NCT00353366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,439

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Typical duration for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

November 16, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2010

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 3, 2011

Completed
Last Updated

March 16, 2021

Status Verified

February 1, 2021

Enrollment Period

3.4 years

First QC Date

July 17, 2006

Results QC Date

July 7, 2011

Last Update Submit

February 23, 2021

Conditions

Infections, RotavirusRotavirus Vaccines

Keywords

safetyPost-marketing surveillance (PMS)RotarixoralFilipinoRotavirusGastroenteritisHuman Rotavirus (HRV) vaccine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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).

  • Number of Subjects Reporting Unsolicited Adverse Events (AE)

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

  • Number of Subjects Reporting Serious Adverse Events (SAE)

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

Study Arms (1)

Cohort Group

Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks

Biological: RotarixOther: Data collection

Interventions

RotarixBIOLOGICAL

Two doses of the oral vaccine

Cohort Group
Data collectionOTHER

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

Cohort Group

Eligibility Criteria

Age6 Weeks - 24 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Filipino subjects aged at least 6 weeks at the time of first vaccination

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

GSK Investigational Site

Alabang, Muntinlupa City, 1780, Philippines

Location

GSK Investigational Site

Binangonan, Rizal, Philippines

Location

GSK Investigational Site

Cainta, Rizal, Philippines

Location

GSK Investigational Site

City of Muntinlupa, 1780, Philippines

Location

GSK Investigational Site

Gen. Trias, Cavite, Philippines

Location

GSK Investigational Site

Imus, Cavite, Philippines

Location

GSK Investigational Site

Los Banos, Laguna, 4027, Philippines

Location

GSK Investigational Site

Makati City, Philippines

Location

GSK Investigational Site

Manila, 1000, Philippines

Location

GSK Investigational Site

Manila, Philippines

Location

GSK Investigational Site

Maybunga, Pasig City, Philippines

Location

GSK Investigational Site

Pasay, Philippines

Location

GSK Investigational Site

Pasig City, Metro Manila, 1600, Philippines

Location

GSK Investigational Site

Quezon City, 1102, Philippines

Location

GSK Investigational Site

Quezon City, 1113, Philippines

Location

GSK Investigational Site

Quezon City, Philippines

Location

GSK Investigational Site

Talaba IV, Bacoor, Cavite, Philippines

Location

GSK Investigational Site

Taytay, Rizal, Philippines

Location

Related 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.

    PMID: 25424932BACKGROUND

MeSH Terms

Conditions

Rotavirus InfectionsGastroenteritis

Interventions

RIX4414 vaccineData Collection

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
GSKClinicalSupportHD@gsk.com
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

November 16, 2006

Primary Completion

March 31, 2010

Study Completion

July 17, 2010

Last Updated

March 16, 2021

Results First Posted

August 3, 2011

Record last verified: 2021-02

Locations

PH(18)