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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02257645
• Other study ID #: LG-VFOS001
• 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

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenza Type B
• Hepatitis
• Hepatitis B
• Pertussis
• Tetanus
• Whooping Cough

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