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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01988857
First received: November 14, 2013
Last updated: October 18, 2016
Last verified: February 2015
  Purpose
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.

Condition Intervention Phase
Diphtheria
Tetanus
Acellular Pertussis
Biological: Boostrix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix™) in Healthy Vietnamese Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within 4 days (Days 0-3) post vaccination period ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 302
Study Start Date: February 2014
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dTpa Group Biological: Boostrix™
Single-dose administered intramuscularly in the deltoid region of non-dominant arm.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years   (Child)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988857

Locations
Vietnam
GSK Investigational Site
Hanoi, Vietnam, 084
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01988857     History of Changes
Other Study ID Numbers: 115739  2013-003859-37 
Study First Received: November 14, 2013
Results First Received: October 18, 2016
Last Updated: October 18, 2016
Health Authority: Vietnam: Ministry of Health

Keywords provided by GlaxoSmithKline:
Vietnam
Children
Reactogenicity
BoostrixTM
Safety
dTpa
Booster
Healthy

Additional relevant MeSH terms:
Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on January 14, 2017