Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b.
Conditions
Interventions
TT:14-DT:9
Product Name: Menitorix
Product Code: HibMenC
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Haemophilus B-TT and neisseria meningitidis group C-TT
TT: 10
Product Name: Prevenar
Pharmaceutical Form: Suspension for injection
Product Name: Meningitec
Pharmaceutical Form: Suspension for injection
Product Name: NeisVac
Pharmaceutical Form: Suspens
2:16DU-/ml
3:64DU/ml
Product Name: Infanrix Hexa
Product Code: DTPa-IPV-HBV / Hib
Pharmaceutical Form: Powder and
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 between, and including, 6-16 weeks (42 to 118 days) of age at the time of the first vaccination. • Subjects for whom 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. • Free of obvious health problems as established by medical history and clinical examination before entering into the study. • Born after a gestation period (between 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: 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 (active and 6 months safety follow-up phases of the study). • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (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 during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3. • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination, BCG vaccination) • History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, meningococcal serogroup C. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid. • History of seizures or neurological disease. • 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 diarrhea or mild upper respiratory infections with or without low-grade febrile illness, i.e oral/axillary/tympanic temperature < 37.5°C / rectal temperature < 38.0°C). • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). • A family history of congenital or hereditary immunodeficiency. • Major congenital defects or serious chronic illness. • Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety • Occurrence of rectal fever >39°C within 4 days (day 0-day 3) after at least one vaccination. ;Main Objective: The main objective of the study is to demonstrate that GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when administered as a 3-dose primary vaccination course, is non-inferior to Prevenar, both co-administered with DTPa-HBV-IPV and Hib-MenC vaccines, in terms of post-immunization febrile reactions with rectal fever > 39.0°C. Criteria for safety: Non-inferiority will be demonstrated if the upper limit of the 95% CI of the difference (10Pn-PD-DiT + Hib-MenC group minus Prevenar group), in terms of percentage of subjects with rectal fever >39.0°C, is lower than 10%. ;Secondary Objective: The secondary objectives of the study are: • To asses the safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when concomitantly administered with DTPa-combined and MenC or Hib-MenC vaccines. • To evaluate, one month post dose III, the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with DTPa-combined and MenC or Hib-MenC vaccines. • To evaluate, two months post dose II, the immunogenicity of the GSK Biologicals’ Hib-MenC conjugate vaccine, when co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar and DTPa-HBV-IPV vaccines. • To evaluate, one month post dose III, the immunogenicity of DTPa-HBV-IPV and Hib-MenC vaccines when concomitantly administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar. | — |
Countries
Germany, Spain
Outcome results
None listed