A prospective, randomized, parallel, single-blind, two-arm, active-controlled, multicentre, phase IV clinical trial to evaluate the immunogenicity and safety of Measles, Mumps, and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Zydus Lifesciences Ltd. compared to Measles, Mumps, and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Serum Institute of India Pvt. Ltd. in healthy infants aged 9-12 months
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 720
- 试验地点
- 14
- 主要终点
- To evaluate the immunogenicity of MMR vaccine of M/s. Zydus Lifesciences Ltd. compared to MMR vaccine of M/s. Serum Institute of India Pvt. Ltd. in healthy infants aged 9-12 months
研究概览
简要总结
This will bea prospective, randomized, two-arm, single-blind, parallel, non-inferiority,multicentre phase IV clinical study planned to evaluate the immunogenicity andsafety of MMR vaccine of M/s. Zydus Lifesciences Ltd. and compare it with theWHO prequalified MMR vaccine of M/s. Serum Institute of India Pvt. Ltd.
Participantsevaluated as per the inclusion and exclusion criteria and should be in goodhealth as determined by medical history and physical examination based onclinical judgment of the investigator. The participant should not have previoushistory of vaccination against measles, mumps and rubella.
Participant will be randomized in oneof the 2 study groups as per their allocated randomization number and will beadministered the allocated study vaccine during visit 1 / day 0 and visit 4 /day 180 in a single-blinded manner.
Healthyinfants aged 9-12 months will be enrolled in this trial. Both the studyvaccines will be available in single dose presentation in lyophilized form. Thevaccine will be reconstituted with the diluent supplied along with the vaccineimmediately prior to vaccination. The enrolled participants will beadministered 2 doses of MMR vaccine at an interval of 180 days.
Participants’parents will be asked to visit follow-up of participant on day 14 (visit 2),day 42 (visit 3), day 180 (visit 4), day 194 (visit 5), and day 222 (visit 6).They will be observed for at least 30 minutes post vaccination after each doseat respective visits.
Blood sampleof (3 ml) each will be collected prior to vaccination at day 0 (visit 1), day42 (visit 3), prior to vaccination at day 180 (visit 4) and day 222 (visit 6)for immuno-logical assessment.
Diaries willbe provided to the enrolled participants parents to record local (injectionssite) and systemic AEs that may occur after vaccination. One diary card will bepro-vided after each vaccination. Solicited local AEs (pain, redness, swelling& induration) will be recorded for 7 days after vaccination; solicitedsystemic AEs (fever, rashes, running nose, cough, cold, diarrhea, vomiting,abnormal crying, loss of appetite, drowsiness & irritability) will berecorded for 14 days after vaccination and unsolicited (other) AEs will berecorded for 42 days after vaccination. The diary card will be collected duringfollow-up visit 42 days after vaccination.
All unsolicited AEs occurring within 42 dayspost-vaccination will be recorded. After 42 days of first vaccination,unsolicited AEs will only be recorded if they are defined as serious adverseevents (SAEs) or medically attended adverse events (MAAEs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 9.00 Month(s) 至 12.00 Month(s)（—）
- 性别
- All
入选标准
- •Healthy infant participant of either gender aged 9 to 12 months at the time of enrollment
- •Participants should be in good health as determined by medical history and physical examination based on clinical judgment of the investigator
- •No previous history of vaccination against measles, mumps and rubella
- •Written informed consent from the subjects parent (mother/father)
- •Participants parent literate enough to fill the diary card
- •Participants and parents likely to be available for follow-up for entire duration of the study Age calculated as per completed months.
排除标准
- •History of hypersensitivity reaction to any component of the vaccines
- •History of hypersensitivity reaction to neomycin, gelatin or albumin
- •History of hypersensitivity to egg proteins.
- •History of laboratory confirmed or suspected measles, mumps or rubella in past
- •Subject exposed to measles, mumps or rubella virus within the past 30 days
- •Fever of any origin or infectious disorder of 3 days or more within the past 30 days
- •Febrile illness (axillary temperature greater than or equals to 37.5°C) at the time of enrollment
- •History of any vaccination within the past month
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, immunological, metabolic or major congenital disorder
- •Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •Participants administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •Subject participated in any clinical study in the past 3 months
- •Any other reason for which the investigator feels that subject should not participate Close contact (family member or neighbour) with laboratory confirmed or clinical diagnosis of measles / mumps / rubella.
结局指标
主要结局
To evaluate the immunogenicity of MMR vaccine of M/s. Zydus Lifesciences Ltd. compared to MMR vaccine of M/s. Serum Institute of India Pvt. Ltd. in healthy infants aged 9-12 months
时间窗: At Day 0, weeks 6, weeks 26, weeks 32
次要结局
- To evaluate the safety of MMR vaccine of M/s. Zydus Lifesciences Ltd. compared to MMR vaccine of M/s. Serum Institute of India Pvt. Ltd. in healthy infants aged 9-12 months(At Day 0, weeks 2, weeks 6, weeks 26, weeks 28, weeks 32)