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 microgram(s)
Concentration type: equal
Concentration number: 16PS
13PD
8TT
5DT-
Trade Name: Havrix-preservative free
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis A virus antigen
Concentration unit: ELISA unit/dose enzyme-linked immunosorbent
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria for municipalities: Clusters are defined to encompass selected municipalities based on the agreement for study participation obtained from the health care centre responsible for the municipality primary health care and well-baby clinics. Note: 1) Health care centres with remote location or low annual birth cohorts (for instance the Åland and Northern Lapland municipalities) may not be offered study participation. 2) In some selected municipalities where no collaboration with health care centres has been set up, there is opportunity for parent(s) to let their child participate in study 10PN-PD-DIT-053 and receive the same vaccination as in the current study. Inclusion criteria for study participants: • A 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 the parent/guardian of the subject. Are the trial subjects under 18? yes Number of subjects for this age range: 47000 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: • Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine other than the study vaccine, or planned use 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%.;Secondary Objective: •Effectiveness in preventing culture-confirmed IPD due to vaccine pneumococcal serotypes in children vaccinated with at least 1 dose =7 mth of life in clusters with 2-dose primary vaccination Criteria: see E.2.1 •Children vaccinated with at least 1 dose from 6 wks-18 mth of age & children starting vaccination =7 mth of life and who completed age-appropriate schedule, effectiveness in preventing culture-confirmed/probable ID caused by: -any & each of vaccine/vaccine-related/other pneumococcal serotypes, H. influenzae types -any other bacterial pathogen •Children vaccinated with at least 1 dose from 6 wks-18 mth: -impact on hospital-diagnosed pneumonia, tympanostomy tube placements (TTPs), outpatient antimicrobial prescriptions, LRTI, URTI -S. pneumoniae/H. influenzae antimicrobial susceptibility •Unvaccinated population, indirect effects on: -culture-confirmed/probable ID, hospital-diagnosed pneumonia -TTPs/outpatient antimicrobial prescriptions (=7 yrs) •Long-term effects;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. ;Timepoint(s) of evaluation of this end point: From the administration of the first vaccine dose up to study end. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •In children starting vaccination within first 7 months of life in clusters with 2-dose primary vaccination course: occurrence of culture-confirmed IPD due to any of the 10 pneumococcal vaccine serotypes. •Occurrence of culture-confirmed/probable ID due to any bacterial pathogen •Occurrence of hospital-diagnosed pneumonia, TTPs, outpatient antimicrobial prescriptions •Antimicrobial susceptibility of S. pneumoniae and H. influenzae isolated from ID (vaccinated children) •Occurrence of upper and lower respiratory tract infections, including AOM (subset of vaccinated subjects in Turku area) ;Timepoint(s) of evaluation of this end point: From the administration of the first vaccine dose up to study end. | — |
Countries
Finland
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed