Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines

Phase 4CompletedNCT00197808

Public Health England392 enrolled

Overview

The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

392

Conditions

Pneumococcal Infections Meningococcal Infections

Interventions

menjugateBIOLOGICAL

men C conjugate vaccine

Men C conjugate vaccineBIOLOGICAL

men C conjugate vaccine

Men C conjugateBIOLOGICAL

men C conjugate vaccine

Men C Conjugate

Eligibility

Sex: ALLMin age: 7 WeeksMax age: 11 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent obtained from parent or legal guardian of infant * Age 7-11 weeks at first dose Exclusion Criteria: * Any contraindications to vaccination as specified in the UK Handbook "Immunisation Against Infectious Disease" (Ed 1996) * \< 7 weeks or \> 11 weeks at first dose

Locations (2)

Hertfordshire Primary Care Trusts

Welwyn Garden City, Hertfordshire, United Kingdom

Gloucestershire Primary Care Trusts

Gloucester, United Kingdom

Outcomes

Primary Outcomes

Immunogenicity

SBA men C responses

Time frame: 3 months after last sample

Data from ClinicalTrials.gov

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