Clinical trials: Maternal Immunization
Pertussis
Maternal Pertussis Wholecell Responses
Pertussis is resurging worldwide. In Africa alone it is estimated that there are 2.1 million cases and 542,000 deaths from pertussis in infants under 1 year with the highest rates of morbidity and mortality in infants <3 months…
- Trial name
- WoMANPOWER (NCT04589312)
- Testing
- Standard of care vaccines, Boostagen, (BioNet-Asia)
- Where
- Uganda
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Respiratory Syncytial Virus (RSV), Maternal Vaccine Exposure
Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy
Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide.
- Conditions
- Respiratory Syncytial Virus (RSV), Maternal Vaccine Exposure, Attitude
- Trial name
- NCT03096574
- Testing
- Questionnaire
- Where
- 4 sites in United Kingdom
- Volunteers
- 1,025 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
HPV
Human Papillomavirus (HPV) Vaccination Acceptance by African-American Parents: Identifying Psychosocial Barriers
This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV vaccination among low-income, African-American teens.
- Trial name
- NCT00680147
- Testing
- brief informational intervention to promote HPV vaccine acceptance
- Where
- United States
- Volunteers
- 614 people, healthy volunteers welcome
- Sponsor
- Syracuse University
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
VACCINE HESITATION
VACCINE HESITATION
Vaccination is one of the gold standards in dealing with infectious diseases. The concept of vaccine hesitancy, which emerged with the emergence of vaccines and continues to maintain its place today, is one of the biggest…
- Trial name
- NCT06222996
- Testing
- vaccine hesitation training
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Yuzuncu Yil University
Tetanus, Tetanus Vaccine
Comparative Study of Two Tetanus Toxoid Vaccination Strategies: Cold Chain Versus Controlled Temperature Chain
The purpose of this study is to determine the effectiveness, safety and feasibility of a tetanus toxoid (TT) vaccination strategy relying on the maintenance of vaccines in a controlled temperature chain (CTC).
- Trial name
- NCT01559597
- Testing
- Tetanus toxoid vaccine
- Where
- Chad
- Volunteers
- 2,129 people, healthy volunteers welcome
- Sponsor
- Epicentre
Influenza
Influenza Vaccine Trial in HIV Uninfected Pregnant Women
Randomised, double blind, placebo controlled trial to assess safety, immunogenicity and efficacy of Trivalent Influenza vaccine in HIV uninfected pregnant women
- Trial name
- MatfluHIVneg (NCT01306669)
- Testing
- Trivalent influenza vaccine, Normal saline
- Where
- South Africa
- Volunteers
- 2,116 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Covid19
Impact of Maternal COVID-19 Disease on Breast Milk and Infant Health
prospective multicenter study The main aim is to study the impact of maternal COVID-19 on breast milk immune, microbiological, and metabolic profile and infant growth and development
- Trial name
- MilkCorona (NCT04768244)
- Testing
- maternal SARS-CoV-2 infection
- Where
- 2 sites in Spain
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Institute of Agrochemistry and Food Technology, National Research Council
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
Maternal Infection Affecting Newborn
Impact of Helminth Infections During Pregnancy on Humoral Vaccine Immunogenicity in Infants
Helminth infection is associated with low vaccine immunogenicity. Pregnant women are particularly sensitive to helminth infection.
- Trial name
- NCT02714348
- Testing
- Effect of helminth infection on vaccine immunogenicity
- Volunteers
- 323 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Death, Infant, Morbidity;Infant
Trial to Compare Two Strains of BCG
The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare BCG-Japan versus BCG-Russia 1:1 in 15,000 infants with respect to…
- Trial name
- STRAIN III (NCT04383925)
- Testing
- BCG-Japan, BCG-Russia
- Where
- Guinea-Bissau
- Volunteers
- 16,390 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Pregnancy Related
Iron and Immune Response to Vaccine (IRONMUM)
Iron deficiency causes anaemia and is common in pregnant women especially for those living in tropical regions where a high burden of infection and poor nutrition can compromise health.
- Trial name
- IRONMUM (NCT05385042)
- Testing
- Sangobion and Thiamine Hydrochloride, Sangobion, Thiamine hydrochloride and Vitamin B12
- Where
- Thailand
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Neonate, Maternal Transmission
Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC
This Phase 3 open-label study aims to assess the safety and immune response of the MVA-BN mpox vaccine when administered subcutaneously to pregnant and postpartum women in the Democratic Republic of the Congo (DRC), a population…
- Conditions
- Neonate, Maternal Transmission, Mpox, Vaccination
- Trial name
- PregInPoxVac (NCT06844500)
- Testing
- MVA-BN standard regimen, MVA-BN standard regimen (Administered as PEP)
- Where
- Democratic Republic of the Congo
- Volunteers
- 359 people, healthy volunteers welcome
- Sponsor
- Jean-Pierre Van geertruyden
Whooping Cough, Maternal Vaccine Exposure
Immunising Mums Against Pertussis 3
This study will aim to recruit at least 70 children who participated in the iMAP2 study whose mothers received a pertussis vaccine in pregnancy as part of the iMAP2 trial and at least 15 children born to mothers who did not…
- Conditions
- Whooping Cough, Maternal Vaccine Exposure, Immunization; Infection
- Trial name
- iMAP3 (NCT03578120)
- Testing
- Pre-school booster vaccine
- Where
- 3 sites in United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Middle Ear Effusion, Tympanic Membrane Perforation
PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers
PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can prevent ear disease in infants.
- Conditions
- Middle Ear Effusion, Tympanic Membrane Perforation, Acute Otitis Media, Pneumococcal Infections
- Trial name
- PneuMum (NCT00714064)
- Testing
- 23vPPV, dTpa (Pneumovax, Boostrix)
- Where
- Australia
- Volunteers
- 227 people, healthy volunteers welcome
- Sponsor
- Menzies School of Health Research
Respiratory Syncytial Virus Infection
The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children <5 years of age worldwide.
- Trial name
- NCT06551506
- Testing
- Abrysvo, Beyfortus
- Where
- 8 sites in United States
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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
Low Birth Weight Infants, Preterm Infants
Predictors and Outcomes of Kangaroo Mother Care: A Quasi-Experimental Study in Pakistan
This quasi-experimental study evaluated the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on the growth, developmental milestones, breastfeeding, vaccination, and mortality of low birth weight infants in…
- Trial name
- NCT06559020
- Testing
- Kangroo mother care
- Where
- Pakistan
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Services Institute of Medical Sciences, Pakistan