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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01207583 |
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Date of registration:
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21/09/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prevenar (PCV-7) Post-Licensure Safety Study In Russia
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Scientific title:
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Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01207583 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion 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.
Age minimum:
3 Months
Age maximum:
23 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy Children After Vaccination
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Intervention(s)
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Other: Non-interventional observational study
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Primary Outcome(s)
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Percentage of Participants With Febrile Reactions Post-dose 1
[Time Frame: Day 1 to Day 3 post-dose 1]
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Percentage of Participants With Febrile Reactions Post-dose 4
[Time Frame: Day 1 to Day 3 post-dose 4]
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Percentage of Participants With Febrile Reactions Post-dose 3
[Time Frame: Day 1 to Day 3 post-dose 3]
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Percentage of Participants With Febrile Reactions Post-dose 2
[Time Frame: Day 1 to Day 3 post-dose 2]
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Secondary Outcome(s)
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
[Time Frame: Day 1 to Day 3 post-dose 1]
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
[Time Frame: Day 1 to Day 3 post-dose 4]
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
[Time Frame: Day 1 to Day 3 post-dose 2]
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
[Time Frame: Day 1 to Day 3 post-dose 3]
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
[Time Frame: Day 1 to Day 3 post-dose 2]
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Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
[Time Frame: Day 1 to Day 3 post-dose 3]
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
[Time Frame: Day 1 to Day 3 post-dose 1]
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Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
[Time Frame: Day 1 to Day 3 post-dose 4]
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Secondary ID(s)
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0887X1-4596
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B1841011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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