Seroimmunity 2007. Serological Study of the Swedish Population Regarding Vaccine Preventable Diseases Within the National Immunization Program (NIP), and a Sub Study Focusing on Foreign Born 14-16 Year-Olds.
试验速览
- 阶段
- 不适用
- 入组人数
- 5,400
- 试验地点
- 1
- 主要终点
- Establishing the immunity situation among specific population groups, concerning diseases targeted by the NIP, by measuring antibody levels in serum using methods In-house ELISAs, Neutralization test (NT) and ELISAs from Dade Behring
研究概览
简要总结
This is a randomized cross-sectional study of the Swedish population. Blood samples will be collected from a subpopulation in order to estimate the age specific sero-prevalence of the Swedish population for diseases included in the National Immunization Program (NIP), and to affirm the population's protection against polio. To be able to recommend complementary immunizations to immigrated children, a sub study focusing on foreign born teenagers will also be done and compared to children of the same age born in Sweden.
详细描述
Besides the main objectives stated in the summary, the study consists of:
Vaccine related objectives:
- To estimate the seroprevalence regarding vaccine preventable diseases in the cohort of children about to enter adulthood (as a "receipt" of the vaccination program's functionality), and thereby form a basis for decision-making regarding recommendations about continuous vaccination in adult age
- To evaluate the concentration of antibodies that full-term newborns receive from their mothers, and to estimate plausible consequences to optimize the schedule of the NIP for each vaccine preventable disease
- To, in different age groups, evaluate changes over time and concentration of antibodies compared to a study conducted in 1997
- To evaluate plausible changes in the seroprevalence, for instance among children, related to an increased use of combined vaccines
- To document the age-specific seroprevalence against other diseases that will be vaccine preventable before start-up of new vaccination program
- To estimate the population seroprevalence against certain diseases against which vaccines have been developed during recent years and that might be introduced into the vaccination program within a couple of decades
Method:
- Adults: one blood sample of 10 mL blood from vein in arm from each individual
- Children: one blood sample of 5-10 mL blood from vein or capillary in arm from each individual
- Cord blood: one blood sample of 10 mL cord blood will be collected from each newborn in connection with childbirth
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed written consent (both groups)
- •immigrated to Sweden after 6 years of age from a country with polio vaccination coverage < 85 % (Sub study group)
- •living and attending school in Stockholm, Gothenburg or Malmoe (Sub study group)
排除标准
- 未提供
结局指标
主要结局
Establishing the immunity situation among specific population groups, concerning diseases targeted by the NIP, by measuring antibody levels in serum using methods In-house ELISAs, Neutralization test (NT) and ELISAs from Dade Behring
时间窗: 3 years
次要结局
- To confirm the protection against polio among the Swedish population by measuring antibody levels in serum using NT against Polio virus types 1-3(3 years)