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

Seasonal Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123954
• Other study ID #: V71_21
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2010
• Last updated: December 13, 2011
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Using the single vaccination for volunteers and follow up within 30 days since the first vaccination to evaluate levels of safety (AEs) after vaccination		30 days, including the follow-up period	Yes