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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

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.

Age & Gender

  • 0 years ~ 0 years
  • Male, Female

Location

North Carolina (Wake)

What will be asked of you

7 clinic visits 5 of which are scheduled at routine checkups which include Physical exam, 3 blood draws after 6 months of age. 13 phone calls

Incentives

Compensation of $75 per clinic visit for cost of travelling

In-person visits : 7
Phone or online visits : 13
Total length of participation : 22 months

Looking for Healthy Volunteers

Requirements for healthy volunteers are different than for those with a specific condition. If you are interested in becoming a healthy volunteer for this study, use the below categories to determine if you are able to participate.

Able to participate:

  • 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).
  • Subject's parent or legal guardian can provide written consent before study procedures.
  • Male or Female, age 6 through 12 weeks at time of first vaccination.
  • Born full term ( gestation of greater or equal to 38 weeks).

Not eligible if:

  • Child in care of foster parents or under protection of an agency
  • Allergy to any component of vaccines or latex
  • Abnormal immune system function
  • Received any blood products or immunoglobulin from birth

Contact the Team

Visit Location

100% Remote (online, phone, text)

Additional Study Information

Principal Investigator

Robert Morgan
UNC Hospitals - UNCPN

Study Topics

Child and Teen Health
Healthy Volunteer or General Population

IRB Number

18-2180

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