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CompletedNCT01123954Updated Dec 14, 2011

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

A Phase 2 interventional study of Seasonal flu vaccine in Seasonal Influenza, sponsored by Novartis Vaccines. Completed at 1 site in Vietnam. Open to participants aged 1 Year to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-14.

Sponsored by Novartis Vaccines · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Non-randomized
Ages
1 Year to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Seasonal Influenza

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Keywords

  • Seasonal influenza
  • Vaccine
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 33 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 45 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Other
    Arm 1

    Biological: Seasonal flu vaccine

Interventions

  • BiologicalSeasonal 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)

06

What researchers measure

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

    Time frame: 30 days, including the follow-up period

07

Study locations

1 site
  • Department of examination and vaccination - Institute Pasteur of Ho Chi Minh City (LAM: Laboratoires d'Analysis Medicale)
    Ho Chi Minh, Vietnam
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01123954
Lead sponsor
Novartis Vaccines
Responsible party
Sponsor
First posted
May 14, 2010
Start date
Jan 2010
Primary completion
Mar 2010
Completion
Apr 2010
Last update
Dec 14, 2011
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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