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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02257645
Other study ID # LG-VFOS001
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 2, 2014
Last updated October 5, 2014
Start date March 2015
Est. completion date September 2016

Study information

Verified date October 2014
Source LG Life Sciences
Contact Hyejin Yoon
Phone 82-2-6924-3148
Email hyejin0611@lgls.com
Is FDA regulated No
Health authority ECs : Guatemala
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3000
Est. completion date September 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
LG Life Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse event up to 12 weeks after vaccination No
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