Immune persistence and booster immunisation against diphtheria, tetanus and pertussis in adults.
Conditions
Interventions
Trade Name: Boostrix
Product Name: Boostrix US
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Purified diphtheria toxoid (D)
Concentration unit: LfU/ml lime flocculation unit(s)/mi
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy ALL the following criteria at study entry: •Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). •Male or female subjects who have received dTpa-0.5, dTpa-0.3 or dTpa-0.133 vaccine in the study 263855/029 (dTpa-029). •Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination. •Healthy subjects as established by medical history and clinical examination. •Female subjects of non-childbearing potential may receive the booster vaccine. ?Non-childbearing potential is defined as pre-menarcheal, current tubal ligation, hysterectomy, ovariectomy or post-menopausal. •Female subjects of childbearing potential may receive the booster vaccine, if the subject: ?practices/has practiced adequate contraception for 30 days prior to vaccination, and ?has a negative pregnancy test on the day of vaccination, and ?agrees to continue adequate contraception during the entire booster epoch. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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
Exclusion criteria: The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: Exclusion criteria to be checked at study entry: •Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029 (dTpa-029). •History of diphtheria, tetanus, or laboratory confirmed pertussis disease. •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. •Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus. •Occurrence of any of the following adverse event after a previous administration of a DTP vaccine : ?hypersensitivity reaction to any component of the vaccine, ?encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine, ?fever greater than or equal to 40 °C (axillary 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 three days of vaccination. •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Additional exclusion criteria to be checked for subjects before the booster vaccination administration: •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 dose. For corticosteroids, prednisone <20 mg/day, or equivalent, inhaled and topical steroids are allowed. •Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period. •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). •Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose 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. ?Subjects with a minor illness (such as mild diarrhoea, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the persistence of anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-PRN antibodies 8.5 and 10 years after the previous booster dose in study 263855/029 (dTpa-029). •To assess the immunogenicity of the administered dTpa vaccine in terms of antibody response to all vaccine antigens, one month after a second booster vaccination in subjects who will receive: ?the dTpa-0.5 vaccine and have previously received the same vaccine. ?the dTpa-0.3 vaccine and have previously received the same vaccine. ?the dTpa-0.5 vaccine and have previously received the dTpa-0.133 vaccine. ;Secondary Objective: To evaluate the safety and reactogenicity of the dTpa-0.5 and dTpa-0.3 vaccine, in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events (SAEs).;Primary end point(s): •Immune persistence at Years 8.5 and 10 after the previous booster dose in study 263855/029 (dTpa-029): ?Seroprotection rates against diphtheria and tetanus. ?Seropositivity rates against pertussis antigens. ?Geometric mean concentrations of antibodies against all vaccine antigens. •Immunogenicity one month after booster vaccination. ?Seroprotection rates against diphtheria and tetanus. ?Seropositivity rates against pertussis antigens. ?Booster response to the pertussis antigens. ?Geometric mean concentrations of antibodies against all vaccine antigens. | — |
Countries
Belgium
Outcome results
None listed