Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine
Post-marketing Clinical Observation of Hualan's Inactivated Influenza Vaccine: A Single Center, Parallelled, Controlled, Randomised Clinical Trial
Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May, 2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza vaccine of Hualanbio has obtained production permission and marketing authorization in May, 2008.
In order to further investigate the safety and immunogenicity of the vaccine in the market, The clinical observation was planned to be conducted in Mianyang city (Yanting County), Sichuan Province, China.
調査の概要
状態
条件
詳細な説明
Dosage and administration route in this clinical trial:
Subjects age 3 years or older was vaccinated following a single 0.5ml dose immunization regime.
The preferred site of injection was the at the skin near outboard deltoid muscle of the upper arm.
The administration route is after the sanitization with 75% alcohol, intramuscularly inject the test vaccine or the control vaccines when the skin was slightly dried for those subjects complied with the inclusion requirements.
Safety indicators:
- Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reaction within 30 minutes ;
- Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reactions through 6 hours to the 29th day ;
- Summarize the adverse events/severe adverse events and the incidence levels from the inclusion of the subjects to the completion of the clinical trial.
Immunogenicity indicators:
Evaluate the Post-vaccination immunogenicity of the test and the control influenza vaccines in persons age 3 years and older by its HI antibody level on Day 28.
Take 1:10 serum dilution as the minimum dilutability. The seroconversion in this trial was defined as the post-vaccination HI antibody titer ≥ 1:40 when the HI antibody < 1:10 before the vaccination or the post-vaccination HI antibody titer quadruply increased when HI antibody ≥ 1:10 before the vaccination.
The Immunogenicity criteria set for this clinical trial is the seroconversion shall be > 40% after 14 days of the vaccination.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Sichuan
-
Mianyang、Sichuan、中国、621000
- Yanting County
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy male or female age 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
- Healthy male or female by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product;
- Be able to comply with the requirement of clinical trial protocol;
- Have no history of vaccination within the past 6 months and vaccination with other product within the latest 1 week;
- Axillary temperature <37.1℃.
Exclusion Criteria:
- Subject that was allergic to eggs and any component of the vaccine, or has history of other allergy;
- Fever, acute disease or acute onset of chronic disease and influenza;
- Guillain-Barre Syndrome
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Inactivated Influenza Vaccine
15μg HA/strain/0.5ml/syringe,
Hualan Biologicals
|
200 subjects were randomly assigned (60 children, 100 adults and 40 elders) to receive Inactivated Influenza Vaccine (Split virion) of Hualan Biologicals, 15ug HA/strain/0.5ml/syringe,
one dose regime
他の名前:
|
アクティブコンパレータ:Inactivated Influenza Vaccine of Pasteur
15ug HA/strain/0.5ml/syringe,
Sanofi Pasteur
|
200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive the Inactivated Influenza Vaccine of Sanofi Pasteur, 15ug HA/strain/0.5 ml/syringe, one dose regime,
他の名前:
|
アクティブコンパレータ:Inactivated Influenza Vaccine of GSK
15ug HA/strain/0.5ml/syringe,
GSK
|
200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive Inactivated Influenza Vaccine (Split virion) of GSK, 15ug HA/strain/0.5ml/syringe,
one dose regime
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
安全性の指標として副作用が発現した被験者数
時間枠:接種後28日
|
局所反応、全身反応、重症度およびAEFI相関
|
接種後28日
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Observation of the immunological effect
時間枠:28 days after the immunization
|
HI antibody seroconversion ratios
|
28 days after the immunization
|
協力者と研究者
捜査官
- 主任研究者:Pei-ru Zhang、Immune Planning Institute of Mianyang Center for Disease Prevention and Control
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- Hualanbio-influenza-IV-002
- Hualanbio-003 (その他の助成金/資金番号:Hualan Biological Engineering INC.)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Inactivated Influenza Vaccineの臨床試験
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GlaxoSmithKline完了
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Serum Institute of India Pvt. Ltd.PATH完了
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GlaxoSmithKline積極的、募集していない