Phase IV Clinical Trial of an Influenza Split Vaccine Anflu
This study has been completed.
Sponsor:
Sinovac Biotech Co., Ltd
Information provided by:
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT00556062
First received: November 8, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: seasonal split influenza vaccine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Clinical Trial for Three Consecutive Lots of Influenza Split Vaccine Anflu by Randomized, Double-Blind and Controlled Design |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by Sinovac Biotech Co., Ltd:
Primary Outcome Measures:
- Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B [ Time Frame: 0, 21 days ]
Secondary Outcome Measures:
- local and systematic adverse reactions after vaccination [ Time Frame: within 3 days after vaccination ]
| Enrollment: | 566 |
| Study Start Date: | September 2007 |
| Study Completion Date: | November 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1: Lot 1 |
Biological: seasonal split influenza vaccine
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
|
| Experimental: 2: Lot 2 |
Biological: seasonal split influenza vaccine
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
|
| Experimental: 3: Lot 3 |
Biological: seasonal split influenza vaccine
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
|
| Active Comparator: 4: control vaccine |
Biological: seasonal split influenza vaccine
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00556062 History of Changes |
| Other Study ID Numbers: | PRO-INF-4005 |
| Study First Received: | November 8, 2007 |
| Last Updated: | November 8, 2007 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013