Clinical trials: Infant Immunizations, active
Respiratory Syncytial Virus, Respiratory Tract Diseases
Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy
This study will be conducted in collaboration with a research network of independent hospital sites to evaluate the vaccine effectiveness (VE) and impact of ABRYSVO vaccination during pregnancy in a real-world population over…
- Trial name
- BERNI (NCT06647654)
- Testing
- ABRYSVO
- Where
- Argentina
- Volunteers
- 1 people
- Sponsor
- Pfizer
Pneumococcal Immunization, Healthy Volunteers
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies"…
- Trial name
- NCT07348692
- Testing
- PCV21 vaccine, 20vPCV licensed vaccine
- Where
- 25 sites in United States, Honduras and 2 more
- Volunteers
- 2,195 people, healthy volunteers welcome
- Sponsor
- Sanofi
Acute Bronchiolitis
Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants
Acute bronchiolitis in infants, mainly caused by the Respiratory Syncytial Virus (RSV), is a public health issue, in terms of morbidity and hospital costs.
- Trial name
- EBINIR (NCT06636955)
- Testing
- biobank, follow up
- Where
- France
- Volunteers
- 900 people
- Sponsor
- University Hospital, Rouen
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
Respiratory Syncytial Virus Infections, Severe Acute Respiratory Infection
Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá
This study aims to evaluate the real-world effectiveness of two preventive immunization strategies against Respiratory Syncytial Virus (RSV)-associated severe acute respiratory infection in infants less than six months of age in…
- Conditions
- Respiratory Syncytial Virus Infections, Severe Acute Respiratory Infection, Bronchiolitis, Viral, Viral Respiratory Tract Infection
- Trial name
- NCT07279298
- Testing
- RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed
- Where
- Colombia
- Volunteers
- 1,097 people
- Sponsor
- Bogotá District Health Secretariat
Poliomyelitis
Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations
The goal of this clinical study is to compare the immunogenicity and safety of one dose of sIPV in adolescents or adults aged 7-50 years with that of three doses of DTaP-IPV-Hib Pentavalent Vaccine in Infants Aged 3 Months
- Trial name
- NCT07354269
- Testing
- sIPV, DTaP-IPV-Hib
- Where
- 3 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Pneumococcal Disease, Invasive
Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants
Phase 2 trial to evaluate safety and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in Healthy Infants
- Trial name
- NCT06790290
- Testing
- Formulation B, Formulation C, Formulation D
- Where
- 3 sites in Philippines
- Volunteers
- 421 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Healthy
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
- Trial name
- NCT07160244
- Testing
- Multivalent Group B streptococcus vaccine, Infanrix hexa, Prevenar 20
- Where
- 219 sites in United States, Argentina and 13 more
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pneumococcal Immunization
Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called…
- Trial name
- NCT06824181
- Testing
- PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine
- Where
- 27 sites in United States, Chile and 2 more
- Volunteers
- 580 people, healthy volunteers welcome
- Sponsor
- Sanofi
Infant, Newborn, Immunity
The Bloom Infant Probiotic (BIP) Study
The goal of this clinical trial is to investigate whether administering a probiotic (Infloran®) to infants who received antibiotics in the first 28 days of life can restore or enhance their immune response to routine vaccines.
- Conditions
- Infant, Newborn, Immunity, Immunisation, Antibiotic Treatment
- Trial name
- BIP (NCT07189390)
- Testing
- Probiotic
- Where
- 2 sites in Australia
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- South Australian Health and Medical Research Institute
RSV Immunization
Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India
The purpose of this study is to describe the safety and efficacy outcomes associated with the use of nirsevimab, administered as per routine clinical practice, in neonates and infants aged 0 to 12 months born during or entering…
- Trial name
- NCT07109297
- Testing
- Nirsevimab
- Where
- 7 sites in India
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Sanofi
Infant Wheeze, Preschool Age Children
The Effectiveness of Early Immunisation With Nirsevimab on Preschool Wheezing in France, Based on an Analysis of Data From the French Health System Database.
Early respiratory syncytial virus (RSV) bronchiolitis is a well-known contributing factor of mid- and long-term respiratory sequelae in children such as recurrent lower tract respiratory infections (LRTIs), preschool wheezing…
- Conditions
- Infant Wheeze, Preschool Age Children, Asthma Childhood
- Trial name
- INSPIRATION (NCT07317141)
- Testing
- Effectiveness of passive immunization with nirsevimab
- Where
- France
- Volunteers
- 218,000 people
- Sponsor
- Hospices Civils de Lyon
Pneumococcal Immunization
Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called…
- Trial name
- NCT06736041
- Testing
- PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine
- Where
- 112 sites in United States, Australia and 4 more
- Volunteers
- 1,714 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
RSV Immunization
Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination
RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months.
- Trial name
- PIPELINE-RSV-F (NCT07232706)
- Testing
- Nirsevimab, Abrysvo
- Where
- France
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Annecy Genevois
Diptheria Immunization, Tetanus Immunization
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
This is a Phase I/II, double-blind, randomized, active controlled, multi-centric clinical trial to assess the reactogenicity, safety and immunogenicity of a SIIPL DTwP-HepB-rPV-Hib vaccine in comparison with HEXASIIL® in healthy…
- Conditions
- Diptheria Immunization, Tetanus Immunization, Pertussis Immunization, Hepatitis B Immunization
- Trial name
- NCT07855172
- Testing
- Hexavalent (DTwP-HepB-rPV-Hib) Vaccine, HEXASIIL
- Where
- Bangladesh
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
HPV Vaccine
Strengthening HPV Immunization Through EPI Leveraged Delivery
This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9…
- Trial name
- SHIELD (NCT07377656)
- Testing
- HPV vaccine, Measles and rubella Vaccine
- Where
- Ghana
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
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
Meningococcal Immunization, Healthy Volunteers
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age.
- Trial name
- NCT06647407
- Testing
- Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine, Meningococcal group B vaccine
- Where
- 39 sites in Brazil, Czechia and 7 more
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Syncytial Virus (RSV), Respiratory Infection Virus
THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness
RSV is a leading cause of severe respiratory illness and hospitalisation for young children, with particularly high rates of RSV respiratory infection observed amongst Aboriginal and Torres Strait Islander children living in…
- Trial name
- THRIVE (NCT07578298)
- Testing
- Nirsevimab (RSV-specific monoclonal antibody)
- Where
- Australia
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Menzies School of Health Research
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
- Where
- 8 sites in Brazil
- Volunteers
- 5,000 people
- Sponsor
- Inova Medical