Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R; Investigational MenC-CRM adjuavnted with 25 ug of LHD153R; Investigational MenC-CRM adjuavnted with 50 ug of LHD153R; Investigational MenC-CRM adjuavnted with 100 ug of LHD153R; Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)
Intervention description: Intramuscular (IM) vaccination of 1 dose of 0.5 mL; IM vaccination of 1 dose of 0.5 mL; IM vaccination of 1 dose of 0.5 mL; IM vaccination of 1 dose of 0.5 mL; IM vaccination of 1 dose of 0.5 mL
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium
      Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults
      (18-45 years of age).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female individuals of 18 through 45 years of age on the day of informed
             consent

          2. Healthy volunteers with good physical and mental health status, determined on the
             basis of the medical history, a physical examination and the results of the screening
             tests as judged by the investigator

          3. Individuals who have voluntarily given written informed consent after the nature of
             the study has been explained according to local regulatory requirements, prior to
             study entry

          4. Individuals who can comply with study procedures including follow-up

          5. Individuals that are able to understand, read and write German language

          6. Females of childbearing potential who are using an effective birth control method
             which they intend to use for at least 30 days after the study vaccination.

        Exclusion Criteria:

          1. Progressive, unstable or uncontrolled clinical conditions

          2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products
             or medical equipment whose use is foreseen in this study

          3. Clinical conditions representing a contraindication to intramuscular vaccination and
             blood draws

          4. Abnormal function of the immune system

          5. Received immunoglobulins or any blood products within 180 days prior to informed
             consent

          6. Received an investigational or non-registered medicinal product within 30 days prior
             to informed consent or intend to participate in another clinical study at any time
             during the conduct of this study

          7. Vulnerable subjects (e.g. persons kept in detention), study personnel or an immediate
             family or household member of study personnel, subjects with legal incapacity or
             limited legal capacity

          8. Any relevant deviation from the laboratory parameters at screening as judged by the
             investigator

          9. Previously received any vaccine that included a MenC antigen

         10. Previously suspected or confirmed disease caused by N. meningitides

         11. Had household contact with and/or intimate exposure to an individual with culture
             proven MenC

         12. A positive serum or urine pregnancy test prior to the study vaccine administration or
             are currently lactating.

         13. A positive drugs-of-abuse test prior to the study vaccine administration;

         14. Received any other vaccines within 30 days prior to enrolment in this study or who are
             planning to receive any vaccine within 30 days from the administration of study
             vaccines

         15. Any other condition that, in the opinion of the investigator, might interfere with the
             results of the study or pose additional risk to the subject due to participation in
             the study.