Status:
COMPLETED
Prevenar (PCV-7) Post-Licensure Safety Study In Russia
Lead Sponsor:
Pfizer
Conditions:
Healthy Children After Vaccination
Eligibility:
All Genders
3-23 years
Brief 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 n...
Eligibility Criteria
Inclusion
- Infants eligible for Prevenar vaccination according to the Regulatory approved terms of the marketing authorization in the Russian Federation:
- Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media).
- Parents or legal guardians willing and able to complete the diary cards.
Exclusion
- Hypersensitivity to the active substances or to any of the excipients;
- Hypersensitivity to diphtheria toxoid;
- Age less than 3 months or greater than or equal to 2 years at enrollment;
- Contraindications as listed in the Package Insert / Russian SmPC for either Prevenar or for any concomitantly used other vaccines;
- Previously vaccinated with 23-valent pneumococcal polysaccharide vaccine;
- Prophylactic use of non-steroidal anti-inflammatory medications and/or acetaminophen (e.g., paracetamol). However, acetaminophen/paracetamol may be administered for treatment of fever, pain, etc.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01207583
Start Date
December 1 2009
End Date
August 1 2011
Last Update
August 31 2012
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Russian State Medical University
Moscow, Russia, 119049
2
Russian Academy of Medical Sciences
Moscow, Russia, 119296
3
Research Institute of Childhood Infections
Saint Petersburg, Russia, 197022
4
City Children's Clinical Hospital #8
Yekaterinburg, Russia, 620085