Infections, Rotavirus
Conditions
Keywords
Gastroenteritis
Brief summary
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.
Interventions
BIOLOGICALRotarix™
Two doses of oral vaccine.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 167 Days
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this PMS. * A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second vaccination. * Written informed consent obtained from the parent or guardian of the subject.
Exclusion criteria
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Acute disease at the time of enrolment. * Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception. * Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine. * Gastroenteritis within 7 days preceding vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) | During the 8-day (Day 0 - Day 7) follow-up period after each vaccination. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited General Symptoms | During the 8-day (Day 0 - Day 7) follow-up period after each vaccination | 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 |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | During the 31-day (Day 0 - Day 30) follow-up period after each vaccination | 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. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | Throughout the study period (from Day 0 up to Day 30) | 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. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rotarix Group 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. | 332 |
| Total | 332 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 2nd dose received outside of the study | 7 |
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 37 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Vaccine not received as out of stock | 9 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Rotarix Group |
|---|---|
| Age, Continuous | 10.4 weeks STANDARD_DEVIATION 4.27 |
| Sex: Female, Male Female | 155 Participants |
| Sex: Female, Male Male | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 332 |
| other Total, other adverse events | 133 / 332 |
| serious Total, serious adverse events | 0 / 332 |
Outcome results
Primary
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.
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) | 42 subjects |
Secondary
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)
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 subjects |
Secondary
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
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Diarrhoea | 14 subjects |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Cough | 43 subjects |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Irritability | 81 subjects |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Loss of appetite | 46 subjects |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Temperature (axillary) | 24 subjects |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms | Vomiting | 67 subjects |
Secondary
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
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 23 subjects |