Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
Clinical Study in Children, 6 Months to 3 Years of Age, to Assess the Immunogenicity and Safety of Two Dose Levels of Thimerosal-free Fluviral® Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
調査の概要
詳細な説明
This is a study of two different dose levels of a new formulation of flu vaccine for the 2008/2009 flu season using the World Health Organization recommended virus strains. Subjects will be randomly put into one of three different groups to receive either one or two doses of:
0.25 mL dose of the new flu vaccine, or 0.5 mL dose of the new flu vaccine or the licensed Vaxigrip flu vaccine (control) The parents of the subjects and the study doctor and nurses will not know the group of their child until the study is completed.
The children will be vaccinated with either one dose or two doses depending on whether or not they have received a flu vaccine before. The doctor will decide on the schedule for each child based on the information provided by the parents. The active phase of the study will last approximately two months for children receiving two doses and one month for those receiving a single dose. An extended safety follow-up will continue until Study Month 6.
Two blood samples will be taken from each subject. These will be used to evaluate how well the vaccine works in the children and which dose level works best compared to the control.
The parents will fill in a diary card for four days to record any reactions or symptoms which may occur after vaccination. Parents will also keep a record of other symptoms that may occur between vaccinations and up to six months after the first vaccination and will keep a record of any medication their child takes in this time period.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Alberta
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Calgary、Alberta、カナダ、T3B 6A8
- GSK Investigational Site
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British Columbia
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Langley、British Columbia、カナダ、V3A 4H9
- GSK Investigational Site
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Manitoba
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Winnipeg、Manitoba、カナダ、R3E 3P4
- GSK Investigational Site
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Newfoundland and Labrador
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Mount Pearl、Newfoundland and Labrador、カナダ、A1N 5B6
- GSK Investigational Site
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3K 6R8
- GSK Investigational Site
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Ontario
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Hamilton、Ontario、カナダ、L8L 5G8
- GSK Investigational Site
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London、Ontario、カナダ、N6H 4P2
- GSK Investigational Site
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London、Ontario、カナダ、N6A 5R9
- GSK Investigational Site
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Mississauga、Ontario、カナダ、L5A 3V4
- GSK Investigational Site
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Newmarket、Ontario、カナダ、L3Y 5G8
- GSK Investigational Site
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Sarnia、Ontario、カナダ、N7T 4X3
- GSK Investigational Site
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Sudbury、Ontario、カナダ、P3E 1H5
- GSK Investigational Site
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Toronto、Ontario、カナダ、M5G 1N8
- GSK Investigational Site
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Prince Edward Island
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Charlottetown、Prince Edward Island、カナダ、C1A 5N4
- GSK Investigational Site
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Quebec
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Montreal、Quebec、カナダ、H3T 1C5
- GSK Investigational Site
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Quebec City、Quebec、カナダ、G1V 4M6
- GSK Investigational Site
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Ste-Foy、Quebec、カナダ、G1X 3V7
- GSK Investigational Site
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Trois Rivières、Quebec、カナダ、G8T 7A1
- GSK Investigational Site
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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:
- A male or female child 6 months to < 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season;
- Subjects must be in good health established by medical history and physical examination before entering into the study;
- Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study;
- Written informed consent obtained from the subject's parent/guardian.
- Parents/guardian access to a consistent means of telephone contact, land line or mobile
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion;
- History of hypersensitivity to any vaccine;
- History of allergy to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;
- History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine.
- Acute disease at the time of enrolment.
- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine;
- Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis;
- Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period.
- Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign.
- Any use of analgesics/antipyretics 12 hours before receipt of vaccine.
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Fluviral F1 Group
Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28.
The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
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one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
他の名前：
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実験的：Fluviral F2 Group
Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28.
The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
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one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
他の名前：
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アクティブコンパレータ：Vaxigrip Group
Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28.
The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
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one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
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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 |
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
時間枠：During the 4-day follow-up period (Days 0-3) after any vaccination
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Solicited local symptoms assessed were pain, redness and swelling.
Any was defined as any solicited local symptom reported regardless of intensity grade.
Grade 3 pain = Cried when limb was moved/spontaneously painful.
Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
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During the 4-day follow-up period (Days 0-3) after any vaccination
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
時間枠：During the 4-day follow-up period (Days 0-3) after any vaccination
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Symptoms assessed were drowsiness, irritability, loss of appetite and fever.
Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination.
Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C).
Grade 3 fever = Axillary temperature ≥ 39.0°C.
For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities.
Related = A general symptom assessed by the investigator as causally related to vaccination.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
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During the 4-day follow-up period (Days 0-3) after any vaccination
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
時間枠：During the 28-day follow-up period (Days 0-27) after vaccination
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Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities.
Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
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During the 28-day follow-up period (Days 0-27) after vaccination
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Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
時間枠：During the 28-day post-vaccination period
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MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol. |
During the 28-day post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
時間枠：During the 6-month safety follow up after vaccination
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MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol. |
During the 6-month safety follow up after vaccination
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Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
時間枠：During the 28-day post-vaccination period
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol. |
During the 28-day post-vaccination period
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Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
時間枠：During the 6-month safety follow up after vaccination
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol. |
During the 6-month safety follow up after vaccination
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies
時間枠：At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
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Titers are presented as geometric mean titers (GMTs).
The reference cut-off value was the seropositivity cut-off of 1:10.
Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.
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At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
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Number of Subjects Seroconverted to HI Antibodies
時間枠：At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.
The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
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At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
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Number of Subjects Seroprotected Against HI Antibodies
時間枠：At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
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A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida. |
At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
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Seroconversion Factor for HI Antibodies
時間枠：At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
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The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0). The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida. |
At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
時間枠：During the 4-day follow-up period (Days 0-3) after any vaccination
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Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
During the 4-day follow-up period (Days 0-3) after any vaccination
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
時間枠：During the 4-day follow-up period (Days 0-3) after any vaccination
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Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
During the 4-day follow-up period (Days 0-3) after any vaccination
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
時間枠：During the 28-day follow-up period (Days 0-27) after vaccination
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Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
During the 28-day follow-up period (Days 0-27) after vaccination
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Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
時間枠：During the 28-day post-vaccination period after vaccination
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MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
During the 28-day post-vaccination period after vaccination
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Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
時間枠：During the 6-month safety follow up after vaccination
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MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
During the 6-month safety follow up after vaccination
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Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
時間枠：During the 28-day post-vaccination period
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
During the 28-day post-vaccination period
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Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
時間枠：During the 6-month safety follow up after vaccination
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol. |
During the 6-month safety follow up after vaccination
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協力者と研究者
スポンサー
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 111635
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
試験データ・資料
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臨床研究報告書
情報識別子：111635情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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データセット仕様
情報識別子：111635情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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統計分析計画
情報識別子：111635情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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インフォームド コンセント フォーム
情報識別子：111635情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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個人参加者データセット
情報識別子：111635情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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研究プロトコル
情報識別子：111635情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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。
GSK Biologicals' influenza vaccine GSK1557482Aの臨床試験
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GlaxoSmithKline完了
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GlaxoSmithKline完了
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GlaxoSmithKline完了
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GlaxoSmithKline完了