Clinical trial NCT01362322: Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents
Official title: Immunogenicity and Safety Study of GSK Biologicals' Boostrix™ Vaccine Using a New Syringe Presentation in Healthy Adolescents Aged 10-15 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diphtheria
Tetanus
Acellular Pertussis
Keywords: dTpa
Boostrix
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 671
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
timeFrame: At Month 1
measure: Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations
timeFrame: At Month 1
measure: Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
timeFrame: At Day 0
measure: Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations
timeFrame: At Day 0
Secondary outcomes:
measure: Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens
timeFrame: At Day 0 (PRE) and at Month 1 (POST)
measure: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
timeFrame: At Day 0 (PRE) vaccine and at Month 1 (POST)
measure: Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations)
timeFrame: At Day 0 (PRE) vaccine and at Month 1 (POST)
measure: Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies
timeFrame: At Month 1
measure: Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens.
timeFrame: At Month 1
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: Within 4 days (Days 0-3) post vaccination period
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: Within 31 days (Days 0-30) post
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: Within 4 days (Days 0-3) post vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Day 0 - Month 1)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: GSK Investigational Site
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Estado de Mexico
country: Mexico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Pavia-Ruz N, Abarca K, Lepetic A, Cervantes-Apolinar MY, Hardt K, Jayadeva G, Kuriyakose S, Han HH, de la O M. Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents--A single blind randomized trial. Hum Vaccin Immunother. 2015;11(7):1770-4. doi: 10.1080/21645515.2015.1041697.