ClinicalTrials.gg
Status unknownNCT02257645Updated Oct 7, 2014

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

An observational study in Diphtheria, Tetanus and Pertussis, sponsored by LG Life Sciences. Status unknown. Open to participants aged 6 Weeks and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-07.

Sponsored by LG Life Sciences (part of LG Chem) · Observational

The sponsor has not verified this record recently (last verified Oct 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
6 Weeks and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Haemophilus Influenza Type B
03

In context

Diphtheria

270 studies on the registry are indexed under Diphtheria; 17 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 970 across 24 observational studies indexed under Diphtheria.

Browse Diphtheria studies →

Lead sponsor

LG Life Sciences is the lead sponsor of 78 studies on the registry; none are open to participants now.

First submitted before LG Life Sciences became part of LG Chem.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Weeks and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Euforvac-Hib vaccine
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What researchers measure

Primary outcomes

  1. Adverse event

    Time frame: up to 12 weeks after vaccination

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02257645
Lead sponsor
LG Life Sciences
Responsible party
Sponsor
First posted
Oct 6, 2014
Start date
Mar 2015
Primary completion
May 2016 (estimated)
Completion
Sep 2016 (estimated)
Last update
Oct 7, 2014

Study contacts

Hyejin Yoon
Contact
hyejin0611@lgls.com
82-2-6924-3148

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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