Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines (sched1)

September 29, 2020 updated by: Public Health England
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Gloucester, United Kingdom, GL1 3NN
        • Gloucestershire Primary Care Trusts
    • Hertfordshire
      • Welwyn Garden City, Hertfordshire, United Kingdom, AL8 6JL
        • Hertfordshire Primary Care Trusts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccine schedule 1
Menjugate vaccine at 2 and 3 months
Biological: menjugate
men C conjugate vaccine
Experimental: Vaccine schedule 2
Menjugate vaccine at 2 and 4 months
Biological: Men C conjugate vaccine
men C conjugate vaccine
Experimental: vaccine schedule3
Neissvacc at 2 and 3 months
Biological: Men C conjugate
men C conjugate vaccine
Experimental: vaccine schedule 4
Neissvacc at 2 and 4 months
Biological: Men C Conjugate
men C conjugate vaccine
Experimental: Vaccine schedule 5
Meningitec at 2 and 3 months
Biological: Men C conjugate
men C conjugate vaccine
Experimental: Vaccine schedule 6
Meningitec at 2 and 4 months
Biological: Men C conjugate
men C conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity
Time Frame: 3 months after last sample
SBA men C responses
3 months after last sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health England

Investigators

  • Study Chair: Elizabeth Coates, PhD, Public Health England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sched1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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