A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vacci… (NCT05630846) | Clinical Trial Compass
CompletedPhase 2
A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age
United States801 participantsStarted 2022-12-14
Plain-language summary
The main purpose of this study is to assess immune response and safety of various potencies of a measles, mumps, rubella, and varicella (MMRVNS) vaccines given to healthy children of 4 to 6 years of age.
Who can participate
Age range4 Years – 6 Years
SexALL
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Inclusion Criteria:
* Healthy participants as established by medical history and clinical examination before entering into the study.
* A male or female between, and including, 4 years and 6 years of age (i.e., from 4 year birthday until the day before the 7-year birthday) at the time of study intervention administration, and in accordance with local regulations.
* Participant who previously received a first dose of varicella-containing vaccine in the second year of life.
* Participant who previously received a single dose of measles-, mumps-, rubella-containing vaccine in the second year of life.
* Written informed consent obtained from the participants' parent(s)/legally acceptable representative(s) (LAR\[s\]) prior to performance of any study-specific procedure (participant informed assent will be obtained from participants in line with local rules and regulations).
* Participants' parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic diaries \[eDiaries\], return for follow-up visits).
Exclusion Criteria:
Medical Conditions
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Hypersensitivity to latex.
* …
What they're measuring
1
GMC of Anti-measles Antibodies at Day 43
Timeframe: At Day 43
2
GMC of Anti-mumps Antibodies at Day 43
Timeframe: At Day 43
3
GMC of Anti-rubella Antibodies at Day 43
Timeframe: At Day 43
4
GMC of Anti-glycoprotein E (gE) Antibodies at Day 43