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OpenTrials
Completed

NCT Number: NCT00353366

To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination

GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.

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Key information

Conditions

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

Age range

6 week–24 week

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Alabang, Muntinlupa City, Philippines

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About this study

The protocol was amended to reflect a change in the prescribing information. The age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination. This protocol posting has been amended in order to comply with FDA AA.

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 (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
  • A Filipino male or female aged at least 6 weeks 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.
  • Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.
  • Any contraindications as stated in the Prescribing Information.

Treatment and study plan

Rotarix

Biological

Two doses of the oral vaccine

Data Collection

Other

Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.

Primary outcomes

  1. Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).

    Time frame: During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).

    Grade 2 or 3 symptoms assessed include fever, vomiting and diarrhea. Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C or rectal temperature above 38.5°C and below or equal to 39.5°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 diarrhea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhea was defined as at least 6 looser than normal stools per day.

Secondary outcomes

  1. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.

    Time frame: During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2).

    Solicited symptoms assessed included cough, diarrhea, fever, irritability, loss of appetite and vomiting. Any = Any reports of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 3 symptom: symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all, grade 3 fever = axillary temperature > 39.0°C, grade 3 vomiting = ≥ 3 episodes of vomiting/day and grade 3 diarrhea = ≥ 6 looser than normal stools/day. Related = symptom assessed by the investigator as causally related to the vaccination regardless of intensity grade.

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

    Time frame: During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

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

    Time frame: Throughout the study period (Day 0 to one month post-Dose 2).

    Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Open, Multicentric, Post-marketing Surveillance Study to Evaluate Safety and Reactogenicity of GSK Bio's Live Attenuated Oral Human Rotavirus (HRV) Vaccine, Rotarix When Administered According to Prescribing Information, in Filipino Subjects Aged at Least 6 Weeks of Age at the Time of First Vaccination

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jul 18, 2006
Registry last updated
Mar 16, 2021

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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