2か月齢以上の健康な乳児を対象とした21価肺炎球菌結合ワクチンのロット間一貫性研究
健康な乳幼児を対象とした21価肺炎球菌結合ワクチンの4回接種レジメンの安全性および免疫原性を調査する第3相、無作為化、修正二重盲検、活性対照、並行群間、ロット間一貫性、4群試験
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™).
The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Trial Transparency email recommended (Toll free for US & Canada)
- 電話番号：option 6 800-633-1610
- メール：Contact-US@sanofi.com
研究場所
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Arkansas
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Fayetteville、Arkansas、アメリカ、72703
- 募集
- Northwest Arkansas Pediatric Clinic- Site Number : 8400039
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California
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Huntington Park、California、アメリカ、90255
- 募集
- Matrix Clinical Research - Huntington Park- Site Number : 8400029
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Los Angeles、California、アメリカ、90008
- 募集
- Community Clinical Research- Site Number : 8400030
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Los Angeles、California、アメリカ、90057
- 募集
- Matrix Clinical Research - Los Angeles- Site Number : 8400028
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Florida
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Tampa、Florida、アメリカ、33613
- 募集
- PAS Research - Tampa- Site Number : 8400034
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Kentucky
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Bardstown、Kentucky、アメリカ、40004
- 募集
- Kentucky Pediatric Research- Site Number : 8400036
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Michigan
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Allen Park、Michigan、アメリカ、48101
- 募集
- Michigan Institute of Research- Site Number : 8400004
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New York
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Syracuse、New York、アメリカ、13210
- 募集
- Nappi Wellness Institute\t- Site Number : 8400037
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South Carolina
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Charleston、South Carolina、アメリカ、29407
- 募集
- Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008
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Simpsonville、South Carolina、アメリカ、29681
- 募集
- Parkside Pediatrics - Simpsonville- Site Number : 8400005
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Spartanburg、South Carolina、アメリカ、29301
- 募集
- Tribe Clinical Research - Spartanburg- Site Number : 8400026
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Texas
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Edinburg、Texas、アメリカ、78539
- 募集
- PAS Research - Children's Care Clinic- Site Number : 8400035
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Richmond、Texas、アメリカ、77469
- 募集
- Pediatric Center - Richmond- Site Number : 8400038
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Utah
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Ogden、Utah、アメリカ、84404
- 募集
- Rio Clinical Trials - Canyon View- Site Number : 8400031
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Bangkok、タイ、10400
- 募集
- Investigational Site Number : 7640002
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Chiang Mai、タイ、50180
- 募集
- Investigational Site Number : 7640004
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Hat Yai、タイ、90110
- 募集
- Investigational Site Number : 7640003
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Khon Kaen、タイ、40002
- 募集
- Investigational Site Number : 7640001
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Pathum Wan、タイ、10330
- 募集
- Investigational Site Number : 7640005
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Guayama、プエルトリコ、00786
- 募集
- Investigational Site Number : 6300005
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San Juan、プエルトリコ、00918
- 募集
- Investigational Site Number : 6300006
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Trujillo Alto、プエルトリコ、00976
- 募集
- Investigational Site Number : 6300007
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San Pedro Sula、ホンジュラス、21104
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- Investigational Site Number : 3400001
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Tegucigalpa、ホンジュラス、11101
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- Investigational Site Number : 3400003
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Tegucigalpa、ホンジュラス、11101
- 募集
- Investigational Site Number : 3400002
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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:
- Aged 42 to 89 days on the day of inclusion
- Participants who are healthy as determined by medical evaluation including medical history and physical examination
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable
Exclusion Criteria:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
- History of microbiologically confirmed Streptococcus pneumoniae infection or disease
- Any contraindication to the routine pediatric vaccine being administered in the study
- History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
- Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3
- Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration.
- Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
- Previous vaccination against Streptococcus pneumoniae
- Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus
- Receipt of more than 1 dose of hepatitis B vaccine
- Receipt of immune globulins, blood or blood-derived products since birth
- Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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：Group 1: PCV21
Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
他の名前：
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実験的：Group 2: PCV21
Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
他の名前：
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実験的：Group 3: PCV21
Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
他の名前：
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アクティブコンパレータ：Group 4: 20vPCV (Cohort A only)
Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
他の名前：
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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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For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
時間枠：30 days after the third dose of PCV21 vaccine
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Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL) |
30 days after the third dose of PCV21 vaccine
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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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For all participants: Serotype specific IgG concentration ≥ 0.35 µg/mL
時間枠：30 days after the third dose of PCV21 vaccine
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Serotype specific IgG concentration ≥ 0.35 μg/mL (seroresponse) for all serotypes included in PCV21 as measured by ECL |
30 days after the third dose of PCV21 vaccine
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For all participants: Presence of any immediate adverse events (AEs)
時間枠：Within 30 minutes after each vaccine injection
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Number of participants experiencing immediate AEs |
Within 30 minutes after each vaccine injection
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For participants in Cohort A (reactogenicity subset): Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
時間枠：Through 7 days after each vaccine injection
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Number of participants experiencing solicited injection site and systemic reactions |
Through 7 days after each vaccine injection
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For all participants: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs
時間枠：Through 30 days after each vaccine injection
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Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs |
Through 30 days after each vaccine injection
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For all participants: Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
時間枠：Throughout the study (through 6 months post-last vaccine injection)
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Number of participants experiencing SAEs and AESIs |
Throughout the study (through 6 months post-last vaccine injection)
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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 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
キーワード
その他の研究ID番号
- PSK00029
- PSK00029 (その他の識別子：Sanofi Identifier)
- U1111-1308-6832 (その他の識別子：WHO ICTRP)
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
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。