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

NCT00750893 | Completed Results

• 1 other identifier: 111700
• Study Type: observational
• Target: 3,111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infections, Rotavirus

Keywords

Gastroenteritis

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Rotarix Group

Subjects who received 2 oral doses of Rotarix. The first dose was administered before 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

Interventions

Rotarix or Rotarix liquid formulation BIOLOGICAL

GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine (oral suspension or prefilled syringe).

Rotarix Group

Eligibility Criteria

• Age: 6 Weeks - 24 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Seoul, 122-896, South Korea

Location

Related Publications (1)

• Shin SM, Kim CS, Karkada N, Liu A, Jayadeva G, Han HH. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix). Hum Vaccin Immunother. 2016 Oct 2;12(10):2590-2594. doi: 10.1080/21645515.2016.1189046. Epub 2016 Aug 5.

  PMID: 27494163 DERIVED

Related Links

• Full CSR posting.

MeSH Terms

Conditions

Rotavirus Infections; Gastroenteritis

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: September 2, 2008
• Primary Completion: June 15, 2013
• Study Completion: June 15, 2013
• Last Updated: March 3, 2020
• Results First Posted: February 25, 2011

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)