Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks
NCT ID: NCT02257645
Last Updated: 2014-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3000 participants
OBSERVATIONAL
2015-03-31
2016-09-30
Brief Summary
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Detailed Description
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The objectives of this safety study are to identify any problems and questionable issues likely to emerge from the actual use of Euforvac-Hib vaccine after launching in the market.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Euforvac-Hib vaccine
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Infant from 6 weeks of age.who is given this vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B
Exclusion Criteria
2. Patients who had a severe reaction to a previous dose of the combination vaccine or any of its constituents is absolute contraindication to subsequent doses of the combination vaccine.
3. Patients who had pertussis, encephalopathy or other serious neurological abnormality in the newborn period
6 Weeks
ALL
Yes
Sponsors
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LG Life Sciences
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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LG-VFOS001
Identifier Type: -
Identifier Source: org_study_id
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