A phase IV, single-blind, randomized, multicenter study to assess the immunogenicity and safety of GSK Biologicals’ dTpa vaccine (Boostrix™) using a new syringe presentation in healthy adolescents aged 10–15 years. - DTPA (BOOSTRIX)-045

GlaxoSmithKline Biologicals0 sites671 target enrollmentMarch 11, 2015

DrugsBOOSTRIX

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 671
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 11, 2015

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•Subject’s parent(s)/Legally Acceptable Representative(s) \[LAR(s)] and subjects who the investigator believes can and are willing to comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow\-up visits).
•A male or female between 10 and 15 years of age (from and including the 10th birthday up to but excluding the 16th birthday) at the time of booster vaccination.
•Prior to protocol amendment 2, subjects who have previously received 5 doses of DTP (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)/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), if required by local regulations.
•Female subjects of non\-childbearing potential may be enrolled in the study.
•\-Non\-childbearing potential is defined as pre\-menarche, current tubal ligation, hysterectomy or ovariectomy.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:

Exclusion Criteria

•Child in care.
•Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune\-modifying drugs within six months prior to the booster dose. For corticosteroids, this will mean prednisone \< 20 mg/day or equivalent, inhaled and topical steroids are allowed.
•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 (pharmaceutical product or device).
•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,