Three-dose primary vaccination of healthy infants between 6-12 weeks (42-90 days) of age at the time of the first vaccination against Streptococcus pneumoniae and booster vaccination at 11-13 months of age.
Conditions
Interventions
FHA:25-PRN:8
INN or Proposed INN: Hepatitis B surface antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Poliovirus, inactivated, 3 ty
2:8
3:32-
INN or Proposed INN: Haemophilus type B polysaccharide conjugated to tetanus toxoid as carrier protein
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: Hib:10-
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who the investigator believes that their parents/guardian(s) 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 male or female between, and including, 6-12 weeks (42-90 days) of age at the time of the first vaccination. Written informed consent obtained from both parents or from the guardian(s) 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 of at least 36 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) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Concurrently participating in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). 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). Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from one month (30 days) before and up to one month (30 days) after each dose of study vaccine with the exception of pandemic influenza vaccine. Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae. Children for whom hepatitis B vaccination is required according to the local recommendations or based on medical needs (for example if the mother is a hepatitis B virus carrier), should not be offered to participate in this randomised single blind study, in which two third of the subjects will not receive hepatitis B vaccination. History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. 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 or mild upper respiratory infection, provided the body temperature is <38°C (rectal measurement) or <37.5°C for oral/axillary/tympanic measurements). Study entry should be delayed until the illness has improved. 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 study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate that GSK Biologicals’ 10 valent pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib (Pediacel) (10Pn-PDC group) is non-inferior to co-administration with DTPa-HBV-IPV/Hib (Infanrix hexa) (10Pn-Hexa group), in terms of immune response to the 10 pneumococcal vaccine serotypes and to protein D, when administered as a three-dose primary vaccination course. Criteria for non-inferiority: For each of the 10 pneumococcal vaccine serotypes and protein D, non-inferiority will be demonstrated if the upper limit of the 2-sided 95% CI of the GMC ratio between groups (10Pn-Hexa group over 10Pn-PDC group), is lower than 2. ;Secondary Objective: Non-inferiority of Pediacel co-administered with 10Pn-PD-DiT to co-administration with Prevenar administered as 3-dose primary vaccination if for each of the DTPa-IPV-Hib antigens the upper limit of the 2-sided 95% CI of the GMC or GMT ratio’s respectively between groups is <2 Impact of 10Pn-PD-DiT on nasopharyngeal carriage of H. influenzae. Safety/reactogenicity of 10Pn-PD-DiT co-administered with Infanrix hexa or Pediacel as 3-dose primary vaccination during first 6 months of life Antibody persistence pre-booster, 6-8 months after completion of primary vaccination with 10Pn-PD-DiT co-administered with Infanrix hexa or Pediacel. One month post-booster, immunogenicity of 10Pn-PD-DiT co-administered with Infanrix hexa or Pediacel at 11-13 months of age Safety/reactogenicity of booster dose of 10Pn-PD-DiT co-administered with Infanrix hexa or Pediacel at 11-13 months of age Antibody persistence 12 months after 4th-dose of 10Pn-PD-DiT co-administered with Infanrix hexa or Pediacel;Primary end point(s): One month after the administration of the 3rd dose of pneumococcal conjugate vaccine: •Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. •Antibody concentration against protein D. | — |
Countries
Netherlands
Outcome results
None listed