Two-dose primary immunization course in healthy infants in the first year of life with a booster dose at 11 months of age against Haemophilus influenzae type b and meningococcal serogroup C diseases.
Conditions
Interventions
Trade Name: Menitorix
Product Name: Menitorix
Product Code: Hib-MenC-TT
Pharmaceutical Form: Powder for solution for injection
INN or Pr
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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. • A healthy male or female subject, between and including, 6 and 12 weeks of age at the time of the first vaccination. • Written informed consent obtained from the parent or guardian of the subject prior to the study entry. • Free of obvious health problems as established by medical history and clinical examination before entering into the study. • Born after a gestation period between and including 36 and 42 weeks. 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) since birth or planned use during the study period. • Chronic administration (defined as more than 14 days) of immunosuppressant 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.) • Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with exception of BCG. • Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio, pneumococcal, Hepatitis B or Hib disease • History of Haemophilus influenzae type b and /or meningococcal serogroup C disease. • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. • A family history of congenital or hereditary immunodeficiency. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. • Major congenital defects or serious chronic illness. • History of any neurologic disorders or seizures. • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Rectal temperature <38°C. • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Additional specific criteria for the booster phase of the study (to be checked at Visit 4) • Previous booster vaccination with a Hib vaccine. • Previous booster vaccination with a serogroup C meningococcal vaccine. • Previous booster vaccination with a DTP containing vaccine. • Previous booster vaccination with a IPV containing vaccine. • Previous booster vaccination with a Hep B containing vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary vaccination (at 1 m post dose 2): To demonstrate the non-inferiority of the Men-C and Hib immune responses induced by GSK Biologicals’ Hib-MenC conjugate vaccine given concomitantly with Infanrix™ penta when administered as a 2-dose primary vaccination course (3-5 m schedule), compared to NeisVac-C™ co-administered with Infanrix™ hexa, in terms of: % of subjects with SBA-MenC titre >= 1:8 and of % of subjects with anti-PRP concentration >= 0.15µg/ml. (Criteria for meeting these objectives: 1 m post dose 2, the lower limit of the standardized asymptotic 95% confidence interval on the difference between the study vaccine group and (minus) the control group is >= to -5 % for the MenC response and >= to -10% for the Hib response).; Secondary Objective: • At 1m post 2 + at 1m post boost: To evaluate the immunogenicity of Infanrix™ penta and Hib-MenC compared to Infanrix™ hexa and NeisVac-C™ in terms of anti-HBs, anti- PRP*, SBA-MenC*, anti-PSC (* except anti-PRP concentration >=0.15µg/ml, SBA-MenC titre >=1:8 at 1m post 2). • Pre boost: To demonstrate the non-inferiority of the primed group Hib-MenC compared to the primed control group, in terms of the % of subjects with SBA-MenC titre >=1:8 and anti-PRP concentration >= 0.15 µg/ml. To evaluate the persistence of the MenC*, PRP*, HB antibodies induced by a 2 dose primary vaccination course with Hib-MenC and Infanrix™-penta vaccines versus the control group vaccines.(* except anti-PRP concentration >=0.15µg/ml and SBA-MenC titre >=1:8). • To evaluate the safety and reactogenicity of Hib-MenC given with Infanrix™ penta compared to NeisVac-C™ given with Infanrix™ hexa. ; Primary end point(s): One month after the second dose (Post vacc II, at 6 months of age), in all subjects • SBA-MenC titre >= 1:8 (seroprotection). • anti-PRP concentration >= 0.15 µg/ml (seroprotection). | — |
Countries
Finland, Italy
Outcome results
None listed