Back to resultsResponse of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines (sched1)
Primary Purpose
Pneumococcal Infections, Meningococcal Infections
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
menjugate
Men C conjugate vaccine
Men C conjugate
Men C Conjugate
Men C conjugate
Men C conjugate
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infections focused on measuring Streptococcus pneumoniae, Neisseria meningitidis
Eligibility 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
Sites / Locations
- Hertfordshire Primary Care Trusts
- Gloucestershire Primary Care Trusts
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Vaccine schedule 1
Vaccine schedule 2
vaccine schedule3
vaccine schedule 4
Vaccine schedule 5
Vaccine schedule 6
Arm Description
Menjugate vaccine at 2 and 3 months
Menjugate vaccine at 2 and 4 months
Neissvacc at 2 and 3 months
Neissvacc at 2 and 4 months
Meningitec at 2 and 3 months
Meningitec at 2 and 4 months
Outcomes
Primary Outcome Measures
Immunogenicity
SBA men C responses
Secondary Outcome Measures
Full Information
NCT ID
NCT00197808
First Posted
September 12, 2005
Last Updated
September 29, 2020
Sponsor
Public Health England
1. Study Identification
Unique Protocol Identification Number
NCT00197808
Brief Title
Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
Acronym
sched1
Official Title
Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Public Health England
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections, Meningococcal Infections
Keywords
Streptococcus pneumoniae, Neisseria meningitidis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
392 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccine schedule 1
Arm Type
Experimental
Arm Description
Menjugate vaccine at 2 and 3 months
Arm Title
Vaccine schedule 2
Arm Type
Experimental
Arm Description
Menjugate vaccine at 2 and 4 months
Arm Title
vaccine schedule3
Arm Type
Experimental
Arm Description
Neissvacc at 2 and 3 months
Arm Title
vaccine schedule 4
Arm Type
Experimental
Arm Description
Neissvacc at 2 and 4 months
Arm Title
Vaccine schedule 5
Arm Type
Experimental
Arm Description
Meningitec at 2 and 3 months
Arm Title
Vaccine schedule 6
Arm Type
Experimental
Arm Description
Meningitec at 2 and 4 months
Intervention Type
Biological
Intervention Name(s)
menjugate
Intervention Description
men C conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Men C conjugate vaccine
Intervention Description
men C conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Men C conjugate
Intervention Description
men C conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Men C Conjugate
Intervention Description
men C conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Men C conjugate
Intervention Description
men C conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Men C conjugate
Intervention Description
men C conjugate vaccine
Primary Outcome Measure Information:
Title
Immunogenicity
Description
SBA men C responses
Time Frame
3 months after last sample
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Weeks
Maximum Age & Unit of Time
11 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Coates, PhD
Organizational Affiliation
Public Health England
Official's Role
Study Chair
Facility Information:
Facility Name
Hertfordshire Primary Care Trusts
City
Welwyn Garden City
State/Province
Hertfordshire
ZIP/Postal Code
AL8 6JL
Country
United Kingdom
Facility Name
Gloucestershire Primary Care Trusts
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
16567982
Citation
Goldblatt D, Southern J, Ashton L, Richmond P, Burbidge P, Tasevska J, Crowley-Luke A, Andrews N, Morris R, Borrow R, Cartwright K, Miller E. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 2006 Apr;25(4):312-9. doi: 10.1097/01.inf.0000207483.60267.e7.
Results Reference
result
PubMed Identifier
20010312
Citation
Goldblatt D, Southern J, Ashton L, Andrews N, Woodgate S, Burbidge P, Waight P, Miller E. Immunogenicity of a reduced schedule of pneumococcal conjugate vaccine in healthy infants and correlates of protection for serotype 6B in the United Kingdom. Pediatr Infect Dis J. 2010 May;29(5):401-5. doi: 10.1097/INF.0b013e3181c67f04.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/16567982
Description
Published study results
Learn more about this trial
Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
We'll reach out to this number within 24 hrs