Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) diseases. MedDRA version: 13.1 Level: PT Classification code 10043376 Term: Tetanus System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 Level: LLT Classification code 10018952 Term: Haemophilus influenzae infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 L
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - A male or female between, and including, 60 and 90 days of age at the time of the first vaccination. - Born after a gestation period of 37 to 42 weeks inclusive. - Subjects who the investigator believes that their 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 visits). - 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 first 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 since birth. 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 the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study. -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). -Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth. -Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). -Family history of congenital or hereditary immunodeficiency. -History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). -Major congenital defects or serious chronic illness. -History of any neurological disorders or seizures. -Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. -Acute disease and/or fever at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. -Fever is defined as temperature = 37.5°C on axillary, oral or tympanic setting, or = 38.0°C on rectal setting. The preferred route for recording temperature in this study will be axillary or rectal. -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 |
|---|---|
| Timepoint(s) of evaluation of this end point: After the third dose of primary vaccination.;Main Objective: To demonstrate that the immunogenicity of at least one DTPa-HBVIPV/ Hib formulation is non-inferior to the licensed formulation in terms of seroprotection rates to diphtheria, tetanus, hepatitis B and PRP antigens and in terms of antibody geometric mean concentrations (GMCs) for pertussis antigens one month after the third dose of the primary vaccination.;Secondary Objective: - To assess the immunological response to the study vaccines in terms of seroprotection status, seropositivity status and antibody concentrations or titres, one month after the third dose of the primary vaccination. - To assess the immunological status towards diphtheria, tetanus pertussis and polio antigens in terms of seroprotection status, seropositivity status and antibody concentrations, before the first dose of the primary vaccination. - To assess the immunological response to pertussis antigens in terms of vaccine response, one month after the third dose of the primary vaccination. - 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 the components of the study vaccines. - Anti-diphtheria, anti-tetanus, anti-HBs and anti-PRP seroprotection status one month after the third dose of primary vaccination. - Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations one month after the third dose of primary vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Immunogenicity with respect to the components of the study vaccines. Anti-diphtheria, anti-tetanus, anti-HBs, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3, anti-PRP, anti-PT, anti-FHA, anti-PRN, 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 third dose of primary vaccination. Vaccine response to PT, FHA and PRN one month after the third dose of primary vaccination. Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, anti-PRN, anti-poliovirus type 1, anti-poliovirus type 2 and anti-poliovirus type 3 antibody concentrations or titres and seroprotection and/or seropositivity status before the first dose of primary vaccination. - Solicited local and general adverse events. Occurrence of solicited local symptoms during the 8-day (Day 0–7) follow-up period after each vaccination. Occurrence of solicited general symptoms during the 8-day (Day 0–7) follow-up period after each vaccination. - Unsolicited adverse events. Occurrence of unsolicited AEs during the 31-day (Day 0–30) follow-up period after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. - Serious adverse events. Occurrence of serious adverse events from Dose 1 up to study end. ;Timepoint(s) of evaluation of this end point: - Before the first dose and after the third dose of primary vaccination. - During the 8-day (Day 0–7) follow-up period after each vaccination - During the 31-day (Day 0–30) follow-up period after each vaccination - From Dose 1 up to study end. | — |
Countries
Dominican Republic, Finland, Lebanon, Panama
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed