To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older

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ClinicalTrials.gov Identifier: NCT04754594

Recruitment Status : Completed

First Posted : February 15, 2021

Last Update Posted : July 13, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

BioNTech SE

Results Submitted - Quality Control (QC) Review Has Not Concluded

Results information for an applicable clinical trial (ACT) is posted within 30 days of submission even if the submission has not completed the ClinicalTrials.gov Results Quality Control (QC) review process. Results information is submitted to ClinicalTrials.gov by the sponsor or investigator, and National Library of Medicine (NLM) staff assess for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.

All versions of ACT results information submissions that have not completed the QC review process are posted on ClinicalTrials.gov (since January 2020). After the QC review process is completed, the results information is posted without QC review comments and previous versions are archived.

Recruitment Status :	Completed
Actual Primary Completion Date :	July 15, 2022
Actual Study Completion Date :	July 15, 2022

Submission Cycle	Results Submitted to ClinicalTrials.gov	Results Returned after Quality Control Review
1	July 14, 2023	August 4, 2023 Submission with QC Comments
2	August 30, 2023	September 22, 2023 Submission with QC Comments
3	October 25, 2023	November 13, 2023 Submission with QC Comments

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nana M, Hodson K, Lucas N, Camporota L, Knight M, Nelson-Piercy C. Diagnosis and management of covid-19 in pregnancy. BMJ. 2022 Apr 26;377:e069739. doi: 10.1136/bmj-2021-069739.

Mohapatra S, Ananda P, Tripathy S. Pharmacological consideration of COVID-19 infection and vaccines in pregnancy. J Chin Med Assoc. 2022 May 1;85(5):537-542. doi: 10.1097/JCMA.0000000000000712. Epub 2022 May 2.

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