Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

Influenza Clinical Trial

Official title:

The Clinical Trial for Three Consecutive Lots of Influenza Split Vaccine Anflu by Randomized, Double-Blind and Controlled Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556062
• Other study ID #: PRO-INF-4005
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2007
• Last updated: November 8, 2007
• Start date: September 2007
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy adults aged 18-60 years old

• Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years

• Not participate in any other clinical trials during the study

• Not receive any immunosuppressive agents during and one month prior to the study

• Be able to understand and sign the informed consent.

Exclusion Criteria:

• Woman: Who breast-feeding or planning to become pregnant during the study

• Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin

• Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain

• Autoimmune disease or immunodeficiency

• Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases

• Guillain-Barre Syndrome

• Women subjects with positive urinary pregnancy test

• Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)

• Axillary temperature >37.0 centigrade at the time of dosing

• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment

• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• seasonal split influenza vaccine
0.5 ml/dose, containing 45 µg influenza HA antigens, 15 µg each subtype; one dose regime
• seasonal split influenza vaccine
0.5 ml/dose, containing 45 µg influenza HA antigens, 15 µg each subtype; one dose regime
• seasonal split influenza vaccine
0.5 ml/dose, containing 45 µg influenza HA antigens, 15 µg each subtype; one dose regime
• seasonal split influenza vaccine
0.5 ml/dose, containing 45 µg influenza HA antigens, 15 µg each subtype; one dose regime

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B		0, 21 days
Secondary	local and systematic adverse reactions after vaccination		within 3 days after vaccination