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

NCT00938327 | Completed Results

• 1 other identifier: 112896
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Infections, Rotavirus

Keywords

Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Subjects Reporting Solicited General Symptoms

  During the 8-day (Day 0 - Day 7) follow-up period after each vaccination

• Number of Subjects Reporting Unsolicited Adverse Events (AEs)

  During the 31-day (Day 0 - Day 30) follow-up period after each vaccination

• Number of Subjects Reporting Serious Adverse Events (SAEs)

  Throughout the study period (from Day 0 up to Day 30)

Study Arms (1)

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™

Interventions

Rotarix™ BIOLOGICAL

Two doses of oral vaccine.

Rotarix Group

Eligibility Criteria

• Age: 6 Weeks - 167 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

subjects from the age of 6 weeks at the time of the first Rotarix™ vaccination and less than 24 weeks of age at the time of second Rotarix™ vaccination

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Bangalore, 560 011, India

Location

GSK Investigational Site

Bangalore, 560 095, India

Location

GSK Investigational Site

Chennai, 600 033, India

Location

GSK Investigational Site

Delhi, 110085, India

Location

GSK Investigational Site

Delhi, 110088, India

Location

GSK Investigational Site

Kolkata, 700064, India

Location

GSK Investigational Site

Kolkata, India

Location

GSK Investigational Site

Mumbai, 400 053, India

Location

GSK Investigational Site

Mumbai, 400081, India

Location

GSK Investigational Site

Mumbai, India

Location

GSK Investigational Site

New Delhi, 110087, India

Location

GSK Investigational Site

Pune, 411044, India

Location

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, Bernardo R, Mehta S, Balasubramanian S, Karkada N, Htay Han H. Reactogenicity and safety of the human rotavirus vaccine, Rotarix in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280.

  PMID: 25424932 DERIVED

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

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: July 9, 2009
• First Posted: July 13, 2009
• Study Start: August 3, 2009
• Primary Completion: February 20, 2010
• Study Completion: April 23, 2010
• Last Updated: January 2, 2018
• Results First Posted: March 16, 2011

Record last verified: 2016-02

Locations

IN (12)