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

Phase 4

Completed

• Conditions: Pneumococcal Infections; Meningococcal Infections

• Registration Number: NCT00197808
• Lead Sponsor: Public Health England

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2018-08
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immunogenicity	3 months after last sample	SBA men C responses

Trial Locations

Locations (2)

Hertfordshire Primary Care Trusts; 🇬🇧 Welwyn Garden City, Hertfordshire, United Kingdom

Gloucestershire Primary Care Trusts; 🇬🇧 Gloucester, United Kingdom