30 completed, 3 active not recruiting, 1 terminated. 22 Phase 3, 7 Phase 4, 4 Phase 2, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 22 | Completed 18, Active not recruiting 3, Terminated 1 |
| Phase 4 | 7 | Completed 7 |
| Phase 2 | 4 | Completed 4 |
| Phase 1 | 2 | Completed 2 |
Follow RotaTeq: new trials by email Literature Review of RotaTeq trials Research Report on RotaTeq
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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 PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine - Pneumococcal Immunization | Phase 3 | Active not recruiting | Sanofi | 580 | 2025-02-27 | 2026-02-13 |
| Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine - Pneumococcal Immunization | Phase 3 | Active not recruiting | Sanofi | 2360 | 2025-02-18 | 2026-04-13 |
| Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine - Pneumococcal Immunization | Phase 3 | Active not recruiting | Sanofi Pasteur, a Sanofi Company | 1714 | 2024-12-18 | 2026-04-22 |
| Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers RSVt vaccine, Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine, Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine - RSV Immunization | Phase 3 | Terminated | Sanofi Pasteur, a Sanofi Company | 2226 | 2024-05-13 | 2026-10-05 |
| 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 Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV) - Meningococcal Immunisation, Healthy Volunteers | Phase 3 | Completed | Sanofi Pasteur, a Sanofi Company | 1528 | 2023-03-27 | 2026-01-21 |
| Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074) RotaTeq (V260), IPV - Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9 | Phase 3 | Completed | Merck Sharp & Dohme LLC | 400 | 2020-08-25 | 2024-07-26 |
| Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants Pneumococcal Conjugate Vaccine formulation 1, Pneumococcal Conjugate Vaccine formulation 2, Pneumococcal Conjugate Vaccine formulation 3 - Pneumococcal Immunisation, Diphtheria Immunisation | Phase 2 | Completed | Sanofi Pasteur, a Sanofi Company | 852 | 2020-05-22 | 2025-09-08 |
| Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) V114, Prevnar 13™, RotaTeq™ - Pneumococcal Infections, Pneumococcal Vaccines | Phase 3 | Completed | Merck Sharp & Dohme LLC | 1720 | 2019-06-19 | 2023-07-28 |
| A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION) Prevnar 13™, V114, RotaTeq™ - Pneumococcal Infections | Phase 3 | Completed | Merck Sharp & Dohme LLC | 900 | 2018-10-18 | 2023-01-17 |
| Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Measles, Mumps, and Rubella Virus Vaccine Live - Healthy Volunteers (Meningococcal Infection) | Phase 3 | Completed | Sanofi Pasteur, a Sanofi Company | 525 | 2018-10-17 | 2023-10-19 |
| Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, DTaP-IPV//Hib vaccine - Healthy Volunteers (Meningococcal Infection) | Phase 3 | Completed | Sanofi Pasteur, a Sanofi Company | 2627 | 2018-04-25 | 2024-10-15 |
| Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study IPV at 14 and 22 weeks of age, Rotarix, IPV at 14 and 22 weeks of age, RotaTeq, IPV at 14 and fIPV at 22 weeks, Rotarix - Poliomyelitis | Phase 4 | Completed | Centers for Disease Control and Prevention | 1144 | 2016-09-01 | 2018-07-18 |
| Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants Heat Stable Rotavirus (HSRV) Vaccine, Placebo for Heatstable Rotavirus vaccine, RotaTeq® - Rotavirus Gastroenteritis | Phase 1 / Phase 2 | Completed | MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd. | 100 | 2016-06-01 | 2017-08-21 |
| Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study Rotarix®,, Rotarix®, with other routine vaccines, RotaTeq®, - Intussusception, Rotavirus Infections | Phase 4 | Completed | Children's Hospital Medical Center, Cincinnati | 144 | 2015-11-01 | 2018-07-12 |
| Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali pentavalent rotavirus vaccine (PRV), measles vaccine (MV), yellow fever vaccine (YFV) - Diarrhea Rotavirus | Phase 4 | Completed | PATH | 600 | 2014-10-01 | 2019-01-02 |
| An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq) RV5 (Pentavalent Rotavirus Vaccine) - Diarrhea, Gastroenteritis | Phase 4 | Completed | Dennis Clements | 66 | 2014-02-01 | 2017-04-21 |
| Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs Rotarix, RotaTeq - Rotavirus Vaccine | Phase 3 | Completed | National Institute of Pediatrics, Mexico | 1498 | 2013-11-01 | 2018-08-08 |
| Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060) RotaTeq™ (V260), DTP-IPV - Rotavirus Disease | Phase 4 | Completed | Merck Sharp & Dohme LLC | 192 | 2013-09-19 | 2018-11-14 |
| Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010) PR5I, Pediacel®, NeisVac-C® - Neisseria Meningitidis, Bacterial Infections | Phase 3 | Completed | MCM Vaccines B.V. | 385 | 2013-05-01 | 2019-02-25 |
| Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination Hexavalent vaccine, NeisVac-C, Prevenar 13 - Neisseria Meningitidis, Bacterial Infections | Phase 3 | Completed | Sanofi Pasteur, a Sanofi Company | 350 | 2013-04-01 | 2017-09-11 |
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Rotavirus Infections (8) · Bacterial Infections (5) · Virus Diseases (5) · Gastroenteritis (4) · Poliomyelitis (4) · Diphtheria (3) · Haemophilus Infections (3) · Hepatitis B (3) · Meningococcal Infections (3) · Tetanus (3) · Whooping Cough (3) · Diarrhea (2) · Meningitis, Meningococcal (2) · Pneumococcal Infections (2) · Dehydration (1)
Merck Sharp & Dohme LLC (13) · Sanofi Pasteur, a Sanofi Company (8) · MCM Vaccines B.V. (2) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · Sanofi (2) · Centers for Disease Control and Prevention (1) · Children's Hospital Medical Center, Cincinnati (1) · Dennis Clements (1) · MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd. (1) · National Institute of Pediatrics, Mexico (1) · PATH (1) · University Hospital, Brest (1)
United States (12) · Puerto Rico (7) · Mexico (5) · Thailand (4) · Honduras (3) · Turkey (Türkiye) (3) · Bangladesh (2) · Australia (1) · Botswana (1) · Canada (1) · Chile (1) · China (1) · Finland (1) · France (1) · India (1)
Dennis A Clements, MD, PhD (1) · K Zaman, MBBS, PhD (1) · Karen Broder, MD (1) · Mary A. Staat, MD, MPH (1) · Myron J. Levin, MD (1) · Samba O Sow, MD, Msc (1)
PMID 16394299, PMID 20540778, PMID 20692030, PMID 20692031, PMID 21389149, PMID 21443962, PMID 23732903, PMID 25080553, PMID 26823540, PMID 27662551, PMID 27755463, PMID 27846055, PMID 27846058, PMID 27939054, PMID 28140752, PMID 28583305, PMID 29564996, PMID 29659924, PMID 30471953, PMID 31104832, PMID 31526218, PMID 35144847, PMID 35961362, PMID 36522265, PMID 36621410, PMID 37846456, PMID 38463163, PMID 38509699, PMID 40833801, PMID 41337697, PMID 41489614
2018 (3)