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Trial - NCT05952505


Column Value
Trial registration number NCT05952505
Full text link
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05952505

First author
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

Zhuoying Huang

Contact
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

huangzhuoying@scdc.sh.cn

Registration date
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

2023-07-19

Recruitment status
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

inclusion criteria: aged 4 years old with legal guardian signing the informed consent able to participate in all planned visits and comply with all research procedures (such as completing diary cards of adverse events and participating visits) with clear vaccination records including no sars-cov-2 vaccine history, with 1 varicella vaccine and 2 measles-containing vaccines history the last attenuated vaccine was administered ≥28 days ago, and other vaccines administered ≥14 days ago with an axillary temperature ≤37.5℃ at the time of vaccination

Exclusion criteria
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

first dose

Number of arms
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

Shanghai Municipal Center for Disease Control and Prevention

Inclusion age min
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

4

Inclusion age max
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

4

Countries
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

540

primary outcome
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps;non-inferiority of the seroconversion rate and IgG antibody level against varicella;non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2

Notes
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : July 20, 2023, 4 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2748, "treatment_name": "Inactivated covid-19 vaccine+mmr vaccine", "treatment_type": "Inactivated virus+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "nan", "treatment_id": 2749, "treatment_name": "Inactivated covid-19 vaccine+varicella vaccine", "treatment_type": "Inactivated virus+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}]