Responses to booster vaccinations in UK toddlers

Phase 4

Completed

Conditions: Responses to vaccinations against Hib, meningococcal serogroup C and 13-valent pneumococcal diseases
Infections and Infestations
Meningococcal infection, unspecified

Registration Number: ISRCTN84763401

Lead Sponsor: Health Protection Agency (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>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 Outcome Measures