Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
研究概览
简要总结
Primary Objective:
- To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series.
Secondary Objectives:
- To describe in each group the immunogenicity parameters one month after the three-dose primary series.
- To describe safety profile after each vaccination in both groups.
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
- 50 Days 至 70 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant of either gender, aged 50 to 70 days inclusive
- •Mother is negative for HBsAg
- •Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
- •Written informed consent form signed by at least one parent or by another legal representative and an independent witness
- •Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.
排除标准
- •Axillary temperature ≥37.1°C on the day of inclusion
- •Current or planned enrolment in another clinical trial during the clinical trial period
- •Known mother's history of Human Immunodeficiency Virus (HIV) infection
- •Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)
- •Receipt of blood-derived products since birth
- •Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial
- •Occurrence of seizures since birth
- •Hypersensitivity to any of the vaccine components
- •Coagulopathy contraindicating intramuscular injection
- •History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases
- •History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections
- •Vaccination within the last 4 weeks.
研究组 & 干预措施
1
DTaP IPV HB-PRP~T vaccine group
干预措施: DTaP-IPV-HB-PRP~T (Biological)
2
PENTAXIM™ and ENGERIX B® vaccines group
干预措施: DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine (Biological)
结局指标
主要结局
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
时间窗: Day 150 (1 month post-vaccination 3)
Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.
Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
时间窗: Day 150 (1 month post-vaccination 3)
Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
时间窗: Day 150 (1 month post-vaccination 3)
Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).
Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
时间窗: 1 month post last vaccination
Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
次要结局
- Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™(Day 0 up to Day 7 post-vaccination)
- Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®(Day 0 up to Day 7 post-vaccination)
- Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®(Day 0 up to Day 7 post-vaccination)