Clinical trials: Maternal Immunization
RSV Infection
Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants in France
Bronchiolitis is a viral lower respiratory tract infection, caused in 50 to 80% of cases by the respiratory syncytial virus (RSV).
- Trial name
- SPIRAV (NCT06881953)
- Testing
- Questionnaire
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Pertussis, Vaccination
Maternal Antibody in Milk After Vaccination
Single-centre observational pilot study exploring pertussis specific antibody concentration in the breastmilk of women vaccinated against pertussis in pregnancy at different gestational ages.
- Conditions
- Pertussis, Vaccination, Pregnancy, Breastmilk
- Trial name
- MAMA (NCT03982732)
- Testing
- Boostrix-IPV
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- St George's, University of London
Vaccination; Infection, Maternal-Fetal Relations
Maternal Determinants of Immunity to Influenza
The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.
- Conditions
- Vaccination; Infection, Maternal-Fetal Relations, Influenza, Immunoglobulins
- Trial name
- MADI-01 (NCT06716567)
- Testing
- Influenza vaccine
- Where
- Belgium
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
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
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
Preparing for Maternal GBS Vaccine Trials in Africa
Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life.
- Conditions
- Group B Streptococcus, Invasive Bacterial Diseases (IBD), Maternal Immunization
- Trial name
- PROTECT (NCT06833957)
- Where
- 10 sites in Kenya, Malawi and 2 more
- Volunteers
- 18,100 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
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
Pain, Breast Feeding
Non-Pharmacological Methods for Reducing Pain During Vaccination in Infants
Pain management in infants is a medical responsibility of all members of the healthcare team, and nurses hold a privileged role in this regard.
- Conditions
- Pain, Breast Feeding, Maternal Behavior
- Trial name
- NCT06886412
- Testing
- Maternal Holding Intervention Group, Breast Feeding Intervention Group
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of Yalova
Vaccine Hesitancy
Impact of Supportive Vaccine Communication on Vaccine Desicion Processes
This research will be carried out as a randomized controlled study with a waitlist in parallel design to evaluate the effect of Supportive Vaccine Communication using Motivational Interviewing on the level of vaccination…
- Trial name
- NCT06680414
- Testing
- Supportive Vaccine Communication Using Motivational Interviewing
- Where
- Turkey (Türkiye)
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Artvin Coruh University
Influenza
Vitamin A and Maternal-infant Flu Vaccine Response
Influenza viral infection can cause serious illness among young infants 0-6 months of age. However, inactivated influenza vaccine is not recommended for this age group but pregnant women can be vaccinated during 2nd - 3rd…
- Trial name
- NCT00817661
- Testing
- Vitamin A
- Where
- Bangladesh
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
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
Respiratory Syncytial Virus (RSV), Maternal Immunization
TARSILA Real-World Evidence Study
The overall objective of Tarsila Study is to estimate the real-world vaccine effectiveness of maternal RSVpreF immunization during pregnancy in Brazil against medically attended (inpatient and outpatient) respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus (RSV), Maternal Immunization, Acute Respiratory Illness (ARI), Lower Respiratory Tract Disease
- Trial name
- TARSILA (NCT07445763)
- Testing
- respiratory syncytial virus bivalent prefusion F vaccine
- Volunteers
- 5,000 people
- Sponsor
- Inova Medical
Respiratory Syncytial Virus Infections
Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset
This study will use a retrospective cohort design and will be conducted within routinely collected national healthcare and statutory demographic datasets held by PHS and National Records of Scotland (NRS).
- Trial name
- BORLAND (NCT07235397)
- Testing
- ABRYSVO
- Volunteers
- 1 people
- Sponsor
- Pfizer
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
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
Hepatitis B, Pregnancy
Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection
Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months…
- Trial name
- NCT03343431
- Testing
- Anti-HBV antiviral prophylaxis
- Where
- 20 sites in Laos, Thailand
- Volunteers
- 504 people
- Sponsor
- Institut de Recherche pour le Developpement
Pregnancy
Observational Maternal COVID-19 Vaccination Study
This is a prospective, observational study. During the study, pregnant women will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days…
- Trial name
- NCT04826640
- Testing
- Observational
- Where
- 4 sites in United States
- Volunteers
- 146 people
- Sponsor
- Duke University
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
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
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