Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine
2018年8月21日 更新者：GlaxoSmithKline
Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines
The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
450
段階
- フェーズ 3
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
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Ansan、大韓民国、425-707
- GSK Investigational Site
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Bucheon-Si, GyeongGi-do,、大韓民国、420-767
- GSK Investigational Site
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Daejeon、大韓民国、301-723
- GSK Investigational Site
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GyeongSangNam-do、大韓民国、641-560
- GSK Investigational Site
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Gyeonggi-do、大韓民国、411-706
- GSK Investigational Site
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Iksan、大韓民国、570-711
- GSK Investigational Site
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Jeju City、大韓民国、690-121
- GSK Investigational Site
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Jeonju Jeonbuk、大韓民国、561-712
- GSK Investigational Site
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Pusan、大韓民国、602-739
- GSK Investigational Site
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Seoul、大韓民国、150-719
- GSK Investigational Site
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Seoul、大韓民国、130-702
- GSK Investigational Site
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Seoul、大韓民国、158-710
- GSK Investigational Site
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Suwon City, Gyeonggi-do、大韓民国、442-723
- GSK Investigational Site
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Wonju-si Kangwon-do、大韓民国、220-701
- GSK Investigational Site
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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
1年～1年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- A male or female between, and including, 12-18 months of age at the time of booster vaccination.
- Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
- Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
- Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
- Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
- Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
- Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
- Acute disease at the time of enrolment.
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：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Synflorix Group
Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
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Intramuscular injection, administered as a single dose
他の名前：
Intramuscular injection, administered as a single dose
他の名前：
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アクティブコンパレータ：Prevenar Group
Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
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Intramuscular injection, administered as a single dose
他の名前：
Intramuscular injection, administered as a single dose
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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 Reporting Grade 3 Adverse Events
時間枠：Within 31 days (Day 0 - Day 30) after booster vaccination.
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Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
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Within 31 days (Day 0 - Day 30) after booster 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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Number of Subjects Reporting Solicited Symptoms
時間枠：Within 4 days (Days 0 to 3) after booster vaccination
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Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
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Within 4 days (Days 0 to 3) after booster vaccination
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Number of Subjects Reporting Unsolicited Adverse Events
時間枠：Within 31 days (Days 0 to 30) after booster vaccination
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An unsolicited adverse event is any adverse event (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study.
Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
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Within 31 days (Days 0 to 30) after booster vaccination
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Number of Subjects Reporting Serious Adverse Events
時間枠：After booster vaccination up to study end (Month 0 to Month 1)
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Serious adverse events are 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.
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After booster vaccination up to study end (Month 0 to Month 1)
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Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
時間枠：One month after booster vaccination (Month 1)
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Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL). Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
One month after booster vaccination (Month 1)
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Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
時間枠：One month after booster vaccination (Month 1)
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Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
One month after booster vaccination (Month 1)
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Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
時間枠：One month after booster vaccination (Month 1)
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Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
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One month after booster vaccination (Month 1)
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Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
時間枠：One month after booster vaccination (Month 1)
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Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
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One month after booster vaccination (Month 1)
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Concentration of Antibodies Against Protein D (PD)
時間枠：One month after booster vaccination (Month 1)
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Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).
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One month after booster vaccination (Month 1)
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Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)
時間枠：One month after booster vaccination (Month 1)
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Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.
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One month after booster vaccination (Month 1)
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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
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Kim CH, Kim JS, Cha SH, Kim KN, Kim JD, Lee KY, Kim HM, Kim JH, Hyuk S, Hong JY, Park SE, Kim YK, Kim NH, Fanic A, Borys D, Ruiz-Guinazu J, Moreira M, Schuerman L, Kim KH. Response to primary and booster vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants. Pediatr Infect Dis J. 2011 Dec;30(12):e235-43. doi: 10.1097/INF.0b013e31822a8541.
- Kim CH et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Spring Conference. Seoul, South Korea, 7-11 June 2011.
- Kim JS et al. Safety and reactogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
- Kim KH et al. Immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
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
2009年6月11日
一次修了 (実際)
2010年1月11日
研究の完了 (実際)
2010年1月11日
試験登録日
最初に提出
2009年5月28日
QC基準を満たした最初の提出物
2009年5月28日
最初の投稿 (見積もり)
2009年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月20日
QC基準を満たした最後の更新が送信されました
2018年8月21日
最終確認日
2016年10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
- 112933
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?
はい
IPD プランの説明
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
試験データ・資料
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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：112933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：112933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：112933情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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注釈付き症例報告書
情報識別子：112933情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
研究プロトコル
情報識別子：112933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：112933情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
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臨床研究報告書
情報識別子：112933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。