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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00197808
First received: September 12, 2005
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: 3 months after last sample ] [ Designated as safety issue: No ]
    SBA men C responses


Enrollment: 392
Study Start Date: April 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Weeks to 11 Weeks
Genders Eligible for Study:   Both
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
  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: 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
Health Protection Agency, United Kingdom
Investigators
Principal Investigator: Elizabeth Miller, MBBS, FRCPath Health Protection Agency, United Kingdom
  More Information

Additional Information:
No publications provided by Health Protection Agency, United Kingdom

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Elizabeth Miller, Consultant epidemiologist, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier: NCT00197808     History of Changes
Other Study ID Numbers: sched1
Study First Received: September 12, 2005
Last Updated: March 27, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Health Protection Agency, United Kingdom:
Streptococcus pneumoniae
Neisseria meningitidis

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

ClinicalTrials.gov processed this record on July 22, 2014