Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00750893
First received: September 10, 2008
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Infections, Rotavirus
Biological: Rotarix™ or Rotarix™ liquid formulation (oral suspension or prefilled syringe)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 8 day follow-up period after each vaccine dose for Year 1 & Year 2 study period ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.

  • Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31 day follow-up period after each vaccine dose for Year 1 & Year 2 study period ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31 day follow-up period after each vaccine dose for Year 3 & Year 4 study period ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31 day follow-up period after each vaccine dose for Year 5 study period ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31 day follow-up period after each vaccine dose for Year 6 study period ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the post marketing study period for Year 1 & Year 2 study period ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the post marketing study period for Year 3 & Year 4 study period ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the post marketing study period for Year 5 study period ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the post marketing study period for Year 6 study period ] [ Designated as safety issue: No ]
    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.


Enrollment: 1052
Study Start Date: September 2008
Study Completion Date: June 2013
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rotarix Group
Subjects who received 2 doses of Rotarix™ or Rotarix™ liquid formulation (oral suspension or prefilled syringe ). The first dose was administered from the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Biological: Rotarix™ or Rotarix™ liquid formulation (oral suspension or prefilled syringe)
GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine.

Detailed Description:

The protocol posting has been amended to reflect the two new vaccine presentations that have been launched in Korea. The current PMS will thus collect safety information from subjects who have received either Rotarix™ or Rotarix™ liquid formulation (oral suspension or prefilled syringe) in the course of their routine clinical practice according to the prescribing information in Korea.

  Eligibility

Ages Eligible for Study:   6 Weeks to 24 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Infants aged at least 6 weeks will be administered two doses of Rotarix™ or Rotarix™ liquid formulation (oral suspension or prefilled syringe) orally as per the prescribing information in Korea.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750893

Locations
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 122-896
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00750893     History of Changes
Other Study ID Numbers: 111700
Study First Received: September 10, 2008
Results First Received: January 28, 2011
Last Updated: March 6, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:
Gastroenteritis

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014