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Evaluating the Safeness of Trivalent Subunit Inactivated Influenza Vaccines in Preventing Flu on Vietnamese Volunteers

NCT ID: NCT01123954

Last Updated: 2011-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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The present study will evaluate the safety in healthy people aged 1- 45 years (male and female) after single intramuscular (IM) dose of trivalent subunit inactivated influenza vaccine till the 30-days follow-up period.

Detailed Description

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Conditions

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Seasonal Influenza

Keywords

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Seasonal influenza Vaccine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type OTHER

Seasonal flu vaccine

Intervention Type BIOLOGICAL

This phase II is performed as a monocenter study site in a population of healthy subjects aged 1 to 45 years. Enrolled subjects received one single IM dose of trivalent subunit inactivated influenza vaccine during the vaccination visit, according to the study protocol (follow-up period: 30 days)

Interventions

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Seasonal flu vaccine

This phase II is performed as a monocenter study site in a population of healthy subjects aged 1 to 45 years. Enrolled subjects received one single IM dose of trivalent subunit inactivated influenza vaccine during the vaccination visit, according to the study protocol (follow-up period: 30 days)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Healthy people with aged 1 to 45 years;
2. Previous history of not being vaccinated by any flu vaccines;
3. Women of childbearing potential agree to apply the contraceptive measures during the study period;
4. Do not have any acute or chronic diseases by screening;
5. Having the abilities of understanding and conforming the study plan;
6. Volunteer to the study;
7. Agree to vaccinate completely and conform the follow up procedure within 30 days after the first vaccination.

Exclusion Criteria

1. Having the suspected symptoms of infecting flu: cough, sore throat, stuffy or running nose, headache, malaise, myalgia and arthralgia, weakness, chilly or sweat;
2. A prior history of allergy to any components of candidate vaccine;
3. Sensitive to eggs or chicken protein, kanamycin, neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80;
4. Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
5. Being immuno deficiency due to treatment;
6. Using immunosuppressive drugs (belong to steroid group) within 06 months before vaccination;
7. Being sickness or cancer or HIV (+);
8. Participating in other study on drug or vaccination;
9. Receipt of other vaccine within 04 weeks before participating in the study;
10. Congenital malformation, mental disorder or members of family having the mental disorder;
11. Using immune globulin or blood products within 03 months before vaccination;
12. Having an acute or chronic diseases that can cause influence on the safety including: hepatic, renal, mental diseases or diabetes and transplantation;
13. Body temperature over 37.5 degree Celcius within 01 week before vaccination;
14. History of alcohol or drugs addicted within 05 years;
15. Planning to travel away from the study site among the visits.
Minimum Eligible Age

1 Year

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of examination and vaccination - Institute Pasteur of Ho Chi Minh City (LAM: Laboratoires d'Analysis Medicale)

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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V71_21

Identifier Type: -

Identifier Source: org_study_id