Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Con… (NCT03537508) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
United States2,627 participantsStarted 2018-04-25
Plain-language summary
The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.
Who can participate
Age range42 Days – 89 Days
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged ≥ 42 to ≤ 89 days on the day of the first study visit.
* Healthy infants as determined by medical history, physical examination, and judgment of the investigator
* Informed consent form has been signed and dated by the parent(s) or guardian, and an independent witness, if required by local regulations
* Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures.
* Infants who received the first dose of hepatitis B vaccine at least 28 days before the first study visit
Exclusion Criteria:
* Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which could have been received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines
* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, PS, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
*…
What they're measuring
1
Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination
Timeframe: Day 30 post 12-month vaccination (Month 13)
2
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination
Timeframe: Day 30 post 6-month vaccination (Month 7)