A Serological Study of Measles, Mumps and Rubella in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella) in Health Centers Where a Phase III Study Should be Conducted
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Immunoresponse after first dose
研究概览
简要总结
On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a mumps seroconversion much lower (71%) than the expected 95%, according to the package insert. This could indicate that a substantial proportion of children was not protected after MMR dose.
详细描述
Given the above and considering: (1) future clinical study with the MMR vaccine produced entirely in Bio-Manguinhos/Fiocruz from technology transfer from GlaxoSmithKline (GSK), (2) the importance to the National Immunization Program (NIP) to provide the population a MMR vaccine to ensure high protection against mumps, similar to what occurs with measles and rubella components, it was considered essential to conduct a preliminary immunogenicity assessment of the MMR vaccine produced by BioManguinhos.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of both sexes;
- •Age between 12 months to 23 months and 29 days;
- •Child in good health, with no significant past medical history;
- •Have completed blood sampling before vaccination;
- •Have not been vaccinated with MMR.
- •Agreement by parents/tutors with the child's participation in the study and signing of the Informed Consent Form (ICF);
- •Parents/Tutors provide name, address, telephone number and other information for the contact if necessary;
- •Parents/Tutors able to understand the risks of the experiment, although minimal;
- •Parents/Tutors able to understand and sign the informed consent form.
- •Availability of return for collecting post-vaccination samples.
- •Exclusion criteria:
- •Children with a history of measles, rubella and / or mumps.
- •Having received MMR vaccine previously, as documented in vaccination card.
- •Having received a transfusion of blood or blood products, including immunoglobulins, within last 12 months.
- •Skin lesions at sites of venipuncture.
- •Child subject to abnormal bleeding after injections.
- •Use within 6 months of corticosteroids (excluding topical or aerosol) and immunosuppressants.
排除标准
- 未提供
结局指标
主要结局
Immunoresponse after first dose
时间窗: 42 days
Assess the immunoresponse for measles, mumps and rubella after vaccination with MMR in children 12-23 months and 29 days old, in the routine of National Immunization Program (NIP) in health units in the city of Rio de Janeiro.
次要结局
- Immunoresponse after revaccination(42 days)