Clinical Trial of Measles, Mumps and Rubella Combined Vaccine, Live

  • STATUS
    Recruiting
  • days left to enroll
    23
  • participants needed
    1068
  • sponsor
    Shanghai Institute Of Biological Products
Updated on 12 April 2022
vaccination
measles
rubella
Accepts healthy volunteers

Summary

To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.

Description

To assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) lot-to-lot consistency in healthy Chinese Children at the age of 8-12 months, and the participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at day 0.

Details
Condition Immunotoxicity, Vaccine
Treatment measles, mumps and rubella combined vaccine, live
Clinical Study IdentifierNCT05161845
SponsorShanghai Institute Of Biological Products
Last Modified on12 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provide vaccination certificate and birth certificate for healthy children aged 8-12
months
Volunteers' legal guardian informed consent, volunteered to participate and signed an
informed consent form;
The volunteer's legal guardian has the ability to understand the research procedures
use the thermometer, scale and fill in the diary card as required, and can complete
the clinical study in accordance with the requirements of the clinical trial protocol

Exclusion Criteria

The axillary body temperature on the day of enrollment was more than 37.0 ℃
Have suffered from measles, mumps and rubella in the past or are suffering from
measles, mumps and rubella
Any previous vaccination containing measles, mumps and rubella
Persons known to be allergic to any ingredient in the investigational vaccine
Any previous history of vaccine or drug allergy
Premature (delivered before the 37th week of pregnancy) and low weight (birth weight <
g)
History of dystocia, asphyxia rescue and nervous system damage
Congenital malformations or developmental disorders, genetic defects, severe
malnutrition, etc
Acute disease, serious chronic disease or acute attack of chronic disease on the day
of vaccination
Have a history of live attenuated vaccine within 28 days before vaccination and other
vaccines within 7 days
Those who receive immune enhancement or inhibitor treatment within 3 months
(continuous oral or drip for more than 14 days)
Suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma
leukemia or other autoimmune diseases
History of asthma, unstable in the past two years, requiring emergency treatment
hospitalization, intubation, oral or intravenous corticosteroids
Have received blood or blood related products
Patients with progressive nervous system diseases have a history of convulsion
epilepsy, encephalopathy, GuillainBarre syndrome, mental history or family history
Have a history of abnormal coagulation function (such as coagulation factor deficiency
and coagulation diseases)
Plan to move out before the end of the study or leave for a long time during the
scheduled study visit
Participating in or planning to participate in other clinical trials in the near
future
The investigator judges any situation that is not suitable to participate in this
clinical trial
Clear my responses

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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