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: May 29, 2014
Last verified: May 2014
  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:
  • Occurrence of each solicited local symptom. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of each solicited general symptom. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Occurrence of Serious Adverse Events (SAEs). [ Time Frame: Day 0 up to study end (Day 30). ] [ Designated as safety issue: No ]

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
Not Applicable.
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. Single booster dose of BoostrixTM will be administered at Visit 1 (Day 0) and subjects will be observed till Visit 2 (Day 30). Safety will be assessed in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31days post vaccination) and serious adverse event (during the trial period).

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01988857     History of Changes
Other Study ID Numbers: 115739
Study First Received: November 14, 2013
Last Updated: May 29, 2014
Health Authority: Vietnam: Ministry of Health

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

ClinicalTrials.gov processed this record on October 20, 2014