Healthy volunteers (toddlers): Booster immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) diseases. MedDRA version: 14.0 Level: PT Classification code 10043376 Term: Tetanus System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10018952 Term: Haemophilus influenzae infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Class
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who participated in the study 113948 (DTPA-HBV-IPV-124 PRI) and received three doses of the new or licensed DTPa-HBV-IPV/Hib study vaccine. - A male or female child between, and including, 12 and 15 months of age at the time of the booster vaccination. - Subjects who the investigator believes that parent(s)/ LAR(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit). - Written informed consent obtained from the parent(s)/LAR(s) of the subject. - 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: 720 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
Exclusion criteria: - Child in care. - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 = 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. - Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). - Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease since the conclusion visit of study 113948 (DTPA-HBV-IPV-124 PRI). - Serious chronic illness. - 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 vaccines. - History of any neurological disorders or seizures. - Administration of immunoglobulins and/or any blood products within the 3 months preceding the booster dose of study vaccine or planned administration during the study period. - Occurrence of any of the following events following previous administration of the study vaccine constitutes an absolute contraindication to further dosing. Anaphylactic or other hypersensitivity reaction. Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. Temperature of = 40.0°C (axillary) or 40.5°C (rectal) within 48 hours of vaccination, not due to another identifiable cause. Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination. Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting = 3 hours. Seizures with or without fever occurring within 3 days of vaccination. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met: - 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° on rectal 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the immunogenicity of at least one DTPa-HBV-IPV/Hib formulation is non-inferior to the licensed formulation in terms of seroprotection rates to diphtheria, tetanus, hepatitis B, poliovirus types 1, 2 and 3 and PRP antigens and in terms of antibody geometric mean concentrations (GMCs) for pertussis antigens one month after the booster dose.;Secondary Objective: - To assess the immunogenicity of the DTPa-HBV-IPV/Hib vaccines in terms of persistence of the antibodies to all vaccine antigens before the booster dose. - To assess the immunological response to the study vaccines in terms of seroprotection status, seropositivity status and antibody concentrations or titres for all vaccine antigens, and in terms of booster response for pertussis antigens, one month after the booster dose. - To assess the safety and reactogenicity of the study vaccines in terms of solicited and unsolicited, local and general symptoms and serious adverse events.;Primary end point(s): - Immunogenicity with respect to components of the study vaccines. Anti-diphtheria, anti-tetanus, anti-HBs, anti-poliovirus types 1, 2 and 3 and anti-PRP seroprotection rates one month after the booster dose. Anti-PT, anti-FHA, anti-PRN antibody concentrations one month after the booster dose.;Timepoint(s) of evaluation of this end point: One month after the booster dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Immunogenicity with respect to the components of the study vaccines. Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, anti-PRN, anti-HBs, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3, anti-PRP, anti-pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F antibody concentrations or titres, and seroprotection and/or seropositivity status one month after the booster dose. Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, anti-PRN, anti-HBs, anti-poliovirus type 1, anti-poliovirus type 2 and anti-poliovirus type 3 and anti-PRP antibody concentrations or titres and seroprotection and/or seropositivity status before the booster dose. Booster response to the PT, FHA and PRN antigens one month after the booster dose. - Solicited local and general symptoms. Occurrence of solicited local and general symptoms during the 4-day (Day 0–3) follow-up period after booster vaccination. - Unsolicited adverse events. Occurrence of unsolicited AEs during the 31-day (Day 0–30) follow-up period after booster vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. - Serious adverse events. Occurrence of serious adverse events from Visit 1 up to 30 days after the booster dose of the study vaccines.;Timepoint(s) of evaluation of this end point: - Before the booster dose. - One month after the booster dose. - During the 4-day (Day 0–3) follow-up period after booster vaccination - During the 31-day (Day 0–30) follow-up period after booster vaccination. - From Visit 1 up to 30 days after the booster dose. | — |
Countries
Dominican Republic, Finland, Lebanon, Panama
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed