Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b (Hib), serogroup C meningococcal and Streptococcus pneumoniae diseases. Booster immunisation of healthy one-year-old children against Hib and serogroup C meningococcal diseases
Conditions
Interventions
Product Name: DTPa-IPV/Hib-MenC-TT vaccine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Purified diphtheria toxoid (D)
Concentration unit: IU international unit(s)
Concentration
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at study entry: •A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination. • Born after 36 to 42 weeks of gestation. • 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) should be enrolled in the study. • 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: The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: • 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, or equivalent, >=0.5 mg/kg/day. 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 vaccination, or planned administration during the 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). • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease. • History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion). • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). • Major congenital defects or serious chronic illness. The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met: • Current febrile illness or axillary temperature >=37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate that GSK Biologicals’ DTPa IPV/Hib-MenC-TT vaccine co-administered with Prevenar (MenC-Combo group) is non-inferior to Pediacel co-administered with Prevenar and Menjugate (Control group), in terms of immune response to Hib and MenC, one month after the third dose of primary vaccination. Criteria for non-inferiority: Non-inferiority in terms of response to PRP will be demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference (Control minus MenC-Combo group) in percentage of subjects with anti-PRP concentrations >= 0.15 micrograms/ml is = 8 is =0.1 IU/ml and with anti-poliovirus type 1, 2 and 3 titres >= 8 is = 0.15 µg/ml • Seropositivity status: rSBA-MenC >= 8 (Proposed, non-validated cut-off for seroprotection) | — |
Countries
United Kingdom
Outcome results
None listed