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

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ClinicalTrials.gov Identifier: NCT00197808
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 28, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Elizabeth Miller, 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.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Meningococcal Infections Biological: menjugate Biological: Men C conjugate vaccine Biological: Men C conjugate Biological: Men C Conjugate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
Study Start Date : April 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010


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




Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: 3 months after last sample ]
    SBA men C responses



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Ages Eligible for Study:   7 Weeks to 11 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197808


Locations
United Kingdom
Hertfordshire Primary Care Trusts
Welwyn Garden City, Hertfordshire, United Kingdom, AL8 6JL
Gloucestershire Primary Care Trusts
Gloucester, United Kingdom, GL1 3NN
Sponsors and Collaborators
Public Health England
Investigators
Principal Investigator: Elizabeth Miller, MBBS, FRCPath Public Health England

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Elizabeth Miller, Consultant epidemiologist, Public Health England
ClinicalTrials.gov Identifier: NCT00197808     History of Changes
Other Study ID Numbers: sched1
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012

Keywords provided by Dr. Elizabeth Miller, Public Health England:
Streptococcus pneumoniae
Neisseria meningitidis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumococcal Infections
Meningococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs