NCT01201902

CompletedPhase 3

A Study to Evaluate the Safety and Immunogenicity of an Inac...

Green Cross Corporation Source

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Other study identifiers

Sponsor study identifier

GC1116

Secondary identifiers

임상제도과 - 649호(2009.9.28)

REGISTRY · Korea Food & Drug Administraion

Study Type

interventional

Actual enrollment (reported)

592

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2009

Actual (reported)

Study Completion

July 2010

Actual (reported)

Brief Summary

The purpose of this study is to assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than or equal to 65 years of age.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 592 participants
Study completion date: July 2010
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2009
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)
Study Completion
July 2010
Actual (reported)
First Submitted
September 13, 2010
Actual (reported)
First Posted
September 15, 2010
Actual (reported)

Last Updated: September 20, 2010
Status Verified: September 2010
Last Update Submitted: September 17, 2010

Conditions

Influenza Infection

Outcome Measures

Primary Outcomes (1)

HI antibody responses after 1 and/or 2 vaccinations
21 days after vaccination

Secondary Outcomes (1)

Solicited local & general AE, Unsolicited AE, AE until 6 months after last vaccination
the date of vaccination until 6 days after vaccination, 42days after first vaccination, 6 months after last vaccination

Study Arms (5)

Group 1 : Low dose with adjuvant

EXPERIMENTAL

Group 1: 18 \~ 64 years old subjects

Biological: Adjuvanted influenza A(H1N1) vaccine

Group 1: High dose with adjuvant

EXPERIMENTAL

Group 1: 18 \~ 64 years old subjects

Biological: Adjuvanted influenza A(H1N1) vaccine

Group1 : Plain vaccine

ACTIVE COMPARATOR

Group 1: 18 \~ 64 years old subjects

Biological: un-adjuvanted influenza A(H1N1) vaccine

Interventions

Adjuvanted influenza A(H1N1) vaccineBiological

0.25ml, Intramuscular on Day 0 and 21

Also known as: Split-virion vaccine

Group 1 : Low dose with adjuvant

Adjuvanted influenza A(H1N1) vaccineBiological

0.5ml, Intramuscular on Day 0 and 21

Also known as:

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Healthy adults age 18 and older.
Are able to understand and comply with planned study procedures.

Sponsors & Collaborators

Green Cross Corporation
Industrylead

MeSH Terms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

Woo-ju Kim
Korea University Guro Hospital
PRINCIPAL INVESTIGATOR

Enrollment

592 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 15, 2010

Study Start

October 2009

Date type not reported

This date has not been verified as actual or estimated.

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Group 2 : Low dose with adjuvant

EXPERIMENTAL

Group 2: greater than or equal to 65 years of age

Biological: Adjuvanted influenza A(H1N1) vaccine

Group 2 : high dose with adjuvant

EXPERIMENTAL

Group 2: greater than or equal to 65 years of age

Biological: Adjuvanted influenza A(H1N1) vaccine

Split-virion vaccine

Group 1: High dose with adjuvant

un-adjuvanted influenza A(H1N1) vaccineBiological

0.5ml, Intramuscular on Day 0 and 21

Also known as: Split-virion vaccine

Group1 : Plain vaccine

Adjuvanted influenza A(H1N1) vaccineBiological

0.25ml, Intramuscular on Day 0 and 21

Also known as: Split-virion vaccine

Group 2 : Low dose with adjuvant

Adjuvanted influenza A(H1N1) vaccineBiological

0.5ml, Intramuscular on Day 0 and 21

Also known as: Split-virion vaccine

Group 2 : high dose with adjuvant

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Provide written informed consent prior to initiation of any study procedures.

You may not qualify if:

Have a known allergy to eggs, chickens or other components of the vaccine(including MF59).
Have immunosuppression including immunodeficiency disease.
Have a history of Guillain-Barre Syndrome.
Have a diagnosis of thrombocytopenia.
Have a chronic disease that the investigator believes may interfere with successful completion of the study. (Excluding regulating hypertension)
Hemophilia Patients or Are receiving anti-coagulating agents. Low-dose aspirin (100mg/day) purpose of prevention is allowed.
Are receiving anti-viral agents.
Have an acute fever, a temperature greater than 38℃(100.4 degrees Fahrenheit) within 72 hours of vaccination or Have a symptom of acute febrile illness within 14 days prior to vaccination in this study.
Received below agents or expect to receive agents within following periods. A. Have immunosuppression therapy, radiotherapy, use of high-dose glucocorticoids or prednisolone(≥15mg/day) within 6 months prior to vaccination in this study.Inhaled, nasal and topical steroids are allowed) B. Have a history of receiving immunoglobulin or other blood product within 3 months prior to vaccination in this study.
C. Received an experimental agent within 1 month prior to vaccination in this study.
D. Received any vaccines(live licensed and inactivated licensed) within 1 month prior to vaccination in this study. (Excluding seasonal Influenza vaccine)
Those who are not eligible to receive vaccine injection in the arm deltoid muscle.
Pregnant females, Nursing mom, Those women who have a chance to become pregnant, but not taking a proper contraception.
Not agree to abstain from drinking following 7 days of vaccination.
Have any condition (clinically regardful medical or psychological condition) that would, in the opinion of the site investigator, render them unable to meet the requirements of the protocol.

Contact the study team to confirm eligibility.

Primary Completion

December 2009

Actual (reported)

Study Completion

July 2010

Actual (reported)

Last Updated

September 20, 2010

Record last verified: 2010-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01201902
Data provider: ClinicalTrials.gov
Source updated: 2010-09-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:06 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (5)

Group 1 : Low dose with adjuvant

Group 1: High dose with adjuvant

Group1 : Plain vaccine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Group 2 : Low dose with adjuvant

Group 2 : high dose with adjuvant

You may not qualify if:

Source record