| Trial registration number
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TCTR20210923013 |
Full text link
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20210923013
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First author
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Rajavadi Tanvisut
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Contact
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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trajavadi@gmail.com
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Registration date
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-09-23
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Recruitment status
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Single group assignment
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Masking
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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- Thai pregnant women, vaccinated with BBIBP-CorV at Chulabhorn Hospital
- Age at least 18 years old
- Gestational age at 1st vaccinated at least 12 complete weeks, confirmed by ultrasonographic measurement
- Willing to keep contact for information after vaccinated
- No history of fever or illness within 14 days before vaccinated
- Not been diagnosed of SARS-CoV-2 infected
- Not been vaccinated with any other type SARS-CoV-2 vaccine
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Exclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
- Deny to complete 2-doses of BBIBP-CorV vaccine
- Multiple gestation
- Immunocompromised or receiving immunosupressive agents
- Anaphylaxis allergic reaction to BBIBP-CorV vaccine
- Diagnosed with any congenital infections such as Rubella, Toxoplasmosis, Parvovirus B-19, Zika virus or Syphilis
- Fetal structural or chromosome abnormalities, or abnormal prenatal aneuploidy screening has not yet been confirmed
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Number of arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1
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Funding
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Chulabhorn Hospital
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Inclusion age min
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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400
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primary outcome
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Immunogenicity after BBIBP-CorV vaccination 1 month after completed vaccination Immunoglobulin and neutralizing antibody to SARS-CoV-2
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Notes
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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Arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "2;Days0-28;Pregnant women", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]
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