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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Russian State Medical University
Moscow, , 119049 Russian Federation
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Children After Vaccination
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-23 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01207583
Pfizer
Completed
Prevenar (PCV-7) Post-Licensure Safety Study In Russia

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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Healthy Children After Vaccination
NCT01207583
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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