A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,054
- 主要终点
- Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)
研究概览
简要总结
This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Participant has a known allergy to any vaccine component of V503 or REPEVAX™
- •Participant has had a severe reaction affecting the brain (e.g., evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine
- •Participant has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus or a component pertussis combination (acellular and whole cell) vaccine
- •Participant ever had Guillain-Barré syndrome or brachial neuritis following a previous dose of a tetanus-containing vaccine
- •Participant has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™
- •Participant has a history of severe allergic reaction that required medical intervention
- •Participant has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections
- •Participant is concurrently enrolled in clinical studies of investigational agents
- •Female participant is pregnant
- •Participant has donated blood within 1 week prior to first study vaccination, or intends to donate during the study
- •Participant is immunocompromised, immunodeficient, or has an autoimmune condition
- •Participant has had a splenectomy
- •Participant has received immunosuppressive therapies in the prior year
- •Participant has received immune globulin product or blood-derived product in the last 3 months
- •Participant has received inactivated vaccine(s) within 14 days or live vaccine(s) within 21 days of first study vaccination
- •Participant has received a marketed HPV vaccine or has participated in an HPV vaccine trial
- •Participant has received a tetanus, diphtheria, pertussis, or poliovirus (inactivated and/or oral poliovirus) vaccination within the last 5 years
- •Participant has a fever ≥100°F within 24 hours of vaccination
- •Participant has any history or current condition, therapy, lab abnormality, or other circumstance such that it is not in the best interest of the participant to participate
- •Participant and parent/legal guardian are unable to give assent/consent
- •Participant is unlikely to adhere to the study procedures or is planning to relocate during the study
- •Participant has recent history of illicit drug or alcohol abuse
- •Participant has a history of HPV
研究组 & 干预措施
Concomitant Vaccination
V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
干预措施: REPEVAX™ (Concomitant) (Biological)
Non-concomitant Vaccination
V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
干预措施: V503 Vaccine (Biological)
Concomitant Vaccination
V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
干预措施: V503 Vaccine (Biological)
Non-concomitant Vaccination
V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
干预措施: REPEVAX™ (Non-concomitant) (Biological)
结局指标
主要结局
Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)
时间窗: Up to 5 days following the Day 1 and Month 1 vaccination / visit
For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.
Percentage of Participants With a Systemic Adverse Experience
时间窗: Up to 15 days following the Day 1 and Month 1 vaccination / visit
For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site.
Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody
时间窗: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of \>=0.1 IU/mL.
Geometric Mean Titers of Pertussis Antibody Responses
时间窗: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL).
Percentage of Participants With a V503 Injection-site Adverse Experience
时间窗: Day 1 through Day 5 following Day 1 vaccination
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503
时间窗: 4 weeks following Month 6 vaccination
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.
Percentage of Participants With a Repevax™ Injection-site Adverse Experience
时间窗: Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint.
Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody
时间窗: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at \>=1:8 dilution of serum.
次要结局
- Percentage of Participants Who Seroconvert for Each of the HPV Types(Month 7)