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GSK V72_57: Safety and Immunogenicity of GSK Meningococcal Group B vaccine and 13-valent Pneumococcal Vaccine administered with routine vaccines

University of North Carolina at Chapel Hill


Description

Primary objective of this study is to test the immune response and safety of a meningitis B vaccine when administered concomitantly with routine infant vaccines in healthy infants age 6-12 weeks.


Keywords:

Pediatrics


Category:

Drug or Biologic
Phase:3

Qualifications

 


Age
0 - 0 years


Gender
Any


Study Population

Healthy Infants 6 through 12 weeks of age at time of first vaccination


Investigator

Robert Morgan

UNC Hospitals - UNCPN

For questions, contact:

Judy Mulvihill
judith.mulvihill@unchealth.unc.edu
(984) 444-7967


Recruitment Period End

August 1, 2023

Location

Primary Location
Capitol Pediatrics & Adolescent Center UNCPN
3801 Computer Dr, Raleigh, NC 27609, USA

Study Qualifications

Gender Any

Age Range 0 - 0 years

Participant qualification(s) 1.Subject's parent or legal guardian can and will comply with the requirements of the study (completion of e-diary, return for follow up visits). 2.Subject's parent or legal guardian can provide written consent before study procedures. 3.Male or Female, age 6 through 12 weeks at time of first vaccination. 4.Healthy subjects as established by medical history and an examination before entering the study. 5.Born full term ( gestation of greater or equal to 38 weeks).

Not eligible if: 1.Child in care (under protection of an agency, cared for by foster parents or living in a group home). 2.Progressive, unstable or uncontrolled clinical condition. 3.Allergy to any component of vaccines. 4.Hypersensitivity to latex. 5.Abnormal function of the immune system. 6.Received any blood products or immunoglobulin from birth. 7.Received an investigational medicinal product from birth. 8.Neuroinflammatory disorders. 9.Congenital disorders that lead to a chronic condition. 10.Current or previous disease caused by N. Meningitidis. 11.Household contact or exposure to an individual with confirmed N. meningitidis and /or Streptococcus pneumonia infection. 12.Received previous meningococcal B or pneumococcal vaccine at any time before informed consent. 13.Received any other routine childhood vaccines prior to informed consent (receipt of 1 dose of Hepatitis B is allowed). 14.Serious chronic illness. 15.Uncorrected congenital malformation.

Number of Visits

    » 7 In person visit(s)

    7 clinic visits 5 of which are scheduled at routine checkups which include Physical exam, 3 blood draws after 6 months of age.

    » 13 Remote visit(s)

    13 phone calls

Participation Period

22 months

Compensation

Compensation of $75 per clinic visit for cost of travelling

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.