A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
2015年9月20日 更新者：Seqirus
A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years.
Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
402
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90036
- Site 286
-
-
Idaho
-
Boise、Idaho、アメリカ、83642
- Site 289
-
-
Missouri
-
Saint Louis、Missouri、アメリカ、63141
- Site 287
-
-
New York
-
Binghamton、New York、アメリカ、13901
- Site 285
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27704
- Site 290
-
Raleigh、North Carolina、アメリカ、27609
- Site 281
-
Winston-Salem、North Carolina、アメリカ、27103
- Site 280
-
-
South Carolina
-
Charleston、South Carolina、アメリカ、29403
- Site 284
-
-
Texas
-
Austin、Texas、アメリカ、78705
- Site 283
-
Fort Worth、Texas、アメリカ、76135
- Site 282
-
San Angelo、Texas、アメリカ、76904
- Site 288
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
5年～8年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Males or females aged 5 to less than 9 years at the time of first study vaccination.
- The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
- In good health, as determined by medical history and a targeted physical examination (if warranted).
Exclusion Criteria:
- Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
- Clinical signs of significant active infection or an elevated oral temperature at study entry.
- A clinically significant medical or psychiatric condition.
- A history of seizures or febrile convulsions or Guillain-Barré syndrome.
- Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
- Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
- Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
- Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
- Currently receiving treatment with warfarin or other anticoagulants.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
|
Subjects will receive one or two study vaccinations depending on their influenza vaccine history.
The vaccine will be administered by intramuscular injection.
|
|
アクティブコンパレータ：Comparator Quadrivalent Influenza Virus Vaccine
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
|
Subjects will receive one or two study vaccinations depending on their influenza vaccine history.
The vaccine will be administered by intramuscular injection.
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 |
|---|---|---|
|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
時間枠：7 days after each administration of vaccine.
|
The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV.
A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F).
The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
|
7 days after each administration of vaccine.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
時間枠：7 days after each administration of vaccine.
|
The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine.
A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F).
The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).
|
7 days after each administration of vaccine.
|
|
The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
時間枠：7 days after each administration of vaccine.
|
Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom.
Excludes subjects with missing intensity information for the whole 7 days.
Mild fever: ≥ 100.4 to < 101.3º
F (≥ 38.0 to < 38.5º C).
Moderate fever: ≥ 101.3 to < 102.2º
F (≥ 38.5 to < 39.0º C).
Severe fever: ≥ 102.2º
F (≥ 39.0º C).
|
7 days after each administration of vaccine.
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
時間枠：7 days after each administration of vaccine.
|
The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
Percentages for intensity are based on the number of subjects with non-missing intensity data.
Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
|
7 days after each administration of vaccine.
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
時間枠：7 days after each administration of vaccine.
|
The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
Percentages for intensity are based on the number of subjects with non-missing intensity data.
Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
|
7 days after each administration of vaccine.
|
|
The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
時間枠：7 days after each administration of vaccine.
|
The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group.
Excludes subjects with missing intensity information for the whole 7 days.
If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality.
However, subjects can be counted more than once overall.
|
7 days after each administration of vaccine.
|
|
The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
時間枠：7 days after each administration of vaccine.
|
The number of subjects experiencing at least one SAE.
|
7 days after each administration of vaccine.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：bioCSL Pty Ltd Clinical Program Director、Seqirus
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年9月1日
一次修了 (実際)
2014年12月1日
研究の完了 (実際)
2014年12月1日
試験登録日
最初に提出
2014年8月6日
QC基準を満たした最初の提出物
2014年8月7日
最初の投稿 (見積もり)
2014年8月8日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年10月16日
QC基準を満たした最後の更新が送信されました
2015年9月20日
最終確認日
2015年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CSLCT-USF-10-69
- 2015-000175-27 (EudraCT番号)
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。