Phase III study to compare MenACYW conjugate vaccine with that of MENVEO when administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the United States. (LULLABY)

Purpose

The main purpose of this study is to find out if the MenACYW vaccine is safe and can protect young children against meningococcal disease when it is given at the same time with the childhood vaccines recommended in the US

Criteria

Eligibility:

Criteria

1.      Born full term (37 weeks or greater) and weighed at least 5 ½ lbs. at birth.

2.      Have first two sets of infant shots.

You cannot:

1.      Have any vaccines within four weeks of trial start.

2.      Have had more than two doses of DtaP, Hib, polio, pneumococcal, hepatitis B, or rotavirus.

3.      Have fever on day of vaccination.

4.      Have any chronic illness

Details

1.      Most visits conducted during well baby exams.

2.      DTaP, Polio, Hib (haemophilus influenza B), Pneumoccal, Rotavirus, Hepatitis B, MMR, and Chickenpox vaccines will be provided free of charge.

3.      Patient will have blood draws at each of the four visits.

4.      Study stipend

Interested in more information on clinical research? Contact WK Health System Clinical Research Department at 318-212-8130

Interested in more information? Contact Us:

IRB: Advarra Institutional Review Board
IRB Number:
Trial Type: NA
Sponsor: Sanofi