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

Primary Purpose

Seasonal Influenza

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
Seasonal flu vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seasonal Influenza focused on measuring Seasonal influenza, Vaccine

Eligibility Criteria

1 Year - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Using the single vaccination for volunteers and follow up within 30 days since the first vaccination to evaluate levels of safety (AEs) after vaccination

Secondary Outcome Measures

Full Information

First Posted
March 24, 2010
Last Updated
December 13, 2011
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01123954
Brief Title
Evaluating the Safeness of Trivalent Subunit Inactivated Influenza Vaccines in Preventing Flu on Vietnamese Volunteers
Official Title
Evaluating the Safeness of Trivalent Subunit Inactivated Influenza Vaccines in Preventing Flu on Vietnamese Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza
Keywords
Seasonal influenza, Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Seasonal flu vaccine
Intervention Description
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)
Primary Outcome Measure Information:
Title
Using the single vaccination for volunteers and follow up within 30 days since the first vaccination to evaluate levels of safety (AEs) after vaccination
Time Frame
30 days, including the follow-up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy people with aged 1 to 45 years; Previous history of not being vaccinated by any flu vaccines; Women of childbearing potential agree to apply the contraceptive measures during the study period; Do not have any acute or chronic diseases by screening; Having the abilities of understanding and conforming the study plan; Volunteer to the study; Agree to vaccinate completely and conform the follow up procedure within 30 days after the first vaccination. Exclusion Criteria: Having the suspected symptoms of infecting flu: cough, sore throat, stuffy or running nose, headache, malaise, myalgia and arthralgia, weakness, chilly or sweat; A prior history of allergy to any components of candidate vaccine; Sensitive to eggs or chicken protein, kanamycin, neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80; 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; Being immuno deficiency due to treatment; Using immunosuppressive drugs (belong to steroid group) within 06 months before vaccination; Being sickness or cancer or HIV (+); Participating in other study on drug or vaccination; Receipt of other vaccine within 04 weeks before participating in the study; Congenital malformation, mental disorder or members of family having the mental disorder; Using immune globulin or blood products within 03 months before vaccination; Having an acute or chronic diseases that can cause influence on the safety including: hepatic, renal, mental diseases or diabetes and transplantation; Body temperature over 37.5 degree Celcius within 01 week before vaccination; History of alcohol or drugs addicted within 05 years; Planning to travel away from the study site among the visits.
Facility Information:
Facility Name
Department of examination and vaccination - Institute Pasteur of Ho Chi Minh City (LAM: Laboratoires d'Analysis Medicale)
City
Ho Chi Minh
Country
Vietnam

12. IPD Sharing Statement

Learn more about this trial

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

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