Prevenar13 was introduced into the national childhood immunisation programme to prevent serious bacterial infections caused by the germ Streptococcus pneumonia, including meningitis, septicaemia and pneumonia.
Conditions
Interventions
Trade Name: Prevenar13
Product Name: Prevenar 13
Pharmaceutical Form: Injection*
INN or Proposed INN: Pneumococcal polysaccharide type 1
Sponsors
Health Protection Agency
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female infants born at term (at least 37 weeks gestation) aged =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participant may not be included in the study if any of the following apply: • History of invasive Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease • Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV) • Bleeding disorders and/or prolonged bleeding time • Major congenital defects or chronic disease • Premature birth (<37 weeks gestation at birth)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure the level and quality (ability of the antibodies to kill the pneumococcus germ) of antibodies against the 13 pneumococcal types that are included in Prevenar13 in infants after they have received their routine primary immunisations at 2, 3 and 4 months of age. ;Secondary Objective: To determine whether Prevenar13 has any effect on immune responses to the other primary immunisation vaccines, including diphtheria, tetanus, pertussis (whooping cough), Hib and MenC.;Primary end point(s): To determine the proportion of infants with pneumococcal serotype-specific IgG antibody concentrations =0.35 µg/ml for the 13 serotypes included in Prevenar13 at one month after completion of primary immunisation | — |
Countries
United Kingdom
Outcome results
None listed