Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Meningococcal Disease, Meningococcal Meningitis
About this trial
This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningitis, healthy subject, vaccine
Eligibility Criteria
Inclusion Criteria: Male and female 11-25 years old healthy subjects; who had received the primary immunization with a vaccine containing DT or Tdap antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry Exclusion Criteria: previous ascertained or suspected disease caused by N. meningitidis previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) serious acute, chronic or progressive disease history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component known or suspected impairment/alteration of immune function, either congenital or acquired
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Tdap + MenACWY-CRM
Tdap + saline
MenACWY-CRM + saline
Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms