Back to resultsImmunogenicity of the Booster Dose of Two MenC Vaccines (CSISP-MENC1)
Primary Purpose
Meningococcal Infection
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
conjugated polysaccharide menC vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Infection focused on measuring Meningococcal vaccine, Immunization, secondary, vaccines conjugated, Meningococcal disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Toddlers with severe diseases or axilar temperature ≥ 38,0ºC at inclusion time
- 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.
Sites / Locations
- Universidad Rey Juan Carlos I
- Centro Superior Investigación en Salud Publica
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
MENC-CRM/MENC-CRM
MENC-CRM/MENC-TT
MENC-TT/MENC-CRM
MENC-TT/MENC-TT
Arm Description
Children primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine
Children Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT
Children primovacccinated with two MenC-TT vaccine doses. Intervention: boosted with one dose MenC-CRM vaccine
Children primovacccinated with two MenC-TT vaccine doses. Intervention boosted with one dose MenC-TT vaccine
Outcomes
Primary Outcome Measures
Serum Bactericidal Activity Against MenC
Serum Antibody Titers Against Haemophilus Influenzae Type b.
Secondary Outcome Measures
Full Information
NCT ID
NCT00392808
First Posted
October 25, 2006
Last Updated
August 6, 2013
Sponsor
Centro Superior de Investigación en Salud Publica
1. Study Identification
Unique Protocol Identification Number
NCT00392808
Brief Title
Immunogenicity of the Booster Dose of Two MenC Vaccines
Acronym
CSISP-MENC1
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Superior de Investigación en Salud Publica
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Children 14 to 18 months of life, previously vaccinated with 2 doses of tetanus toxoid conjugated polysaccharide men C vaccine or three doses of the CRM197 conjugated polysaccharide men C vaccine before 7 months of age, are randomized to receive any of the two vaccines. Serum antibody activity against meningococcus C will be measured inmediately before and 4 weeks after the booster dose. Children will also be vaccinated with a combined vaccine containing DTaP+IPV+Hib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Infection
Keywords
Meningococcal vaccine, Immunization, secondary, vaccines conjugated, Meningococcal disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
389 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MENC-CRM/MENC-CRM
Arm Type
Experimental
Arm Description
Children primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine
Arm Title
MENC-CRM/MENC-TT
Arm Type
Experimental
Arm Description
Children Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT
Arm Title
MENC-TT/MENC-CRM
Arm Type
Experimental
Arm Description
Children primovacccinated with two MenC-TT vaccine doses. Intervention: boosted with one dose MenC-CRM vaccine
Arm Title
MENC-TT/MENC-TT
Arm Type
Experimental
Arm Description
Children primovacccinated with two MenC-TT vaccine doses. Intervention boosted with one dose MenC-TT vaccine
Intervention Type
Biological
Intervention Name(s)
conjugated polysaccharide menC vaccine
Intervention Description
Booster vaccine dose at 14 to 18 months.
Primary Outcome Measure Information:
Title
Serum Bactericidal Activity Against MenC
Time Frame
One month after booster dose
Title
Serum Antibody Titers Against Haemophilus Influenzae Type b.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Months
Maximum Age & Unit of Time
19 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Toddlers with severe diseases or axilar temperature ≥ 38,0ºC at inclusion time
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Diez-Domingo, PhD
Organizational Affiliation
Centro Superior Investigacion Salud Publica (CSISP)
Official's Role
Study Chair
Facility Information:
Facility Name
Universidad Rey Juan Carlos I
City
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Centro Superior Investigación en Salud Publica
City
Valencia
ZIP/Postal Code
46020
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
20375851
Citation
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.
Results Reference
result
PubMed Identifier
19927040
Citation
Diez-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.
Results Reference
result
Learn more about this trial
Immunogenicity of the Booster Dose of Two MenC Vaccines
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