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Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01988857
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : December 12, 2016
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE November 14, 2013
First Posted Date  ICMJE November 20, 2013
Results First Submitted Date  ICMJE October 18, 2016
Results First Posted Date  ICMJE December 12, 2016
Last Update Posted Date August 2, 2018
Actual Study Start Date  ICMJE February 22, 2014
Actual Primary Completion Date May 10, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
  • Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within 4 days (Days 0-3) post vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within 4 days (Days 0-3) post vaccination period ]
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: Within 31 days (Days 0-30) post vaccination period ]
    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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (From Day 0 to Day 30) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2013)
  • Occurrence of each solicited local symptom. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination. ]
  • Occurrence of each solicited general symptom. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination. ]
  • Occurrence of unsolicited symptoms according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. [ Time Frame: During the 31-day (Day 0-Day 30) follow-up period after booster vaccination. ]
  • Occurrence of Serious Adverse Events (SAEs). [ Time Frame: Day 0 up to study end (Day 30). ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
Official Title  ICMJE Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix™) in Healthy Vietnamese Children
Brief Summary This study will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old children. Data that are available globally on the age group from four to six years of age will be used to bridge the age gap in this study and aid in the registration of the vaccine for children from the age of four years.
Detailed Description

A phase III, single-group, open-label study of GSK Biologicals' vaccine BoostrixTM administered as a booster vaccine dose in healthy Vietnamese children aged 6-10 years. A single booster dose of BoostrixTM will be administered at Visit 1 (Day 0) and subjects will be observed until Visit 2 (Day 30). Safety will be assessed in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period).

This protocol summary was updated following an administrative change of adding the EudraCT number to this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Tetanus
  • Acellular Pertussis
Intervention  ICMJE Biological: Boostrix™
Single-dose administered intramuscularly in the deltoid region of non-dominant arm.
Study Arms  ICMJE Experimental: dTpa Group
Intervention: Biological: Boostrix™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2014)
302
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2013)
300
Actual Study Completion Date  ICMJE May 10, 2014
Actual Primary Completion Date May 10, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6 and 10 years of age at the time of the vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Written informed assent to be obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s), as required by local regulations.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects who have previously completed their routine vaccinations against diphtheria, tetanus and pertussis diseases according to the local recommended vaccination schedule at that time and have not received the vaccine in the last two years prior to study dose administration.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced abstinence or adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. Inhaled and topical steroids are allowed.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccine dose, or planned administration during the study period.
  • Administration of immunoglobulins and/or any blood products within the three months preceding Visit 1 or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • A history of previous or intercurrent diphtheria, tetanus or pertussis disease.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Major congenital defects or serious chronic illness.
  • Acute disease and/or fever at the time of enrollment.
  • Pregnant or lactating female.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01988857
Other Study ID Numbers  ICMJE 115739
2013-003859-37 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP