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

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.

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Key information

Conditions

Seasonal Influenza

Age range

1 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Ho Chi Minh City, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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)

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: May 14, 2010
Registry last updated: Dec 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed