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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2009-012202-39-GB |
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Date of registration:
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23/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ dTpa-IPV vaccine (Boostrix Polio) compared with Sanofi Pasteur MSD’s dTpa-IPV vaccine (Repevax), when co-administered with GSK Biologicals’ MMR vaccine (Priorix) in 3 and 4-year-old healthy children. - DTPA-IPV (BOOSTRIX-IPV)-009
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Scientific title:
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A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ dTpa-IPV vaccine (Boostrix Polio) compared with Sanofi Pasteur MSD’s dTpa-IPV vaccine (Repevax), when co-administered with GSK Biologicals’ MMR vaccine (Priorix) in 3 and 4-year-old healthy children. - DTPA-IPV (BOOSTRIX-IPV)-009 |
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Date of first enrolment:
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10/11/2010 |
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Target sample size:
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384 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012202-39 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• A male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age).
• Subjects who have received a complete three-dose primary vaccination with DTPa and IPV in the first six months of life, in line with recommendations in the UK.
• Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life (up to the 2nd birthday), in line with recommendations in the UK.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time of enrolment.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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(s) 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) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. For corticosteroids, this will mean prednisone < 0.5 mg/kg/day or equivalent, inhaled and topical steroids are allowed.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period (up to Visit 2), with the exception of inactivated influenza vaccine.
• 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).
• Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life.
• Previous measles, mumps and/or rubella second dose vaccination.
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease.
• Known exposure to measles, mumps and/or rubella within 30 days prior to study start.
• Any confirmed or suspected immunosuppressive or immunodeficiency 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 systemic hypersensitivity to neomycin and polymyxin.
• Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation.
• Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine:
- Hypersensitivity reaction to any component of the vaccine;
- Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine;
- Fever = 40°C (axillary temperature/oral temperature) within 48 hours of vaccination, not due to another identifiable cause;
- Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination;
- Convulsions with or without fever, occurring within 3 days of vaccination.
• Acute disease and/or fever at the time of enrolment or within 24 hours of study vaccine administration.
- Fever is defined as temperature ? 37.5°C on oral or axillary setting.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Booster immunisation against diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and rubella in healthy preschool children previously vaccinated with 3 doses of DTPa and polio vaccine.
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Intervention(s)
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Trade Name: Boostrix Polio
Product Name: Boostrix Polio
Product Code: dTpa-IPV
Pharmaceutical Form: Suspension for injection
Current Sponsor code: DT
Other descriptive name: Diphtheria toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 2-
Current Sponsor code: TT
Other descriptive name: Tetanus toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 20-
Current Sponsor code: PT
Other descriptive name: Pertussis toxoid
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 8-
Current Sponsor code: FHA
Other descriptive name: Filamentous Haemagglutinin
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 8-
Other descriptive name: Pertactin
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-
Other descriptive name: Inactivated poliovirus Type 1 - 2 - 3
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 40-8-32-
Trade Name: Repevax
Product Name: Repevax
Product Code: dTpa-IPV
Pharmaceutical Form: Suspension for injection
Current Sponsor code: Diphteria Toxoid
Other descriptive name: DT
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration numbe
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Primary Outcome(s)
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Secondary Objective: • To assess the immunogenicity of the study vaccines in terms of seroprotection/seropositivity rates, GMCs/GMTs for all antigens, prior to and one month after booster vaccination.
• To assess the immune response to the study vaccines in terms of the percentage of subjects with booster response to the pertussis and polio antigens, one month after booster vaccination.
• To assess the immune response to the MMR vaccine in terms of seroconversion rates against mumps, measles and rubella, 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.
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Main Objective: • To demonstrate that GSK Biologicals’ dTpa-IPV vaccine is non-inferior to Sanofi
Pasteur MSD’s dTpa-IPV vaccine in terms of percentages of subjects with immune
response to the diphtheria, tetanus and polio antigens, one month after booster
vaccination.
• To demonstrate that GSK Biologicals’ dTpa-IPV vaccine given as a single booster
dose in this study is non-inferior to GSK Biologicals’ DTPa vaccine (Infanrix) given
as a primary series in the German household contact study APV-039 in terms of anti-
PT, anti-FHA and anti-PRN geometric mean concentrations (GMCs), one month
after booster vaccination.
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Primary end point(s): • Immunogenicity with respect to the components of the study vaccines.
One month after booster vaccination:
- Booster responses to the diphtheria and tetanus antigens.
- Anti-poliovirus types 1, 2 and 3, anti-PT, anti-FHA and anti-PRN antibody titres/concentrations.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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