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| Column | Value |
|---|---|
| Trial registration number | NCT05135585 |
|
Full text link
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Nov. 17, 2022, 4 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Nov. 17, 2022, 4 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Nov. 30, 2021, 11 p.m. Source : ClinicalTrials.gov |
2021-11-26 |
|
Recruitment status
Last imported at : Nov. 17, 2022, 4 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
nonRCT |
|
Allocation
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Single group assignment |
|
Masking
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: adults from melanesian, polynesian, european or other community origin adults vaccinated with 2 doses of pfizer comirnaty vaccine, administered between 3 and 12 weeks apart adults planning to be present in the territory and to be available on both sampling dates (1 and 6 months) |
|
Exclusion criteria
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
persons who received the second dose of vaccine more than 12 weeks after the first dose persons vaccinated against covid-19 with a vaccine other than pfizer comirnaty women who report being pregnant or breastfeeding (where the immune response may be altered) immunocompromised persons (immunosuppressive treatment, immunomodulator, hiv positive, splenectomy, long term corticosteroid therapy, autoimmune diseases such as rheumatoid arthritis, lupus, spondyloarthritis, etc.) people who are not intellectually capable of answering the questionnaire persons under guardianship, curatorship or any other legal incapacity persons with documented covid-19 infection (known positive sars-cov-2 serology prior to inclusion, positive pcr or antigen test) |
|
Number of arms
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
1 |
|
Funding
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Institut Pasteur |
|
Inclusion age min
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
20 |
|
Inclusion age max
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
New Caledonia |
|
Type of patients
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Nov. 17, 2022, 4 a.m. Source : ClinicalTrials.gov |
680 |
|
primary outcome
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Measurement by ELISA tests of the presence of antibodies at 1 month after the second dose of Pfizer COMIRNATY vaccine in the New Caledonian population |
|
Notes
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : Nov. 29, 2021, 10:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "2", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |