Primary and booster immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b and serogroup C meningococcal diseases.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination. • Born after a gestation period of 36 to 42 weeks inclusive. • Subjects who the investigator believes that their parents/ guardians 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 or guardian 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: 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: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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) 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 immunoglobulins and/or any blood products since birth or planned administration during the study period. • Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4. • 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. • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth. • History of seizures or progressive neurological disease. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). • Major congenital defects or serious chronic illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine (Combo group) is non-inferior to GSK Biologicals’ DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine co-administered with Novartis’ meningococcal serogroup C vaccine (Menjugate) (Control group), in terms of immune response to Hib and MenC antigens, one month after the second vaccine dose.;Secondary Objective: • Demonstrate DTPa-HBV-IPV/Hib-MenC-TT vaccine is non-inferior (NI) to Infanrix hexa + Menjugate, in terms of response to Hib and MenCs, 1 month after 3rd dose. • Demonstrate DTPa-HBV-IPV/Hib-MenC-TT vaccine is NI to Infanrix hexa +Menjugate, in terms of response to T, D, HBV, 3 poliovirus types & pertussis, 1 month after 3rd dose. • Demonstrate DTPa-HBV-IPV/Hib-MenC-TT is NI to Infanrix hexa + Menjugate in terms of response to T, D, HBV, 3 poliovirus types & pertussis, 1 month after the 2nd dose. • Assess the response in terms of SP/S+ rates, GMCs/GMTs, 1 month after the 2nd dose. • Assess the persistence of response to in terms of SP/S+ rates & GMCs/GMTs, before the 3rd dose. • Assess the response in terms of SP/S+ rates, GMCs/GMTs & in terms of booster response for pertussis antigens, 1 month after the 3rd dose. • Assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib-MenC-TT vaccine;Primary end point(s): Immunogenicity one month after the second vaccine dose: • Seroprotection status: Anti-PRP antibody concentrations >=0.15 µg/ml. • Seropositivity status: rSBA-MenC titres >=8. | — |
Countries
Slovakia
Outcome results
None listed