Clinical trials: Maternal Immunization
Hepatitis B
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course…
- Trial name
- NCT00880477
- Testing
- DTPa-HBV-IPV/Hib vaccine, DTPa-IPV/Hib vaccine, EngerixTM-B
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pain, Anxiety
Effects of Mother-Sung Lullabies on Infant Pain and Maternal Anxiety
Childhood pain can cause long-term and psychologically harmful effects. Music can reduce pain and anxiety. This study aimed to investigate the effects of the mother-sung lullaby during vaccine administration on vaccine-induced…
- Trial name
- NCT04692584
- Testing
- The Lullaby Group
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mehmet Akif Ersoy University
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
Tuberculosis, HIV
Safety and Immunogenicity of MVA85A Prime and Bacille Calmette-Guerin Boost Vaccination
Rationale: The Bacille Calmette-Guérin (BCG) vaccine protects children against disseminated tuberculosis (TB) including TB meningitis and miliary TB, but efficacy against pulmonary TB is inconsistent among children and adults.
- Trial name
- MVA(TB)029 (NCT01650389)
- Testing
- MVA85A, Candin, BCG Vaccine SSI
- Where
- 2 sites in South Africa
- Volunteers
- 248 people
- Sponsor
- Mark Hatherill
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
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
Influenza Viral Infections
Effectiveness of Trivalent Inactivated Influenza Maternal Vaccination Among Pregnant Women and Their Newborns in South Africa
This is a case-control study embedded in a surveillance system to determine the effectiveness of antenatal maternal influenza vaccination against laboratory-confirmed influenza-associated hospitalised illness in infants <6 months…
- Trial name
- NCT02465190
- Where
- South Africa
- Volunteers
- 175 people
- Sponsor
- National Institute for Communicable Diseases, 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
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus
STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON)
This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical…
- Conditions
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease, Respiratory Tract Diseases
- Trial name
- STREETON (NCT07122661)
- Testing
- ABRYSVO
- Where
- Australia
- Volunteers
- 1 people
- Sponsor
- Pfizer
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
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
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
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
HIV-1
Prevention of Mother-to-child Transmission of HIV-1 Using a Responsive Intervention
The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue…
- Trial name
- PROMISE-EPI (NCT03870438)
- Testing
- Lamivudine Oral Solution
- Where
- 6 sites in Burkina Faso, Zambia
- Volunteers
- 1,506 people
- Sponsor
- ANRS, Emerging Infectious Diseases
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
HPV VACCINATION
Health Belief Model-based Education and Motivational Interview Regarding the HPV Vaccination Decision
This research is a single-blind, randomized, parallel-controlled experimental study designed to determine the effect of Health Belief Model (SIM)-based motivational interviews given to mothers of high school students on mothers'…
- Trial name
- NCT04992741
- Testing
- education and motivational interview
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Yasemin ATEŞEYAN
RSV Infection
A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the…
- Trial name
- NCT06866405
- Testing
- RSVpreF
- Where
- 97 sites in United States, Argentina and 2 more
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Pfizer