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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01123954
First received: March 24, 2010
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Seasonal Influenza
 Biological: Seasonal flu vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluating the Safeness of Trivalent Subunit Inactivated Influenza Vaccines in Preventing Flu on Vietnamese Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Novartis:

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 [ Time Frame: 30 days, including the follow-up period ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Biological: 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)

  Eligibility

Ages Eligible for Study:   1 Year to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123954

Locations
Vietnam
Department of examination and vaccination - Institute Pasteur of Ho Chi Minh City (LAM: Laboratoires d'Analysis Medicale)
Ho Chi Minh, Vietnam
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01123954     History of Changes
Other Study ID Numbers: V71_21
Study First Received: March 24, 2010
Last Updated: December 13, 2011
Health Authority: Vietnam: Ministry of Health

Keywords provided by Novartis:
Seasonal influenza
Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013