NCT02274285已完成3 期
Immunogenicity and Safety of the DTaP-IPV/Hib Vaccine SP0204) Given as Three-dose Primary and One-dose Booster Vaccinations Versus Co-administration of DTaP-IPV Vaccine (DD-687) and Hib Vaccine (DF-098) in Infants in Japan
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 12
- 主要终点
- Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3
研究概览
简要总结
Primary objective:
- To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens).
Secondary objectives:
- To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B).
- To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B).
- To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)
详细描述
Participants will be enrolled in two steps (Cohort 1 and Cohort 2). Step one will enroll Cohort 1 made of 40 participants randomized in two groups with a 1:1 ratio.
After review of the local and systemic adverse events occurring during the 7 Days following the first dose administered in these subjects, 2nd vaccination of Cohort 1 participants will resume and enrollment of the participants of Cohort number 2 will start. Step two will enroll Cohort 2 made of subjects randomized in two groups with a 1:1 ratio.
A sub-study Group C will be enrolled and will receive the vaccine by intramuscular route.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Months 至 68 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 months to 68 months inclusive (recommended 3 to 8 months for Groups A and B; 2 months for Group C) on the day of inclusion
- •Informed consent form signed by the parent(s) or other legal representative
- •Able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
- •Any serious disease whether acute or chronic
- •Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
- •History of diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b infections
- •History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
- •History of anaphylaxis to any of the study vaccine components
- •Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b infections with a trial vaccine or another vaccine
- •Congenital or current acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •Participation in another clinical trial preceding the trial inclusion
- •Planned participation in another clinical trial during the present trial period
- •Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
- •Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination
- •Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination
- •Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
- •Subject ineligible according to the Investigator's clinical judgment
- •Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
结局指标
主要结局
Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3
时间窗: 21 Days post-dose 3
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
次要结局
- Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with DTaP IPV/Hib vaccine.(Day 0 (post-vaccination) up to 21 days post each vaccination)
- Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination(21 Days post-dose 3)
- Percentage of participants with Seroprotection to vaccine antigens following vaccination(Day 0 (pre-vaccination ) and 21 Days post-dose 3)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
3 期
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B VaccineHaemophilus Influenzae Type bPoliomyelitisAcellular PertussisTetanusDiphtheriaNCT00325143GlaxoSmithKline702
已完成
3 期
Vaccination of Children Following Allogeneic Stem Cell TransplantationAllogeneic Haematopoietic Stem Cell TransplantationNCT00169728Heinrich-Heine University, Duesseldorf53
进行中（未招募）
1 期
Study to Assess the Immune Response and the Safety Profile of DTaP-IPVHB- PRP~T Combined Vaccine Given Concomitantly or Sequentially with 4CMenB Vaccine in Italian InfantsHaemophilus influenzae type b immunisationMedDRA version: 21.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: PTClassification code 10069533Term: Haemophilus influenzae type b immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2019-002585-12-ITSANOFI PASTEUR396
进行中（未招募）
1 期
Study to Assess the Immune Response and the Safety Profile of DTaP-IPV-HB-PRP~T Combined Vaccine Given Concomitantly or Sequentially with 4CMenB Vaccine in Italian and Finnish InfantsHaemophilus influenzae type b immunisationMedDRA version: 21.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: PTClassification code 10069533Term: Haemophilus influenzae type b immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2019-002585-12-FISanofi Pasteur200
未知
3 期
Immunogenicity and Safety of the DTaP-IPV (sanofi Pasteur Kitasato) Combined Vaccine (DD-687) given subcutaneously as a three-dose primary and booster vaccination versus commercially available DTaP (Kitasato) and Oral Polio Virus (OPV) Vaccines in Infants in JapaProphylaxis of pertussis, diphtheria, tetanus, and poliomyelitis infection.JPRN-jRCT2080221313DAIICHISANKYO Co.,Ltd., Sanofi Aventis KK374