Infections, Rotavirus Clinical Trial
Official title:
Safety of GlaxoSmithKline Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix or Rotarix Liquid Formulation (Oral Suspension or Prefilled Syringe) When Administered According to the Prescribing Information in Korea
NCT number | NCT00750893 |
Other study ID # | 111700 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2, 2008 |
Est. completion date | June 15, 2013 |
Verified date | February 2020 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.
Status | Completed |
Enrollment | 3111 |
Est. completion date | June 15, 2013 |
Est. primary completion date | June 15, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Weeks to 24 Weeks |
Eligibility |
Inclusion Criteria: - Infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the PMS. - A male or female infant from the age of 6 weeks at the time of the first vaccination. - Written informed consent obtained from the parent or guardian of the infant. Exclusion Criteria: • At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | GSK Investigational Site | Seoul |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting. | During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period | |
Primary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period | 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. | During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period | |
Primary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period | 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. | During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period | |
Primary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period | 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. | During the 31 day follow-up period after each vaccine dose for Year 5 study period | |
Primary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period | 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. | During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period | |
Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. | During the post-marketing study period for Year 1 & Year 2 study period | |
Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. | During the post-marketing study period for Year 3 & Year 4 study period | |
Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. | During the post-marketing study period for Year 5 study period | |
Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. | During the post-marketing study period for Year 1 to Year 6 study period |
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