFrame: From birth up to 1 year of age
measure: Incidence Rates of Infant Subjects With RSV Hospitalizations
timeFrame: From birth up to 1 year of age
Other outcomes:
Locations:
city: Villanueva- Guaymallen
country: Argentina
facility: GSK Investigational Site
state: Mendoza
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Rio Cuarto
country: Argentina
facility: GSK Investigational Site
city: Dhaka
country: Bangladesh
facility: GSK Investigational Site
city: Dhaka
country: Bangladesh
facility: GSK Investigational Site
city: Belo Horizonte
country: Brazil
facility: GSK Investigational Site
state: Minas Gerais
city: Santa Maria
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Ribeirão Preto
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Cali
country: Colombia
facility: GSK Investigational Site
city: Medellin
country: Colombia
facility: GSK Investigational Site
city: Medellin
country: Colombia
facility: GSK Investigational Site
city: Santa Fe De Bogota
country: Colombia
facility: GSK Investigational Site
city: Villavicencio
country: Colombia
facility: GSK Investigational Site
city: Alor Setar
country: Malaysia
facility: GSK Investigational Site
city: Alor Setar
country: Malaysia
facility: GSK Investigational Site
city: Kota Kinabalu
country: Malaysia
facility: GSK Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: GSK Investigational Site
city: Kuching
country: Malaysia
facility: GSK Investigational Site
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Oaxaca
country: Mexico
facility: GSK Investigational Site
city: Chiriquí
country: Panama
facility: GSK Investigational Site
city: Juán Diaz
country: Panama
facility: GSK Investigational Site
city: La Chorrera
country: Panama
facility: GSK Investigational Site
city: Panama City
country: Panama
facility: GSK Investigational Site
city: Panamá
country: Panama
facility: GSK Investigational Site
city: Cebu
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Parow Valley
country: South Africa
facility: GSK Investigational Site
city: Soshanguve
country: South Africa
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiang Mai
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: