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Clinical Trial Results:
Assessment of the immunogenicity and safety of marketed vaccines for COVID-19 after regular schedule and adapted vaccine schedules and routes: BNT162b2 (Comirnaty®; Pfizer-BioNTech), mRNA-1273 Vaccine (COVID-19 Vaccine Moderna®; Moderna) and COVID-19 Vaccine (ChAdOx1-S [recombinant])(Vaxzevria®, AstraZeneca)

Summary
EudraCT number	2021-001993-52
Trial protocol	BE
Global end of trial date	08 Jul 2022

Results information
Results version number	v1(current)
This version publication date	05 Jul 2025
First version publication date	05 Jul 2025
Other versions

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

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Trial information

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Sponsor protocol code

IMCOVAS

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

University of Antwerp

Sponsor organisation address

Prinsstraat 13, Antwerp, Belgium, 2000

Public contact

Centre for the Evaluation of Vaccination, University of Antwerp, +32 032652565, cev@uantwerpen.be

Scientific contact

Centre for the Evaluation of Vaccination, University of Antwerp, +32 032652565, cev@uantwerpen.be

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

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?

Analysis stage

Final

Date of interim/final analysis

08 Jul 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

08 Jul 2022

Global end of trial reached?

Yes

Global end of trial date

08 Jul 2022

Was the trial ended prematurely?

Main objective of the trial

The main objective of the trial is to assess non-inferiority of the humoral immune response against SARS-Cov-2 infection of different vaccines and adapted vaccine schedules in comparison with the reference schedule, at 28 days post second study vaccine.

Protection of trial subjects

The study is conducted in accordance with the required ethical principles, including the Declaration of Helsinki and Good Clinical Practice and compliant applicable laws and regulations, including the General Data Protection Regulation to protect confidentiality. Subjects are protected to the risks associated to vaccination and blood draw by having procedures done by trained medical personnel and remaining under medical observation during at least 30 minutes after vaccination. Subjects with severe allergic reactions to vaccine components or anaphylaxis in the past are excluded to mitigate the risk of anaphylaxis. Diary cards are used to collect solicited and unsolicited adverse events after vaccination. Investigators will timely and accurate monitor the safety after vaccination and holding rules are defined in advance.

Background therapy

Evidence for comparator

Actual start date of recruitment

26 May 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 566

Worldwide total number of subjects

566

EEA total number of subjects

566

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)

Adults (18-64 years)

566

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Volunteers were recruited in four study centres across Belgium. Participant recruitment started on 26th of May 2021. The final participant was included on 24th of June 2021.

Screening details

A total of 580 participants were screened for inclusion into the trial. A total of 14 individuals were deemed ineligible to participate in the IMCOVAS trial. Of this group, 8 failed to meet the inclusion criteria while 7 met one of the exclusion criteria. Therefore a total of 566 participants were enrolled into the trial.

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Single blind ^[1]

Roles blinded

Subject, Assessor

Blinding implementation details

The trial is partially single blind. Subjects and study personnel, not involved in vaccine administration, are not informed about the brand and dose of the 1st & 2nd study vaccination, until 14 days after the 2nd vaccination, when the reporting period of adverse events is finished. For the intradermal administration and long-interval randomization groups, the subjects and personnel will know the brand of the vaccine, due the trial design nature.

Are arms mutually exclusive

Yes

Group 1A: Pfizer regular scheme

Arm description

Subjects received a standard dose of BNT162b2 followed by a standard dose of BNT162b2 administered intramuscularly 28 days apart, as foreseen per the standard dosing scheme.

Arm type

Active comparator

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Comirnaty

Pharmaceutical forms

Dispersion for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received one dose of 0.3mL BNT162b2 (30 micrograms of COVID-19 mRNA Vaccine) intramuscular on Day 0 and Day 28.

Group 1B: Pfizer - Moderna scheme

Arm description

Subjects received a standard dose BNT162b2 followed by a standard dose mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Spikevax

Pharmaceutical forms

Dispersion for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received one dose of 0.5mL mRNA-1273 (100 microgram mRNA) intramuscular on Day 28.

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Comirnaty

Pharmaceutical forms

Dispersion for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received one dose of 0.3mL BNT162b2 (30 micrograms of COVID-19 mRNA Vaccine) intramuscular on Day 0.

Group 1 C: Pfizer-AstraZeneca scheme

Arm description

Subjects received a standerd dose of BNT162b2 followed by a standard dose of COVID-19 Vaccine (ChAdOx1-S [recombinant]) administered intramuscularly 28 days apart.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Comirnaty

Pharmaceutical forms

Dispersion for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received one dose of 0.3mL BNT162b2 (30 micrograms of COVID-19 mRNA Vaccine) intramuscular on Day 0.

Investigational medicinal product name

COVID-19 Vaccine (ChAdOx1-S [recombinant])

Investigational medicinal product code

Other name

Vaxzevria

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received one dose of COVID-19 Vaccine (ChAdOx1-S [recombinant]) (0.5mL Vaxzevria, (not less than 2.5 × 108 infectious units (Inf.U) Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein (ChAdOx1-S)) intramuscular on Day 28.

Group 1D: Pfizer low dose scheme

Arm description

Subjects received a low dose of BNT162b2 followed by a low dose of BNT162b2 administered intramuscularly 28 days apart.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Comirnaty

Pharmaceutical forms

Dispersion for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received one dose of 0.2 mL BNT162b2 (20 micrograms of COVID-19 mRNA Vaccine) intramuscular on Day 0 and Day 28.

Group 1E: Pfizer long interval scheme

Arm description

Subjects received a standard dose of BNT162b2 followed by a standard dose of BNT162b2 administered intramuscularly 12 weeks apart.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Comirnaty

Pharmaceutical forms

Dispersion for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received one dose of 0.3mL BNT162b2 (30 micrograms of COVID-19 mRNA Vaccine) intramuscular on Day 0 and Day 84.

Group 1F: Pfizer intradermal scheme

Arm description

Subjects received BNT162b2 followed by BNT162b2 administered intradermal 28 days apart.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Comirnaty

Pharmaceutical forms

Dispersion for injection

Routes of administration

Intradermal use

Dosage and administration details

Subjects received one dose of 0.06 mL BNT162b2 (6 micrograms of COVID-19 mRNA Vaccine) intradermal on Day 0 and Day 28.

Group 3A: Moderna regular scheme

Arm description

Subjects received a standard dose of mRNA-1273, followed by a standard dose of mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Arm type

Active comparator

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Spikevax

Pharmaceutical forms

Dispersion for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received one dose of 0.5mL mRNA-1273 (100 microgram mRNA) intramuscular on Day 0 and Day 28.

Group 3B: Moderna low dose scheme

Arm description

Subjects received a low dose of mRNA-1273, followed by a low dose of mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Spikevax

Pharmaceutical forms

Dispersion for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received one dose of 0.25mL mRNA-1273 (50 microgram mRNA) intramuscular on Day 0 and Day 28.

Notes
[1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
Justification: The trial is partially single blind. Subjects and study personnel, not involved in vaccine administration, are not informed about the brand and dose of the 1st & 2nd study vaccination, until 14 days after the 2nd vaccination, when the reporting period of adverse events is finished. For the intradermal administration and long-interval randomization groups, the subjects and personnel will know the brand of the vaccine, due the trial design nature.

Number of subjects in period 1	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Started	67	77	63	72	72	72	70	73
Completed	65	73	61	69	62	65	65	71
Not completed	2	4	2	3	10	7	5	2
Consent withdrawn by subject	-	-	1	2	6	3	3	1
Physician decision	-	-	1	-	-	-	-	-
Went abroad	-	-	-	-	1	-	-	-
Lost to follow-up	2	4	-	1	3	4	2	1

Baseline characteristics

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Reporting group title

Group 1A: Pfizer regular scheme

Reporting group description

Subjects received a standard dose of BNT162b2 followed by a standard dose of BNT162b2 administered intramuscularly 28 days apart, as foreseen per the standard dosing scheme.

Reporting group title

Group 1B: Pfizer - Moderna scheme

Reporting group description

Subjects received a standard dose BNT162b2 followed by a standard dose mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Reporting group title

Group 1 C: Pfizer-AstraZeneca scheme

Reporting group description

Subjects received a standerd dose of BNT162b2 followed by a standard dose of COVID-19 Vaccine (ChAdOx1-S [recombinant]) administered intramuscularly 28 days apart.

Reporting group title

Group 1D: Pfizer low dose scheme

Reporting group description

Subjects received a low dose of BNT162b2 followed by a low dose of BNT162b2 administered intramuscularly 28 days apart.

Reporting group title

Group 1E: Pfizer long interval scheme

Reporting group description

Subjects received a standard dose of BNT162b2 followed by a standard dose of BNT162b2 administered intramuscularly 12 weeks apart.

Reporting group title

Group 1F: Pfizer intradermal scheme

Reporting group description

Subjects received BNT162b2 followed by BNT162b2 administered intradermal 28 days apart.

Reporting group title

Group 3A: Moderna regular scheme

Reporting group description

Subjects received a standard dose of mRNA-1273, followed by a standard dose of mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Reporting group title

Group 3B: Moderna low dose scheme

Reporting group description

Subjects received a low dose of mRNA-1273, followed by a low dose of mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Reporting group values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme	Total
Number of subjects	67	77	63	72	72	72	70	73	566
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0	0
Adults (18-64 years)	67	77	63	72	72	72	70	73	566
From 65-84 years	0	0	0	0	0	0	0	0	0
85 years and over	0	0	0	0	0	0	0	0	0
Gender categorical
Units: Subjects
Female	31	37	37	33	35	36	36	38	283
Male	36	40	26	39	37	36	34	35	283

End points

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Reporting group title

Group 1A: Pfizer regular scheme

Reporting group description

Subjects received a standard dose of BNT162b2 followed by a standard dose of BNT162b2 administered intramuscularly 28 days apart, as foreseen per the standard dosing scheme.

Reporting group title

Group 1B: Pfizer - Moderna scheme

Reporting group description

Subjects received a standard dose BNT162b2 followed by a standard dose mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Reporting group title

Group 1 C: Pfizer-AstraZeneca scheme

Reporting group description

Subjects received a standerd dose of BNT162b2 followed by a standard dose of COVID-19 Vaccine (ChAdOx1-S [recombinant]) administered intramuscularly 28 days apart.

Reporting group title

Group 1D: Pfizer low dose scheme

Reporting group description

Subjects received a low dose of BNT162b2 followed by a low dose of BNT162b2 administered intramuscularly 28 days apart.

Reporting group title

Group 1E: Pfizer long interval scheme

Reporting group description

Subjects received a standard dose of BNT162b2 followed by a standard dose of BNT162b2 administered intramuscularly 12 weeks apart.

Reporting group title

Group 1F: Pfizer intradermal scheme

Reporting group description

Subjects received BNT162b2 followed by BNT162b2 administered intradermal 28 days apart.

Reporting group title

Group 3A: Moderna regular scheme

Reporting group description

Subjects received a standard dose of mRNA-1273, followed by a standard dose of mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Reporting group title

Group 3B: Moderna low dose scheme

Reporting group description

Subjects received a low dose of mRNA-1273, followed by a low dose of mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Primary: Geometric mean titer of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain 28days post second study vaccination

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End point title

Geometric mean titer of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain 28days post second study vaccination

End point description

Primary endpoint analyses are performed on a modified Intention-To-Treat population (mITT). This mITT comprises of eligible participants who where still in the study at the primary endpoint visit, seronegative for COVID-19 at baseline, received both study vaccines, did not receive a vaccine outside the study 14 days after each study vaccination, did not receive a COVID-19 vaccine outside the study, and had not been identified with a COVID-19 infection before or on the primary endpoint evaluation visit. Antibody responses at baseline and after vaccination were assessed using an enzyme-linked immunosorbent assay (ELISA) for the quantitative detection of IgG-class antibodies to Receptor Binding Domain (RBD). The GMT outcome measures is used to assess the non-inferiority of the humoral immune response against SARS-Cov-2 infection of different vaccines and adapted vaccine schedules in comparison with the reference schedule, after 2 vaccine doses.

End point type

Primary

End point timeframe

28 days post second study vaccination

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	57	68	59	69	51	67	66	68
Units: Titers
geometric mean (confidence interval 95%)	3325 (2765 to 3997)	4394 (3703 to 5213)	1352 (1101 to 1660)	2770 (2333 to 3290)	3006 (2481 to 3643)	2059 (1732 to 2448)	5094 (3791 to 6847)	4912 (3659 to 6595)

GMT ratio for group 1b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1B compared to reference schedule 1A in IgG levels 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1B: Pfizer - Moderna scheme

Number of subjects included in analysis

125

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0 ^[1]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.32

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.98

upper limit

Notes
[1] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority.

GMT ratio for group 1c

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1C compared to reference schedule 1A in IgG levels 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1 C: Pfizer-AstraZeneca scheme

Number of subjects included in analysis

116

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 1 ^[2]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.41

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.29

upper limit

Notes
[2] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1d

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1D compared to reference schedule 1A in IgG levels 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1D: Pfizer low dose scheme

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.008 ^[3]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.83

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.62

upper limit

Notes
[3] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1e

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1E compared to reference schedule 1A in IgG levels 28 days post second vaccine.

Comparison groups

Group 1E: Pfizer long interval scheme v Group 1A: Pfizer regular scheme

Number of subjects included in analysis

108

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.002 ^[4]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.66

upper limit

Notes
[4] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1f

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1F compared to reference schedule 1A in IgG levels 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1F: Pfizer intradermal scheme

Number of subjects included in analysis

124

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.564 ^[5]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.62

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.46

upper limit

Notes
[5] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority.

GMT ratio for group 3b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 3B compared to reference schedule 3A in IgG levels 28 days post second vaccine.

Comparison groups

Group 3A: Moderna regular scheme v Group 3B: Moderna low dose scheme

Number of subjects included in analysis

134

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0 ^[6]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.96

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.79

upper limit

Notes
[6] - For the Moderna comparison a p-value < 0.025 implies non-inferiority

Secondary: Numer of subjects with absenteeism (at least one day) from work after first vaccination

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End point title

Numer of subjects with absenteeism (at least one day) from work after first vaccination

End point description

To assess the impact of all different vaccination schedules on productivity, participants were asked to provide information regarding absenteeism from work within five days after the first study vaccination. Only participants in the mITT population who were employed at the time of completing the questionnaire are included.

End point type

Secondary

End point timeframe

Absenteeism for at least one day within 5 days after first study vaccination.

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	42	52	51	46	37	48	48	51
Units: Number of participants	1	2	1	1	2	0	6	1

No statistical analyses for this end point

Secondary: Numer of subjects with absenteeism from work (at least one day) after second vaccination

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End point title

Numer of subjects with absenteeism from work (at least one day) after second vaccination

End point description

To assess the impact of all different vaccination schedules on productivity, participants were asked to provide information regarding absenteeism from work within five days after the second study vaccination. Only participants in the mITT population who were employed at the time of completing the questionnaire are included.

End point type

Secondary

End point timeframe

Absenteeism within 5 days after second study vaccination.

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	41	54	51	53	40	46	53	49
Units: Subjects	3	21	18	2	4	2	16	9

No statistical analyses for this end point

Secondary: Geometric mean titer of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain 28 days post third study vaccination

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End point title

Geometric mean titer of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain 28 days post third study vaccination

End point description

This non-inferiority analysis is performed on the mITT population, which includes participants who received three COVID-19 vaccines as per study protocol, did not experience a breakthrough infection, and did not receive a COVID-19 vaccine outside of the study (n=271). Therefore, this analysis investigates the pure vaccine effect 28 days after the third COVID-19 vaccine. Antibody responses at baseline and after vaccination were assessed using an enzyme-linked immunosorbent assay (ELISA) for the quantitative detection of IgG-class antibodies to Receptor Binding Domain (RBD). The GMT outcome measures is used to assess the non-inferiority of the humoral immune response against SARS-Cov-2 infection of different vaccines and adapted vaccine schedules in comparison with the reference schedule, after 3 vaccine doses.

End point type

Secondary

End point timeframe

28 days post third vaccination

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	30	31	34	35	29	35	35	42
Units: Titers
geometric mean (confidence interval 95%)	3011 (2399 to 3780)	3433 (2758 to 4274)	3305 (2593 to 4213)	2990 (2419 to 3697)	2980 (2357 to 3768)	3350 (2707 to 4145)	4107 (3068 to 5499)	3392 (2546 to 4521)

GMT ratio for group 1b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1B compared to reference schedule 1A in IgG levels 28 days post third vaccine.

Comparison groups

Group 1B: Pfizer - Moderna scheme v Group 1A: Pfizer regular scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.000048 ^[7]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.14

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.78

upper limit

Notes
[7] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority.

GMT ratio for group 1c

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1C compared to reference schedule 1A in IgG levels 28 days post third vaccine.

Comparison groups

Group 1 C: Pfizer-AstraZeneca scheme v Group 1A: Pfizer regular scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.000378 ^[8]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.1

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.72

upper limit

Notes
[8] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1d

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1D compared to reference schedule 1A in IgG levels 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1D: Pfizer low dose scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.000894 ^[9]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.99

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.68

upper limit

Notes
[9] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1e

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1E compared to reference schedule 1A in IgG levels 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1E: Pfizer long interval scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.001486

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.99

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.67

upper limit

GMT ratio for group 1f

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1F compared to reference schedule 1A in IgG levels 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1F: Pfizer intradermal scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.000053 ^[10]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.11

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.77

upper limit

Notes
[10] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 3b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 3B compared to reference schedule 3A in IgG levels 28 days post third vaccine.

Comparison groups

Group 3A: Moderna regular scheme v Group 3B: Moderna low dose scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.010742 ^[11]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.83

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.66

upper limit

Notes
[11] - For the Moderna comparison a p-value < 0.025 implies non-inferiority

Secondary: Geometric mean titer of neutralizing antibodies binding to Wuhan NT50 at 28 days after second study vaccination

Top of page

End point title

Geometric mean titer of neutralizing antibodies binding to Wuhan NT50 at 28 days after second study vaccination

End point description

Neutralizing antibody capacity against Wuhan was tested with a neutralisation assay on all available serum samples of the modified Intention-To-Treat population at 28 days after second study vaccination.

End point type

Secondary

End point timeframe

28 days after second study vaccination

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	57	66	59	69	51	67	66	68
Units: Titers
geometric mean (confidence interval 95%)	643 (521 to 794)	815 (666 to 997)	388 (305 to 492)	541 (443 to 661)	1451 (1168 to 1803)	432 (353 to 527)	958 (797 to 1152)	932 (776 to 1119)

GMT ratio for group 1b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1B compared to reference schedule 1A in nAB Wuhan NT50 at 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1B: Pfizer - Moderna scheme

Number of subjects included in analysis

123

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0 ^[12]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.27

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.95

upper limit

Notes
[12] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1c

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1C compared to reference schedule 1A in nAB Wuhan NT50 at 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1 C: Pfizer-AstraZeneca scheme

Number of subjects included in analysis

116

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.64204 ^[13]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.6

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.43

upper limit

Notes
[13] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority.

GMT ratio for group 1d

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1D compared to reference schedule 1A in nAB Wuhan NT50 at 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1D: Pfizer low dose scheme

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.00455 ^[14]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.84

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.63

upper limit

Notes
[14] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1e

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1E compared to reference schedule 1A in nAB Wuhan NT50 at 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1E: Pfizer long interval scheme

Number of subjects included in analysis

108

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0 ^[15]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

2.26

Confidence interval

level

97.5%

sides

1-sided

lower limit

1.66

upper limit

Notes
[15] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority.

GMT ratio for group 1f

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1F compared to reference schedule 1A in nAB Wuhan NT50 at 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1F: Pfizer intradermal scheme

Number of subjects included in analysis

124

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.28896 ^[16]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.67

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.5

upper limit

Notes
[16] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority.

GMT ratio for group 3b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 3B compared to reference schedule 3A in nAB Wuhan NT50 at 28 days post second vaccine.

Comparison groups

Group 3A: Moderna regular scheme v Group 3B: Moderna low dose scheme

Number of subjects included in analysis

134

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0 ^[17]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.97

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.81

upper limit

Notes
[17] - For the Moderna comparison a p-value < 0.025 implies non-inferiority

Secondary: Geometric mean titer of neutralizing antibodies binding to Delta NT50 at 28 days after second study vaccination

Top of page

End point title

Geometric mean titer of neutralizing antibodies binding to Delta NT50 at 28 days after second study vaccination

End point description

Neutralizing antibody capacity against Delta was tested with a neutralisation assay on a subset of available serum samples of the modified Intention-To-Treat population at 28 days after second study vaccination.

End point type

Secondary

End point timeframe

28 days after 2nd study vaccination

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	29	30	30	30	28	30	30	30
Units: Titer
geometric mean (confidence interval 95%)	109 (88 to 135)	133 (108 to 164)	70 (54 to 90)	104 (84 to 128)	221 (178 to 275)	64 (52 to 79)	146 (118 to 181)	148 (119 to 184)

GMT ratio for group 1b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1B compared to reference schedule 1A in nAB Delta NT50 at 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1B: Pfizer - Moderna scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.00001 ^[18]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.22

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.83

upper limit

Notes
[18] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1c

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1C compared to reference schedule 1A in nAB Delta NT50 at 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1 C: Pfizer-AstraZeneca scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.45626 ^[19]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.64

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.42

upper limit

Notes
[19] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority.

GMT ratio for group 1d

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1D compared to reference schedule 1A in nAB Delta NT50 at 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1D: Pfizer low dose scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.00313 ^[20]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.96

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.65

upper limit

Notes
[20] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority.

GMT ratio for group 1e

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1E compared to reference schedule 1A in nAB Delta NT50 at 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1E: Pfizer long interval scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0 ^[21]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

2.03

Confidence interval

level

97.5%

sides

1-sided

lower limit

1.36

upper limit

Notes
[21] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority.

GMT ratio for group 1f

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1F compared to reference schedule 1A in nAB Delta NT50 at 28 days post second vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1F: Pfizer intradermal scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.67547 ^[22]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.59

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.4

upper limit

Notes
[22] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority.

GMT ratio for group 3b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 3B compared to reference schedule 3A in nAB Delta NT50 at 28 days post second vaccine.

Comparison groups

Group 3B: Moderna low dose scheme v Group 3A: Moderna regular scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.00146 ^[23]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.01

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.75

upper limit

Notes
[23] - For the Moderna comparison a p-value < 0.025 implies non-inferiority

Secondary: Geometric mean titer of neutralizing antibodies binding to Wuhan NT50 at 28 days after third vaccination

Top of page

End point title

Geometric mean titer of neutralizing antibodies binding to Wuhan NT50 at 28 days after third vaccination

End point description

Neutralizing antibody capacity against Wuhan was tested with a neutralisation assay at 28 days after third vaccination. Only COVID-19 naïve participants from the humoral immunogenicity subset of the modified Intention-To-treat population are included in this analysis.

End point type

Secondary

End point timeframe

28 days after third vaccination

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	17	19	16	15	15	16	19	22
Units: Titer
geometric mean (confidence interval 95%)	1990 (1328 to 3190)	1730 (1163 to 2574)	2947 (1824 to 4763)	1948 (1266 to 2996)	1682 (1104 to 2563)	1907 (1274 to 2853)	2721 (1220 to 6067)	1640 (793 to 3394)

GMT ratio for group 1b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1B compared to reference schedule 1A in nAB Wuhan NT50 at 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1B: Pfizer - Moderna scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.08971 ^[24]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.87

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.47

upper limit

Notes
[24] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1c

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1C compared to reference schedule 1A in nAB Wuhan NT50 at 28 days post third vaccine.

Comparison groups

Group 1 C: Pfizer-AstraZeneca scheme v Group 1A: Pfizer regular scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.00112 ^[25]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.48

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.73

upper limit

Notes
[25] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1d

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1D compared to reference schedule 1A in nAB Wuhan NT50 at 28 days post third vaccine.

Comparison groups

Group 1D: Pfizer low dose scheme v Group 1A: Pfizer regular scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.04197 ^[26]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.98

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.51

upper limit

Notes
[26] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1e

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1E compared to reference schedule 1A in nAB Wuhan NT50 at 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1E: Pfizer long interval scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.12448 ^[27]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.85

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.44

upper limit

Notes
[27] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1f

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1F compared to reference schedule 1A in nAB Wuhan NT50 at 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1F: Pfizer intradermal scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.04843 ^[28]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.96

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.5

upper limit

Notes
[28] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 3b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 3B compared to reference schedule 3A in nAB Wuhan NT50 at 28 days post third vaccine.

Comparison groups

Group 3A: Moderna regular scheme v Group 3B: Moderna low dose scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.57356 ^[29]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.6

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.37

upper limit

Notes
[29] - For the Moderna comparison a p-value < 0.025 implies non-inferiority

Secondary: Geometric mean titer of neutralizing antibodies binding to Delta NT50 at 28 days after third vaccination

Top of page

End point title

Geometric mean titer of neutralizing antibodies binding to Delta NT50 at 28 days after third vaccination

End point description

Neutralizing antibody capacity against Delta was tested with a neutralisation assay at 28 days after third vaccination. Only COVID-19 naïve participants from the humoral immunogenicity subset of the modified Intention-To-treat population are included in this analysis.

End point type

Secondary

End point timeframe

28 days after third vaccination

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	17	19	16	15	15	16	19	22
Units: Titer
geometric mean (confidence interval 95%)	571 (379 to 861)	432 (290 to 641)	859 (524 to 1408)	663 (428 to 1026)	504 (325 to 783)	587 (385 to 894)	556 (226 to 1369)	354 (155 to 809)

GMT ratio for group 1b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1B compared to reference schedule 1A in nAB Delta NT50 at 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1B: Pfizer - Moderna scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.24595 ^[30]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.76

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.38

upper limit

Notes
[30] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1c

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1C compared to reference schedule 1A in nAB Delta NT50 at 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1 C: Pfizer-AstraZeneca scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.00238 ^[31]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.5

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.68

upper limit

Notes
[31] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1d

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1D compared to reference schedule 1A in nAB Delta NT50 at 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1D: Pfizer low dose scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.01548 ^[32]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.16

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.56

upper limit

Notes
[32] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1e

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1E compared to reference schedule 1A in nAB Delta NT50 at 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1E: Pfizer long interval scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.11509 ^[33]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.88

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.42

upper limit

Notes
[33] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 1f

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 1F compared to reference schedule 1A in nAB Delta NT50 at 28 days post third vaccine.

Comparison groups

Group 1A: Pfizer regular scheme v Group 1F: Pfizer intradermal scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.03962 ^[34]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

1.03

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.5

upper limit

Notes
[34] - For the Pfizer comparisons a p-value <0.005 implies non-inferiority

GMT ratio for group 3b

Statistical analysis description

Demonstrate non-inferiority of adapted schedule 3B compared to reference schedule 3A in nAB Delta NT50 at 28 days post third vaccine.

Comparison groups

Group 3A: Moderna regular scheme v Group 3B: Moderna low dose scheme

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.48837 ^[35]

Method

Mixed models analysis

Parameter type

GMT ratio

Point estimate

0.64

Confidence interval

level

97.5%

sides

1-sided

lower limit

0.38

upper limit

Notes
[35] - For the Moderna comparison a p-value < 0.025 implies non-inferiority

Secondary: Number of participants with at least one solicited local adverse events

Top of page

End point title

Number of participants with at least one solicited local adverse events

End point description

The number of participants in the modified Intention-To-Treat population who reported at least one solicited local adverse event are reported. Following solicited local adverse events were surveyed among the participants through a diary: injection site erythema, injection site induration, injection site pain tenderness and injection site swelling.

End point type

Secondary

End point timeframe

14 days after first and second vaccination

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	57	68	59	69	52	67	66	68
Units: Participants	56	68	59	68	50	66	66	68

No statistical analyses for this end point

Secondary: Number of participants with at least one solicited systemic adverse events

Top of page

End point title

Number of participants with at least one solicited systemic adverse events

End point description

The number of participants in the modified Intention-To-Treat population who reported at least one solicited systemic adverse event are reported. Following solicited systemic adverse events were surveyed among the participants through a diary: arthralgia, chest pain, chills, dyspnoea, fatigue, headache, malaise, myalgia, nausea, neurological symptom, petechiae, pyrexia and vomiting.

End point type

Secondary

End point timeframe

14 days after fisrt and second vaccination

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	57	68	59	69	52	67	66	68
Units: Number of participants	52	64	54	57	33	55	64	58

No statistical analyses for this end point

Secondary: Number of participants with at least one unsolicited adverse events

Top of page

End point title

Number of participants with at least one unsolicited adverse events

End point description

The number of participants in the modified Intention-To-Treat population who reported at least one unsolicited adverse event are reported. Unsolicited adverse events were surveyed among the participants through a diary.

End point type

Secondary

End point timeframe

14 days after first and second vaccination

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	57	68	59	69	52	67	66	68
Units: Number of participants	28	36	29	29	26	48	36	40

No statistical analyses for this end point

Secondary: Number of participants with at least one severe adverse events

Top of page

End point title

Number of participants with at least one severe adverse events

End point description

End point type

Secondary

End point timeframe

Throughout the entire study

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	67	77	63	72	72	72	70	73
Units: Number of participants	2	4	3	9	2	0	1	5

No statistical analyses for this end point

Post-hoc: Number of participants in the modified intention to treat population, who completed the trial final visit and received a third COVID-19 vaccine, with a breakthrough infection after primary endpoint

Top of page

End point title

Number of participants in the modified intention to treat population, who completed the trial final visit and received a third COVID-19 vaccine, with a breakthrough infection after primary endpoint

End point description

End point type

Post-hoc

End point timeframe

Between primary endpoint evaluation and final visit.

End point values	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Number of subjects analysed	55	55	51	63	46	58	58	60
Units: Number of participants	36	45	31	50	39	39	48	42

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Solicited AEs: from time of vaccination until 5 days post-study-vaccination for 1st and 2nd vaccination. Unsolicited AEs: from time of vaccination until 14 days post-study-vaccination for 1st and 2nd vaccination. SAE, AESI and MAAE: entire study period

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Group 1A: Pfizer regular scheme

Reporting group description

Subjects received a standard dose of BNT162b2 followed by a standard dose of BNT162b2 administered intramuscularly 28 days apart, as foreseen per the standard dosing scheme.

Reporting group title

Group 1B: Pfizer - Moderna scheme

Reporting group description

Subjects received a standard dose BNT162b2 followed by a standard dose mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Reporting group title

Group 1 C: Pfizer-AstraZeneca scheme

Reporting group description

Subjects received a standerd dose of BNT162b2 followed by a standard dose of COVID-19 Vaccine (ChAdOx1-S [recombinant]) administered intramuscularly 28 days apart.

Reporting group title

Group 1D: Pfizer low dose scheme

Reporting group description

Subjects received a low dose of BNT162b2 followed by a low dose of BNT162b2 administered intramuscularly 28 days apart.

Reporting group title

Group 1E: Pfizer long interval scheme

Reporting group description

Subjects received a standard dose of BNT162b2 followed by a standard dose of BNT162b2 administered intramuscularly 12 weeks apart.

Reporting group title

Group 1F: Pfizer intradermal scheme

Reporting group description

Subjects received BNT162b2 followed by BNT162b2 administered intradermal 28 days apart.

Reporting group title

Group 3A: Moderna regular scheme

Reporting group description

Subjects received a standard dose of mRNA-1273, followed by a standard dose of mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Reporting group title

Group 3B: Moderna low dose scheme

Reporting group description

Subjects received a low dose of mRNA-1273, followed by a low dose of mRNA-1273 Vaccine administered intramuscularly 28 days apart.

Serious adverse events	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 67 (2.99%)	4 / 77 (5.19%)	3 / 63 (4.76%)	6 / 72 (8.33%)	2 / 72 (2.78%)	0 / 72 (0.00%)	1 / 70 (1.43%)	5 / 73 (6.85%)
number of deaths (all causes)	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Wrist fracture
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	1 / 63 (1.59%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Clavicle fracture
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	2 / 73 (2.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spinal fracture
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Splenic rupture
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cartilage injury
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	1 / 77 (1.30%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meniscus injury
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	1 / 77 (1.30%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Scar
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 67 (1.49%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Gastric bypass
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	1 / 63 (1.59%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nasal septal operation
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intervertebral disc operation
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mammoplasty
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	1 / 77 (1.30%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Carotid artery occlusion
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 67 (1.49%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	1 / 77 (1.30%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis noninfective
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	1 / 70 (1.43%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Biliary colic
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Nephrolithiasis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Invertebral disc degeneration
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	1 / 73 (1.37%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Diverticulitis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	1 / 63 (1.59%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	1 / 73 (1.37%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonsillar abscess
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	1 / 73 (1.37%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Group 1A: Pfizer regular scheme	Group 1B: Pfizer - Moderna scheme	Group 1 C: Pfizer-AstraZeneca scheme	Group 1D: Pfizer low dose scheme	Group 1E: Pfizer long interval scheme	Group 1F: Pfizer intradermal scheme	Group 3A: Moderna regular scheme	Group 3B: Moderna low dose scheme
Total subjects affected by non serious adverse events
subjects affected / exposed	67 / 67 (100.00%)	77 / 77 (100.00%)	63 / 63 (100.00%)	72 / 72 (100.00%)	69 / 72 (95.83%)	72 / 72 (100.00%)	69 / 70 (98.57%)	73 / 73 (100.00%)
Nervous system disorders
Dizziness
alternative assessment type: Non-systematic
subjects affected / exposed	2 / 67 (2.99%)	4 / 77 (5.19%)	2 / 63 (3.17%)	3 / 72 (4.17%)	2 / 72 (2.78%)	0 / 72 (0.00%)	2 / 70 (2.86%)	4 / 73 (5.48%)
occurrences all number	3	5	2	3	2	0	2	5
Headache
subjects affected / exposed	45 / 67 (67.16%)	59 / 77 (76.62%)	48 / 63 (76.19%)	37 / 72 (51.39%)	28 / 72 (38.89%)	40 / 72 (55.56%)	44 / 70 (62.86%)	46 / 73 (63.01%)
occurrences all number	57	94	74	50	42	53	70	73
General disorders and administration site conditions
Axillary pain
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	1 / 72 (1.39%)	0 / 72 (0.00%)	2 / 70 (2.86%)	4 / 73 (5.48%)
occurrences all number	0	0	0	0	1	0	2	4
Chest pain
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 67 (1.49%)	3 / 77 (3.90%)	7 / 63 (11.11%)	5 / 72 (6.94%)	2 / 72 (2.78%)	2 / 72 (2.78%)	6 / 70 (8.57%)	5 / 73 (6.85%)
occurrences all number	1	4	7	6	3	2	6	9
Chills
subjects affected / exposed	12 / 67 (17.91%)	34 / 77 (44.16%)	28 / 63 (44.44%)	10 / 72 (13.89%)	3 / 72 (4.17%)	4 / 72 (5.56%)	34 / 70 (48.57%)	26 / 73 (35.62%)
occurrences all number	12	35	29	10	4	4	36	26
Fatigue
subjects affected / exposed	53 / 67 (79.10%)	66 / 77 (85.71%)	51 / 63 (80.95%)	54 / 72 (75.00%)	35 / 72 (48.61%)	48 / 72 (66.67%)	51 / 70 (72.86%)	53 / 73 (72.60%)
occurrences all number	76	96	75	75	51	67	89	85
Injection Site Bruising
alternative assessment type: Non-systematic
subjects affected / exposed	2 / 67 (2.99%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	6 / 72 (8.33%)	1 / 70 (1.43%)	0 / 73 (0.00%)
occurrences all number	2	0	0	0	0	7	1	0
Injection site discolouration
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	4 / 72 (5.56%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences all number	0	0	0	0	0	6	0	0
Injection site discomfort
subjects affected / exposed	36 / 67 (53.73%)	42 / 77 (54.55%)	19 / 63 (30.16%)	37 / 72 (51.39%)	37 / 72 (51.39%)	45 / 72 (62.50%)	28 / 70 (40.00%)	35 / 73 (47.95%)
occurrences all number	66	68	31	59	63	77	47	52
Injection site erythema
subjects affected / exposed	4 / 67 (5.97%)	10 / 77 (12.99%)	8 / 63 (12.70%)	3 / 72 (4.17%)	6 / 72 (8.33%)	69 / 72 (95.83%)	21 / 70 (30.00%)	17 / 73 (23.29%)
occurrences all number	5	12	8	3	6	140	34	18
Injection site haemorrhage
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	2 / 77 (2.60%)	0 / 63 (0.00%)	0 / 72 (0.00%)	1 / 72 (1.39%)	4 / 72 (5.56%)	3 / 70 (4.29%)	3 / 73 (4.11%)
occurrences all number	0	2	0	0	1	5	4	3
Injection site induration
subjects affected / exposed	6 / 67 (8.96%)	21 / 77 (27.27%)	8 / 63 (12.70%)	5 / 72 (6.94%)	9 / 72 (12.50%)	27 / 72 (37.50%)	22 / 70 (31.43%)	19 / 73 (26.03%)
occurrences all number	9	28	9	9	12	40	30	23
Injection site movement impairment
alternative assessment type: Non-systematic
subjects affected / exposed	4 / 67 (5.97%)	4 / 77 (5.19%)	5 / 63 (7.94%)	5 / 72 (6.94%)	2 / 72 (2.78%)	0 / 72 (0.00%)	5 / 70 (7.14%)	6 / 73 (8.22%)
occurrences all number	5	6	5	7	3	0	5	6
Inejction site pain
subjects affected / exposed	62 / 67 (92.54%)	75 / 77 (97.40%)	58 / 63 (92.06%)	59 / 72 (81.94%)	51 / 72 (70.83%)	49 / 72 (68.06%)	67 / 70 (95.71%)	71 / 73 (97.26%)
occurrences all number	109	126	99	104	88	71	133	120
Injection site pruritus
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 67 (1.49%)	2 / 77 (2.60%)	2 / 63 (3.17%)	1 / 72 (1.39%)	1 / 72 (1.39%)	26 / 72 (36.11%)	6 / 70 (8.57%)	5 / 73 (6.85%)
occurrences all number	1	3	2	1	1	33	6	6
Injection site swelling
subjects affected / exposed	3 / 67 (4.48%)	11 / 77 (14.29%)	5 / 63 (7.94%)	2 / 72 (2.78%)	4 / 72 (5.56%)	47 / 72 (65.28%)	15 / 70 (21.43%)	13 / 73 (17.81%)
occurrences all number	3	12	5	3	5	74	18	16
Injection site warmth
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	6 / 77 (7.79%)	2 / 63 (3.17%)	1 / 72 (1.39%)	1 / 72 (1.39%)	4 / 72 (5.56%)	4 / 70 (5.71%)	2 / 73 (2.74%)
occurrences all number	0	7	2	1	1	5	6	2
Malaise
subjects affected / exposed	21 / 67 (31.34%)	48 / 77 (62.34%)	39 / 63 (61.90%)	22 / 72 (30.56%)	9 / 72 (12.50%)	13 / 72 (18.06%)	36 / 70 (51.43%)	38 / 73 (52.05%)
occurrences all number	24	50	42	25	10	15	39	40
Pyrexia
subjects affected / exposed	5 / 67 (7.46%)	27 / 77 (35.06%)	18 / 63 (28.57%)	5 / 72 (6.94%)	2 / 72 (2.78%)	1 / 72 (1.39%)	22 / 70 (31.43%)	9 / 73 (12.33%)
occurrences all number	5	28	24	5	2	1	22	9
Gastrointestinal disorders
Abdominal pain
alternative assessment type: Non-systematic
subjects affected / exposed	3 / 67 (4.48%)	9 / 77 (11.69%)	5 / 63 (7.94%)	6 / 72 (8.33%)	2 / 72 (2.78%)	2 / 72 (2.78%)	3 / 70 (4.29%)	6 / 73 (8.22%)
occurrences all number	3	9	5	6	2	2	3	7
Diarrhoea
alternative assessment type: Non-systematic
subjects affected / exposed	3 / 67 (4.48%)	3 / 77 (3.90%)	3 / 63 (4.76%)	5 / 72 (6.94%)	1 / 72 (1.39%)	4 / 72 (5.56%)	3 / 70 (4.29%)	3 / 73 (4.11%)
occurrences all number	3	3	3	5	1	8	3	3
Nausea
subjects affected / exposed	10 / 67 (14.93%)	24 / 77 (31.17%)	20 / 63 (31.75%)	9 / 72 (12.50%)	12 / 72 (16.67%)	9 / 72 (12.50%)	24 / 70 (34.29%)	24 / 73 (32.88%)
occurrences all number	12	27	22	11	13	11	27	27
Vomiting
subjects affected / exposed	1 / 67 (1.49%)	4 / 77 (5.19%)	4 / 63 (6.35%)	1 / 72 (1.39%)	2 / 72 (2.78%)	2 / 72 (2.78%)	4 / 70 (5.71%)	1 / 73 (1.37%)
occurrences all number	1	4	4	1	2	2	4	1
Respiratory, thoracic and mediastinal disorders
Cough
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 67 (1.49%)	3 / 77 (3.90%)	5 / 63 (7.94%)	1 / 72 (1.39%)	4 / 72 (5.56%)	1 / 72 (1.39%)	0 / 70 (0.00%)	3 / 73 (4.11%)
occurrences all number	1	4	5	1	4	1	0	3
Dyspnoea
subjects affected / exposed	4 / 67 (5.97%)	7 / 77 (9.09%)	6 / 63 (9.52%)	2 / 72 (2.78%)	1 / 72 (1.39%)	1 / 72 (1.39%)	3 / 70 (4.29%)	6 / 73 (8.22%)
occurrences all number	4	7	6	2	2	1	3	7
Oropharyngeal pain
alternative assessment type: Non-systematic
subjects affected / exposed	2 / 67 (2.99%)	4 / 77 (5.19%)	3 / 63 (4.76%)	2 / 72 (2.78%)	2 / 72 (2.78%)	5 / 72 (6.94%)	3 / 70 (4.29%)	3 / 73 (4.11%)
occurrences all number	2	4	3	3	2	5	4	3
Skin and subcutaneous tissue disorders
Eczema
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	1 / 77 (1.30%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	0 / 70 (0.00%)	3 / 73 (4.11%)
occurrences all number	0	1	0	0	0	0	0	4
Pruritus
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	1 / 77 (1.30%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	4 / 72 (5.56%)	1 / 70 (1.43%)	0 / 73 (0.00%)
occurrences all number	0	1	0	0	0	4	1	0
Skin hyperpigmentation
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	0 / 77 (0.00%)	0 / 63 (0.00%)	0 / 72 (0.00%)	0 / 72 (0.00%)	4 / 72 (5.56%)	0 / 70 (0.00%)	0 / 73 (0.00%)
occurrences all number	0	0	0	0	0	4	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	13 / 67 (19.40%)	27 / 77 (35.06%)	24 / 63 (38.10%)	15 / 72 (20.83%)	10 / 72 (13.89%)	6 / 72 (8.33%)	22 / 70 (31.43%)	17 / 73 (23.29%)
occurrences all number	14	28	27	17	12	7	25	20
Back pain
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 67 (0.00%)	1 / 77 (1.30%)	6 / 63 (9.52%)	3 / 72 (4.17%)	1 / 72 (1.39%)	4 / 72 (5.56%)	2 / 70 (2.86%)	0 / 73 (0.00%)
occurrences all number	0	1	6	3	1	5	2	0
Myalgia
subjects affected / exposed	27 / 67 (40.30%)	46 / 77 (59.74%)	27 / 63 (42.86%)	22 / 72 (30.56%)	13 / 72 (18.06%)	14 / 72 (19.44%)	36 / 70 (51.43%)	31 / 73 (42.47%)
occurrences all number	31	52	31	25	15	16	46	35
Infections and infestations
COVID-19
alternative assessment type: Non-systematic
subjects affected / exposed	26 / 67 (38.81%)	35 / 77 (45.45%)	26 / 63 (41.27%)	39 / 72 (54.17%)	31 / 72 (43.06%)	32 / 72 (44.44%)	40 / 70 (57.14%)	40 / 73 (54.79%)
occurrences all number	27	37	26	39	31	32	40	41
Nasopharyngitis
alternative assessment type: Non-systematic
subjects affected / exposed	5 / 67 (7.46%)	9 / 77 (11.69%)	4 / 63 (6.35%)	6 / 72 (8.33%)	4 / 72 (5.56%)	5 / 72 (6.94%)	7 / 70 (10.00%)	3 / 73 (4.11%)
occurrences all number	5	10	4	7	4	5	7	3
Pharyngitis
alternative assessment type: Non-systematic
subjects affected / exposed	2 / 67 (2.99%)	3 / 77 (3.90%)	1 / 63 (1.59%)	0 / 72 (0.00%)	0 / 72 (0.00%)	3 / 72 (4.17%)	2 / 70 (2.86%)	0 / 73 (0.00%)
occurrences all number	2	4	1	0	0	3	3	0

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Were there any global substantial amendments to the protocol? Yes

10 Jun 2021

Removal of groups 2a, 2b, 2c and 2d, due to the accelerated national vaccinatino campaign and age limitations for these study groups. No participants were recruited at that time in those study groups. Removal of age and gender stratification.

23 Dec 2021

Allow the participants to receive a COVID-19 vaccine outside of the trial, during the national vaccination campaign for a third COVID-19 vaccine dose. Addition of an ad hoc post 3rd COVID-19 vaccine dose visit.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/39019657

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Geometric mean titer of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain 28days post second study vaccination

Primary: Geometric mean titer of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain 28days post second study vaccination

Secondary: Numer of subjects with absenteeism (at least one day) from work after first vaccination

Secondary: Numer of subjects with absenteeism (at least one day) from work after first vaccination

Secondary: Numer of subjects with absenteeism from work (at least one day) after second vaccination

Secondary: Numer of subjects with absenteeism from work (at least one day) after second vaccination

Secondary: Geometric mean titer of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain 28 days post third study vaccination

Secondary: Geometric mean titer of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain 28 days post third study vaccination

Secondary: Geometric mean titer of neutralizing antibodies binding to Wuhan NT50 at 28 days after second study vaccination

Secondary: Geometric mean titer of neutralizing antibodies binding to Wuhan NT50 at 28 days after second study vaccination

Secondary: Geometric mean titer of neutralizing antibodies binding to Delta NT50 at 28 days after second study vaccination

Secondary: Geometric mean titer of neutralizing antibodies binding to Delta NT50 at 28 days after second study vaccination

Secondary: Geometric mean titer of neutralizing antibodies binding to Wuhan NT50 at 28 days after third vaccination

Secondary: Geometric mean titer of neutralizing antibodies binding to Wuhan NT50 at 28 days after third vaccination

Secondary: Geometric mean titer of neutralizing antibodies binding to Delta NT50 at 28 days after third vaccination

Secondary: Geometric mean titer of neutralizing antibodies binding to Delta NT50 at 28 days after third vaccination

Secondary: Number of participants with at least one solicited local adverse events

Secondary: Number of participants with at least one solicited local adverse events

Secondary: Number of participants with at least one solicited systemic adverse events

Secondary: Number of participants with at least one solicited systemic adverse events

Secondary: Number of participants with at least one unsolicited adverse events

Secondary: Number of participants with at least one unsolicited adverse events

Secondary: Number of participants with at least one severe adverse events

Secondary: Number of participants with at least one severe adverse events

Post-hoc: Number of participants in the modified intention to treat population, who completed the trial final visit and received a third COVID-19 vaccine, with a breakthrough infection after primary endpoint

Post-hoc: Number of participants in the modified intention to treat population, who completed the trial final visit and received a third COVID-19 vaccine, with a breakthrough infection after primary endpoint

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

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