Infections, Rotavirus
Conditions
Keywords
Gastroenteritis
Brief summary
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
Interventions
BIOLOGICALRotarix™
Two oral doses, with at least 4 weeks interval in-between
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 19 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol . * A male or female at least 6 weeks of age at the time of the first 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. * Acute disease at the time of enrolment. * Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception. * Any contraindication as stated in the updated and approved Prescribing Information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One >= Grade 2 Fever, Vomiting or Diarrhoea | During the 8-day solicited follow-up period | Grade 2 fever was defined as axillary temperature \> 38.0 to \<= 39.0 degrees Celsius and grade 3 fever as axillary temperature \> 39.0 degrees Celsius. Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Each Type of Solicited General Symptoms | During the 8-day follow-up period | Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | During the 31-day follow-up period | Unsolicited AEs cover 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 (Day 0 to Month 3 or 4) | SAEs assessed include medical occurrences that result in death, is 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
Sri Lanka
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rotarix Group Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age. | 522 |
| Total | 522 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Protocol Violation | 14 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Rotarix Group |
|---|---|
| Age, Continuous | 12.5 weeks STANDARD_DEVIATION 5.62 |
| Sex: Female, Male Female | 267 Participants |
| Sex: Female, Male Male | 255 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 247 / 522 |
| serious Total, serious adverse events | 1 / 522 |
Outcome results
Primary
Number of Subjects With at Least One >= Grade 2 Fever, Vomiting or Diarrhoea
Grade 2 fever was defined as axillary temperature \> 38.0 to \<= 39.0 degrees Celsius and grade 3 fever as axillary temperature \> 39.0 degrees Celsius. Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.
Time frame: During the 8-day solicited follow-up period
Population: Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotarix Group | Number of Subjects With at Least One >= Grade 2 Fever, Vomiting or Diarrhoea | 78 subjects |
Secondary
Number of Subjects Reporting Each Type of Solicited General Symptoms
Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.
Time frame: During the 8-day follow-up period
Population: Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited General Symptoms | Cough | 71 subjects |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited General Symptoms | Diarrhoea | 24 subjects |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited General Symptoms | Irritability | 124 subjects |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited General Symptoms | Loss of appetite | 83 subjects |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited General Symptoms | Fever | 152 subjects |
| Rotarix Group | Number of Subjects Reporting Each Type of Solicited General Symptoms | Vomiting | 45 subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, is 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 (Day 0 to Month 3 or 4)
Population: Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs cover 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 follow-up period
Population: Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 25 subjects |