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Evaluate Safety of GCFLU® Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old

Primary Purpose

Influenza, Human

Status

Completed

Phase

Phase 4

Locations

Vietnam

Study Type

Interventional

Intervention

GCFLU® Influenza vaccine (Split virion, Inactivated)

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza, GCFLU, vaccine, Vietnam

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subject must meet all criteria below to participate in study

A person who is a 3-year-old or older, healthy and can be followed up for 21 days
Subject who gave voluntary written consent to participate in the study, and able to comply with the study requirements. With subjects aged from 3 years to below 18 years, parents/legal representative will give voluntary consent to participate in this study, and subjects from 12 to under 18 years old will give voluntary written consent for children.

Exclusion Criteria:

Subject have one of criteria below must not participate in study

Subject with a known hypersensitivity or allergic reaction to eggs or eggs products, to chicken or chicken products, to any component of the study vaccine, neomycin or gentamicin.
Subjects with immune system disorder including immune deficiency disease.
Subjects with a history of Guillain-Barre syndrome.
Subjects with severe chronic disease (e.g.; cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal/kidney dysfunction or hemoglobinopathy etc.) who in the investigator's opinion may have a difficulty in participating in the study.
Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
Subject who had acute fever with body temperature exceeding 37.50 Celsius (armpit calculated) before vaccination with the study drug.
Subjects who had received other vaccination within 14 days before vaccination with the study drug, or those who had another vaccination scheduled during the study.
Pregnant women, breast-feeding women or women of childbearing potential who do not use an appropriate method of contraception (use of condom, intrauterine contraceptive device, or hormone contraceptives, or of a male partner had vasectomy).
Subjects who had participated in other clinical study within 28 days priors to vaccination with the study drug, or those who had another clinical trial scheduled during the study.

Sites / Locations

Ben Luc Health centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GCFLU® Influenza vaccine (Split virion, Inactivated)

Arm Description

One dose 0.5 mL vaccine GCFLU® administered intramuscularly.

Outcomes

Primary Outcome Measures

Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general).

Safety of GCFLU® by assessing the frequency, rate and severity of solicited adverse events (local and general)

Safety of GCFLU® by assessing the frequency, rate and severity of unsolicited adverse events.

Safety of GCFLU® by assessing the frequency, rate and severity of serious adverse events.

Secondary Outcome Measures

Full Information

NCT ID

NCT02723812

First Posted

February 22, 2016

Last Updated

March 24, 2016

Sponsor

Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products

Collaborators

Green Cross Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02723812

Brief Title

Evaluate Safety of GCFLU® Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old

Official Title

A Bridging Study to Evaluate Safety of GCFLU® One Dose (0.5ml) (Seasonal Influenza Vaccine) Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products

Collaborators

Green Cross Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

An open label, non-comparative bridging study to evaluate the safety of GCFLU® (seasonal influenza vaccine) administered intramuscularly in healthy Vietnamese volunteer aged from 3 years old

Detailed Description

A bridging study to evaluate safety of seasonal influenza vaccine GCFLU® pre-filled syringe inj. One dose (0.5 ml) after exposure administered intramuscularly. The study conducted in Ben Luc District of Long An province, in which 120 healthy Vietnamese volunteer aged from 5 year old will be enroll to the study. All subject will receive only one dose (0.5 ml) vaccine in Day 0. Study variables will be collected to determine and provide the evidence for the safety of GCFLU®, include: Local and systemic adverse event (AE) in 30 minutes after vaccination. Local and systemic AE in 7 days after vaccination Unsolicited AE over 21 days after vaccination. Serious adverse event (SAE) after vaccination and in 21 days of observation periods Study protocol has been reviewed and approved by Pasteur Institute in Ho Chi Minh City (HCMC) Institutional Review Board (IRB), Vietnam Ministry of Health - Independent Ethics Committee (IEC) and Vietnam Minister of Health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Human

Keywords

Influenza, GCFLU, vaccine, Vietnam

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GCFLU® Influenza vaccine (Split virion, Inactivated)

Arm Type

Experimental

Arm Description

One dose 0.5 mL vaccine GCFLU® administered intramuscularly.

Intervention Type

Biological

Intervention Name(s)

GCFLU® Influenza vaccine (Split virion, Inactivated)

Other Intervention Name(s)

GCFLU® pre-filled syringe inj.

Primary Outcome Measure Information:

Title

Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general).

Time Frame

30 minutes after vaccination.

Title

Safety of GCFLU® by assessing the frequency, rate and severity of solicited adverse events (local and general)

Time Frame

For 7 days after vaccination.

Title

Safety of GCFLU® by assessing the frequency, rate and severity of unsolicited adverse events.

Time Frame

During 21 days after vaccination.

Title

Safety of GCFLU® by assessing the frequency, rate and severity of serious adverse events.

Time Frame

During 21 days after vaccination.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject must meet all criteria below to participate in study A person who is a 3-year-old or older, healthy and can be followed up for 21 days Subject who gave voluntary written consent to participate in the study, and able to comply with the study requirements. With subjects aged from 3 years to below 18 years, parents/legal representative will give voluntary consent to participate in this study, and subjects from 12 to under 18 years old will give voluntary written consent for children. Exclusion Criteria: Subject have one of criteria below must not participate in study Subject with a known hypersensitivity or allergic reaction to eggs or eggs products, to chicken or chicken products, to any component of the study vaccine, neomycin or gentamicin. Subjects with immune system disorder including immune deficiency disease. Subjects with a history of Guillain-Barre syndrome. Subjects with severe chronic disease (e.g.; cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal/kidney dysfunction or hemoglobinopathy etc.) who in the investigator's opinion may have a difficulty in participating in the study. Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection. Subject who had acute fever with body temperature exceeding 37.50 Celsius (armpit calculated) before vaccination with the study drug. Subjects who had received other vaccination within 14 days before vaccination with the study drug, or those who had another vaccination scheduled during the study. Pregnant women, breast-feeding women or women of childbearing potential who do not use an appropriate method of contraception (use of condom, intrauterine contraceptive device, or hormone contraceptives, or of a male partner had vasectomy). Subjects who had participated in other clinical study within 28 days priors to vaccination with the study drug, or those who had another clinical trial scheduled during the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thuong Nguyen Vu, PhD.

Organizational Affiliation

Pasteur Institute, Ho Chi Minh City

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ben Luc Health centre

City

Ben Luc

State/Province

Long An

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Evaluate Safety of GCFLU® Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old

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