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

NCT ID: NCT01207583

Last Updated: 2012-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Healthy Children After Vaccination

Keywords

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vaccine infant healthy subjects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy children after vaccination

healthy children after vaccination

Non-interventional observational study

Intervention Type OTHER

Non-interventional observational study

Interventions

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Non-interventional observational study

Non-interventional observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Russian State Medical University

Moscow, , Russia

Site Status

Russian Academy of Medical Sciences

Moscow, , Russia

Site Status

Research Institute of Childhood Infections

Saint Petersburg, , Russia

Site Status

City Children's Clinical Hospital #8

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0887X1-4596&StudyName=Prevenar%20%28PCV-7%29%20Post-Licensure%20Safety%20Study%20In%20Russia

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1841011

Identifier Type: -

Identifier Source: secondary_id

0887X1-4596

Identifier Type: -

Identifier Source: org_study_id