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OpenTrials
Completed

NCT Number: NCT00938327

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

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.

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Key information

Conditions

Infections, Rotavirus Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

6 week–167 day

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Bangalore, India

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rotarix™

Biological

Two doses of oral vaccine.

Primary outcomes

  1. 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.

    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 outcomes

  1. Number of Subjects Reporting Solicited General Symptoms

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

    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

  2. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

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

    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.

  3. Number of Subjects Reporting Serious Adverse Events (SAEs)

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

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 13, 2009
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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