Clinical trials: Immunization
Yellow Fever Immunization
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and…
- Trial name
- NCT07103148
- Testing
- Yellow fever vaccine (live), Measles, combinations with mumps and rubella, live attenuated
- Where
- 15 sites in Honduras, Mexico and 1 more
- Volunteers
- 2,440 people, healthy volunteers welcome
- Sponsor
- Sanofi
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.
RSV Immunization
Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12…
- Trial name
- CORAL (NCT06397768)
- Testing
- RSVt vaccine, Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine, Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine
- Where
- 72 sites in United States, Mexico and 1 more
- Volunteers
- 2,226 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
Meningococcal Immunization, Healthy Volunteers
Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea
This surveillance is to investigate the safety profile of MenQuadfi®, when administered to participants aged 6 weeks to 55 years under the real-world clinical practice settings as per approved indications, including the Adverse…
- Trial name
- NCT07621653
- Testing
- Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine
- Where
- 9 sites in South Korea
- Volunteers
- 706 people, healthy volunteers welcome
- Sponsor
- Sanofi
Diptheria Immunization, Tetanus Immunization
Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV
In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing…
- Conditions
- Diptheria Immunization, Tetanus Immunization, Pertussis Immunization, Hepatitis B Immunization
- Trial name
- NCT06413121
- Testing
- Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV, Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV
- Where
- 11 sites in Bangladesh, India
- Volunteers
- 1,557 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
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
Pneumococcal Immunization
Study of the Safety 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 document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate…
- Trial name
- NCT06824194
- Testing
- PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine
- Where
- 132 sites in United States, Honduras and 4 more
- Volunteers
- 2,360 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
Pneumococcal Immunization, Safety
A Study to Learn More About Prevenar 20 Once it is Out in the Korean Market
The purpose of this study is to understand the safety of Prevenar 20 (Pneumococcal 20-valent conjugate vaccine) once it is out in the Korean market.
- Trial name
- NCT06760208
- Testing
- Pneumococcal 20-valent conjugate vaccine
- Where
- South Korea
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pneumococcal Immunization, Healthy Volunteers
Study 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
- NCT06975878
- Testing
- PCV21 vaccine, Vaxneuvance vaccine, Hexyon vaccine
- Where
- 49 sites in Belgium, Czechia and 6 more
- Volunteers
- 1,092 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
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
Immunization; Infection
Phase 3 Study of BK1310 in Healthy Infants
The purpose of this study is to: (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310. (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy…
- Trial name
- NCT02992925
- Testing
- DPT-IPV-Hib-High（Combined Vaccine）, DPT-IPV-Hib-Low（Combined Vaccine）, Hib vaccine
- Where
- 3 sites in Japan
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Immunization
Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants
The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.
- Trial name
- NCT03188692
- Testing
- DPT-IPV-Hib (Combined Vaccine)
- Where
- 3 sites in Japan
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization, Healthy Volunteers
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
Primary Objective: To provide serum samples (collected from participants before vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to Center for Biologics Evaluation and Research (CBER) for further…
- Trial name
- NCT04551677
- Testing
- Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation, Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization, Healthy Volunteers
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (>=) 65…
- Trial name
- NCT05050318
- Testing
- Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation, Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile…
- Trial name
- NCT05513053
- Testing
- Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
- Where
- 35 sites in United States, Czechia and 2 more
- Volunteers
- 1,308 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza Immunization
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the…
- Trial name
- NCT05513391
- Testing
- Recombinant influenza vaccine (RIV4), Quadrivalent influenza vaccine (IIV4)
- Where
- 31 sites in United States, Poland and 1 more
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company