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

Completed

• Conditions: Infections, Rotavirus; Rotavirus Vaccines
• Interventions: Biological: Rotarix; Other: Data collection

• Registration Number: NCT00353366
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-18
• Study Start: 2006-11-16
• Primary Completion: 2010-03-31
• Study Completion: 2010-07-17
• Results First Submitted: 2011-07-07
• Results First Submitted QC: 2011-07-07
• Results First Posted: 2011-08-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1439

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort Group	Rotarix	Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
Cohort Group	Data collection	Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).	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 Outcome Measures

Name	Time	Method
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.	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.
Number of Subjects Reporting Unsolicited Adverse Events (AE)	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.
Number of Subjects Reporting Serious Adverse Events (SAE)	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇭 Taytay, Rizal, Philippines