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

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ClinicalTrials.gov Identifier: NCT02723812
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Collaborator:
Green Cross Corporation
Information provided by (Responsible Party):
Nguyen Vu Thuong, Pasteur Institute, Ho Chi Minh City

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

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: GCFLU® Influenza vaccine (Split virion, Inactivated) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : November 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: GCFLU® Influenza vaccine (Split virion, Inactivated)
One dose 0.5 mL vaccine GCFLU® administered intramuscularly.
Biological: GCFLU® Influenza vaccine (Split virion, Inactivated)
Other Name: GCFLU® pre-filled syringe inj.




Primary Outcome Measures :
  1. Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general). [ Time Frame: 30 minutes after vaccination. ]
  2. Safety of GCFLU® by assessing the frequency, rate and severity of solicited adverse events (local and general) [ Time Frame: For 7 days after vaccination. ]
  3. Safety of GCFLU® by assessing the frequency, rate and severity of unsolicited adverse events. [ Time Frame: During 21 days after vaccination. ]
  4. Safety of GCFLU® by assessing the frequency, rate and severity of serious adverse events. [ Time Frame: During 21 days after vaccination. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723812


Locations
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Vietnam
Ben Luc Health centre
Ben Luc, Long An, Vietnam
Sponsors and Collaborators
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Green Cross Corporation
Investigators
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Principal Investigator: Thuong Nguyen Vu, PhD. Pasteur Institute, Ho Chi Minh City

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Responsible Party: Nguyen Vu Thuong, Vice Director, Pasteur Institute, Ho Chi Minh City
ClinicalTrials.gov Identifier: NCT02723812     History of Changes
Other Study ID Numbers: VX-2015.02
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nguyen Vu Thuong, Pasteur Institute, Ho Chi Minh City:
Influenza
GCFLU
vaccine
Vietnam

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs