Status:
COMPLETED
A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center Study
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningococcal Immunization
Eligibility:
All Genders
60-40 years
Phase:
PHASE1
Brief Summary
The study will include groups of adults, toddlers, and infants who will receive different formulations of TetraMen-T, and one group of infants who will receive a control vaccine, Menjugate®. The prima...
Detailed Description
Up to 24 months
Eligibility Criteria
Inclusion
- Subject is healthy, as determined by medical history and physical assessment.
- At the time of vaccination on Day 0, subject was the following age: Adults: aged ≥18 to \< 40 years Toddlers: aged ≥12 to \< 19 months Infants: aged 2 months + 28 days (60 to 88 days)
- Institutional Review Board (IRB)-approved informed consent form signed by the subject or the subject's parent/legal guardian.
Exclusion
- Participants are excluded from the study if any of the following criteria apply:
- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
July 25 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2008
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT06165276
Start Date
July 25 2006
End Date
August 27 2008
Last Update
December 11 2023
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