Clinical trials: Maternal Immunization
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
SARS-CoV-2 Infection, COVID-19
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability…
- Conditions
- SARS-CoV-2 Infection, COVID-19, Maternal Immunization
- Trial name
- NCT04754594
- Testing
- BNT162b2
- Where
- 90 sites in United States, Brazil and 3 more
- Volunteers
- 726 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
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 Chronic Infection, Pregnancy
Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand
Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV).
- Trial name
- iTAP (NCT01745822)
- Testing
- tenofovir disoproxil fumarate
- Where
- 17 sites in Thailand
- Volunteers
- 654 people
- Sponsor
- Institut de Recherche pour le Developpement
Group B Streptococcal Infection
Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women
This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women.
- Trial name
- NCT05154578
- Testing
- GBS-NN/NN2 Vaccine
- Where
- 10 sites in Denmark, South Africa and 1 more
- Volunteers
- 269 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
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
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
Hepatitis B
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™.
- Trial name
- NCT00240539
- Testing
- Blood sampling
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pregnancy, Postpartum Period
Sleep Disruption in New Mothers: An Intervention Trial
The purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant.
- Conditions
- Pregnancy, Postpartum Period, Sleep Disturbance
- Trial name
- MOMS (NCT01321710)
- Testing
- Sleep hygiene, Dietary information, Acetaminophen
- Where
- United States
- Volunteers
- 152 people
- Sponsor
- University of California, San Francisco
Influenza
TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations
The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be administered annually to all children aged 6 months to 18 years as well as women who are pregnant during the influenza season.
- Trial name
- NCT01146912
- Testing
- Text Message, automated call
- Where
- United States
- Volunteers
- 30,537 people
- Sponsor
- Columbia University
Diphtheria
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.
- Trial name
- NCT02757950
- Testing
- Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]
- Where
- Brazil
- Volunteers
- 2,462 people
- Sponsor
- GlaxoSmithKline
Immunization; Infection, Pregnancy Related
VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination
COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not…
- Conditions
- Immunization; Infection, Pregnancy Related, COVID-19
- Trial name
- NCT05570630
- Testing
- VAX-MOM COVID-19 Intervention, Standard of Care
- Where
- United States
- Volunteers
- 6,911 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Whooping Cough
Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States
The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.
- Trial name
- NCT03973905
- Testing
- Not applicable / dataset analysis
- Where
- Belgium
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women
The purpose of this research study is to learn more about the safety of 2 licensed flu vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women who are breastfeeding and to compare the immune…
- Trial name
- NCT01181323
- Testing
- Cold-adapted live attenuated influenza virus vaccine, trivalent, Trivalent inactivated influenza vaccine
- Where
- 6 sites in United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)