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Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines

This study is currently recruiting participants.
Verified January 2013 by Leiden University Medical Center
Sponsor:
Information provided by (Responsible Party):
L.G. Visser, MD, PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01782066
First received: January 30, 2013
Last updated: January 31, 2013
Last verified: January 2013
History of Changes

January 30, 2013
January 31, 2013
January 2013
October 2013   (final data collection date for primary outcome measure)
Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01782066 on ClinicalTrials.gov Archive Site
Local and systemic adverse events (subject log and investigator inspection). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines
Dose Finding and Reactogenicity of Reduced-dose Intradermal Administration of Two Quadrivalent Meningococcal Conjugate Vaccines (Menveo® and Nimenrix®) in Healthy Adults (MENID-1).

Invasive meningococcal disease is a worldwide problem with serious repercussions for those affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is prohibitive in many low-resource settings at home and abroad. By harnessing the special immunologic properties of the skin, a dose reduction may be achieved by intradermal administration of the vaccine. The cost savings associated with dose reduction will increase availability of the vaccine.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Meningococcal Disease
Biological: MEN-ACYW135 reduced-dose intradermal administration
Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.
Other Names:
  • Menveo
  • Nimenrix
  • Experimental: Menveo, dose escalating
    Intervention: Biological: MEN-ACYW135 reduced-dose intradermal administration
  • Experimental: Nimenrix, dose escalating
    Intervention: Biological: MEN-ACYW135 reduced-dose intradermal administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Meningococcal C naive subjects are required to fulfill all of the following criteria:

  • Age ≥ 30 years
  • Good health according to the investigator
  • Willingness and ability to adhere to the study regimen
  • Able to give informed consent

Meningococcal C experienced subjects are required to fulfill all of the following criteria:

  • Age ≥ 18 years
  • Good health according to the investigator
  • Willingness and ability to adhere to the study regimen
  • Able to give informed consent

Exclusion Criteria:

Meningococcal C naïve subjects should not have:

  • Known previous invasive meningococcal infection
  • Known or suspected previous vaccination against meningococcal disease
  • Known or suspected allergy against any of the vaccine components
  • Close contact in the last 60 days with a person known to be Neisseria positive
  • History of unusual or severe reactions to any previous vaccination
  • Family history of Guillain-Barré Syndrome
  • Known or suspected immune deficiency, either congenital or acquired
  • Administration of plasma or blood products less than three months prior to inclusion in the study
  • Pregnancy (breastfeeding is allowed)
  • Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)
  • Any infectious disease
  • Bleeding disorders or use of anticoagulants
  • Participation as a subject in another trial in the last 3 months

Meningococcal C experienced subjects should not have:

  • Known or suspected allergy against any of the vaccine components
  • Known previous vaccination with a quadrivalent meningococcal vaccine (either conjugate or polysaccharide)
  • Close contact in the last 60 days with a person known to be Neisseria positive
  • History of unusual or severe reactions to any previous vaccination
  • Family history of Guillain-Barré Syndrome
  • Known or suspected immune deficiency, either congenital or acquired
  • Administration of plasma or blood products less than three months prior to inclusion in the study
  • Pregnancy (breastfeeding is allowed)
  • Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)
  • Any infectious disease
  • Bleeding disorders or use of anticoagulants
  • Participation as a subject in another trial in the last 3 months
Both
18 Years and older
Yes
Not Provided
Netherlands
 
NCT01782066
MENID-1, 2012-003085-41
Yes
L.G. Visser, MD, PhD, Leiden University Medical Center
Leiden University Medical Center
Not Provided
Principal Investigator: Leo Visser, MD, PhD Leiden University Medical Center
Leiden University Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP