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 Menactra™ and Adacel™ 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
- 1,241
- 主要终点
- Percentage of Participants With a V503 Injection-site Adverse Experience
研究概览
简要总结
This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and Adacel™.
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
- •Subject is in good health
- •Subject's parent/legal guardian can read, understand, and complete the vaccine report card
- •Subject is not sexually active and does not plan on becoming sexually active during the study
- •Subject has received a documented full primary immunization series against diphtheria, tetanus, and pertussis (not in the last 5 years)
排除标准
- •Subject has a known allergy to any vaccine component of V503, Menactra™, or Adacel™
- •Subject has a condition that is a contraindication to vaccination with Menactra™ or Adacel™
- •Subject has any coagulation disorder
- •Female subject is pregnant
- •Subject is immunocompromised or immunodeficient
- •Subject has had a splenectomy
- •Subject has received immunosuppressive therapies in the prior year
- •Subject has received any immune globulin product or blood-derived product in the last 3 months
- •Subject has received inactivated vaccines within 14 days or live vaccines within 21 days of the first study vaccination
- •Subject has received a marketed HPV vaccine or has participation in an HPV vaccine trial
- •Subject has received a meningococcal vaccine
- •Subject has a fever >= 100F within 24 hours of vaccination
- •Subject has a history of HPV
研究组 & 干预措施
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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
干预措施: V503 (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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
干预措施: V503 (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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
干预措施: Comparator: Adacel™ (Non-concomitant) (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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
干预措施: Comparator: Menactra™ (Concomitant) (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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
干预措施: Comparator: Adacel™ (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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
干预措施: Comparator: Menactra™ (Non-Concomitant) (Biological)
结局指标
主要结局
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 study vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.
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.
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 to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.
Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience
时间窗: Day 1 through Day 5 following Day 1 or 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 study vaccine is also an AE. Only injection-site AEs in the arm that received Menactra™ and Adacel™ vaccination were reported for this endpoint. 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.
Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody
时间窗: 4 weeks following Day 1 or Month 1 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. The lower limit of quantitation of the assay was defined as 0.01 International Units (IU)/mL. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limit of quantitation of the assay was defined as 0.04 IU/mL. Acceptable titers refer to the World Health Organization-defined protective titers of \>=0.1 IU/mL.
Geometric Mean Titers of Pertussis Antibody Responses
时间窗: 4 weeks following Day 1 or Month 1 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. The titers were expressed as Enzyme-linked Immunoassay Units (ELU)/mL.
Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups
时间窗: Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
For the Concomitant Vaccination group, serum samples were collected at Day 1 (baseline) and 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected at Month 1 (baseline) and 4 weeks after the Month 1 vaccination. Bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The serum bactericidal titer is reported as the reciprocal of the final serum dilution giving \>50% killing in 60 minutes.
次要结局
- Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503(Month 7)
- Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™(4 weeks following Day 1 or Month 1 vaccination)