Adults 6 Weeks to 14 Weeks, any sex, with Infections, Rotavirus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).Primary· From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo
An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Group
Value
95% CI
Rotarix Group
34
Placebo Group
23
Number of Subjects Reporting Unsolicited Adverse Events (AEs), According to Medical Dictionary for Regulatory Activities (MedDRA) Classification.Secondary· Within 31 days after any Rotarix vaccine/Placebo dose.
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Group
Value
95% CI
Rotarix Group
196
Placebo Group
138
Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.Secondary· Within 15 days after each Rotarix vaccine/Placebo dose.
Solicited symptoms included Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5 degrees Celsius (°C)), Irritability, Loss of appetite, and Vomiting
Diarrhea
Group
Value
95% CI
Rotarix Group
9
Placebo Group
5
Fever
Group
Value
95% CI
Rotarix Group
54
Placebo Group
29
Irritability
Group
Value
95% CI
Rotarix Group
133
Placebo Group
66
Loss of appetite
Group
Value
95% CI
Rotarix Group
81
Placebo Group
45
Vomiting
Group
Value
95% CI
Rotarix Group
52
Placebo Group
27
Number of Subjects for Whom Presence of Rotavirus (RV) Gastroenteritis (GE) Was Detected in Stools.Secondary· From Dose 1 up to 1 month after Dose 2 of Rotarix vaccine/Placebo
Gastroenteritis (GE): diarrhoea with or without vomiting. Rotavirus (RV) GE: A GE episode was a RV GE if a stool sample taken during or not later than 7 days after the episode was RV positive by Enzyme Linked Immunosorbent Assay.
Group
Value
95% CI
Rotarix Group
3
Placebo Group
2
Seroconversion to Anti-rotavirus Immunoglobulin A (IgA) Antibody.Secondary· At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo
Number of subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL).
Group
Value
95% CI
Rotarix Group
126
Placebo Group
13
Serum Anti-Rotavirus IgA Antibody Concentration.Secondary· At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo
Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals, calculated on all subjects.
Group
Value
95% CI
Rotarix Group
202.2
153.1 – 267.1
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 1.3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study will be performed in four European countries (France, Poland, Spain, and Portugal). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04031846 — Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
· Phase 3
· completed
NCT01309646 — Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
· Phase 3
· completed
NCT01000974 — Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants
· Phase 3
· completed
NCT01090453 — Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants
· Phase 2
· completed
NCT00938327 — Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
· completed
Other GlaxoSmithKline trials
Trials by the same sponsor.
NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam
· Phase 2, PHASE3
· not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose
· Phase 1
· not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH
· Phase 3
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 8 June 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00420745.