Immunogenicity and Safety of GSK Biologicals' DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) (SB213503) in Healthy Indian Infants
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Number of seroprotected subjects in terms of anti-polysaccharide Polyribosyl-Ribitol Phosphate (anti-PRP) antibodies.
研究概览
简要总结
The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian regulatory authority. The 6, 10 and 14 week schedule reflects the current Indian standard of care.
详细描述
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Experimental design: Phase III, open-label, non-randomised, multi-centric, single-country study with a single group.
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Duration of the study: The intended duration of the study will be approximately 3 months per subject.
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Treatment group and vaccination schedule: All subjects will receive three doses of the vaccine at 6, 10 and 14 weeks of age.
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DTPa-IPV/Hib Group: Subjects who will receive DTPa-IPV/Hib vaccine (Infanrix-IPV/Hib).
Other routine registered childhood vaccinations as part of National Immunisation Programme are permitted. Information regarding vaccine administered since birth until study completion will be collected and documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 9 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects' parent(s)/Legally Acceptable Representatives [LARs] 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 9 weeks of age (42-69 days) at the time of the first vaccination.
- •Written informed consent obtained from the parents/LARs 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.
- •Born full-term [i.e., after a gestation period of 37 to less than 42 completed weeks (259 to 293 days)].
排除标准
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before first dose of study vaccine (Day-29 to Day 0), or planned use during the study period.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Chronic administration of immunosuppressants or other immune-modifying drugs from birth to within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
- •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 and 30 days after the last dose of vaccine with the exception of human rotavirus vaccine, hepatitis B vaccine, pneumococcal conjugate vaccine and other vaccines given as a part of the national immunisation schedule, that are allowed at any time during the study period.
- •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.
- •History of diphtheria, tetanus, pertussis, poliomyelitis and Hib disease.
- •Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease prior to study enrolment, with the exception of a birth dose of hepatitis B and/or Baccillus Calmette-Guerin (BCG) vaccines and/or oral poliovirus (OPV) vaccine as per local standard of care. The BCG vaccination should occur at least 30 days prior to first dose of vaccination in the study.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Family history of congenital or hereditary immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders or seizures.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature ≥37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
研究组 & 干预措施
DTPa-IPV/Hib Group
All subjects will receive three doses of primary vaccination at 6, 10 and 14 weeks of age.
干预措施: Infanrix-IPV/Hib (Biological)
结局指标
主要结局
Number of seroprotected subjects in terms of anti-polysaccharide Polyribosyl-Ribitol Phosphate (anti-PRP) antibodies.
时间窗: One month after the third dose of primary vaccination (Month 3)
A seroprotected subject is a subject whose anti-PRP antibody concentration is greater than or equal to (≥) 0.15 micrograms per millilitre (µg/ml).
Number of seroprotected subjects in terms of anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.
时间窗: One month after the third dose of primary vaccination (Month 3)
A seroprotected subject is a subject whose anti-D/anti-T antibody concentration is greater than or equal to (≥) 0.1 International Units per millilitre (IU/ml).
Number of seroprotected subjects in terms of anti-poliomyelitis (anti-Polio) types 1, 2 and 3 antibodies.
时间窗: One month after the third dose of primary vaccination (Month 3)
A seroprotected subject is a subject whose anti-Polio 1, 2 and 3 antibody titers are greater than or equal to (≥) 8 median effective dose (ED50).
Number of subjects with vaccine response to pertussis toxoid (PT), Filamentous Haemagglutinin (FHA) and pertactin (PRN) antigens.
时间窗: One month after the third dose of primary vaccination (Month 3)
Vaccine response to pertussis antigens is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lesser than the assay cut-off value), or maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ assay cut-off value).
次要结局
- Number of subjects with solicited local symptoms.(During the 4-day period (Days 0-3) following each vaccination.)
- Anti-PRP antibody concentrations.(Before the first dose of primary vaccination (Day 0))
- Number of seroprotected subjects in terms of anti-Polio type 1, 2 and 3 antibodies.(Before the first dose of primary vaccination (Day 0))
- Number of seroprotected subjects in terms of anti-PRP antibodies.(Before the first dose of primary vaccination (Day 0))
- Anti-Polio type 1, 2 and 3 antibody titres.(Before the first dose of primary vaccination (Day 0))
- Anti-PT, anti-FHA and anti-PRN antibody concentrations.(Before the first dose of primary vaccination (Day 0))
- Number of seropositive subjects in terms of anti-PT, anti-FHA and anti-PRN antibodies.(Before the first dose of primary vaccination (Day 0))
- Anti-D and anti-T antibody concentrations.(One month after the third dose of primary vaccination (Month 3).)
- Number of subjects with solicited general symptoms.(During the 4-day period (Days 0-3) following each vaccination.)
- Number of subjects with unsolicited adverse events (AEs).(During the 31-day period (Days 0-30) following each vaccination.)
- Number of subjects with serious adverse events (SAEs).(From dose 1 (Day 0) until study end (Month 3))