NCT02257645

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

October 2, 2014

Last Update Submit

October 5, 2014

Conditions

DiphtheriaTetanusPertussisHepatitis BHaemophilus Influenza Type B

Outcome Measures

Primary Outcomes (1)

  • Adverse event

    up to 12 weeks after vaccination

Study Arms (1)

Euforvac-Hib vaccine

Eligibility Criteria

Age6 Weeks+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DiphtheriaTetanusWhooping CoughHepatitis B

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Central Study Contacts

Hyejin Yoon

CONTACT

82-2-6924-3148hyejin0611@lgls.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 6, 2014

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

October 7, 2014

Record last verified: 2014-10