These are vaccines routinely given to infants in the UK and are not administered with respect to existing medical condition(s), rather in the prevention of diseases. MedDRA version: 15.0 Level: LLT Classification code 10027276 Term: Meningococcal meningitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Pediacel
Product Name: PEDIACEL
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Purified diphtheria toxoid
Sponsors
St George's University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Infants born at =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contraindications to vaccination as specified in the “Green Book” – Immunisation Against Infectious Disease, 2006 HMSO17.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare the immunological responses of infants born prematurely to Prevenar after 2 doses at 2 and 4 months of age with 3 doses at 2, 3 and 4 months of age (“early protection”). 2. To evaluate the immunological responses of infants born prematurely to Prevenar when vaccinated under a 3-dose accelerated schedule (2, 3 and 4 months of age) compared with a 3-dose extended schedule (2, 4 and 6 months of age). 3. To evaluate the immunological responses of infants born prematurely when vaccinated under the new national schedule to: · Hib · Meningococcal C · Diphtheria · Tetanus ; Secondary Objective: 1. To evaluate the immunological responses of infants born prematurely when vaccinated under the current national immunisation schedule to: Hib Meningococcal C Diphtheria Tetanus Pertussis 2. To describe the lymphocyte profile of preterm infants at different gestations and ages ; Primary end point(s): (i) Immunoglobulin G (IgG) geometric mean concentrations (GMCs) for the 13 pneumococcal serotypes included in Prevenar13® at one month after completion of primary immunisations (Prevenar13® administered at 2+4, 2+3+4 or 2+4+6 months); (ii) Proportion of infants with IgG concentrations =0.35 ?g/ml for the 13 serotypes in Prevenar13® at one month after completion of primary immunisations. ;Timepoint(s) of evaluation of this end point: This study aims to determine the immunogenicity and reactogenicity of the recently licensed 13-valent pneumococcal conjugate vaccine (PCV13, Prevenar13®) at 3 different immunisation schedules when give concomitantly with routine vaccinations to premature infants born before 35 weeks gestation. 200 premature infants will be recruited by study personnel at 9 different hospitals and randomised to one of th | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (i) IgG GMCs for the 13 pneumococcal serotypes in Prevenar13® immediately prior to administering the 13-month Prevenar13® booster dose (ii) Proportion of infants with IgG concentrations =0.35 ?g/ml for the 13 serotypes in Prevenar13® immediately prior to administering the 13-month Prevenar13® booster dose (iii) IgG GMCs for the 13 pneumococcal serotypes in Prevenar13® at 1 month after administering the 13-month Prevenar13® booster dose (iv) Proportion of infants with IgG concentrations =0.35 ?g/ml for the 13 serotypes in Prevenar13® at 1 month after administering the 13-month Prevenar13® booster dose (v) Antibody concentrations/titres for Hib, MCC, pertussis, diphtheria and tetanus at one month after completion of primary immunisation (vi) Proportion of infants with protective/threshold concentrations/titres for Hib, MCC, pertussis, diphtheria and tetanus at one month after completion of primary immunisation (vii) ) Antibody concentrations/titres for Hib, MCC, pertussis, diphtheria and tetanus at 12 months of age (viii) Proportion of infants with protective/threshold concentrations/titres for Hib, MCC, pertussis, diphtheria and tetanus at 12 months of age (ix) Antibody concentrations/titres for Hib and MCC at 14 months of age (2 months after Hib/MCC booster dose) (x) Proportion of infants with protective concentrations/titres for Hib and MCC at 14 months of age (2 months after Hib/MCC booster dose) (xi) The percentage of children experiencing fever, local reactions and non-febrile systemic reactions within the 7 days following each vaccine dose. ;Timepoint(s) of evaluation of this end point: This study aims to determine the immunogenicity and reactogenicity of the recently licensed 13-valent pneumococcal conjugate vaccine (PCV13, Prevenar13®) at 3 different immun | — |
Countries
United Kingdom
Contacts
Public ContactJoint Research Office
St George's University of London
Outcome results
None listed