CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Non-interventional observational studyother
Likely dose
Not stated in record
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Search/NCT01207583
NCT01207583N/ACompleted
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Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination

Pfizer·observational·Posted Sep 23, 2010·Updated Aug 31, 2012

In Brief

An observational study evaluating Non-interventional observational study for Healthy Children After Vaccination. Completed, enrolled 100 participants across 4 sites.

Detailed Summary

This study is planned to monitor the local and/or systemic reactions and compatibility of PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with the observational nature of this protocol, Prevenar will be administered as standard of care. The aim of this study is to estimate the incidence of febrile reactions more than 38.0 degrees Celsius, specifically (≥38 to \< 39 degrees C; \> 39 to \< 40 degrees C and \> 40 degrees C, and the frequency of other local or systemic reactions following vaccination with Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Children After Vaccination
CountriesRussia
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 23, 2010
Enrollment StartDec 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.8 years ago

Interventions

Non-interventional observational studyother

Non-interventional observational study