Infections, Rotavirus
Conditions
Keywords
Human rotavirus vaccine
Brief summary
The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.
Interventions
BIOLOGICALRotarix TM
Oral, 2 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent(s)/Legally Acceptable Representative(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Infants who have received a previous dose of hepatitis B immunoglobulin after birth.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs with the exception of Hepatitis B immunoglobulin since birth. Child is unlikely to remain in the study area for the duration of the study. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Previous vaccination against rotavirus. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * Acute disease and/or fever at the time of enrolment. * Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period. * Gastroenteritis within 7 days preceding the study vaccine administration. * Previous confirmed occurrence of Rotavirus gastroenteritis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. | 2 months post-Dose 2 (at study 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Anti-rotavirus IgA Antibody Concentrations. | 2 months post-Dose 2 (at study Month 4) | Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects. |
| Number of Subjects Reporting Solicited General Symptoms. | During the 8-day (Days 0-7) post-vaccination period | 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. |
| Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample. | From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2) | 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). |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs). | Within the 31-day (Days 0-30) follow-up period after vaccination | 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. |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | During the entire study period (from Dose 1 at Day 0 up to Month 4) | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rotarix Group subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Rotarix Group |
|---|---|
| Age, Continuous | 8.9 Weeks STANDARD_DEVIATION 0.8 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
Primary
Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotarix Group | Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. | 15 Subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs).
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 1 Subjects |
Secondary
Number of Subjects Reporting Solicited General Symptoms.
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.
Time frame: During the 8-day (Days 0-7) post-vaccination period
Population: The Total vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms. | Cough | 6 Subjects |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms. | Diarrhoea | 1 Subjects |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability | 11 Subjects |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms. | Loss of appetite | 10 Subjects |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature (Tympanic on rectal seting (>=38.0°C)) | 5 Subjects |
| Rotarix Group | Number of Subjects Reporting Solicited General Symptoms. | Vomiting | 2 Subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
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.
Time frame: Within the 31-day (Days 0-30) follow-up period after vaccination
Population: The Total vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 4 Subjects |
Secondary
Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotarix Group | Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample. | 0 Subjects |
Secondary
Serum Anti-rotavirus IgA Antibody Concentrations.
Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Rotarix Group | Serum Anti-rotavirus IgA Antibody Concentrations. | 254.7 U/mL |