Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

NCT00556062 | Completed Phase 4

• 1 other identifier: PRO-INF-4005
• Study Type: interventional
• Target: 566
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B

  0, 21 days

Secondary Outcomes (1)

• local and systematic adverse reactions after vaccination

  within 3 days after vaccination

Study Arms (4)

1: Lot 1

EXPERIMENTAL

Biological: seasonal split influenza vaccine

2: Lot 2

EXPERIMENTAL

Biological: seasonal split influenza vaccine

3: Lot 3

EXPERIMENTAL

Biological: seasonal split influenza vaccine

4: control vaccine

ACTIVE COMPARATOR

Biological: seasonal split influenza vaccine

Interventions

seasonal split influenza vaccine BIOLOGICAL

0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime

1: Lot 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Zhilun Zhang

  Tianjin centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 9, 2007
• Study Start: September 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 9, 2007

Record last verified: 2007-11