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OpenTrials
Completed

NCT Number: NCT00779779

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

This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).

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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–19 week

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Colombo, 03, Sri Lanka

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 .
  • A male or female at least 6 weeks of age at the time of the first 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.
  • Acute disease at the time of enrolment.
  • Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
  • Any contraindication as stated in the updated and approved Prescribing Information

Treatment and study plan

Rotarix™

Biological

Two oral doses, with at least 4 weeks interval in-between

Primary outcomes

  1. Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea

    Time frame: During the 8-day solicited follow-up period

    Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.

    Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.

    Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.

Secondary outcomes

  1. Number of Subjects Reporting Each Type of Solicited General Symptoms

    Time frame: During the 8-day follow-up period

    Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.

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

    Time frame: During the 31-day follow-up period

    Unsolicited AEs cover 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 (Day 0 to Month 3 or 4)

    SAEs assessed include medical occurrences that result in death, is 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

Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 24, 2008
Registry last updated
Aug 28, 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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