Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
2019年4月29日 更新者：MCM Vaccines B.V.
A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months (V419-007-03)
This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine.
The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
1250
段階
- フェーズ 3
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ヶ月～2ヶ月 (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
- Healthy infants able to attend all study visits
- Parent(s)/legal representative able to read, understand, and complete study questionnaires
Exclusion Criteria
- History of congenital or acquired immunodeficiency
- Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids
- History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder
- Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines
- Has any chronic illness that could interfere with study conduct or completion
- Received any immune globulin, blood, or blood-derived products since birth
- Received a dose of hepatitis B vaccine prior to the study
- Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines, or any combination thereof
- Fever within 24 hours prior to enrollment
- Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment
- Has a coagulation disorder
- Has developmental delay or neurological disorder
- Participant or his/her mother has a medical history of hepatitis B surface antigen (HBsAg) seropositivity
- History of measles, mumps, rubella, varicella, Haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：PR5I
V419 + RotaTeq + Prevenar 13 + ProQuad
|
V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age
Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age
ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age
|
|
アクティブコンパレータ：INFANRIX™ hexa
INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad
|
RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age
Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age
ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age
INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
|
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 |
|---|---|---|
|
Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
時間枠：One month after post-dose 3 of PRI5 (5 months old)
|
Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria & poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus.
Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria & tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 & 3 (IPV1, 2 & 3) are reported.
95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson.
The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 & 3 (90%).
|
One month after post-dose 3 of PRI5 (5 months old)
|
|
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months
時間枠：One month after Toddler dose of PRI5 (13 months old)
|
Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria & poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 & 3 (FIM) & Pertactin (PRN).
Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria & tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 & 3, and seroresponse to PT, FHA, FIM and PRN are reported.
95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson.
The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%).
|
One month after Toddler dose of PRI5 (13 months old)
|
|
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
時間枠：One month after post-dose 3 of PRI5 (5 months old)
|
Antibody titres were measured by RIA for PRP, MIT for diphtheria & poliovirus, and ELISA for tetanus.
Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria & tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 & 3 (IPV1, 2 & 3) are reported.
The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
|
One month after post-dose 3 of PRI5 (5 months old)
|
|
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old
時間枠：One month after Toddler dose of PRI5 (13 months old)
|
Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, & PRN.
Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 & 3, and seroresponse to PT, FHA, and PRN are reported.
The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
|
One month after Toddler dose of PRI5 (13 months old)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
時間枠：One month after Toddler dose of PRI5 (13 months old)
|
Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA.
Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported.
95% CI were calculated based on the exact binomial method by Clopper and Pearson.
The immune response to ProQuad vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits: 90% for measles, mumps & rubella, and 76% for varicella.
|
One month after Toddler dose of PRI5 (13 months old)
|
|
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
時間枠：One month after Toddler dose of PRI5 (13 months old)
|
Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA.
Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported.
The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
|
One month after Toddler dose of PRI5 (13 months old)
|
|
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination
時間枠：Day 1 to Day 15 after any vaccination
|
Global safety was assessed by measuring injection-site and systemic AEs reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 to Day 15 (D1-D15) after each hexavalent vaccination.
Solicited injection-site and systemic AEs were reported daily from Day 1 to Day 5 (D1-D5) after each hexavalent vaccination.
AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)).
The investigator assessed whether systemic AEs were related (V-related) or not to the vaccine.
All AEs (related and unrelated) are reported.
|
Day 1 to Day 15 after any vaccination
|
|
Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination
時間枠：Day 1 to Day 5 after any vaccination
|
Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from Day 1 (D1) to Day 5 (D5) after vaccination.
AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)).
|
Day 1 to Day 5 after any vaccination
|
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Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination
時間枠：Day 1 to Day 15 after any vaccination
|
Unsolicited ISRs with incidence ≥1% after any vaccination were reported daily on the VRC by the parent(s) or legal representative from (D1-D15).
AEs at injection sites were always considered as vaccine-related ISRs
|
Day 1 to Day 15 after any vaccination
|
|
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination
時間枠：Day 1 to Day 5 after any vaccination
|
Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination.
The investigator assessed whether these systemic AEs were related or not to the vaccines.
All (related and unrelated) AEs are reported.
|
Day 1 to Day 5 after any vaccination
|
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出版物と役立つリンク
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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 (実際)
2011年5月26日
一次修了 (実際)
2013年3月13日
研究の完了 (実際)
2013年3月13日
試験登録日
最初に提出
2011年4月22日
QC基準を満たした最初の提出物
2011年4月22日
最初の投稿 (見積もり)
2011年4月26日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月30日
QC基準を満たした最後の更新が送信されました
2019年4月29日
最終確認日
2019年4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
- V419-007
- 2010-021490-37 (EudraCT番号)
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
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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