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

Infections, Rotavirus Clinical Trial

Official title:

Post Marketing Surveillance to Monitor the Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered According to the Prescribing Information to Indian Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938327
• Other study ID #: 112896
• Status: Completed
• Phase: N/A
• First received: July 9, 2009
• Last updated: December 7, 2017
• Start date: August 3, 2009
• Est. completion date: April 23, 2010

Study information

• Verified date: February 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: April 23, 2010
• Est. primary completion date: February 20, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 167 Days

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this PMS.

• A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second 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.

• Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

• Acute disease at the time of enrolment.

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

• Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine.

• Gastroenteritis within 7 days preceding vaccination.

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• Rotarix™
Two doses of oral vaccine.

Locations

Country	Name	City	State
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Chennai
India	GSK Investigational Site	Delhi
India	GSK Investigational Site	Delhi
India	GSK Investigational Site	Kolkata
India	GSK Investigational Site	Kolkata
India	GSK Investigational Site	Mumbai
India	GSK Investigational Site	Mumbai
India	GSK Investigational Site	Mumbai
India	GSK Investigational Site	New Delhi
India	GSK Investigational Site	Pune

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

India, 

References & Publications (2)

Kumar k et al. Safety and reactogenicity of RIX4414 live attenuated human rotavirus vaccine: An Indian post-marketing surveillance study. Abstract presented at the 48th National Conference of Indian Academy of Pediatrics (Pedicon). Jaipur, India, 19-23 January 2011.

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 Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea)	Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C.; Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day.	During the 8-day (Day 0 - Day 7) follow-up period after each vaccination.
Secondary	Number of Subjects Reporting Solicited General Symptoms	Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents = 1 hour after feeding within a day	During the 8-day (Day 0 - Day 7) follow-up period after each vaccination
Secondary	Number of Subjects Reporting Unsolicited Adverse Events (AEs)	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 (Day 0 - Day 30) follow-up period after each vaccination
Secondary	Number of Subjects Reporting Serious Adverse Events (SAEs)	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.	Throughout the study period (from Day 0 up to Day 30)