Trial Outcomes & Findings for Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth. (NCT NCT01198769)
NCT ID: NCT01198769
Last Updated: 2018-08-20
Results Overview
Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (\<) 20 U/mL.
COMPLETED
PHASE4
15 participants
2 months post-Dose 2 (at study Month 4)
2018-08-20
Participant Flow
Participant milestones
| Measure |
Rotarix Group
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
Baseline characteristics by cohort
| Measure |
Rotarix Group
n=15 Participants
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
|
|---|---|
|
Age, Continuous
|
8.9 Weeks
STANDARD_DEVIATION 0.80 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 months post-Dose 2 (at study Month 4)Population: The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.
Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (\<) 20 U/mL.
Outcome measures
| Measure |
Rotarix Group
n=15 Participants
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
|
|---|---|
|
Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.
|
15 Subjects
|
SECONDARY outcome
Timeframe: 2 months post-Dose 2 (at study Month 4)Population: The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.
Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.
Outcome measures
| Measure |
Rotarix Group
n=15 Participants
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
|
|---|---|
|
Serum Anti-rotavirus IgA Antibody Concentrations.
|
254.7 U/mL
Interval 145.0 to 447.7
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-vaccination periodPopulation: The Total vaccinated cohort included all subjects with at least one vaccine administration documented.
Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.
Outcome measures
| Measure |
Rotarix Group
n=15 Participants
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
|
|---|---|
|
Number of Subjects Reporting Solicited General Symptoms.
Cough
|
6 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms.
Diarrhoea
|
1 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms.
Irritability
|
11 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms.
Loss of appetite
|
10 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms.
Temperature (Tympanic on rectal seting (>=38.0°C))
|
5 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms.
Vomiting
|
2 Subjects
|
SECONDARY outcome
Timeframe: From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)Population: The Total vaccinated cohort included all subjects with at least one vaccine administration documented.
RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample. GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Rotarix Group
n=15 Participants
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
|
|---|---|
|
Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.
|
0 Subjects
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) follow-up period after vaccinationPopulation: The Total vaccinated cohort included all subjects with at least one vaccine administration documented.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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=15 Participants
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
|
4 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (from Dose 1 at Day 0 up to Month 4)Population: The Total vaccinated cohort included all subjects with at least one vaccine administration documented.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Outcome measures
| Measure |
Rotarix Group
n=15 Participants
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
|
|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs).
|
1 Subjects
|
Adverse Events
Rotarix Group
Serious adverse events
| Measure |
Rotarix Group
n=15 participants at risk
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
|
|---|---|
|
Infections and infestations
Bronchiolitis
|
6.7%
1/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
Other adverse events
| Measure |
Rotarix Group
n=15 participants at risk
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Eczema
|
13.3%
2/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
Infections and infestations
Bronchiolitis
|
6.7%
1/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
Infections and infestations
Pharyngitis
|
6.7%
1/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
General disorders
Cough
|
40.0%
6/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
General disorders
Diarrhoea
|
6.7%
1/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
General disorders
Irritability
|
73.3%
11/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
General disorders
Loss of appetite
|
66.7%
10/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
General disorders
Temperature
|
33.3%
5/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
|
General disorders
Vomiting
|
13.3%
2/15 • SAEs: During the entire study period (from Dose 1 at Day 0 up to Month 4). Unsolicited AEs: Within the 31-day (Days 0-30) follow-up period after vaccination. Solicited general symptoms: During the 8-day (Days 0-7) post-vaccination period
|
Additional Information
GSK Response Center
GlaxoSmithKline
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