Responses to vaccinations against Hib, meningococcal serogroup C and 13-valent pneumococcal diseases Infections and Infestations Meningococcal infection, unspecified
Conditions
Interventions
There is only one treatment group. All participants will receive a single dose of each of three vaccines - Hib/MenC (Menitorix®), PCV13 (Prevenar13®), MMR (Priorix®/MMRvaxpro®)
Sponsors
Health Protection Agency (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female infants: 1. With written informed consent obtained from the parent or legal guardian of the infant to participate in the study and to allow the infant?s General Practitioner (GP) to be informed of participation in the study and be contacted, if required, for confirmation of the vaccination history 2. Who have received all their primary immunisations by the time they are 6 months old, including: 2.1. Two doses of any MenC vaccine, with a 3-8 week interval be-tween the first and second dose, with the vaccine product identified by product name or batch number from either the parent-held ?Red Book? or the GP records 2.2. Who are available for their routine 12-month booster vaccines and both blood tests as described in Study Schedule (Section 6.2) 2.3. Do not fulfill any of the exclusion criteria
Exclusion criteria
Exclusion criteria: Participant may not be included in the study if any of the following apply: 1. History of invasive Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease 2. Confirmed or suspected immunosuppression or immunodeficiency (including HIV) 3. Receipt of a meningococcal quadrivalent conjugate vaccine prior to the 12-month booster 4. Bleeding disorders and/or prolonged bleeding time 5. Major congenital defects or chronic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Immunoglobulin G (IgG) geometric mean concentrations (GMCs) with 95% Confidence Intervals (95% CI) for Hib capsular polysaccharide and proportions of infants achieving antibody concentrations of =0.15 µg/mL or =1.00 µg/mL (putative antibody levels considered to provide short-term and long-term protection against invasive disease, respectively) immediately before and 21-42 days after the routine 12-month vaccinations in infants who received MCC-CRM followed by MCC-TT in infancy and compare with infants who received other MCC vaccine combinations 2. Achieving SBA titres =8 (the putative protective anti-body titre) or =128 (more discriminatory antibody titre) immediately before and 21-42 days after receiving the 12-month booster vaccines in infants who received MCC-CRM followed by MCC-TT in infancy and compare with infants who received other MCC vaccine combinations. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Immunoglobulin G (IgG) geometric mean concentrations (GMCs) with 95% Confidence Intervals (95% CI) for Hib capsular polysac-charide and proportion achieving antibody concentrations of =0.15 µg/mL or =1.00 µg/mL immediately before and 21-42 days after receiving the 12-month booster vaccines in four groups of in-fants receiving different MCC vaccine combinations in infancy. 2. Serum bactericidal antibody (SBA) titres with 95% CI for MenC and the proportion achieving SBA titres =8 or =128 immediately before and 21-42 days after receiving the 12-month booster vac-cines in four groups of infants receiving different MCC vaccine combinations in infancy 3. IgG GMC with 95% CI and proportions achieving antibody concen-trations of = 0.35 µg/ml for each of the 13 pneumococcal serotypes included in Prevenar13® immediately before and 21-42 days after receiving the 12-month booster vaccines Diphtheria, tetanus and pertussis antigens (PT, PRN, FHA and then FIMS) IgG antibody GMCs with 95%CI and proportions of infants achieving antibody levels =0.1 IU/ml or =1.0 IU/ml ) for diphtheria and tetanus (i) immediately before and (ii) 21-42 days after receiving the 12-month booster vaccines. | — |
Countries
United Kingdom
Outcome results
None listed