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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: July 9, 2009
Last updated: January 9, 2014
Last verified: January 2014
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.

Condition Intervention Phase
Infections, Rotavirus
Biological: Rotarix™
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) [ Time Frame: During the 8-day (Day 0 - Day 7) follow-up period after each vaccination. ] [ Designated as safety issue: No ]

    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.

Secondary Outcome Measures:
  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 8-day (Day 0 - Day 7) follow-up period after each vaccination ] [ Designated as safety issue: No ]
    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

  • Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0 - Day 30) follow-up period after each vaccination ] [ 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: Throughout the study period (from Day 0 up to Day 30) ] [ 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: 332
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotarix Group
Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
Biological: Rotarix™
Two doses of oral vaccine.


Ages Eligible for Study:   6 Weeks to 167 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  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 identifier: NCT00938327

GSK Investigational Site
Bangalore, India, 560 011
GSK Investigational Site
Bangalore, India, 560 095
GSK Investigational Site
Chennai, India, 600 033
GSK Investigational Site
Delhi, India, 110085
GSK Investigational Site
Delhi, India, 110088
GSK Investigational Site
Kolkata, India, 700064
GSK Investigational Site
Kolkata, India
GSK Investigational Site
Mumbai, India, 400081
GSK Investigational Site
Mumbai, India
GSK Investigational Site
Mumbai, India, 400 053
GSK Investigational Site
New Delhi, India, 110087
GSK Investigational Site
Pune, India, 411044
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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.
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.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00938327     History of Changes
Other Study ID Numbers: 112896 
Study First Received: July 9, 2009
Results First Received: February 17, 2011
Last Updated: January 9, 2014
Health Authority: India: IRB

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Rotavirus Infections
RNA Virus Infections
Reoviridae Infections
Virus Diseases processed this record on February 11, 2016