Immunogenicity of the Booster Dose of Two MenC Vaccines
CSISP-MENC1
Randomized, Open Label, Active Control, Parallel Assignment Clinical Trial to Evaluate the Immunogenicity of Polysaccharide Meningococcal C Vaccines Conjugated With Tetanus Toxoid or CRM197 Given as a Booster Dose at 14-18 Months of Life.
2 other identifiers
interventional
389
1 country
2
Brief Summary
The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to assess the interchangeability of the two different vaccines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2007
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2006
CompletedFirst Posted
Study publicly available on registry
October 26, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
October 11, 2013
CompletedOctober 11, 2013
August 1, 2013
1.3 years
October 25, 2006
August 6, 2013
August 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Serum Bactericidal Activity Against MenC
One month after booster dose
Serum Antibody Titers Against Haemophilus Influenzae Type b.
One year
Study Arms (4)
MENC-CRM/MENC-CRM
EXPERIMENTALChildren primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine
MENC-CRM/MENC-TT
EXPERIMENTALChildren Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT
MENC-TT/MENC-CRM
EXPERIMENTALChildren primovacccinated with two MenC-TT vaccine doses. Intervention: boosted with one dose MenC-CRM vaccine
MENC-TT/MENC-TT
EXPERIMENTALChildren primovacccinated with two MenC-TT vaccine doses. Intervention boosted with one dose MenC-TT vaccine
Interventions
Booster vaccine dose at 14 to 18 months.
Eligibility Criteria
You may qualify if:
- Healthy toddlers of both sexes
- Toddlers of 14 to 19 months of age (including the day that the toddler is 14 and the day before he is 19 months of age)
- Children previously vaccinated with two doses of polysaccharide meningococcal C vaccine conjugated to tetanus toxoid or three doses of polysaccharide meningococcal C conjugated to CRM197 before 7 month of age.
- Informed consent signed by one or both parents who are adequately informed about the study.
You may not qualify if:
- Toddlers with severe chronic diseases
- Toddlers who have received any other vaccine within the last month or with a programmed vaccination within the 28 subsequent days after the administration of the vaccine of study.
- Toddlers with clinical or bacteriological diagnosis of previous meningococcal disease.
- Toddlers with hypersensitivity to any of the components of the vaccines to study or antibiotics used during the manufacturing process that could be present as non- detectable traces (streptomycin, neomycin, polymyxin B).
- Toddlers with personal history of convulsions.
- Toddlers with known bleeding disorder no controlled
- Toddlers with known congenital or acquired immunodeficiency
- Toddlers who are receiving or have been received any treatment that could change the immune response (administration of intravenous immunoglobulin, systemic corticosteroids or haemoderivates) within the 3 previous months.
- A toddler that under investigator opinion is probable to be lost during the follow-up
- A toddler that is currently included or is planned to be included in any other clinical trial.
- A toddler that under investigator opinion must not be included in the study due to other medical or social reasons.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Universidad Rey Juan Carlos I
Madrid, 28922, Spain
Centro Superior Investigación en Salud Publica
Valencia, 46020, Spain
Related Publications (2)
Diez-Domingo J, Planelles-Cantarino MV, Baldo-Torrenti JM, Ubeda-Sansano I, Jubert-Rosich A, Puig-Barbera J, Gutierrez-Gimeno MV. Antibody persistence 12 months after a booster dose of meningococcal-C conjugated vaccine in the second year of life. Pediatr Infect Dis J. 2010 Aug;29(8):768-70. doi: 10.1097/INF.0b013e3181d9e653.
PMID: 20375851RESULTDiez-Domingo J, Cantarino MV, Torrenti JM, Sansano MI, Rosich AJ, Merino AH, de Miguel AG, Gonzalez JB, Marcos MD; MenC Study Group. A randomized, multicenter, open-label clinical trial to assess the immunogenicity of a meningococcal C vaccine booster dose administered to children aged 14 to 18 months. Pediatr Infect Dis J. 2010 Feb;29(2):148-52. doi: 10.1097/INF.0b013e3181b9a831.
PMID: 19927040RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Javier Diez-Domingo
- Organization
- Centro Superior de Investigacion en Salud Publica
Study Officials
- STUDY CHAIR
Javier Diez-Domingo, PhD
Centro Superior Investigacion Salud Publica (CSISP)
Publication Agreements
- PI is Sponsor Employee
- Yes
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
October 25, 2006
First Posted
October 26, 2006
Study Start
January 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2009
Last Updated
October 11, 2013
Results First Posted
October 11, 2013
Record last verified: 2013-08