Booster immunisation of healthy adults against diphtheria, tetanus, pertussis and poliomyelitis. MedDRA version: 14.0 Level: PT Classification code 10043376 Term: Tetanus System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Classification code 10034738 Term: Pertussis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Classification code 10013023 Term: Diphtheria System Organ Class: 10021881 - Infections and infestati
Conditions
Interventions
Trade Name: Boostrix-Polio
Product Name: Boostrix-Polio
Product Code: dTpa-IPV
Pharmaceutical Form: Suspension for injection
Current Sponsor code: D
Other descriptive name: diphtheria toxoid
Concentra
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who the investigator believes can and will comply with the requirements of the protocol. •Male or female subjects who have received a dTpa-IPV, dTpa + IPV or Td-IPV vaccine in study NCT01277705. •Written informed consent obtained from the subject. •Healthy subjects as established by medical history and clinical examination before entering into the study. •Female subjects of non-childbearing potential may be enrolled in the study. –Non-childbearing potential is defined as pre-menarcheal, current tubal ligation, hysterectomy, ovariectomy or post-menopausal. •Female subjects of childbearing potential may be enrolled in the study and 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 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of the 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. •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. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. •Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT01277705. In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Td-IPV group. •History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT01277705. •Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination. •Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus. •Occurrence of any of the following adverse event (AE) 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 = 40°C within 48 hours of vaccination not due to another identifiable cause, –collapse or shock-like state within 48 hours of vaccination, –convulsions with or without fever, occurring within 3 days of vaccination. •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. •Pregnant or lactating female. •Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To exhibit one month after a booster dose of dTpa-IPV vaccine, that the booster dose elicits seroprotective antibody concentrations when given 10 years after a dose of: -dTpa-IPV vaccine or co-administered dTpa+IPV vaccines, in at least 80% of the subjects against diphtheria, the 3 polio antigens and in at least 90% of the subjects against tetanus. -dTpa-IPV vaccine, in at least 80% of the subjects against diphtheria, the 3 polio antigens and in at least 90% of the subjects against tetanus. -co-administered dTpa+IPV vaccines, in at least 80% of the subjects against diphtheria, the 3 polio antigens and in at least 90% of the subjects against tetanus. -Sanofi Pasteur MSD’s Td-IPV, one in at least 80% of the subjects against diphtheria, the 3 polio antigens and in at least 90% of the subjects against tetanus. •To assess the persistence of antibodies to diphtheria, tetanus, PT, FHA, PRN and poliovirus antigens type 1, 2 and 3, 10 years after the booster dose in dTpa-IPV-003 study.;Secondary Objective: •To assess the immune response to the pertussis component of the study vaccine in terms of seropositivity rates and booster response, one month after vaccination. •To assess the immune response to the study vaccine in terms of antibody concentrations/titres against all vaccine antigens, one month after vaccination. •To evaluate the safety and reactogenicity of GSK Biologicals’ dTpa-IPV vaccine in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events (SAEs). ;Primary end point(s): •Immunogenicity with respect to booster vaccination. -Seroprotection rates against diphtheria, tetanus and poliovirus types 1, 2 and 3. •Immune persistence after the booster dose given in the study NCT01277705. -Seroprotection rates against diphtheria, tetanus and poliovirus types 1, 2 and 3. -Anti-PT, anti-FHA and anti-PRN seropositivity rates. -Geometric mean concentrations/titres (GMCs/ GMTs) to all vaccine antigens.;Timepoint(s | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Immunogenicity with respect to booster vaccination, one month after booster vaccination in all subjects. ?-Booster response to the PT, FHA and PRN antigens. ?-Anti-PT, anti-FHA and anti-PRN seropositivity rates. ?-GMCs/GMTs to all vaccine antigens. •Solicited local and general symptoms. ?-Occurrence of solicited local and general symptoms during the 4-day (Day 0–Day 3) follow-up period after booster vaccination. •Unsolicited adverse events. ?-Occurrence of unsolicited symptoms during the 31-day (Day 0–Day 30) follow-up period after booster vaccination. •Serious adverse events ?-Occurrence of serious adverse events (SAEs) from the booster dose up to study end.;Timepoint(s) of evaluation of this end point: Immunogenicity with respect to booster vaccination: One month (Month 1) after the booster dose of Boostrix-Polio vaccine Occurrence of solicited local and general symptoms: During the 4-day (Day 0-3) follow-up period after booster vaccination Occurrence of unsolicited adverse events: During the 31-day (Day 0-30) follow-up period after booster vaccination Occurrence of serious adverse events: From the booster dose (Day 0) up to study end (Month 1) | — |
Countries
Germany
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed