Trial Outcomes & Findings for Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants (NCT NCT00938327)
NCT ID: NCT00938327
Last Updated: 2018-01-02
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
332 participants
Primary outcome timeframe
During the 8-day (Day 0 - Day 7) follow-up period after each vaccination.
Results posted on
2018-01-02
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
332
|
|
Overall Study
COMPLETED
|
272
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
37
|
|
Overall Study
2nd dose received outside of the study
|
7
|
|
Overall Study
Vaccine not received as out of stock
|
9
|
Baseline Characteristics
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
Baseline characteristics by cohort
| Measure |
Rotarix Group
n=332 Participants
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.
|
|---|---|
|
Age, Continuous
|
10.4 weeks
STANDARD_DEVIATION 4.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 8-day (Day 0 - Day 7) follow-up period after each vaccination.Population: Analysis was performed on the Total Vaccinated Cohort.
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.
Outcome measures
| Measure |
Rotarix Group
n=332 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea)
|
42 subjects
|
SECONDARY outcome
Timeframe: During the 8-day (Day 0 - Day 7) follow-up period after each vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort.
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
Outcome measures
| Measure |
Rotarix Group
n=332 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Cough
|
43 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Diarrhoea
|
14 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Irritability
|
81 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Loss of appetite
|
46 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Temperature (axillary)
|
24 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Vomiting
|
67 subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Day 0 - Day 30) follow-up period after each vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort.
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.
Outcome measures
| Measure |
Rotarix Group
n=332 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
23 subjects
|
SECONDARY outcome
Timeframe: Throughout the study period (from Day 0 up to Day 30)Population: Analysis was performed on the Total Vaccinated Cohort.
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.
Outcome measures
| Measure |
Rotarix Group
n=332 Participants
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.
|
|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
0 subjects
|
Adverse Events
Rotarix Group
Serious events: 0 serious events
Other events: 133 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rotarix Group
n=332 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
1/332 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Constipation
|
0.90%
3/332 • Number of events 3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
45/332 • Number of events 55 • 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.
|
|
Psychiatric disorders
Decreased activity
|
0.30%
1/332 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.9%
46/332 • Number of events 54 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.60%
2/332 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
16/332 • Number of events 18 • 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.
|
|
Gastrointestinal disorders
Flatulence
|
0.30%
1/332 • Number of events 1 • 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.
|
|
Nervous system disorders
Hypersomnia
|
0.30%
1/332 • Number of events 1 • 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.
|
|
General disorders
Inflammation
|
0.30%
1/332 • Number of events 1 • 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.
|
|
Psychiatric disorders
Irritability
|
24.4%
81/332 • Number of events 97 • 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.
|
|
Eye disorders
Lacrimation increased
|
0.30%
1/332 • Number of events 1 • 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.
|
|
Nervous system disorders
Lethargy
|
0.30%
1/332 • Number of events 1 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
0.90%
3/332 • Number of events 3 • 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.
|
|
Infections and infestations
Otitis media acute
|
0.30%
1/332 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Pollakiuria
|
0.30%
1/332 • Number of events 1 • 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.
|
|
General disorders
Pyrexia
|
7.5%
25/332 • Number of events 28 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.30%
1/332 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.30%
1/332 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.60%
2/332 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.30%
1/332 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
20.2%
67/332 • Number of events 83 • 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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER