Status:

UNKNOWN

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

Lead Sponsor:

LG Life Sciences

Conditions:

Diphtheria

Tetanus

Eligibility:

All Genders

6+ years

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 i...

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 t...

Eligibility Criteria

Inclusion

  • Patients who had been signed informed consent by subjects legally acceptable Representative
  • 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

  • Patients with hypersensitivity to any component for the vaccine
  • 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.
  • Patients who had pertussis, encephalopathy or other serious neurological abnormality in the newborn period

Key Trial Info

Start Date :

March 1 2015

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2016

Estimated Enrollment :

3000 Patients enrolled

Trial Details

Trial ID

NCT02257645

Start Date

March 1 2015

End Date

September 1 2016

Last Update

October 7 2014

Active Locations (0)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 0 (0 locations)

No Results Found

We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.

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