Status:
COMPLETED
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
Lead Sponsor:
Novartis Vaccines
Conditions:
Meningococcal Disease
Meningococcal Meningitis
Eligibility:
All Genders
55-89 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.
Eligibility Criteria
Inclusion
- Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.
Exclusion
- Serious, acute, or chronic illnesses are reasons for exclusion.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
751 Patients enrolled
Trial Details
Trial ID
NCT01214837
Start Date
October 1 2010
End Date
May 1 2012
Last Update
October 9 2018
Active Locations (40)
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1
Birmingham, Alabama, United States
2
Fayetteville, Arkansas, United States
3
Jonesboro, Arkansas, United States
4
Little Rock, Arkansas, United States