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Vaccine

BNT162b2 for COVID-19

Phase 3
Waitlist Available
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 7 days after dose 1 and dose 2
Awards & highlights

Study Summary

This study is evaluating whether a vaccine may help prevent the flu in pregnant women.

Eligible Conditions
  • COVID-19
  • Coronavirus
  • Maternal Immunization

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after dose 2 through 1 month after delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after dose 2 through 1 month after delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Describe the immune response in pregnant women and reference to the immune response in nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection
Describe the immune response in pregnant women and reference to the immune response to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.
Percentage of maternal participants reporting adverse events
+3 more
Secondary outcome measures
Assess the safety of maternal immunization in infants born to maternal participants who were vaccinated with BNT162b2 during pregnancy
Confirmed COVID 19 in participants with and without evidence of infection prior to vaccination
Confirmed COVID 19 in participants without evidence of infection prior to vaccination
+3 more

Side effects data

From 2021 Phase 4 trial • 160 Patients • NCT04588480
92%
Injection site pain (PAIN)
63%
Fatigue (FATIGUE)
54%
Headache (HEADACHE)
49%
Chills (CHILLS)
36%
Pyrexia (FEVER)
29%
Arthralgia (JOINT PAIN)
24%
Myalgia (MUSCLE PAIN)
19%
Injection site erythema (REDNESS)
16%
Injection site swelling (SWELLING)
8%
Diarrhoea (DIARRHEA)
3%
Nasopharyngitis
2%
Headache
1%
Pyrexia
1%
Pneumonia
1%
Ovarian neoplasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
BNT162b2
Placebo
Placebo Then BNT162b2

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BNT162b2Experimental Treatment1 Intervention
2 doses
Group II: PlaceboPlacebo Group1 Intervention
2 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BNT162b2
2020
Completed Phase 4
~91490

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
64 Previous Clinical Trials
107,880 Total Patients Enrolled
20 Trials studying COVID-19
97,856 Patients Enrolled for COVID-19
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,907,618 Total Patients Enrolled
67 Trials studying COVID-19
1,437,970 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,088,786 Total Patients Enrolled
49 Trials studying COVID-19
1,426,747 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
2021. "To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04754594.
~164 spots leftby Apr 2025
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