Clinical trials: Newborn Vaccine Immunogenicity
Rheumatoid Arthritis, Spondylitis, Ankylosing
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary…
- Conditions
- Rheumatoid Arthritis, Spondylitis, Ankylosing, Spondyloarthritis, Systemic Lupus Erythematosus
- Trial name
- RZVRheum (NCT05879419)
- Testing
- Recombinant Herpes Zoster Vaccine (RZV), MTX Discontinuation, MMF Discontinuation
- Where
- Brazil
- Volunteers
- 2,005 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Poliomyelitis
Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama
The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for…
- Trial name
- NCT05654467
- Testing
- Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine (nOPV3), Sabin Monovalent Oral Poliomyelitis Vaccine Type 3 (mOPV3)
- Where
- 3 sites in Panama
- Volunteers
- 1,532 people, healthy volunteers welcome
- Sponsor
- PATH
Tuberculosis
Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI…
- Trial name
- MTBVAC-Ph1b (NCT02729571)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Virus Disease, DNA Virus Infections
The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates
The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the Chinese health neonates.
- Conditions
- Virus Disease, DNA Virus Infections, Hepadnaviridae Infections
- Trial name
- NCT01183611
- Testing
- Experimental recombinant hepatitis B vaccine, HBIG, Active Comparator hepatitis B vaccine, Experimental recombinant hepatitis B vaccine
- Where
- China
- Volunteers
- 1,740 people
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
Safety Issues
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
- Trial name
- NCT03462108
- Testing
- Rotavirus (Bio Farma) Vaccine
- Where
- 4 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
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
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
Streptococcus Agalactiae Infection, Neonatal Sepsis
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like…
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis
- Trial name
- NCT06592586
- Testing
- GBS-NN/NN2 vaccine
- Where
- 6 sites in Denmark, South Africa
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
This randomized phase I trial studies the side effects of vaccine therapy in preventing cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor stem cell transplant.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Trial name
- NCT01588015
- Testing
- tetanus-CMV fusion peptide vaccine, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- City of Hope Medical Center
Sickle Cell Disease
Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
The purpose of this study is to measure whether PCV21 vaccine (investigational pneumococcal vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20vPCV…
- Trial name
- NCT07247188
- Testing
- PCV21, 20vPCV
- Where
- 7 sites in United States, Dominican Republic
- Volunteers
- 100 people
- Sponsor
- Sanofi
Pertussis, Diphtheria
Maternal Immunization With Tetanus Toxoid, Reduced Diphtheria Toxoid, Reduced-dose (2 µg) Recombinant Pertussis Vaccine (TdaP2gen) and Its Effect on the Immune Response in Thai Infants up to 15-18 Months Old
Pertussis remains a major global public health problem. In Thailand, pertussis vaccination is recommended during pregnancy at 20-32 weeks' gestation, together with routine childhood diphtheria-tetanus-pertussis vaccination…
- Conditions
- Pertussis, Diphtheria, Tetanus, Vaccine-Preventable Diseases
- Trial name
- M-PRIME (NCT07621341)
- Testing
- Maternal TdaP2gen vaccine, Infant Acellular Pertussis-containing Vaccine, Infant Whole-cell Pertussis-containing Vaccine
- Where
- Thailand
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Chiang Mai University
Tuberculosis
Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in Newborn Infants in South Africa
Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis (TB) for residents in endemic areas…
- Trial name
- NCT01479972
- Testing
- VPM1002, BCG
- Where
- South Africa
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
Down Syndrome
Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome
The purpose of this study is to test in adults with Down Syndrome the safety, tolerability and immunogenicity of a vaccine, ACI-24.
- Trial name
- 3-Star (NCT02738450)
- Testing
- ACI-24 low dose, ACI-24 high dose
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- AC Immune SA
Infections, Rotavirus
Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
- Trial name
- NCT01110044
- Testing
- 251154 vaccine, Infanrix hexa™, Synflorix™
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Dermatitis, Atopic, Hay Fever
Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.
- Trial name
- NCT00189917
- Testing
- IMVAMUNE (MVA-BN)
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Diphtheria, Pertussis
Pertussis Vaccine in Healthy Pregnant Women
The purpose of this study is to look at the safety and immunogenicity of a combination vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap).
- Conditions
- Diphtheria, Pertussis, Tetanus
- Trial name
- NCT00707148
- Testing
- Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
- Where
- 4 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
SARS-CoV2 Infection, Covid19
Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study
The PLAN-V Study is an Ontario-based prospective, longitudinal study that will consist of extensive biosampling and detailed data collection from pregnant women/individuals, who have received the COVID-19 vaccine during their…
- Conditions
- SARS-CoV2 Infection, Covid19, Vaccine Reaction, Pregnancy Related
- Trial name
- PLAN-V (NCT05115617)
- Where
- 7 sites in Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Ottawa Hospital Research Institute
Invasive Pneumococcal Infections, Sickle Cells Disease
Immunogenicity Study of an Anti-pneumococcal Vaccination Strategy in Patients With Sickle Cells Disease
Streptococcus pneumoniae is the major cause of bacterial infection in patients with sickle cells disease. The 23-valent pneumococcal polysaccharide vaccine (PSV) is supposed to be poorly immunogenic in these patients.
- Trial name
- DREVAC (NCT02274415)
- Testing
- Vaccination with the combined vaccine (Prevenar13 ®), Vaccination with the polysaccharide vaccine (Pneumo 23 ®)
- Where
- France
- Volunteers
- 116 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Duchenne Muscular Dystrophy, Spinal Muscular Atrophy
Flu Vaccine Study in Neuromuscular Patients 2011
The purpose of the study is to compare the immune response of two different injection methods (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine among patients with neuromuscular conditions who…
- Conditions
- Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Congenital Muscular Dystrophy
- Trial name
- NCT01422200
- Testing
- 2011-2012 seasonal flu vaccine Subcutaneous, 2011-2012 seasonal flu vaccine Intramuscular
- Volunteers
- 22 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Pneumococcal Infections, Streptococcus Pneumoniae
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants.
- Conditions
- Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- PCV-7 (NCT00273325)
- Where
- 10 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network