Three-dose primary vaccination against Streptococcus pneumoniae (S pneumoniae) and Haemophilus influenzae (H influenzae) in healthy infants between 6-14 weeks (42-104 days) of age at the time of the first vaccination and 12-15 months of age at the time of booster vaccination. MedDRA version: 14.0 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Classification code 10061190 Term: Haemoph
Conditions
Interventions
Product Name: 10 valent pneumococcal conjugate vaccine combined with free pneumococcal proteins, adsorbed
Product Code: 10PCV/dPly/PhtD-10-AlPO4
Pharmaceutical Form: Suspension for injection
INN or Pr
DT:10-
INN or Proposed INN: Pneumoccocal free proteins
Other descriptive name: dPly/PhtD
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: dPly:20
PhtD:20-
Product Name: 10 valent pneumococcal conjugate vaccine combined with free pneumococcal proteins, adsorbed
Product Code: 10PCV/dPly/PhtD-30-AlPO4
Pharmaceutical Form:
INN or Proposed INN: Pn
DT:10-
INN or Proposed INN: Pneumococ
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). • A male or female between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination. • Written informed consent obtained from the parents/LAR(s) of the subject. • Healthy subjects as established by medical history and clinical examination before entering into the study. • Born after a gestation period of 36 to 42 weeks inclusive. 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: • Child in care • 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 in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines. The licensed flu vaccines are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF. • 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). • Previous vaccination against S. pneumoniae. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • Family history of congenital or hereditary immunodeficiency. • History of any hypersensitivity reaction following any previous vaccination. • Major congenital defects or any chronic illness. • History of any neurological disorders or seizures. • Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature = 38.0°C (100.4°F) on rectal setting or = 37.5°C (99.5°F) on oral or axillary setting. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. • Administration of immunoglobulins and/or any blood products since birth or planned administration during the primary epoch and during the period starting three months before booster vaccination and ending one month after the booster vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: First primary objective: Non-inferiority of the candidate pneumococcal vaccine (dPly 10µg and PhtD 10µg) versus 10Pn-PD-DiT vaccine when administered with DTPa-HBV-IPV/Hib as a 3-dose primary vaccination, in terms of post-primary immunization fever > 40.0°C (rectal temperature) with causal relationship to vaccination. Second primary objective (sequential): Non-inferiority of the candidate pneumococcal vaccine (dPly 30µg and PhtD 30µg) versus 10Pn-PD-DiT vaccine when administered with DTPa-HBV-IPV/Hib as a 3-dose primary vaccination, in terms of post-primary immunization fever > 40.0°C (rectal temperature) with causal relationship to vaccination. (see protocol for detailed criteria for non-inferiority) ;Secondary Objective: • To compare the protein doses (10µg or 30µg) contained in the candidate pneumococcal vaccine when given as a 3-dose primary vaccination course to infants and co-administered with DTPa-HBV-IPV/Hib, in terms of post-dose 3 immune response (see protocol for detailed criteria for superiority of one formulation over the other). • Immune responses to the candidate pneumococcal vaccine co-administered with DTPa-HBV-IPV/Hib, post-dose 3 and post-booster vaccination. • Safety & reactogenicity of the candidate pneumococcal vaccine and DTPa-HBV-IPV/Hib, when co-administered as a 3-dose primary vaccination at 2-3-4 months of age and as a booster dose at 12-15 months of age. • Immune response to DTPa-HBV-IPV/Hib when co-administered with the candidate pneumococcal vaccine, post-dose 3 and post-booster vaccination. • Persistence of antibodies against antigens in the candidate pneumococcal vaccine and DTPa-HBV-IPV/Hib, 8-11 months post-dose 3.;Primary end point(s): Occurrence of fever >40°C (rectal temperature) with causal relationship to vaccination within 7 days (Day 0-Day 6) after at least one dose of the primary vaccination. | — |
Countries
Czech Republic, Germany, Poland, Sweden
Outcome results
None listed