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)

This study has been completed.
Sponsor:
Collaborators:
Institute of Child Health
National Institute of Biological Standards and Control
Information provided by:
Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00625677
First received: February 19, 2008
Last updated: September 1, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Meningococcal Infections
Pneumococcal Infections
Biological: NeisVacC (Meningococcal C conjugate vaccine)
Biological: Menjugate (Meningococcal C conjugate vaccine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Health Protection Agency, United Kingdom:

Estimated Enrollment: 130
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Meningococcal C conjugate vaccine
  • Menjugate
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

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.

  Eligibility

Ages Eligible for Study:   7 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625677

Locations
United Kingdom
Health Protection Agency
Gloucester, United Kingdom
Health Protection Agency
London, United Kingdom
Sponsors and Collaborators
Health Protection Agency, United Kingdom
Institute of Child Health
National Institute of Biological Standards and Control
Investigators
Principal Investigator: Elizabeth Miller, BSc MBBS FFPHM FRCPath Health Protection Agency, United Kingdom
  More Information

Additional Information:
No publications provided

Responsible Party: Prof Elizabeth Miller, Health Protection Agency
ClinicalTrials.gov Identifier: NCT00625677     History of Changes
Other Study ID Numbers: Sched2, EudraCT No: 2007−004056−36
Study First Received: February 19, 2008
Last Updated: September 1, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Health Protection Agency, United Kingdom:
meningococcal serogroup C vaccine
reduced dose
meningococcal serogroup C conjugate vaccine
pneumococcal conjugate vaccine

Additional relevant MeSH terms:
Communicable Diseases
Infection
Meningococcal Infections
Pneumococcal Infections
Bacterial Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Neisseriaceae Infections
Streptococcal Infections

ClinicalTrials.gov processed this record on October 29, 2014