Immunogenicity of PCV-7 Vaccine in VLBW Infants

Completed

Conditions studied: Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature

In brief

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.

Key facts

Study ID

NCT00273325

Run by

NICHD Neonatal Research Network

People needed

368

Starts

2004-07-01

Expected to finish

2009-03-01

Last updated by the study team

2019-03-22

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Wayne State University — Detroit, Michigan, United States
• University of Rochester — Rochester, New York, United States
• Wake Forest University — Charlotte, North Carolina, United States
• RTI International — Durham, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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