Adults 5 Weeks to 10 Weeks, any sex, with Infections, Rotavirus or Rotavirus Vaccines. 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 Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) AntibodyPrimary· At Month 3
Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
84
Number of Seroconverted Subjects for Anti-RV IgA AntibodySecondary· At Month 3
Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group.
Group
Value
95% CI
Rotarix-Placebo-Rotarix Group
71
Serum IgA Antibody Concentrations Against RotavirusSecondary· At Month 3
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups.
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
68
50.1 – 92.1
Rotarix-Placebo-Rotarix Group
75.6
52.5 – 109
Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or DiarrheaSecondary· During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses
Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (\>) 38.5 - less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature \> 38.0 - ≤ 39.0°C. Grade 3 fever = rectal temperature \> 39.5°C or axillary temperature \> 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day.
Any symptom, Dose 1 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
57
Rotarix-Placebo-Rotarix Group
68
Placebo Group
35
Any symptom, Dose 2 [N=149, 147, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
52
Rotarix-Placebo-Rotarix Group
36
Placebo Group
19
Any symptom, Dose 3 [N= 146, 147, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
29
Rotarix-Placebo-Rotarix Group
38
Placebo Group
24
Any symptom, Across doses [N= 150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
86
Rotarix-Placebo-Rotarix Group
91
Placebo Group
48
Number of Subjects Reporting Any, Grade 3 and Related Solicited General SymptomsSecondary· During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses
Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = ≥ 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomi
Any Cough/ runny nose, D1 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
52
Rotarix-Placebo-Rotarix Group
44
Placebo Group
23
Grade 3 Cough/ runny nose, D1 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
0
Rotarix-Placebo-Rotarix Group
1
Placebo Group
1
Related Cough/ runny nose, D1 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
1
Rotarix-Placebo-Rotarix Group
0
Placebo Group
1
Any Diarrhea, D1 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
5
Rotarix-Placebo-Rotarix Group
4
Placebo Group
6
Grade 3 Diarrhea, D1 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
2
Rotarix-Placebo-Rotarix Group
0
Placebo Group
0
Related Diarrhea, D1 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
5
Rotarix-Placebo-Rotarix Group
4
Placebo Group
5
Any Fever, D1 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
122
Rotarix-Placebo-Rotarix Group
117
Placebo Group
54
Grade 3 Fever, D1 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
3
Rotarix-Placebo-Rotarix Group
5
Placebo Group
0
Number of Subjects Reporting RV in Gastroenteritis (GE) EpisodesSecondary· From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3
Presence of RV (vaccine strain or wild-type) in GE stools.
Between Dose 1 and before Dose 2 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
1
Rotarix-Placebo-Rotarix Group
0
Placebo Group
1
Between Dose 2 and before Dose 3 [N=149, 147, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
0
Rotarix-Placebo-Rotarix Group
0
Placebo Group
0
Between Dose 3 and Month 3 [N=146, 147, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
0
Rotarix-Placebo-Rotarix Group
0
Placebo Group
0
Between Dose 1 and Month 3 [N=150, 150, 75]
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
1
Rotarix-Placebo-Rotarix Group
0
Placebo Group
1
Number of Subjects Reporting Any Unsolicited Adverse Event (AE)Secondary· During the 31-day (Days 0-30) period following any study vaccine dose or placebo
An unsolicited AE covers 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
53
Rotarix-Placebo-Rotarix Group
60
Placebo Group
19
Number of Subjects With Serious Adverse Events (SAEs)Secondary· During the entire study period (from Day 0 to Month 3)
Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.
Group
Value
95% CI
Placebo-Rotarix-Rotarix Group
1
Rotarix-Placebo-Rotarix Group
1
Placebo Group
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
Publications & conference data
1 peer-reviewed publication 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
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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: 2 January 2020
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/NCT00432380.