Clinical trial NCT01123954: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Influenza
Keywords: Seasonal influenza
Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 33
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Using the single vaccination for volunteers and follow up within 30 days since the first vaccination to evaluate levels of safety (AEs) after vaccination
timeFrame: 30 days, including the follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: Department of examination and vaccination - Institute Pasteur of Ho Chi Minh City (LAM: Laboratoires d'Analysis Medicale)
Study officials:
References: