Clinical trials: Newborn Vaccine Immunogenicity
Atopic Dermatitis
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
- Trial name
- NCT00316602
- Testing
- IMVAMUNE
- Where
- 22 sites in United States, Mexico
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Arsenic--Toxicology, Immunologic Disorders Complicating Pregnancy
Pregnancy, Arsenic and Immune Response
As the global availability of vaccines increases, and reaches areas disproportionately affected by arsenic and malnutrition, resolving questions about potential environmental and biologic barriers to maternal immunization has…
- Conditions
- Arsenic--Toxicology, Immunologic Disorders Complicating Pregnancy, Vaccine Response Impaired, Micronutrient Deficiency
- Trial name
- PAIR (NCT03930017)
- Testing
- Seasonal influenza vaccine - VAXIGRIP TETRA influenza vaccine (quadrivalent, split virion, inactivated)
- Where
- Bangladesh
- Volunteers
- 784 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Poliomyelitis
Clinical Trial of Novel OPV2 Vaccine
Though OPV is safe and effective, it can mutate and reacquire neurovirulence in rare circumstances. This can result in vaccine-associated paralytic polio and circulating vaccine-derived polioviruses.
- Trial name
- NCT04693286
- Testing
- novel oral polio type 2 vaccine (nOPV2)
- Where
- Bangladesh
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
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)
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
Poliomyelitis
Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
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
- NCT05644184
- Testing
- Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1), Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
- Where
- Bangladesh
- Volunteers
- 2,232 people, healthy volunteers welcome
- Sponsor
- PATH
Streptococcus Agalactiae Infection, Neonatal Sepsis
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
The main objective of the Phase 2 part of the trial is to assess the immunogenicity of GBS-NN/NN2 vaccine at birth in infant participants and to determine the occurrence of serious adverse events (SAEs) and adverse event of…
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis
- Trial name
- MOTIVATION (NCT07922226)
- Testing
- GBS-NN/NN2 vaccine
- Volunteers
- 6,600 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Diphtheria, Hepatitis B
Pentavalent DTaP-Hep B-IPV
The purpose of this study is to evaluate the safety of administering a combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration of a HepB vaccine at birth and the same…
- Conditions
- Diphtheria, Hepatitis B, Poliomyelitis, Pertussis
- Trial name
- NCT00133445
- Testing
- DTaP-Hep B-IPV Vaccine, Monovalent Hep B Vaccine
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Meningococcal Disease
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement…
- Trial name
- NCT02141516
- Testing
- rMenB+OMV
- Where
- 20 sites in Italy, Poland and 3 more
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Novartis
Smallpox, Atopic Dermatitis
Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with a history of mild to moderate Atopic Dermatitis.
- Trial name
- NCT00389103
- Testing
- MVA (smallpox vaccine)
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240526
- Testing
- Engerix™ -B, Hepatitis B immunoglobulin (HBIg)
- Where
- Thailand
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Dermatitis, Atopic
Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study
Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People who have atopic dermatitis often have complications from skin infections; these can include eczema herpeticum…
- Trial name
- NCT01737710
- Testing
- Fluzone® Intradermal Vaccine, Fluzone® (Intramuscular) vaccine
- Where
- 5 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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
Autosomal-dominant Hyper-IgE Syndrome
Safety, Tolerability, and Immunogenicity of One Dose of NDV 3A Vaccine in People With STAT3-Mutated Hyper-IgE Syndrome
Background: AD-HIES is a disease that weakens the immune system. It puts people at risk for infections, particularly Staph and Candida infections.
- Trial name
- NCT02996448
- Testing
- NDV-3A
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Poliomyelitis
Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines
The main objectives of this study are to : evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines…
- Trial name
- NCT06137664
- Testing
- Novel oral poliomyelitis vaccine type 1 (nOPV1), Novel oral poliomyelitis vaccine type 2 (nOPV2), Novel oral poliomyelitis vaccine type 3 (nOPV3)
- Where
- 2 sites in Bangladesh
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- PATH
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
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
Measles, Rubella
Measles-Rubella Vaccine Immunogenicity at 6 and 9 Months of Age
This is an open-label, randomized, 2-arm clinical trial in healthy infants in Bangladesh. The primary purpose of the study is to assess the immunogenicity of measles-rubella (MR) vaccine when delivered at 6 months.
- Conditions
- Measles, Rubella, Rubella Syndrome, Congenital
- Trial name
- NCT03071575
- Testing
- Measles-rubella (MR) vaccine at 6 months of age, Measles-rubella (MR) vaccine at 9 months of age
- Where
- Bangladesh
- Volunteers
- 637 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention