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

Infections, Rotavirus Clinical Trial

Official title:

Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779779
• Other study ID #: 111664
• Status: Completed
• Start date: November 22, 2008
• Est. completion date: August 26, 2009

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: August 26, 2009
• Est. primary completion date: May 25, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 19 Weeks

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .

• A male or female at least 6 weeks of age at the time of the first vaccination.

• Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Acute disease at the time of enrolment.

• Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.

• Any contraindication as stated in the updated and approved Prescribing Information

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• Rotarix™
Two oral doses, with at least 4 weeks interval in-between

Locations

Country	Name	City	State
Sri Lanka	GSK Investigational Site	Colombo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Sri Lanka, 

References & Publications (1)

Ruberu D et al. Post-marketing surveillance of a live-attenuated human rotavirus vaccine (Rotarix™) in India and Sri Lanka. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand, 18-20 October 2011.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea	Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.; Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.; Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.	During the 8-day solicited follow-up period
Secondary	Number of Subjects Reporting Each Type of Solicited General Symptoms	Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.	During the 8-day follow-up period
Secondary	Number of Subjects Reporting Unsolicited Adverse Events (AEs)	Unsolicited AEs cover 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
Secondary	Number of Subjects Reporting Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, is 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	Throughout the study period (Day 0 to Month 3 or 4)