A prospective study to evaluate the immune response of UK infants receiving the 13-valent pneumococcal conjugate vaccine as part of their routine primary immunisation schedule at 2 and 4 months (code: P13UK) - P13UK

Phase 1

• Conditions: 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.

• Registration Number: EUCTR2010-023865-22-GB
• Lead Sponsor: Health Protection Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-07
• Study Completion: 2013-06-30
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Male or female infants born at term (at least 37 weeks gestation) aged <6 months:

• 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

• Who have received all their primary immunisations in the 1st 6 months of life, including:
- 3 doses of Pediacel®
- 2 doses of Prevenar13®, with the 1st dose given at 6-12 weeks of age and the 2nd
dose at 8-12 weeks after the 1st dose
- 2 doses of any MenC vaccine

• Do not fulfil any of the Exclusion Criteria
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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