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Prevenar (PCV-7) Post-Licensure Safety Study In Russia

NCT01207583 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2012-08-31

Study results available
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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.

Conditions

  • Healthy Children After Vaccination

Interventions

OTHER

Non-interventional observational study

Non-interventional observational study

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
3 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Russia

Study Locations

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Entities

Companies

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 NCT01207583 on ClinicalTrials.gov