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Clinical Trials/ISRCTN37262487
ISRCTN37262487
Completed
N/A

Safety and immunogenicity of conjugate vaccine for meningococcal C disease: a randomised study

Bio-Manguinhos/Fiocruz (Brazil)0 sites60 target enrollmentDecember 10, 2008
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ConditionsMeningococcus C diseaseInfections and InfestationsMeningococcal infection

Overview

Phase
N/A
Intervention
Not specified
Conditions
Meningococcus C disease
Sponsor
Bio-Manguinhos/Fiocruz (Brazil)
Enrollment
60
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 10, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Bio-Manguinhos/Fiocruz (Brazil)

Eligibility Criteria

Inclusion Criteria

  • •1\. Healthy
  • •2\. Both sexes
  • •3\. Aged between 18 and 50 years
  • •4\. Capable of understanding and signing Free and Informed Consent Form
  • •5\. Intellectual level which permits filling out records of adverse events at home
  • •6\. Capable of understanding risks of the experiment
  • •7\. Willing test for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • •8\. Clinical examination without significant abnormalities
  • •9\. Laboratorial tests within normal range, or only with clinically non\-significant alterations
  • •10\. Pre\-vaccinal level of antibodies against tetanus below 5 IU/mL

Exclusion Criteria

  • •1\. Pregnancy or breastfeeding
  • •2\. Personal history of meningitis, any kind
  • •3\. Previous serious adverse event to any vaccination
  • •4\. Severe adverse event to tetanus toxoids
  • •5\. Vaccination against tetanus in the last 2 years
  • •6\. Anti\-allergic vaccines 14 days or less before vaccination
  • •7\. Blood products in the last 12 months
  • •8\. Any vaccination 30 days or less before vaccination in test
  • •9\. Chronic use of any medication, except trivial ones
  • •10\. Previous use of cytotoxic or immunosuppressive therapy

Outcomes

Primary Outcomes

Not specified

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