Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks

LG Life Sciences3,000 enrolled

Overview

A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B in infants.

Euforvac-Hib vaccine manufactured by LG Life science in Korea, but it's not marketed in Korea. It is distributed to UN agencies in diverse countries. Thus, WHO recommended LG Life Science to conduct the safety study for assessing the vaccine safety if Euforvac-Hib is prequalified. 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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenza Type B

Eligibility

Sex: ALLMin age: 6 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who had been signed informed consent by subjects legally acceptable Representative 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: 1. Patients with hypersensitivity to any component for the vaccine 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

Outcomes

Primary Outcomes

Adverse event

Time frame: up to 12 weeks after vaccination

Central Contacts

Hyejin Yoon

CONTACT

82-2-6924-3148 hyejin0611@lgls.com

Data from ClinicalTrials.gov

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