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Immunogenicity of PCV-7 Vaccine in VLBW Infants

NCT00273325 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 368

Last updated 2019-03-22

No results posted yet for this study

Summary

Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants. This study evaluated the effectiveness and safety of the vaccine given in routine practice to very low birth weight infants, looking at blood antibody levels 4-6 weeks after the final vaccine dose, and adverse events, survival, infections, and neurodevelopmental outcomes at 18-22 months corrected age.

Conditions

  • Pneumococcal Infections
  • Streptococcus Pneumoniae
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • NICHD Neonatal Research Network

    lead NETWORK

Principal Investigators

  • Ronald N. Goldberg, MD · Duke University

  • Barbara J. Stoll, MD · Emory University

  • Abhik Das, PhD · RTI International

  • Krisa P. Van Meurs, MD · Stanford University

  • Waldemar A. Carlo, MD · University of Alabama at Birmingham

  • Shahnaz Duara, MD · University of Miami

  • Carl T. D'Angio, MD · University of Rochester

  • Pablo J. Sanchez, MD · University of Texas, Southwestern Medical Center at Dallas

  • T. Michael O'Shea, MD MPH · Wake Forest University

  • Seetha Shankaran, MD · Wayne State University

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2007-07-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00273325 on ClinicalTrials.gov