Active immunization of children from the age of 6 weeks up to 18 months of age at the time of first vaccination, against Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and Haemophilus influenzae. The immunization schedule will depend on the age at the time of the first 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 Classif
Conditions
Interventions
PS-DT for serotype 19F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 32PS/26PD-16TT/10DT
Trade Name: Havrix-preservative free
Pharmaceutical Form:
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who the investigator believes that their parent(s)/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. • Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination. • Written informed consent obtained from parent(s) or from the guardian(s) of the subject. 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) within 30 days preceding the first dose of study vaccine, or planned use of such a vaccine other than the study vaccine(s) during the entire study period. • Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine during the study period. If a child belongs to a high risk group for pneumococcal infections (such as children with an anatomic or functional asplenia, HIV infection, chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, CSF fistula or with significant immunodeficiency) for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program. • Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period. • Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period. • Known severe hypersensitivity to any component of the study vaccines, including neomycin. • Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate the effectiveness of 10Pn-PD-DiT vaccine in preventing culture-confirmed IPD due to vaccine pneumococcal serotypes in children vaccinated with at least one dose of 10Pn-PD-DiT within the first 7 months of life in clusters assigned to a 3-dose primary vaccination course. Criteria for effectiveness: Effectiveness (VE) in preventing culture-confirmed IPD due to the 10 vaccine serotypes will be demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type [VT] IPD VE = 0%) is lower than 5%. refer to 10PN-PD-DIT-043 study (EudraCT number : 2008-005149-48);Secondary Objective: •Effectiveness in preventing culture-confirmed IPD due to vaccine pneumococcal serotypes in children vaccinated with at least 1 dose of 10Pn-PD-DiT within first 7 months of life in clusters assigned to a 2-dose primary vaccination course Criteria: see Main objective •Effectiveness in preventing culture-confirmed/probable ID, reducing hospital-diagnosed pneumonia and impact on tympanostomy tube placement & outpatient antimicrobial prescriptions in combination with study 10PN-PD-DIT-043 (EudraCT number: 2008-005149-48) •Impact on nasopharyngeal carriage of S. pneumoniae, H. influenzae and/or other bacterial pathogens, on acute otitis media in children starting vaccination <18 months of age (MOA) •Impact on lower and upper respiratory tract infections, including acute otitis media in children starting vaccination <18 MOA (Turku subset) •Immuno in children who received age-appropriate vaccination schedule •Safety/reacto in children starting vaccination <18 MOA;Primary end point(s): In children starting vaccination within the first 7 months of life in clusters assigned to a 3-dose primary vaccination course: • Occurrence of culture-confirmed IPD due to any of the 10 pneumococcal vaccine serotypes. refer to 10PN-PD-DIT-043 study (EudraCT number : 2008-005149-48);Timepoint(s) of evaluation of this end point: from administration of 1st vaccine d | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • In children starting vaccination within first 7 months of life in clusters assigned to a 2-dose primary vaccination course: occurrence of culture-confirmed IPD due to any of the 10 pneumococcal vaccine serotypes. refer to 10PN-PD-DIT-043 study (EudraCT number : 2008-005149-48) • Occurrence of culture-confirmed/probable ID due to any bacterial pathogen • Occurrence of hospital-diagnosed pneumonia, tympanostomy tube placements, outpatient antibiotic prescriptions • Antimicrobial susceptibility of S. pneumoniae & H. influenzae isolated from ID • Occurrence of H. influenzae, S. pneumoniae and/or other bacterial pathogens in the nasopharynx & acquisition of new H. influenzae and/or S. pneumoniae strains • Concentration of antibodies & opsonophagocytic activity against components of the investigational pneumococcal conjugate vaccine (subset) • Occurrence of acute otitis media (AOM), recurrent AOM, AOM by severity, AOM with documented antimicrobial prescription • Occurrence of lower & upper respiratory tract infections, including AOM (Turku subset) • Occurrence of solicited local/general adverse events (AE), unsolicited AEs, SAEs;Timepoint(s) of evaluation of this end point: Culture-confirmed/probable ID: from administration of 1st vaccine dose up to study end Culture-confirmed ID (in children starting vaccination within 1st 7 months of life): 2 weeks post-primary vaccination Hospital-diagnosed pneumonia, tympanostomy, antibiotic prescriptions/susceptibility, AOM: from administration of 1st vaccine dose up to study end Occurrence/acquisition: prior to 1st vaccination, 1 month post-dose 1 & post-dose 2, before booster dose, 3 months post-booster and at last scheduled visit Immuno: 1 month post-dose 1, post-dose 2 & post-dose 3, before booster dose and at last scheduled visit Solicited AEs: within 4 days after each vaccination Unsolicited AEs: within 4 days after each vaccination SAEs: following administration of 1st vaccine dose up | — |
Countries
Finland
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed