Three dose primary vaccination of preterm infants between 8-16 weeks (56-118 days) of age at the time of first vaccination against Streptococcus pneumoniae.
Conditions
Interventions
PS-DT for serotype 19F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: PS:32
DT:9
Trade Name: Infanrix Hexa
Product Name: Infanrix Hexa
Product Code: DTPa HBV IPV + Hib
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Diphtheria toxoid
FHA:50-PRN:16
INN or Proposed INN: Hepatitis B surface antigen
Concentration unit: µg/µl microgram(s)/microlitre
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Poliovirus (in
3:64DU/ml
INN or Proposed INN: Haemophilus type b polysaccharide conjugated to TT
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 40-80-
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects: •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 male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination. •Written informed consent obtained from the parent or guardian of the subject. •Born after a gestation period of >27 weeks (at least 189 days). Subjects of the Preterm I and Preterm II group: •Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks. *Medically stable refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery. Subjects of the Full term group: •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 vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up) •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth 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 from one month (30 days) before the first dose of vaccines (Visit 1) and up to Visit 6. •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus 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, BGC vaccination) •History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis. •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, mild upper respiratory infection with or without temperature increase, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38°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, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the active phase of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and reactogenicity of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine when administered as a 3-dose primary vaccination course and co-administered with DTPa-HBV-IPV/Hib vaccine in preterm infants.;Secondary Objective: To assess the immunogenicity of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib vaccine in preterm infants, one month post dose III vaccination.;Primary end point(s): Occurrence of core fever >39°C (rectal temperature) or >38.5°C (oral, axillary or tympanic temperature) within 4 days (day 0-day 3) after at least one vaccination. | — |
Countries
Greece, Spain
Outcome results
None listed