| Trial registration number
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NCT05329064 |
Full text link
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05329064
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First author
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Qing Lin Tan
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Contact
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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tan.qing.lin@kkh.com.sg
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Registration date
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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2022-04-14
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Recruitment status
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Single group assignment
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Masking
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
healthy children aged 5 to 11 years old
no contraindications to mrna covid-19 pfizer-biontech vaccines
had never received any covid-19 vaccine before
never had previous covid-19 infections
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Exclusion criteria
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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children outside the age group.
immunocompromised children.
participants with previous history of covid-19 infection.
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Number of arms
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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1
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Funding
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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KK Women's and Children's Hospital
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Inclusion age min
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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5
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Inclusion age max
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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11
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Countries
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Singapore
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Type of patients
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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150
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primary outcome
Last imported at : May 1, 2022, 3:30 a.m.
Source : ClinicalTrials.gov
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Geometric mean titres (GMT) neutralizing antibody levels at 2m;Percentage neutralizing antibody levels at 2m;WHO International units/ml neutralizing antibody levels at 2m
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Notes
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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Phase 4
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Arms
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "nan", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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