Immunogenicity and safety of BoostrixTM using a new syringe in 10 to 15-year-old adolescents.

• Register: EUCTR
• Last refreshed on: 16 March 2015
• Main ID: EUCTR2013-003768-30-Outside-EU/EEA
• Date of registration: 11/03/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Immunogenicity and safety of BoostrixTM using a new syringe in 10 to 15-year-old adolescents.
• Scientific title: 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
• Target sample size: 671
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003768-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: New or previous syringe presentation Number of treatment arms in the trial: 2

Countries of recruitment

Chile, Mexico

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion 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:
-has a negative pregnancy test on the day of vaccination; and
-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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 671
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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,
-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 (no laboratory testing required).
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine (including latex).
•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.
-Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0°C on rectal setting. The preferred route for recording tempera-ture in this study will be oral or axillary.
-Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection), without fever, may be enrolled at the discretion of the investigator.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions, if applicable.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Booster immunization of healthy adolescents against diphtheria, tetanus and pertussis.

Intervention(s)

Trade Name: BOOSTRIX
Product Name: BOOSTRIX
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Current Sponsor code: D
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 2-
INN or Proposed INN: -
Current Sponsor code: T
Other descriptive name: TETANUS TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 20-
INN or Proposed INN: -
Current Sponsor code: PT
Other descriptive name: PERTUSSIS TOXOID
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 8-
INN or Proposed INN: -
Current Sponsor code: FHA
Other descriptive name: FILAMENTOUS HAEMAGGLUTININ
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 8-
INN or Proposed INN: -
Current Sponsor code: PRN
Other descriptive name: PERTUSSIS PERTACTIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: One month after booster vaccination (Month 1).

Main Objective: To demonstrate that Boostrix administered using the new syringe presentation is non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to all vaccine antigens, one month after booster vaccination.

Secondary Objective: •To assess the immunogenicity to the study vaccines in terms of seroprotection or seropositivity rates, one month after booster vaccination.
•To assess the immune response to the study vaccines in terms of booster response to diphtheria, tetanus and pertussis antigens, one month after booster vaccination.
•To assess the safety and reactogenicity of the study vaccines in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events.

Primary end point(s): Immunogenicity with respect to components of the study vaccine.
-Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Immunogenicity with respect to the components of the study vaccines-Prior to and one month after booster vaccination.
Booster response to all vaccine antigens-One month after booster vaccination.
Occurrence of solicited local and general symptoms-During the 4-day (Day 0–Day 3) follow-up period after booster vaccination.
Occurrence of unsolicited symptoms and Serious Adverse Events-During the 31-day (Day 0–Day 30) follow up period after booster vaccination.

Secondary end point(s): Immunogenicity with respect to the components of the study vaccines.
Booster response to all vaccine antigens.
Occurrence of solicited local and general symptoms.
Occurrence of unsolicited symptoms and Serious Adverse Events.

Secondary ID(s)

114778

Source(s) of Monetary Support

GlaxoSmithKline Biologicals