Study to Evaluate the Immune Response of United Kingdom (UK) Infants Receiving DTaP/Hib/IPV, Meningococcal C Conjugate and Pneumococcal Conjugate Vaccines, Antibody Persistence and Responses to Booster Doses in the Second Year of Life (Sched2)

March 20, 2019 updated by: Public Health England

A Phase IV, Randomized Study to Evaluate the Immune Response of UK Infants Receiving DTaP/Hib/IPV, Meningococcal C Conjugate and Pneumococcal Conjugate Vaccines, Antibody Persistence and Responses to Booster Doses in the Second Year of Life

The purpose of this study is:

To assess whether there are differences in antibody persistence eight months post primary (pre-booster) or in responses to the booster with regard to the Meningococcal C Conjugate (MCC) vaccine given in infancy.

To examine levels of diphtheria and tetanus antibody pre- and post-booster, with regard to the carrier proteins contained in the conjugate vaccines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is a well recognised benefit in reducing the number of injections included in an immunisation programme, particularly for infants where delivery of many antigens in the first few months of life is essential in providing protection against deadly diseases. Reducing the number of injections would reduce distress to infants, parents and healthcare workers, make the schedule as cost effective as possible and would give greater flexibility to include vaccination against novel antigens in the future.

The UK recommended immunisation schedule up to 13 months of age was revised from 4 September 2006 so that infants receive three doses of Pediacel (diphtheria, tetanus, whooping cough, Hib and polio containing vaccine), two doses of Prevenar (pneumococcal vaccine, PNC) and two doses of meningococcal C vaccine, MCC, which can be one of three licensed products, Meningitec, Menjugate or NeisVacC. Previous studies have however shown that these three MCC products behave quite differently from each other when given with other vaccines and under different dose schedules. To that end the two products which seem viable as single dose options under the UK schedule, Menjugate and NeisvacC, will be included in this study.

Assessment of the absolute number of doses of vaccine needed to protect against disease essential in maximising the efficiency of the schedule and this study will further examine the dose requirement for meningococcal C conjugate (MCC) vaccine where there are data to suggest that this would be possible, both in the published peer reviewed literature and in an ongoing study conducted by our group. This study will be the first to test this under the accelerated UK schedule and in the presence of pneumococcal conjugate vaccine. This study also includes a booster phase where children receive a dose of MCC, PNC and Hib in the second year of life in accordance with the national schedule. There is a need for boosters in the second year of life to increase circulating antibody which has dropped significantly by a year of age. As expected, responses to boosting have been shown to be significantly higher than those achieved after primary immunisation with variation between products following a similar pattern to that seen with the primary series.

The current study is designed to allow assessment of a single dose of MCC vaccine given at three months of age for the two products that have shown potential to afford protection in the ongoing study above. In the previous study the first dose was given at two months of age and as responses tend to improve with age it is anticipated that this single dose being given later will result in higher antibodies than seen in the above study.

The aim of this study will be to provide data on which to base a decision about a further reduction in MCC vaccination in infancy from two doses to a single dose which would afford the benefits discussed above.

Study Type

Interventional

Enrollment (Anticipated)

130

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
        • Health Protection Agency
      • London, United Kingdom
        • Health Protection Agency

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:

  • No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
  • Written informed consent obtained from the parent or legal guardian of the infant
  • Infant aged no less than 7 weeks exactly, and no more than 11 weeks 6 days

Exclusion Criteria:

  • None

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: 1

Pediacel - 2,3,4 months Prevenar - 2,4 months Menjugate - 3 months Hib/ pneumo conjugate/ Men C conjugate - 12 months

Blood collected - 4,5,12,13 months
Biological: Menjugate (Meningococcal C conjugate vaccine)
Dosage
Other Names:
  • Menjugate
  • Meningococcal C conjugate vaccine
Experimental: 2

Pediacel - 2,3,4 months Prevenar - 2,4 months Neis-vacC - 3 months Hib/ pneumo conjugate/ Men C conjugate - 12 months

Blood collected - 4,5,12,13 months
Biological: NeisVacC (Meningococcal C conjugate vaccine)
Dosage
Other Names:
  • Meningococcal C conjugate vaccine
  • Neis-vacC

Collaborators and Investigators

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

Sponsor

Public Health England

Collaborators

Institute of Child Health
National Institute of Biological Standards and Control

Investigators

  • Principal Investigator: Elizabeth Miller, BSc MBBS FFPHM FRCPath, 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

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

February 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sched2
  • EudraCT No: 2007-004056-36

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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