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

NCT01207583

Last updated date
Study Location
Russian State Medical University
Moscow, , 119049, Russian Federation
Contact
1-800-718-1021

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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.

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Healthy Children After VaccinationPrevenar (PCV-7) Post-Licensure Safety Study In Russia NCT01207583
  1. Moscow,
  2. Moscow,
  3. Saint Petersburg,
  4. Yekaterinburg,
ALL GENDERS
3 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Prevenar (PCV-7) Post-Licensure Safety Study In Russia
Official Title Prevenar 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 Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants and Children from 3 months to 23 months at enrollment
Condition Healthy Children After Vaccination
Intervention Other: Non-interventional observational study
Non-interventional observational study
Study Groups/Cohorts healthy 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 Status Completed
Actual Enrollment
 (submitted: September 21, 2010)
100
Original Actual Enrollment Same as current
Actual Study Completion Date August 2011
Actual Primary Completion Date August 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
Ages 3 Months to 23 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT01207583
Other Study ID Numbers 0887X1-4596
B1841011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2012