Trial Outcomes & Findings for Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants (NCT NCT00969228)
NCT ID: NCT00969228
Last Updated: 2020-01-18
Results Overview
Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
684 participants
Primary outcome timeframe
One month after the second vaccine dose
Results posted on
2020-01-18
Participant Flow
Participant milestones
| Measure |
Rotarix Group
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
508
|
176
|
|
Overall Study
COMPLETED
|
465
|
162
|
|
Overall Study
NOT COMPLETED
|
43
|
14
|
Reasons for withdrawal
| Measure |
Rotarix Group
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Porcine circovirus detection in vaccine
|
38
|
14
|
Baseline Characteristics
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
Baseline characteristics by cohort
| Measure |
Rotarix Group
n=508 Participants
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
n=176 Participants
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
Total
n=684 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.8 Weeks
STANDARD_DEVIATION 1.25 • n=5 Participants
|
8.9 Weeks
STANDARD_DEVIATION 1.26 • n=7 Participants
|
8.8 Weeks
STANDARD_DEVIATION 1.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
231 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
277 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
374 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after the second vaccine dosePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.
Outcome measures
| Measure |
Rotarix Group
n=318 Participants
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
n=114 Participants
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
|---|---|---|
|
Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A
|
280 subjects
|
5 subjects
|
SECONDARY outcome
Timeframe: One month after the second vaccine dosePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Concentrations are given as Geometric Mean Concentrations (GMCs). Note: In the Placebo Group the value was below the assay cut-off (20 units per milliliter).
Outcome measures
| Measure |
Rotarix Group
n=280 Participants
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
n=114 Participants
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
|---|---|---|
|
Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations
|
208.5 units per milliliter (U/mL)
Interval 174.2 to 249.5
|
NA units per milliliter (U/mL)
Values were below the assay cut-off of 20 units per milliliter.
|
SECONDARY outcome
Timeframe: During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose.Population: Analysis was performed on the Total Vaccinated Cohort.
Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.
Outcome measures
| Measure |
Rotarix Group
n=508 Participants
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
n=176 Participants
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Solicited Symptoms
Cough
|
180 subjects
|
66 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Diarrhoea
|
20 subjects
|
7 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Irritability
|
290 subjects
|
106 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Loss of appetite
|
174 subjects
|
60 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Fever
|
67 subjects
|
18 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Vomiting
|
95 subjects
|
36 subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Day 0 - Day 30) follow-up period after each vaccine dosePopulation: 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=508 Participants
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
n=176 Participants
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
148 subjects
|
59 subjects
|
SECONDARY outcome
Timeframe: Throughout the study period (2-3 months).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=508 Participants
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
n=176 Participants
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
17 subjects
|
13 subjects
|
SECONDARY outcome
Timeframe: From Dose 1 up to 1 month after Dose 2.Population: Analysis was performed on the Total Vaccinated Cohort.
Outcome measures
| Measure |
Rotarix Group
n=508 Participants
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
n=176 Participants
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)
|
0 subjects
|
0 subjects
|
Adverse Events
Rotarix Group
Serious events: 17 serious events
Other events: 367 other events
Deaths: 0 deaths
Placebo Group
Serious events: 13 serious events
Other events: 134 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotarix Group
n=508 participants at risk
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
n=176 participants at risk
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
|---|---|---|
|
Infections and infestations
Pharyngitis
|
0.20%
1/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.00%
0/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.57%
1/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia apiration
|
0.00%
0/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.57%
1/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Pneumonia bacterial
|
0.20%
1/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.00%
0/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.57%
1/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Congenital, familial and genetic disorders
Solitary kidney
|
0.00%
0/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.57%
1/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Bronchiolitis
|
1.2%
6/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
2.8%
5/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Gastroenteritis
|
0.98%
5/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
2.3%
4/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
General disorders
Pyrexia
|
0.79%
4/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.00%
0/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Urinary tract infection
|
0.39%
2/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
1.1%
2/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Bronchitis
|
0.20%
1/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.57%
1/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Bronchopneumonia
|
0.39%
2/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.00%
0/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.57%
1/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.00%
0/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.57%
1/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.57%
1/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.20%
1/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.00%
0/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Otitis externa
|
0.20%
1/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.00%
0/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Otitis media
|
0.20%
1/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
0.00%
0/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
Other adverse events
| Measure |
Rotarix Group
n=508 participants at risk
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
|
Placebo Group
n=176 participants at risk
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
|
|---|---|---|
|
General disorders
Cough
|
35.4%
180/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
37.5%
66/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
General disorders
Irritability
|
57.1%
290/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
60.2%
106/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
General disorders
Loss of appetite
|
34.3%
174/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
34.1%
60/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
General disorders
Fever
|
13.2%
67/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
10.2%
18/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
General disorders
Vomiting
|
18.7%
95/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
20.5%
36/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
|
Infections and infestations
Nasopharynigitis
|
5.7%
29/508 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
9.7%
17/176 • Solicited symptoms: during the 8-day follow-up period after each dose of vaccine. Unsolicited adverse events: during the 31-day follow-up after any dose of Rotarix vaccine or placebo. Serious adverse events: during the entire study period (2-3 months)
|
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