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

A Multicenter, Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization Against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenza Type B in Infants

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02257645

Enrollment

3000

Registered

2014-10-06

Start date

2015-03-31

Completion date

2016-09-30

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, Haemophilus Influenza Type B, Hepatitis B, Pertussis, Tetanus

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Adverse event	up to 12 weeks after vaccination

Contacts

Primary ContactHyejin Yoon

hyejin0611@lgls.com82-2-6924-3148

Outcome results