CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 368 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00273325
NCT00273325N/ACompleted

Observational Study of the Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Very-low-birth-weight Infants

NICHD Neonatal Research Network·observational·Posted Jan 9, 2006·Updated Mar 22, 2019

In Brief

An observational study for Pneumococcal Infections and 5 related conditions. Completed, enrolled 368 participants across 10 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 9, 2006
Enrollment StartJul 1, 2004
Primary CompletionJul 1, 2007
Study CompletionMar 1, 2009
TodayJul 1, 2026
Enrollment to primary: 3 yearsPosted 20.5 years ago