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

NCT ID: NCT02723812

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Influenza, Human

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GCFLU® Influenza vaccine (Split virion, Inactivated)

One dose 0.5 mL vaccine GCFLU® administered intramuscularly.

Group Type: EXPERIMENTAL

GCFLU® Influenza vaccine (Split virion, Inactivated)

Intervention Type: BIOLOGICAL

Interventions

GCFLU® Influenza vaccine (Split virion, Inactivated)

Intervention Type: BIOLOGICAL

Other Intervention Names

GCFLU® pre-filled syringe inj.

Eligibility Criteria

Inclusion Criteria

Subject must meet all criteria below to participate in study

1. A person who is a 3-year-old or older, healthy and can be followed up for 21 days

2. 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

1. 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.

2. Subjects with immune system disorder including immune deficiency disease.

3. Subjects with a history of Guillain-Barre syndrome.

4. 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.

5. Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.

6. Subject who had acute fever with body temperature exceeding 37.50 Celsius (armpit calculated) before vaccination with the study drug.

7. 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.

8. 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).

9. 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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Nguyen Vu Thuong

Vice Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thuong Nguyen Vu, PhD.

Role: PRINCIPAL_INVESTIGATOR

Pasteur Institute, Ho Chi Minh City

Locations

Ben Luc Health centre

Bến Lức, Long An, Vietnam

Countries

Vietnam

Other Identifiers

VX-2015.02

Identifier Type: -

Identifier Source: org_study_id