Clinical trials: Maternal
Hepatitis B
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240500
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Preterm Delivery, Inadequate Milk Production
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Induction and support of lactation in women with preterm delivery and inadequate milk production.
- Trial name
- MERMAID (NCT02545127)
- Testing
- Merotocin
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals
Respiratory Syncytial Virus Infections
A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA).
- Trial name
- NCT05045144
- Testing
- RSVPreF3(120 μg), Flu Quadrivalent influenza vaccine (15 μg HA)
- Where
- 36 sites in United States, Canada and 3 more
- Volunteers
- 1,586 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study.
- Trial name
- NCT05705440
- Testing
- RSVPreF3 vaccine, Control
- Where
- 138 sites in United States, Argentina and 21 more
- Volunteers
- 3,855 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240526
- Testing
- Engerix™ -B, Hepatitis B immunoglobulin (HBIg)
- Where
- Thailand
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pregnancy
Maternal Fetal Device Performance Singleton
Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which supports the decision making for pregnant women and the overall fetal health…
- Trial name
- NCT06726343
- Testing
- Fetal Monitoring Device, Investigational Fetal Monitoring Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- GE Healthcare
Fetal Monitoring
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation.
- Trial name
- NST (NCT04915131)
- Testing
- Bloomlife MFM-Pro
- Where
- 2 sites in United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Bloom Technologies
Respiratory Syncytial Virus Infections
A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers
The purpose of this study was to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in…
- Trial name
- GRACE (NCT04605159)
- Testing
- RSV MAT
- Where
- 159 sites in United States, Argentina and 22 more
- Volunteers
- 11,194 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obstetric Labour, Premature
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide…
- Trial name
- ARIOS (NCT02292784)
- Testing
- Retosiban, Atosiban
- Where
- 26 sites in United States, Belgium and 9 more
- Volunteers
- 98 people
- Sponsor
- GlaxoSmithKline
Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration…
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease
- Trial name
- CRADLE (NCT02154425)
- Testing
- Breast milk sampling, Certolizumab Pegol
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 17 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Acellular Pertussis, Tetanus
Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA…
- Conditions
- Acellular Pertussis, Tetanus, Poliomyelitis, Diphtheria
- Trial name
- NCT02422264
- Testing
- Infanrix hexa, Prevnar13
- Where
- 30 sites in Australia, Canada and 4 more
- Volunteers
- 601 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers
The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the…
- Trial name
- NCT04980391
- Testing
- RSV MAT
- Where
- 35 sites in United States, Brazil and 7 more
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age
The purpose of this study was to evaluate the reactogenicity, safety and immune response of a single intramuscular dose of the respiratory syncytial virus maternal (RSV MAT) vaccine in healthy non-pregnant girls 9-17 years of age…
- Trial name
- NCT05169905
- Testing
- RSV MAT vaccine, dTpa vaccine
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pregnancy
Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer…
- Trial name
- NCT01400880
- Testing
- Electrode-based Sensor
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Convergent Engineering, Inc.
Respiratory Tract Infection
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in…
- Trial name
- NCT04424316
- Testing
- RSVpreF
- Where
- 464 sites in United States, Argentina and 16 more
- Volunteers
- 14,727 people, healthy volunteers welcome
- Sponsor
- Pfizer
Respiratory Syncytial Virus Infections
A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization
The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined…
- Trial name
- NCT02624947
- Testing
- RSV F vaccine with adjuvant, Formulation buffer
- Where
- 88 sites in United States, Argentina and 9 more
- Volunteers
- 4,636 people, healthy volunteers welcome
- Sponsor
- Novavax
Respiratory Syncytial Virus Infections
A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women
The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data.
- Trial name
- NCT03674177
- Testing
- GSK3888550A RSV Maternal vaccine formulation 1, GSK3888550A RSV Maternal vaccine formulation 2, GSK3888550A RSV Maternal vaccine formulation 3
- Where
- 11 sites in United States, Finland and 1 more
- Volunteers
- 502 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Hepatitis B
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks.
- Conditions
- Diphtheria, Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT02853929
- Testing
- Infanrix hexa
- Where
- 29 sites in Australia, Canada and 4 more
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
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.
- Trial name
- PEPNI (NCT03614676)
- Testing
- Blood sample collection, Cord blood sample collection, Maternal Diary Card
- Where
- 40 sites in Argentina, Bangladesh and 8 more
- Volunteers
- 4,493 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA
A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta
The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of…
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease
- Trial name
- CRIB (NCT02019602)
- Testing
- Blood sampling from mother, Blood sampling from infant, Blood sampling from umbilical cord
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 37 people
- Sponsor
- UCB BIOSCIENCES, Inc.