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

• Sponsor: Novartis Vaccines (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01123954
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 11.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Influenza	Biological: Seasonal flu vaccine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluating the Safeness of Trivalent Subunit Inactivated Influenza Vaccines in Preventing Flu on Vietnamese Volunteers
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: 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)

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Vaccines
• ClinicalTrials.gov Identifier: NCT01123954
• Other Study ID Numbers: V71_21
• First Posted: May 14, 2010
• Last Update Posted: Dec 14, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Novartis Vaccines: Seasonal influenza; Vaccine
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Dec 14, 2011