Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04754594|
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 Infection COVID-19 Maternal Immunization||Biological: BNT162b2 Other: Placebo||Phase 2 Phase 3|
The Phase 2 portion of the study will include approximately 350 pregnant women randomized 1:1 to receive BNT162b2 or placebo (saline) at 27 to 34 weeks' gestation. IRC review of safety data through 7 days after the second dose for all Phase 2 participants will be completed before participants in the Phase 3 portion can be enrolled.
The Phase 3 portion of this study will assess the safety, tolerability, and immunogenicity of BNT162b2 among pregnant women enrolled at 24 to 34 weeks' gestation.
Maternal participants who originally received placebo will receive BNT162b2 at defined time points as part of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER|
|Actual Study Start Date :||February 16, 2021|
|Estimated Primary Completion Date :||June 27, 2022|
|Estimated Study Completion Date :||June 27, 2022|
Placebo Comparator: Placebo
- Percentage of maternal participants reporting: Local reactions [ Time Frame: For 7 Days after Dose 1 and Dose 2 ]Pain at the injection site, redness, and swelling as self-reported on electronic diaries
- Percentage of maternal participants reporting systemic events [ Time Frame: For 7 days after Dose 1 and Dose 2 ]Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
- Percentage of maternal participants reporting adverse events [ Time Frame: From Dose 1 through 1 month after Dose 2 ]As elicited by investigational site staff
- Percentage of maternal participants reporting serious adverse events [ Time Frame: From Dose 1 through 6 months after delivery ]As elicited by investigational site staff
- Demonstrate non inferiority of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection. [ Time Frame: 1 month after Dose 2 ]GMR, estimated by the ratio of the geometric mean of SARS CoV 2 neutralizing titers in pregnant women to those in nonpregnant female participants
- Demonstrate non inferiority of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection [ Time Frame: 1 month after Dose 2 ]GMR, estimated by the ratio of the geometric mean of SARS CoV 2 neutralizing titers in pregnant women to those in nonpregnant female participants
- Confirmed COVID 19 in participants without evidence of infection prior to vaccination [ Time Frame: 7 days after Dose 2 through 1 month after delivery ]1000 person years of follow-up
- Confirmed COVID 19 in participants with and without evidence of infection prior to vaccination. [ Time Frame: 7 days after Dose 2 through 1 month after delivery ]1000 person years of follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754594
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|