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

Last updated on October 20, 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.
Show details

- 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.
Show details

- 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

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Descriptive Information
Brief TitlePrevenar (PCV-7) Post-Licensure Safety Study In Russia
Official TitlePrevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination
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 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.

Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationInfants and Children from 3 months to 23 months at enrollment
ConditionHealthy Children After Vaccination
InterventionOther: Non-interventional observational study
Non-interventional observational study
Study Groups/Cohortshealthy children after vaccination
healthy children after vaccination
Intervention: Other: Non-interventional observational study
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: September 21, 2010)
100
Original Actual EnrollmentSame as current
Actual Study Completion DateAugust 2011
Actual Primary Completion DateAugust 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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:

  • 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.
Sex/Gender
Sexes Eligible for Study:All
Ages3 Months to 23 Months   (Child)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesRussian Federation
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01207583
Other Study ID Numbers0887X1-4596
B1841011
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2012

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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