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Rotavirus vaccine

Generic Name
Rotavirus vaccine
Brand Names
Rotarix, Rotateq
Drug Type
Biotech
Background

Rotavirus commonly infects children and infants causing severe diarrhea and vomiting leading to potentially fatal dehydration. Two rotavirus vaccines are available for the prevention of rotavirus gastroenteritis, Rotateq and Rotarix. Rotateq is a live vaccine consisting of 5 reassorted human-bovine viral strains. Rotarix is a live attenuated vaccine containing the 89-12 human strain. Rotavirus vaccines are 90% effective in protecting against severe rotavirus infection.

Indication

Rotarix is indicated for prevention of rotavirus gastroenteritis caused by G1, G3, G4, and G9 types in infants aged 6-24 weeks .

Rotateq is indicated for the prevention of rotavirus gastroenteritis caused by G1, G2, G3, G4, and G9 types in infants aged 6-32 weeks .

Associated Conditions
Rotavirus Gastroenteritis caused by rotavirus G1, Rotavirus Gastroenteritis caused by rotavirus G2, Rotavirus Gastroenteritis caused by rotavirus G3, Rotavirus Gastroenteritis caused by rotavirus G4, Rotavirus Gastroenteritis caused by rotavirus G9

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Phase 3
Recruiting
Conditions
Pneumococcal Immunization
Interventions
First Posted Date
2025-02-13
Last Posted Date
2025-04-17
Lead Sponsor
Sanofi
Target Recruit Count
2320
Registration Number
NCT06824194
Locations
🇭🇳

Investigational Site Number : 3400003, Tegucigalpa, Honduras

🇵🇷

Investigational Site Number : 6300002, Bayamon, Puerto Rico

🇭🇳

Investigational Site Number : 3400001, San Pedro Sula, Honduras

and more 38 locations

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

Phase 3
Recruiting
Conditions
Pneumococcal Immunization
Interventions
First Posted Date
2025-02-13
Last Posted Date
2025-05-09
Lead Sponsor
Sanofi
Target Recruit Count
580
Registration Number
NCT06824181
Locations
🇺🇸

The Medici Medical Research- Site Number : 8400008, Hollywood, Florida, United States

🇺🇸

Atlantis Clinical Research, LLC- Site Number : 8400009, Miami, Florida, United States

🇺🇸

Helios- Site Number : 8400016, Burleson, Texas, United States

and more 8 locations

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Phase 3
Recruiting
Conditions
Pneumococcal Immunization
Interventions
Biological: PCV21 vaccine
Biological: Prevnar 20 vaccine
Biological: M-M-R II vaccine
Biological: Hexaxim Vaccine
First Posted Date
2024-12-16
Last Posted Date
2025-05-20
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
Target Recruit Count
1630
Registration Number
NCT06736041
Locations
🇺🇸

Eclipse Clinical Research- Site Number : 8400029, Tucson, Arizona, United States

🇺🇸

Northwest Arkansas Pediatrics- Site Number : 8400030, Fayetteville, Arkansas, United States

🇺🇸

Century Research Institute- Site Number : 8400065, Huntington Park, California, United States

and more 67 locations

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants

Phase 1
Recruiting
Conditions
Meningococcal Immunization
Healthy Volunteers
Interventions
First Posted Date
2024-10-17
Last Posted Date
2025-05-13
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
Target Recruit Count
750
Registration Number
NCT06647407
Locations
🇩🇰

Investigational Site Number : 2080002, Hvidovre, Denmark

🇨🇿

Investigational Site Number : 2030007, Plzeň, Czechia

🇨🇿

Investigational Site Number : 2030004, Ostrava, Czechia

and more 15 locations

Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers

Phase 3
Active, not recruiting
Conditions
RSV Immunization
Interventions
Biological: Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine
Biological: Streptococcus pneumoniae vaccine
Biological: Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine
Biological: Measles, mumps, and rubella vaccine
Biological: Varicella virus vaccine
Biological: Placebo
First Posted Date
2024-05-03
Last Posted Date
2025-01-14
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
Target Recruit Count
2226
Registration Number
NCT06397768
Locations
🇲🇽

Investigational Site Number : 4840004, Mexico City, Mexico

🇵🇷

Investigational Site Number : 6300004, Trujillo Alto, Puerto Rico

🇺🇸

South Alabama Medical Clinic- Site Number : 8400065, Grand Bay, Alabama, United States

and more 64 locations

Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

Phase 3
Active, not recruiting
Conditions
Meningococcal Immunisation
Healthy Volunteers
Interventions
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Biological: Pneumoccocal Vaccine
Biological: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)
Biological: Measles, Mumps, and Rubella Vaccine live (MMR)
Biological: DTaP-IPV-Hib-HepB vaccine
Biological: Typhoid conjugate vaccine (TCV)
First Posted Date
2023-04-03
Last Posted Date
2024-11-27
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
Target Recruit Count
1528
Registration Number
NCT05794230
Locations
🇮🇳

Investigational Site Number : 3560006, Chennai, India

🇮🇳

Investigational Site Number : 3560007, Hyderabad, India

🇮🇳

Investigational Site Number : 3560016, Kanpur, India

and more 12 locations

Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa

Phase 2
Completed
Conditions
Diarrhea
Diarrhea Rotavirus
Interventions
First Posted Date
2020-12-09
Last Posted Date
2025-05-15
Lead Sponsor
Centre for Infectious Disease Research in Zambia
Target Recruit Count
720
Registration Number
NCT04658914
Locations
🇿🇲

Chawama first level hospital, Lusaka, Zambia

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

First Posted Date
2018-08-08
Last Posted Date
2025-01-14
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1196
Registration Number
NCT03621670
Locations
🇬🇧

GSK Investigational Site, Edinburg, United Kingdom

Optimising Rotavirus Vaccine in Aboriginal Children

Phase 4
Active, not recruiting
Conditions
Viral Gastroenteritis Due to Rotavirus
Interventions
Drug: Placebo
First Posted Date
2016-10-21
Last Posted Date
2024-03-06
Lead Sponsor
Telethon Kids Institute
Target Recruit Count
1000
Registration Number
NCT02941107
Locations
🇦🇺

Menzies School of Health Research, Darwin, Northern Territory, Australia

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh

Phase 3
Completed
Conditions
Rotavirus Diarrhea
Vaccine Virus Shedding
Tropical Enteropathy
Interventions
Biological: IPV (inactivated polio vaccine)
Biological: IPV
First Posted Date
2011-06-17
Last Posted Date
2025-04-29
Lead Sponsor
University of Vermont
Target Recruit Count
700
Registration Number
NCT01375647
Locations
🇧🇩

International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh

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