Clinical trials: Maternal Immunization
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
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
Influenza Human
Field Trial of Maternal Influenza Immunization in Asia
This project is designed to assess the efficacy of immunizing women during pregnancy with influenza vaccine on the health of these women during their pregnancy and for 6 months post-partum as well as on the health of their…
- Trial name
- Mothers'Gift (NCT01034254)
- Testing
- influenza vaccine
- Where
- Nepal
- Volunteers
- 3,693 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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)
Infant, Pain
Kangaroo Care Reduces Infant Pain Caused By Vaccination
The aim of this randomized controlled study determine the effect of KMC on pain in infants during vaccination.
- Conditions
- Infant, Pain, Kangaroo Mother Care, Nursing
- Trial name
- NCT04596137
- Testing
- İnfant pain management
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Eskisehir Osmangazi University
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
COVID-19 Vaccines
Impact of Maternal COVID-19 Vaccines on Breast Milk
prospective multicenter study The main aim is to study the impact of maternal COVID-19 vaccination on breast milk immune, microbiological, and metabolic profile.
- Trial name
- MilkCorona (NCT04751734)
- Testing
- Covid vaccines
- Where
- 2 sites in Spain
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Institute of Agrochemistry and Food Technology, National Research Council
Influenza, Whooping Cough
Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake
The purpose of this study is to evaluate the AFIX-OB model to determine its impact on the change in flu and pertussis (Tdap) uptake, provider knowledge, attitudes and beliefs, and patient knowledge, attitudes and beliefs…
- Trial name
- AFIX-OB (NCT04678271)
- Testing
- AFIX-OB Quality Improvement Package
- Where
- United States
- Volunteers
- 202 people, healthy volunteers welcome
- Sponsor
- Yale University
Pregnancy, Neonatal Mortality
Scalable Public Health Empowerment, Research, and Education Sites (SPHERES)
SPHERES is a health service research trial in the Indonesian primary care system designed to improve health system performance using a structured data-driven action model.
- Conditions
- Pregnancy, Neonatal Mortality, Tuberculosis, Hepatitis B
- Trial name
- SPHERES (NCT07126041)
- Testing
- Prescription for Action (SPHERES Model)
- Where
- 2 sites in Indonesia
- Volunteers
- 1,750,000 people, healthy volunteers welcome
- Sponsor
- Oxford University Clinical Research Unit Indonesia
H1N1v Influenza
H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A H1N1v Vaccination in Pregnant Women
Pregnant women are at particular risk during the imminent H1N1v influenza pandemic. The new H1N1v virus requires urgent political and medical decisions on vaccination strategies in order to minimize severe disease and death from…
- Trial name
- NCT01012557
- Testing
- Focetria
- Where
- 2 sites in Denmark
- Volunteers
- 296 people, healthy volunteers welcome
- Sponsor
- Copenhagen Studies on Asthma in Childhood
Pertussis, Whooping Cough
Maternal Tdap Immunization in Guatemala
Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) is a potential strategy to protect young infants against pertussis before they are fully vaccinated because maternal…
- Trial name
- NCT02301702
- Testing
- Tdap, Td
- Where
- Guatemala
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- Emory University
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 of Safety, Reactogenicity and Immune Response of the Repeat Vaccination Against RSV When Given to Female Participants of 18-49 Years of Age During Their Subsequent Uncomplicated Pregnancy
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a single intramuscular dose of the investigational respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine during subsequent…
- Trial name
- NCT05229068
- Testing
- RSV MAT
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal
Maternal Immunization With MenAfriVac™
The World Health Organization (WHO) recommends that infants receive a single dose of the meningococcal serogroup A-tetanus toxoid conjugate vaccine, MenAfriVac, when they reach at least 9 months of age.
- Trial name
- NCT03746665
- Testing
- meningococcal serogroup A conjugate vaccine
- Where
- The Gambia
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Under Five Child Health Nutrition and Immunization
Naunehal - Integrated Immunization & MNCH Interventions; A Quasi-Experimental Study
Maternal, newborn, and child health (MNCH) are an area of concern in Pakistan with many health and nutrition indicators at sub-optimal levels.
- Trial name
- NCT05135637
- Testing
- Mobile health services, Private practitioner engagement for immunization, Community engagement and mobilization
- Where
- Pakistan
- Volunteers
- 8,100 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Microbial Colonization
Lactamica 9: Neisseria Lactamica Inoculation in Late Pregnancy
Bacteria living in the nose and throat are generally harmless, but in some circumstances cause infections of the lungs (pneumonia) and brain (meningitis), which are among the commonest causes of death worldwide in young children…
- Trial name
- NCT04784845
- Testing
- N. lactamica Y92-1009
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Southampton
HIV Infections, Neonatal Infection
Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
Maternal infections affect the basal immune status of neonates. One of the possible mechanism is the fetomaternal microchimerism, in which some cells and active substances are exchanged bi-directionally between maternal and fetal…
- Conditions
- HIV Infections, Neonatal Infection, LTBI - Latent Tuberculosis Infection, Immune Tolerance
- Trial name
- IMMUNEO (NCT03383211)
- Testing
- RNAseq
- Where
- 2 sites in Moldova
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- George Washington University
Procedural Pain
Analgesic Properties of Oral Sucrose During Immunizations
The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute…
- Trial name
- NCT00446875
- Testing
- Administration of oral Sucrose
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Milton S. Hershey Medical Center
Pertussis
Pertussis Immunization During Pregnancy: Effect in Term and Preterm Infants
Young infants are most vulnerable to severe disease and even death when infected with Bordetella Pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates.
- Trial name
- MAMA (NCT02511327)
- Testing
- Infant pertussis vaccination
- Where
- Belgium
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Universiteit Antwerpen
Obesity
Optimising Protection for Pregnant Women and Infants With Maternal Vaccination
This study has been designed to investigate if: 1. BMI affects the immunogenicity of influenza and pertussis vaccines given during pregnancy. 2.
- Trial name
- OPTIWIN (NCT03457194)
- Testing
- Quadrivalent Influenza Vaccine, DTP Vaccine (Multiple Actives)
- Where
- Australia
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Women's and Children's Hospital, Australia