Status:
COMPLETED
Immunogenicity of the Booster Dose of Two MenC Vaccines
Lead Sponsor:
Centro Superior de Investigación en Salud Publica
Conditions:
Meningococcal Infection
Eligibility:
All Genders
14-19 years
Phase:
PHASE4
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 interc...
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 befo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT00392808
Start Date
January 1 2007
End Date
May 1 2009
Last Update
October 11 2013
Active Locations (2)
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1
Universidad Rey Juan Carlos I
Madrid, Spain, 28922
2
Centro Superior Investigación en Salud Publica
Valencia, Spain, 46020