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

GlaxoSmithKline332 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

332

Conditions

Infections, Rotavirus

Interventions

Rotarix™BIOLOGICAL

Two doses of oral vaccine.

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 167 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (12)

GSK Investigational Site

Bangalore, India

GSK Investigational Site

Bangalore, India

GSK Investigational Site

Chennai, India

GSK Investigational Site

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

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

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.

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

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.

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

Data from ClinicalTrials.gov

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