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

NCT01123954 | Completed Phase 2

• 1 other identifier: V71_21
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Influenza

Keywords

Seasonal influenza; Vaccine

Outcome Measures

Primary Outcomes (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

Study Arms (1)

Arm 1

OTHER

Biological: Seasonal flu vaccine

Interventions

Seasonal flu vaccine BIOLOGICAL

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)

Arm 1

Eligibility Criteria

• Age: 1 Year - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

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

Ho Chi Minh City, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: May 14, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 14, 2011

Record last verified: 2011-12

Locations

VN (1)