An observational study in Infections, Rotavirus, sponsored by GlaxoSmithKline. Completed at 12 sites in India. Open to participants aged 6 Weeks to 167 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-02.
Sponsored by GlaxoSmithKline · Observational
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
101 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.
This study's enrollment of 332 is below the median of 885 across 31 observational studies indexed under Rotavirus Infections.
Browse Rotavirus Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
subjects from the age of 6 weeks at the time of the first Rotarix™ vaccination and less than 24 weeks of age at the time of second Rotarix™ vaccination
Exclusion Criteria:
Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
Biological: Rotarix™
Two doses of oral vaccine.
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea)
Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day.
Time frame: During the 8-day (Day 0 - Day 7) follow-up period after each vaccination.
Number of Subjects Reporting Solicited General Symptoms
Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day
Time frame: During the 8-day (Day 0 - Day 7) follow-up period after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 31-day (Day 0 - Day 30) follow-up period after each vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Throughout the study period (from Day 0 up to Day 30)
| Milestone | Rotarix Group |
|---|---|
| Started | 332 |
| Completed | 272 |
| Not completed | 60 |
| Withdrew: Adverse event | 2 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 37 |
| Withdrew: 2nd dose received outside of the study | 7 |
| Withdrew: Vaccine not received as out of stock | 9 |
Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day.
| subjects | Rotarix Group |
|---|---|
| Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) | 42 |
Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day
| subjects | Rotarix Group |
|---|---|
| Cough | 43 |
| Diarrhoea | 14 |
| Irritability | 81 |
| Loss of appetite | 46 |
| Temperature (axillary) | 24 |
| Vomiting | 67 |
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
| subjects | Rotarix Group |
|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 23 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
| subjects | Rotarix Group |
|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 |
Collected over Serious adverse events: throughout the study period (Day 0-Day 30). Other adverse events: during the 8-day (Day 0-Day 7) follow-up period after each vaccination.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotarix Group | 0/332 (0%) | 0/332 (0%) | 133/332 (40.1%) |
| Event | Rotarix Group |
|---|---|
| IrritabilityPsychiatric disorders | 81/332 |
| VomitingGastrointestinal disorders | 67/332 |
| Decreased appetiteMetabolism and nutrition disorders | 46/332 |
| CoughRespiratory, thoracic and mediastinal disorders | 45/332 |
| PyrexiaGeneral disorders | 25/332 |
| DiarrhoeaGastrointestinal disorders | 16/332 |
| ConstipationGastrointestinal disorders | 3/332 |
| NasopharyngitisInfections and infestations | 3/332 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 2/332 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 2/332 |
| Age, Continuous(weeks) | Rotarix Group |
|---|---|
| Mean | 10.4 ± 4.27 |
| Sex: Female, Male(Participants) | Rotarix Group |
|---|---|
| Female | 155 |
| Male | 177 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline