Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
sched1
1 other identifier
interventional
392
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2005
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedOctober 1, 2020
August 1, 2018
4.8 years
September 12, 2005
September 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunogenicity
SBA men C responses
3 months after last sample
Study Arms (6)
Vaccine schedule 1
EXPERIMENTALMenjugate vaccine at 2 and 3 months
Vaccine schedule 2
EXPERIMENTALMenjugate vaccine at 2 and 4 months
vaccine schedule3
EXPERIMENTALNeissvacc at 2 and 3 months
vaccine schedule 4
EXPERIMENTALNeissvacc at 2 and 4 months
Vaccine schedule 5
EXPERIMENTALMeningitec at 2 and 3 months
Vaccine schedule 6
EXPERIMENTALMeningitec at 2 and 4 months
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent obtained from parent or legal guardian of infant
- Age 7-11 weeks at first dose
You may not qualify if:
- Any contraindications to vaccination as specified in the UK Handbook "Immunisation Against Infectious Disease" (Ed 1996)
- \< 7 weeks or \> 11 weeks at first dose
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hertfordshire Primary Care Trusts
Welwyn Garden City, Hertfordshire, AL8 6JL, United Kingdom
Gloucestershire Primary Care Trusts
Gloucester, GL1 3NN, United Kingdom
Related Publications (2)
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.
PMID: 16567982RESULTGoldblatt 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.
PMID: 20010312DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elizabeth Coates, PhD
Public Health England
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
April 1, 2005
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
October 1, 2020
Record last verified: 2018-08