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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02723812 |
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Date of registration:
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22/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluate Safety of GCFLU® Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old
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Scientific title:
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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 |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02723812 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Thuong Nguyen Vu, PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pasteur Institute, Ho Chi Minh City |
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Key inclusion & exclusion criteria
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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.
Age minimum:
3 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Influenza, Human
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Intervention(s)
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Biological: GCFLU® Influenza vaccine (Split virion, Inactivated)
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Primary Outcome(s)
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Safety of GCFLU® by assessing the frequency, rate and severity of serious adverse events.
[Time Frame: During 21 days after vaccination.]
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Safety of GCFLU® by assessing the frequency, rate and severity of unsolicited adverse events.
[Time Frame: During 21 days after vaccination.]
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Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general).
[Time Frame: 30 minutes after vaccination.]
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Safety of GCFLU® by assessing the frequency, rate and severity of solicited adverse events (local and general)
[Time Frame: For 7 days after vaccination.]
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Secondary ID(s)
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VX-2015.02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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