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

GlaxoSmithKline1,439 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,439

Conditions

Infections, Rotavirus Rotavirus Vaccines

Interventions

RotarixBIOLOGICAL

Two doses of the oral vaccine

Data collectionOTHER

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

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 24 WeeksHealthy 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 (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.

Locations (18)

GSK Investigational Site

Alabang, Muntinlupa City, Philippines

GSK Investigational Site

Binangonan, Rizal, Philippines

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

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

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.

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

Number of Subjects Reporting Unsolicited Adverse Events (AE)

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.

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

Data from ClinicalTrials.gov

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