Download PDF

Clinical Trial Results:
Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study To Evaluate The Safety, Tolerability, Immunogenicity, And Efficacy Of Sars-Cov-2 RNA Vaccine Candidates Against Covid-19 In Healthy Individuals

Summary
EudraCT number	2020-002641-42
Trial protocol	DE
Global end of trial date	10 Feb 2023

Results information
Results version number	v2(current)
This version publication date	28 Sep 2023
First version publication date	26 Aug 2023
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

C4591001

ISRCTN number

US NCT number

NCT04368728

WHO universal trial number (UTN)

Sponsor organisation name

BioNTech SE

Sponsor organisation address

An der Goldgrube 12, Mainz, Germany, 55131

Public contact

BioNTech clinical trials patient information, BioNTech SE, 49 6131 90840, patients@biontech.de

Scientific contact

BioNTech clinical trials patient information, BioNTech SE, 49 6131 90840, patients@biontech.de

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-002861-PIP02-20

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

28 Apr 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

10 Feb 2023

Was the trial ended prematurely?

Main objective of the trial

Phase 1: To describe safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses. Phase 2/3: To evaluate efficacy of prophylactic BNT162b2 against confirmed COVID-19 occurring from 7 days after second dose in subjects without evidence of infection before vaccination and in subjects with or without evidence of infection before vaccination; To define the safety profile of prophylactic BNT162b2 in the first 360 subjects randomized (Phase 2), all subjects randomized (Phase 2/3); and subjects 12 to 15 years of age (Phase 3); To demonstrate noninferiority of anti–reference strain immune response after a third dose of BNT162b2 at 30 μg compared to after 2 doses of BNT162b2, in the same individuals; To demonstrate noninferiority of anti-SA immune response after 1 dose (BNT162b2-experienced) or 2 doses (BNT162b2-naïve) of BNT162b2SA compared to anti–reference strain immune response after 2 doses of BNT162b2, in the same individuals.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

29 Apr 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 5775

Country: Number of subjects enrolled

Brazil: 2898

Country: Number of subjects enrolled

Germany: 500

Country: Number of subjects enrolled

South Africa: 800

Country: Number of subjects enrolled

Turkey: 500

Country: Number of subjects enrolled

United States: 36461

Worldwide total number of subjects

46934

EEA total number of subjects

500

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

3019

Adults (18-64 years)

34709

From 65 to 84 years

9164

85 years and over

Subject disposition

Top of page

Recruitment details

The study consisted of 2 parts, Phase 1 and Phase 2/3. The overall period presented below was created to support display of the demographic characteristics for all study phases. The complete disposition information is presented below in separate tables for each individual phase, respectively.

Screening details

A total of 46934 subjects were randomised and assigned to the treatment. The study consisted of 2 parts. Phase 1: to identify preferred vaccine candidate and dose level of candidate vaccine; Phase 2/3: an expanded cohort and efficacy part.

Period 1 title

Overall period

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Phase 1: BNT162b1 10 mcg dose: 18-85 years of age

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram (mcg) BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

10 mcg: 250 mcg/0.5 mL

Phase 1: BNT162b1 20 mcg dose:18-85 years of age

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

20 mcg: 250 mcg/0.5 mL

Phase 1: BNT162b1 30 mcg dose:18-85 years of age

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 mcg/0.5 mL

Phase 1: BNT162b1 100 mcg dose:18-55 years of age

Arm description

Subjects aged 18-55 years were randomised to receive 2 doses of 100 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly and received only 1 dose due to reactogenicity.

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

100 mcg: 250 mcg/0.5 mL

Phase 1: Placebo: 18-85 years of age

Arm description

Subjects were originally randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Normal saline (0.9% sodium chloride solution for injection)

Phase 1: BNT162b2 10 mcg dose: 18-85 years of age

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

10 mcg: 250 mcg/0.5 mL

Phase 1: BNT162b2 20 mcg dose: 18-85 years of age

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

20 mcg: 250 mcg/0.5 mL

Phase 1: BNT162b2 30 mcg dose: 18-85 years of age

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 mcg/0.5 mL

Phase 2/3: BNT162b2 (30mcg): 12-15 years of age

Arm description

Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 mcg/0.5 mL

Phase 2/3: Placebo: 12-15 years of age

Arm description

Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Normal saline (0.9% sodium chloride solution for injection)

Phase 2/3: BNT162b2 (30 mcg): >=16 years of age

Arm description

Subjects randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 mcg/0.5 mL

Phase 2/3: Placebo: >=16 years of age

Arm description

Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Normal saline (0.9% sodium chloride solution for injection)

Phase 3: BNT162b2 SA 30 mcg: 18-55 years of age

Arm description

Subjects aged 18-55 years were assigned to receive 2 doses of 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 SA

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 mcg/0.5 milliliter

Number of subjects in period 1	Phase 1: BNT162b1 10 mcg dose: 18-85 years of age	Phase 1: BNT162b1 20 mcg dose:18-85 years of age	Phase 1: BNT162b1 30 mcg dose:18-85 years of age	Phase 1: BNT162b1 100 mcg dose:18-55 years of age	Phase 1: Placebo: 18-85 years of age	Phase 1: BNT162b2 10 mcg dose: 18-85 years of age	Phase 1: BNT162b2 20 mcg dose: 18-85 years of age	Phase 1: BNT162b2 30 mcg dose: 18-85 years of age	Phase 2/3: BNT162b2 (30mcg): 12-15 years of age	Phase 2/3: Placebo: 12-15 years of age	Phase 2/3: BNT162b2 (30 mcg): >=16 years of age	Phase 2/3: Placebo: >=16 years of age	Phase 3: BNT162b2 SA 30 mcg: 18-55 years of age
Started	24	24	24	12	39	24	24	24	1134	1130	22071	22071	333
Completed	24	24	24	12	39	24	24	24	1134	1130	22071	22071	333

Period 2 title

Phase 1

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject

Are arms mutually exclusive

Phase 1:BNT162b1 10 mcg dose: 18-85 years of age (2 doses)

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

10 mcg: 250 mcg/0.5 mL

Phase 1:BNT162b1 20 mcg dose:18-85 years of age (2 doses)

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

20 mcg: 250 mcg/0.5 mL

Phase 1:BNT162b1 30 mcg dose:18-85 years of age (2 doses)

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 mcg/0.5 mL

Phase 1:BNT162b1 100 mcg dose:18-85 years of age (1 dose)

Arm description

Subjects aged 18-85 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.

Arm type

Experimental

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

100 mcg: 250 mcg/0.5 mL

Phase 1: Placebo: 18-85 years of age

Arm description

Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

Arm type

Placebo

Investigational medicinal product name

BNT162b1

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Normal saline (0.9% sodium chloride solution for injection)

Phase 1: BNT162b2: 10 mcg dose: 18-85 years of age

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

10 mcg: 250 mcg/0.5 mL

Phase 1: BNT162b2: 20 mcg dose: 18-55 years of age

Arm description

Subjects aged 18-55 years were randomised to receive 2 doses of 20 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

20 mcg: 250 mcg/0.5 mL

Phase 1: BNT162b2: 30 mcg dose: 18-85 years of age

Arm description

Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 mcg/0.5 mL

Number of subjects in period 2	Phase 1:BNT162b1 10 mcg dose: 18-85 years of age (2 doses)	Phase 1:BNT162b1 20 mcg dose:18-85 years of age (2 doses)	Phase 1:BNT162b1 30 mcg dose:18-85 years of age (2 doses)	Phase 1:BNT162b1 100 mcg dose:18-85 years of age (1 dose)	Phase 1: Placebo: 18-85 years of age	Phase 1: BNT162b2: 10 mcg dose: 18-85 years of age	Phase 1: BNT162b2: 20 mcg dose: 18-55 years of age	Phase 1: BNT162b2: 30 mcg dose: 18-85 years of age
Started	24	24	24	12	39	24	24	24
Completed	14	18	13	8	23	20	19	16
Not completed	10	6	11	4	16	4	5	8
Consent withdrawn by subject	-	1	2	-	1	-	-	-
No longer meets eligibility criteria	5	-	5	1	7	3	1	4
Unspecified	-	-	-	-	2	1	1	1
Lost to follow-up	-	-	-	1	-	-	-	1
Protocol deviation	5	5	4	2	6	-	3	2

Period 3 title

Phase 2/3: Blinded Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject, Monitor, Carer, Data analyst, Assessor

Are arms mutually exclusive

Phase 2/3: BNT162b2 (30 mcg): 12-15 years of age

Arm description

Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 mcg/0.5 mL

Phase 2/3: Placebo 12-15 years of age

Arm description

Subjects aged 12-15 years were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Normal saline (0.9% sodium chloride solution for injection)

Phase 2/3: BNT162b2 (30 mcg): >=16 years of age

Arm description

Subjects aged greater than or equal to 16 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 mcg/0.5 mL

Phase 2/3: Placebo for >=16 years of age

Arm description

Subjects aged greater than or equal to 16 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Normal saline (0.9% sodium chloride solution for injection)

Number of subjects in period 3	Phase 2/3: BNT162b2 (30 mcg): 12-15 years of age	Phase 2/3: Placebo 12-15 years of age	Phase 2/3: BNT162b2 (30 mcg): >=16 years of age	Phase 2/3: Placebo for >=16 years of age
Started	1134	1130	22071	22071
Completed	3	2	21	37
Not completed	1131	1128	22050	22034
Physician decision	-	-	5	7
Subjects entered open label period	1119	1110	21500	21351
Withdrawal by parent/guardian	1	5	1	-
Consent withdrawn by subject	1	7	139	250
No longer meets eligibility criteria	-	2	16	21
Adverse event, non-fatal	-	-	9	9
Death	-	-	18	16
Refused further study procedures	-	-	2	-
Medication error without associated adverse event	-	-	1	-
Pregnancy	-	-	-	1
Unspecified	3	1	33	11
Randomised but not vaccinated	3	1	55	48
Lost to follow-up	4	2	256	281
Protocol deviation	-	-	15	39

Period 4 title

Phase 2/3: Open label

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Phase 2/3: BNT162b2 (30 mcg): 12-15 years of age

Arm description

Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 microgram/0.5 milliliter

Phase2/3: Placebo 12-15 years of age

Arm description

Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Normal saline (0.9% sodium chloride solution for injection)

Phase 2/3: BNT162b2 (30 mcg) >=16 years of age

Arm description

Subjects aged >=16 years of age were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 microgram/0.5 milliliter

Phase 2/3: Placebo

Arm description

Subjects aged >=16 years of age were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Normal saline (0.9% sodium chloride solution for injection)

Number of subjects in period 4	Phase 2/3: BNT162b2 (30 mcg): 12-15 years of age	Phase2/3: Placebo 12-15 years of age	Phase 2/3: BNT162b2 (30 mcg) >=16 years of age	Phase 2/3: Placebo
Started	1119	1110	21500	21351
Completed	560	661	6954	10428
Not completed	559	449	14546	10923
Consent withdrawn by subject	49	52	1500	1792
Physician decision	-	-	35	31
No longer meets eligibility criteria	107	114	940	1580
Adverse event, non-fatal	-	-	4	6
Death	-	1	67	68
Pregnancy	-	-	1	2
Refused further study procedure	-	-	7	12
Unspecified	293	173	9647	3608
Lost to follow-up	59	55	1089	1402
Withdrawal by parent/guardian	14	19	2	-
Protocol deviation	37	35	1254	2422

Period 5 title

Phase 3: BNT162b2-Naïve Subjects

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Phase 3: BNT162b2 SA 30 mcg: 18-55 years of age

Arm description

Subjects aged 18-55 years were assigned to receive 2 doses of 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Arm type

Experimental

Investigational medicinal product name

BNT162b2 SA

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 mcg: 250 microgram/0.5 milliliter

Number of subjects in period 5	Phase 3: BNT162b2 SA 30 mcg: 18-55 years of age
Started	333
Completed	228
Not completed	105
Consent withdrawn by subject	19
Adverse event, non-fatal	1
No longer meets eligibility criteria	8
Unspecified	24
Lost to follow-up	50
Protocol deviation	3

Baseline characteristics

Top of page

Reporting group title

Phase 1: BNT162b1 10 mcg dose: 18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram (mcg) BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b1 20 mcg dose:18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b1 30 mcg dose:18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b1 100 mcg dose:18-55 years of age

Reporting group description

Subjects aged 18-55 years were randomised to receive 2 doses of 100 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly and received only 1 dose due to reactogenicity.

Reporting group title

Phase 1: Placebo: 18-85 years of age

Reporting group description

Subjects were originally randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Reporting group title

Phase 1: BNT162b2 10 mcg dose: 18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b2 20 mcg dose: 18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b2 30 mcg dose: 18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 2/3: BNT162b2 (30mcg): 12-15 years of age

Reporting group description

Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 2/3: Placebo: 12-15 years of age

Reporting group description

Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Reporting group title

Phase 2/3: BNT162b2 (30 mcg): >=16 years of age

Reporting group description

Subjects randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 2/3: Placebo: >=16 years of age

Reporting group description

Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

Reporting group title

Phase 3: BNT162b2 SA 30 mcg: 18-55 years of age

Reporting group description

Subjects aged 18-55 years were assigned to receive 2 doses of 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group values	Phase 1: BNT162b1 10 mcg dose: 18-85 years of age	Phase 1: BNT162b1 20 mcg dose:18-85 years of age	Phase 1: BNT162b1 30 mcg dose:18-85 years of age	Phase 1: BNT162b1 100 mcg dose:18-55 years of age	Phase 1: Placebo: 18-85 years of age	Phase 1: BNT162b2 10 mcg dose: 18-85 years of age	Phase 1: BNT162b2 20 mcg dose: 18-85 years of age	Phase 1: BNT162b2 30 mcg dose: 18-85 years of age	Phase 2/3: BNT162b2 (30mcg): 12-15 years of age	Phase 2/3: Placebo: 12-15 years of age	Phase 2/3: BNT162b2 (30 mcg): >=16 years of age	Phase 2/3: Placebo: >=16 years of age	Phase 3: BNT162b2 SA 30 mcg: 18-55 years of age	Total
Number of subjects	24	24	24	12	39	24	24	24	1134	1130	22071	22071	333	46934
Age Categorical
Units: Subjects
<=18 years	0	0	0	0	0	0	0	0	1134	1130	378	377	0	3019
Between 18 and 65 years	12	12	12	12	21	12	12	12	0	0	17130	17141	333	34709
>=65 years	12	12	12	0	18	12	12	12	0	0	4563	4553	0	9206
Age Continuous
Units: Years
arithmetic mean (standard deviation)	49.5 ± 21.36	57.7 ± 14.76	52.9 ± 18.88	38.3 ± 9.34	51.0 ± 19.18	52.4 ± 18.13	54.3 ± 18.87	52.9 ± 17.46	13.6 ± 1.11	13.6 ± 1.11	49.7 ± 15.99	49.6 ± 16.06	35.7 ± 10.72	-
Sex: Female, Male
Units: Subjects
Female	13	11	14	7	22	17	13	15	564	544	10724	10952	160	23056
Male	11	13	10	5	17	7	11	9	570	586	11347	11119	173	23878
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1	0	1	0	1	1	1	0	132	130	5716	5710	42	11735
Not Hispanic or Latino	23	24	22	12	38	23	23	24	1000	997	16281	16261	288	35016
Unknown or Not Reported	0	0	1	0	0	0	0	0	2	3	74	100	3	183
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0	0	0	4	3	222	217	0	446
Asian	3	0	4	1	1	1	0	2	72	71	951	947	26	2079
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	3	0	53	31	0	87
Black or African American	1	2	0	0	0	0	2	1	52	57	2098	2121	40	4374
White	20	22	20	11	38	23	22	21	973	963	18090	18103	261	38567
More than one race	0	0	0	0	0	0	0	0	24	29	580	540	4	1177
Unknown or Not Reported	0	0	0	0	0	0	0	0	6	7	77	112	2	204

End points

Top of page

Reporting group title

Phase 1: BNT162b1 10 mcg dose: 18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram (mcg) BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b1 20 mcg dose:18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b1 30 mcg dose:18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b1 100 mcg dose:18-55 years of age

Reporting group description

Subjects aged 18-55 years were randomised to receive 2 doses of 100 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly and received only 1 dose due to reactogenicity.

Reporting group title

Phase 1: Placebo: 18-85 years of age

Reporting group description

Subjects were originally randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Reporting group title

Phase 1: BNT162b2 10 mcg dose: 18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b2 20 mcg dose: 18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b2 30 mcg dose: 18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 2/3: BNT162b2 (30mcg): 12-15 years of age

Reporting group description

Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 2/3: Placebo: 12-15 years of age

Reporting group description

Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Reporting group title

Phase 2/3: BNT162b2 (30 mcg): >=16 years of age

Reporting group description

Subjects randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 2/3: Placebo: >=16 years of age

Reporting group description

Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

Reporting group title

Phase 3: BNT162b2 SA 30 mcg: 18-55 years of age

Reporting group description

Subjects aged 18-55 years were assigned to receive 2 doses of 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1:BNT162b1 10 mcg dose: 18-85 years of age (2 doses)

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1:BNT162b1 20 mcg dose:18-85 years of age (2 doses)

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1:BNT162b1 30 mcg dose:18-85 years of age (2 doses)

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1:BNT162b1 100 mcg dose:18-85 years of age (1 dose)

Reporting group description

Subjects aged 18-85 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.

Reporting group title

Phase 1: Placebo: 18-85 years of age

Reporting group description

Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

Reporting group title

Phase 1: BNT162b2: 10 mcg dose: 18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b2: 20 mcg dose: 18-55 years of age

Reporting group description

Subjects aged 18-55 years were randomised to receive 2 doses of 20 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 1: BNT162b2: 30 mcg dose: 18-85 years of age

Reporting group description

Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 2/3: BNT162b2 (30 mcg): 12-15 years of age

Reporting group description

Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 2/3: Placebo 12-15 years of age

Reporting group description

Subjects aged 12-15 years were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Reporting group title

Phase 2/3: BNT162b2 (30 mcg): >=16 years of age

Reporting group description

Reporting group title

Phase 2/3: Placebo for >=16 years of age

Reporting group description

Subjects aged greater than or equal to 16 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

Reporting group title

Phase 2/3: BNT162b2 (30 mcg): 12-15 years of age

Reporting group description

Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase2/3: Placebo 12-15 years of age

Reporting group description

Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Reporting group title

Phase 2/3: BNT162b2 (30 mcg) >=16 years of age

Reporting group description

Subjects aged >=16 years of age were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Reporting group title

Phase 2/3: Placebo

Reporting group description

Subjects aged >=16 years of age were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

Reporting group title

Phase 3: BNT162b2 SA 30 mcg: 18-55 years of age

Reporting group description

Subjects aged 18-55 years were assigned to receive 2 doses of 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

Subject analysis set title

BNT162b1 10 mcg dose: 18-55 years of age

Subject analysis set type

Per protocol