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

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.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections Streptococcal Infections

Age range

7 week–11 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hertfordshire Primary Care Trusts, Welwyn Garden City, Hertfordshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menjugate

Biological

men C conjugate vaccine

Men C conjugate vaccine

Biological

men C conjugate vaccine

Men C conjugate

Biological

men C conjugate vaccine

Primary outcomes

Immunogenicity

Time frame: 3 months after last sample

SBA men C responses

Sponsors and collaborators

Lead sponsor

Public Health England

Other Gov

Registry information

Acronym: sched1

Important dates

Study start: 2005
Primary completion: 2010
Study completion: 2010
First posted: Sep 20, 2005
Registry last updated: Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed