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

September 10, 2008
March 6, 2014
September 2008
January 2010   (final data collection date for primary outcome measure)
  • 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.
  • Occurrence of solicited adverse event (AE) [ Time Frame: During 8 days after each vaccine dose ]
  • Occurrence of unsolicited AE [ Time Frame: During 31 days after each vaccine dose ]
  • Occurrence of Serious adverse events [ Time Frame: During the entire PMS period ]
Complete list of historical versions of study NCT00750893 on ClinicalTrials.gov Archive Site
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Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Infections, Rotavirus
Biological: Rotarix™ or Rotarix™ liquid formulation (oral suspension or prefilled syringe)
GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine.
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.
Intervention: Biological: Rotarix™ or Rotarix™ liquid formulation (oral suspension or prefilled syringe)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1052
June 2013
January 2010   (final data collection date for primary outcome measure)

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.

Both
6 Weeks to 24 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00750893
111700
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP