Status:

COMPLETED

Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

Lead Sponsor:

Boston Children's Hospital

Collaborating Sponsors:

Medical Research Council Unit, The Gambia

University of British Columbia

Conditions:

Newborn Vaccine Immunogenicity

Eligibility:

All Genders

Up to 1 years

Phase:

NA

Brief Summary

Infection is the most common cause of death in early life, especially for newborns and can be reduced by immunization but insufficient knowledge of how vaccines protect the very young limits their opt...

Detailed Description

While the greatest number of vaccines is administered to the very young, vaccine preventable infections remain a major cause of morbidity and mortality, especially for the newborn. To improve vaccine-...

Eligibility Criteria

Inclusion

  • \<24 hours of age
  • \>37 weeks gestational age
  • HIV unexposed
  • Healthy (no malformations, normal temperature range and vital signs for age)

Exclusion

  • Premature (\<37 weeks gestational age)
  • Hepatitis B antigen-positive mother
  • HIV-positive or HIV-exposed
  • Febrile, unstable vital signs

Key Trial Info

Start Date :

September 6 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 29 2022

Estimated Enrollment :

911 Patients enrolled

Trial Details

Trial ID

NCT03246230

Start Date

September 6 2017

End Date

August 29 2022

Last Update

December 6 2023

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Institute for Medical Research

Goroka, Eastern Highlands Province, Papua New Guinea

2

Medical Research Council Unit, The Gambia

Fajara, The Gambia, 000273