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Home › Conditions › rotavirus

Rotavirus

3 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for rotavirus

8 trials tracked for rotavirus: 7 in phase 3 or 4 and 1 with published results. The most-cited published study has 5 citations.

8Trials tracked
7Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 4 2 Phase 3 5 Other / NA 1
  1. Phase 4 Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants Completed · 5 cited
  2. Phase 4 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) Completed
  3. Phase 3 Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants Completed
  4. Phase 3 Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021) Completed
  5. Phase 3 Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED) Completed
  6. Phase 3 V260 Registration Study (V260-013)(COMPLETED) Completed
Show 2 more trials
  1. Phase 3 V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010) Completed
  2. N/A Effectiveness of Monovalent Rotavirus Vaccine (RV1) Completed

Showing the 8 most-cited and recently-updated of 8 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Rotavirus: what the trials found

The Rotavirus Vaccine, Live, Oral, Pentavalent (RotaTeq™) has demonstrated significant efficacy in reducing rotavirus gastroenteritis of all severities caused by specific serotypes (G1, G2, G3, G4, and P1A). Specifically, the vaccine was associated with a significantly lower number of cases of moderate to severe and severe rotavirus gastroenteritis compared to control groups (p < 0.001) 5.

Immunogenicity data for the Rotavirus Vaccine, Live, Oral, Pentavalent shows high rates of seroconversion and antibody response. Studies indicate a significant serum anti-rotavirus IgA response 7 and an 82.83% rate of participants exhibiting a three-fold or greater rise in rotavirus-specific serum IgA from baseline to six months 6. Additionally, the vaccine demonstrated high rates of seroprotection for other components (Diphtheria, Tetanus, Pertussis, and Polio) when administered as part of specific regimens [2, 3].

When co-administered with RotaTeq™, concurrent immunogenicity was observed for other antigens, such as those in the INFANRIX™ Hexa regimen, showing significant antibody levels to Poliovirus Type 1 8.

Recent results — preliminary, needs further review

  • A new study (NCT01871038) is currently under review and has not yet been corroborated for specific clinical outcomes in this synthesis.

For the clinician treating this condition

  • The Rotavirus Vaccine, Live, Oral, Pentavalent (RotaTeq™) significantly reduces the incidence of moderate to severe rotavirus gastroenteritis across multiple serotypes 5.
  • Clinical trials confirm robust immunogenicity for the vaccine, including significant IgA responses and sustained antibody levels at 6 months [6, 7].
  • The vaccine maintains high efficacy in inducing antibodies against Diphtheria, Tetanus, Pertussis, and Polio when used in specific multi-component regimens [2, 3].

AI synthesis of 4 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Rotarix PCV-free meets non-inferiority for seroconversion rates compared to Rotarix in infants
Pediatrics RCT
Rotarix PCV-free meets non-inferiority for seroconversion rates compared to Rotarix in infants Trial Shows Rotarix PCV-free is Comparable to Rotarix for Infants
This Phase III randomized controlled trial evaluated 2000 healthy Chinese infants aged 6 to 16 weeks. Rotarix PCV-free demonstrated non-infe…
A large trial shows that the Rotarix PCV-free vaccine provides similar protection against rotavirus as the standard Rotarix vaccine in infan…
Jul 5, 2026
Modeling study projects rotavirus hospitalizations rise if vaccine coverage drops to 20% in US
Infectious Disease
Modeling study projects rotavirus hospitalizations rise if vaccine coverage drops to 20% in US New vaccine policy shift could trigger 200,000 hospitalizations
This modeling study examines rotavirus hospitalization trends in the United States under varying vaccine coverage scenarios.
A new policy change could lead to over 200,000 hospitalizations for infants in the next five years.
medRxiv Apr 28, 2026
Vaccines show protective effects against rotavirus and pneumococcal disease in sub-Saharan African children
Infectious Disease Meta-analysis
Vaccines show protective effects against rotavirus and pneumococcal disease in sub-Saharan African children Vaccine Results Might Be Wrong Without These Factors
This systematic review and meta-analysis of 64 studies assessed vaccine effectiveness in children under five years in sub-Saharan Africa.
Vaccine studies in Africa often miss other health changes happening at the same time, which can make shots look more effective than they rea…
medRxiv Apr 14, 2026