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Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01362322
First received: May 19, 2011
Last updated: May 15, 2014
Last verified: July 2013
  Purpose

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.


Condition Intervention Phase
Diphtheria
Tetanus
Acellular Pertussis
Biological: Boostrix TM (new syringe presentation)
Biological: Boostrix TM (previous syringe presentation)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Boostrix™ Vaccine Using a New Syringe Presentation in Healthy Adolescents Aged 10-15 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations [ Time Frame: One month after booster vaccination (Month 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to the components of the study vaccine in terms of number of seroprotected/seropositive subjects [ Time Frame: Prior to (Day 0) and one month after booster vaccination (Month 1) ] [ Designated as safety issue: No ]
  • Number of subjects with solicited local and general symptoms [ Time Frame: During the 4-day (Day 0- Day 3) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
  • Number of subjects with unsolicited adverse events [ Time Frame: During the 31-day (Day 0- Day 30) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
  • Number of subjects with serious adverse events [ Time Frame: From the booster dose up to study end (Day 0 to Month 1) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with a booster response [ Time Frame: One month after booster vaccination (Month 1) ] [ Designated as safety issue: No ]

Enrollment: 671
Study Start Date: July 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects will receive BoostrixTM in a new syringe presentation (using prefilled syringes from a different manufacturer).
Biological: Boostrix TM (new syringe presentation)
Single dose, intramuscular administration in a new syringe presentation
Active Comparator: Group B
Subjects will receive BoostrixTM in previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle).
Biological: Boostrix TM (previous syringe presentation)
Single dose, intramuscular administration in previous syringe presentation

Detailed Description:

The protocol has been updated following Protocol amendment 1 date 03 August 2011 leading to the update of the exclusion criteria to allow subjects in Mexico to receive the flu vaccine in accordance with the local standard of care.

The protocol has been updated following Protocol amendment 2 dated 14 December 2011 due to the recruitment constraints as a result of the DT/dTpa vaccination campaign in the countries. The inclusion and exclusion criteria were amended to allow the participation of those who have already received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine.

  Eligibility

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject's parent(s)/Legally Acceptable Representative(s) and subjects who the investigator believes can and are willing to comply with the requirements of the protocol.
  • A male or female between 10 and 15 years of age at the time of booster vaccination.
  • Prior to protocol amendment 2, subjects who have previously received 5 doses of diphtheria-tetanus-pertussis vaccine (whole cell/acellular [w/a]) as part of primary and booster vaccination, in line with local recommendations.
  • After protocol amendment 2, subjects who have previously received 6 doses of either DT(P) (w/a)/ dTpa vaccine as part of primary and booster vaccination, in line with local recommendations.
  • Healthy subjects as determined by the investigator based on medical history and clinical examination before entering into the study.
  • Written informed consent to be obtained before study entry from the parent(s)/ Legally Acceptable Representative(s) of the subject.
  • Written informed assent to be obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative(s), if required by local regulations.
  • 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 a negative pregnancy test on the day of vaccination,
    • if sexually active, has practiced adequate contraception for 30 days prior to vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after booster vaccination.

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 the booster dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose of vaccine - with the exception of influenza vaccine which is allowed up to 7 days before the study vaccine dose, or planned in the period ≥ 7 days after the study vaccine dose.
  • 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.
  • A history of vaccination against these diseases since the 5th or the 6th dose of DT(P)/dT(pa). For subjects who have received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine, the interval between the last DT(P)/dT(pa) vaccination and the administration of the study vaccine should be at least 18 months.
  • Occurrence of any of the following adverse event after a previous administration of a Boostrix vaccine :

    • known hypersensitivity to any component of the vaccine, or have shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines,
    • encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
    • transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Acute disease and/or fever at the time of enrolment.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions, if applicable.
  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: NCT01362322

Locations
Chile
GSK Investigational Site
Santiago, Chile
Mexico
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64460
GSK Investigational Site
Estado de Mexico, Mexico, 55075
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01362322     History of Changes
Other Study ID Numbers: 114778
Study First Received: May 19, 2011
Last Updated: May 15, 2014
Health Authority: Chile: Instituto de Salud Pública de Chile
Mexico: Secretaría de Salud

Keywords provided by GlaxoSmithKline:
dTpa
Boostrix

ClinicalTrials.gov processed this record on November 20, 2014