Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Rotavirus Vaccines
Keywords: safety
Post-marketing surveillance (PMS)
Rotarix
oral
Filipino
Rotavirus
Gastroenteritis
Human Rotavirus (HRV) vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-18
Enrollment: 1439
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Filipino subjects aged at least 6 weeks at the time of first vaccination

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).
timeFrame: During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).
Secondary outcomes:
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2).
measure: Number of Subjects Reporting Unsolicited Adverse Events (AE)
timeFrame: During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.
measure: Number of Subjects Reporting Serious Adverse Events (SAE)
timeFrame: Throughout the study period (Day 0 to one month post-Dose 2).
Other outcomes:
Locations:
city: Alabang, Muntinlupa City
country: Philippines
facility: GSK Investigational Site
city: Binangonan, Rizal
country: Philippines
facility: GSK Investigational Site
city: Cainta, Rizal
country: Philippines
facility: GSK Investigational Site
city: Gen. Trias, Cavite
country: Philippines
facility: GSK Investigational Site
city: Imus, Cavite
country: Philippines
facility: GSK Investigational Site
city: Los Banos, Laguna
country: Philippines
facility: GSK Investigational Site
city: Makati City
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Maybunga, Pasig City
country: Philippines
facility: GSK Investigational Site
city: Muntinlupa City
country: Philippines
facility: GSK Investigational Site
city: Pasay City
country: Philippines
facility: GSK Investigational Site
city: Pasig City, Metro Manila
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Talaba IV, Bacoor, Cavite
country: Philippines
facility: GSK Investigational Site
city: Taytay, Rizal
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.