In 4 year old children, does having received a birth dose of acellular pertussis vaccine compared to not having received a birth dose of acellular pertussis vaccine affect immunogenicity and safety before and after a booster dose of an acellular pertussis vaccine.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
研究概览
简要总结
In 2010 when this study began, Australian infants < 5 months old and children aged 2-4 years were highly susceptible to pertussis disease and were overrepresented in case numbers. This was suspected to largely be driven by gaps in immune-protection because the vaccine schedule did not include a booster dose during the second year of life. We proposed these gaps could be overcome by the addition of a birth dose of a pertussis vaccine and the (re)-introduction of a booster dose at 18-months of age into the childhood immunisation schedule. Here we present the long-term (4-year) antibody follow up of children administered an additional birth dose of pertussis vaccine or who received the standard DTPa schedule in infancy and then received either a high-dose DTPa (Infanrix), low-dose dTpa (Boostrix) or did not return (no 18-month booster). Antibodies to pertussis were measured before and after a booster dose 4-years. By 4 years of age, most children who were not administered a booster dose at 18 months had antibody levels at or below those associated with pertussis seropositivity. This supports the current recommendation for a pertussis booster dose in the second year of life. All children responded to a booster dose of either low or high dose vaccine at 4 years. These results support the current national immunization program in Australia which recommends a booster dose of a pertussis/tetanus/diphtheria vaccine at 4 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 4 Years 至 5 Years（—）
- 性别
- All
入选标准
- •Children who are between 4 years and 4 years 364 days old are eligible to participate in this study and who are subjects previously enrolled in the First Phase study.
- •(ACTRN12609000905268)
排除标准
- •1. Contraindications to vaccination as listed in the current NHMRC Australian Immunisation Handbook 10th Edition or as listed in the Infanrix-IPV or Boostrix-IPV Product Information. DTPa-IPV or dTpa-IPV vaccine will not be administered to individuals known to be hypersensitive to any component of the vaccine or residues carried over from manufacture (such as formaldehyde and glutaraldehyde).
- •2. Evidence of a second booster diphtheria, tetanus, pertussis vaccination since completion of the first booster vaccine at 18- 24 months old.
- •3. Administration of immunoglobulins or any blood products within the 3 month period prior to the first visit; in which case, a delay in enrolment will be considered in the absence of other excluding criteria.
- •4. Any confirmed or suspected immunosuppressive or immunodeficient condition contraindicating MMR vaccination.
- •5. History of serious chronic illness or condition which in the judgement of the clinical investigator would preclude study participation.
- •6. History of neurologic disease or seizure (excluding simple febrile seizure).
- •7. Must not have had the vaccinations scheduled for age 4 years (ie Infanrix-IPV and measles mumps rubella vaccine).