Status:
COMPLETED
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pneumococcal Infections
Streptococcus Pneumoniae
Eligibility:
All Genders
Up to 3 years
Brief 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 pr...
Detailed Description
Streptococcus pneumoniae causes an estimated 10-25% of all pneumonias in the United States, and is responsible for an estimated 40,000 deaths per year. Invasive pneumococcal disease has a peak inciden...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Gestational age \<32 0/7 weeks
- Included in Neonatal Research Network Generic Database
- Family has a telephone at home
- Anticipated availability for blood draw 4-6 weeks following 3rd vaccine dose
- Consent obtained before first dose of PCV-7 is given
- Exclusion criteria
- Known immunodeficiency
- HIV exposure
- Parental non-consent
- Primary care pediatrician not willing to participate
- Enrollment in a conflicting trial
- Infant has not received first dose of PCV-7 vaccine by 3 months of age
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT00273325
Start Date
July 1 2004
End Date
March 1 2009
Last Update
March 22 2019
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Stanford University
Palo Alto, California, United States, 94304
3
University of Miami
Miami, Florida, United States, 33136
4
Emory University
Atlanta, Georgia, United States, 30303