Immunogenicity, Reactogenicity and Safety Study of Pediarix®, Hiberix® and Prevenar 13® Co-administered With Two Different Formulations of GSK Biologicals' HRV Vaccine (444563) in Healthy Infants 6-12 Weeks of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,280
- 试验地点
- 48
- 主要终点
- Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value.
研究概览
简要总结
The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects' parent(s)/[LAR(s)] who, in the opinion of the investigator can and will comply with the requirements of the protocol.
- •A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
- •Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 1), or planned use during the study period.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (≥0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Administration of long-acting immune-modifying drugs at any time during the study period.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of vaccine administration and ending at Visit 4, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, if administered at a site which is different from the sites used to administer the co-administered vaccines.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
- •Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
- •History of IS.
- •Very prematurely born infants (born ≤28 weeks of gestation).
- •Family history of congenital or hereditary immunodeficiency.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Major congenital defects or serious chronic illness.
- •Previous vaccination against Haemophilus type b (Hib), diphtheria, tetanus, pertussis, pneumococcus, RV and/or poliovirus.
- •Previous confirmed occurrence of RV GE, Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or polio disease.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •GE within 7 days preceding the study vaccine administration.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Hypersensitivity to latex.
- •History of any neurological disorders or seizures.
- •History of Severe combined immunodeficiency (SCID).
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum.
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
结局指标
主要结局
Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value.
时间窗: At Month 5 (One month after Dose 3 of co-administered vaccines)
Immunogenicity was assessed using ChemiLuminescence ImmunoAssay (CLIA) in terms of seroprotection rates against Hepatitis B. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-HB antibody concentrations ≥ 10 milli International Units/milliliter (mIU/mL).
Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value.
时间窗: At Month 5 (One month after Dose 3 of co-administered vaccines)
Immunogenicity was assessed using Enzyme Linked Immunosorbent Assay (ELISA) in terms of seroprotection rates against diphtheria toxoid. A seroprotected subject is a subject whose antibody concentration is greater than or equal to (≥) the level defining clinical protection. The following seroprotection thresholds were applicable:anti-D antibody concentrations ≥ 0.1 International Units/milliliter (IU/mL), anti-T antibody concentrations ≥ 0.1 IU/mL.
Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value.
时间窗: At Month 5 (One month after Dose 3 of co-administered vaccines)
Immunogenicity was assessed using virus micro-neutralization test in terms of seroprotection rates against polio virus types 1, 2 and 3. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-polio virus types 1, 2 and 3 types antibody titers ≥ 8 Estimated Dose 50% (ED50).
Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations.
时间窗: At Month 5 (One month after Dose 3 of co-administered vaccines)
Antibody concentrations against PT, FHA and PRN were determined and expressed as Geometric Mean Concentrations (GMCs).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.
Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations.
时间窗: At Month 5 (One month after Dose 3 of co-administered vaccines)
Antibody concentrations against pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were determined and expressed as GMCs in micrograms per milliliter (µg/mL).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.
Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL.
时间窗: At Month 5 (One month after Dose 3 of co-administered vaccines)
Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL.
时间窗: At Month 5 (One month after Dose 3 of co-administered vaccines)
Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.
时间窗: At Month 5 (One month after Dose 3 of co-administered vaccines)
Seroresponse is defined as the percentage of subjects showing an antibody concentration above a threshold that leads to 95% seroresponse in the HRV lyophilized Group. The cut-offs used were as follows: anti-PT (18.566 IU/mL), anti-FHA (35.711 IU/mL) and anti-PRN (11.034 IU/mL).
次要结局
- Immunogenicity in Terms of Anti-HBs Antibody Concentrations.(At Month 5 (One month after Dose 3 of co-administered vaccines))
- Number of Subjects With Any Unsolicited AEs.(During the 31-day (Days 1-31) follow-up period after each HRV vaccination.)
- Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations.(At Month 5 (One month after Dose 3 of co-administered vaccines))
- Number of Subjects With Any Solicited General Adverse Events (AEs).(During the 8-day (Days 1-8) follow-up period after each HRV vaccination.)
- Number of Seropositive Subjects With Anti-Rota Virus Immunoglobulin A (Anti-RV IgA) Antibody Concentrations Above or Equal to Cut-off Value of 20 Units/Milliliter (U/mL).(At Month 5 (Three months after Dose 2 of HRV vaccine))
- Number of Seropositive Subjects With Anti-RV IgA Antibody Concentrations Above or Equal to Cut-off Value of 90 U/mL.(At Month 5 (Three months after Dose 2 of HRV vaccine))
- Number of Seropositive Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above or Equal to Cut-off Value.(At Month 5 (One month after Dose 3 of co-administered vaccines))
- Number of Seropositive Subjects With Anti-PnPS Antibody Concentrations Above or Equal to Cut-off Value.(At Month 5 (One month after Dose 3 of co-administered vaccines))
- Immunogenicity in Terms of Anti-PRP Antibody Concentrations.(At Month 5 (One month after Dose 3 of co-administered vaccines))
- Immunogenicity in Terms of Anti-poliovirus Types 1, 2 and 3 Antibody Titers.(At Month 5 (One month after Dose 3 of co-administered vaccines))
- Number of Subjects With Any Serious Adverse Events (SAEs).(During the entire study period (Day 1 to Month 10))