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

Infections, Rotavirus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353366
• Other study ID #: 103366
• Secondary ID: 2012-004039-21
• Status: Completed
• Start date: November 16, 2006
• Est. completion date: July 17, 2010

Study information

• Verified date: February 2021
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1439
• Est. completion date: July 17, 2010
• Est. primary completion date: March 31, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 24 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections
• Rotavirus Vaccines

Intervention

Biological:
• Rotarix
Two doses of the oral vaccine

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

Locations

Country	Name	City	State
Philippines	GSK Investigational Site	Alabang, Muntinlupa City
Philippines	GSK Investigational Site	Binangonan, Rizal
Philippines	GSK Investigational Site	Cainta, Rizal
Philippines	GSK Investigational Site	Gen. Trias, Cavite
Philippines	GSK Investigational Site	Imus, Cavite
Philippines	GSK Investigational Site	Los Banos, Laguna
Philippines	GSK Investigational Site	Makati City
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Maybunga, Pasig City
Philippines	GSK Investigational Site	Muntinlupa City
Philippines	GSK Investigational Site	Pasay City
Philippines	GSK Investigational Site	Pasig City, Metro Manila
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Talaba IV, Bacoor, Cavite
Philippines	GSK Investigational Site	Taytay, Rizal

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, Bernardo R, Mehta S, Balasubramanian S, Karkada N, Htay Han H. Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).
Secondary	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.	During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2).
Secondary	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.	During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.
Secondary	Number of Subjects Reporting Serious Adverse Events (SAE)	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.	Throughout the study period (Day 0 to one month post-Dose 2).