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Clinical Trial Results:
A Randomized, Observer-blind, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive (HORIZON 2)

Summary
EudraCT number	2020-005720-11
Trial protocol	Outside EU/EEA
Global end of trial date	14 Aug 2023

Results information
Results version number	v1(current)
This version publication date	06 Mar 2024
First version publication date	06 Mar 2024
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

VAC31518COV3006

ISRCTN number

US NCT number

NCT05007080

WHO universal trial number (UTN)

Sponsor organisation name

Janssen Vaccines & Prevention B.V.

Sponsor organisation address

Newtonweg 1, Leiden, Netherlands, 2333 CP

Public contact

Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com

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

Yes

EMA paediatric investigation plan number(s)

EMEA-002880-PIP01-20

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?

Analysis stage

Final

Date of interim/final analysis

14 Aug 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

14 Aug 2023

Was the trial ended prematurely?

Main objective of the trial

The primary purpose of this study is to assess the safety, reactogenicity, and humoral immune response of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents.

Protection of trial subjects

This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

27 Sep 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 35

Country: Number of subjects enrolled

Brazil: 55

Country: Number of subjects enrolled

India: 108

Country: Number of subjects enrolled

Mexico: 37

Country: Number of subjects enrolled

South Africa: 64

Worldwide total number of subjects

299

EEA total number of subjects

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)

299

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Of the 304 randomized subjects, 3 subjects were randomized to an arm that was closed prior to vaccination due to ethical reasons and one was not vaccinated. One subject was excluded from the analysis due to lack of a valid informed consent form and is not presented in the below table.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Single blind ^[1]

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo

Arm description

Subjects received a single dose of Ad26.COV.S 2.5*10^10 virus particle (vp) as intramuscular (IM) injection on Day 1 and placebo matching to Ad26.COV.S 2.5*10^10 vp as IM injection on Day 57. Subjects were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Subjects received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received placebo matching to Ad26.COV2.S 2.5*10^10 vp administered as IM injection on Day 57.

Investigational medicinal product name

Ad26.COV2.S

Investigational medicinal product code

JNJ-78436735

Other name

Ad26COVS1, VAC31518

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received single dose of Ad26.COV2.S 2.5*10^10 vp administered as IM injection on Day 1 and Ad26.COV.S 2.5*10^10 vp as a booster vaccination on Day 184.

Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo

Arm description

Subjects received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 57. Subjects were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Subjects received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received placebo matching to Ad26.COV2.S 1.25*10^10 administered as IM injection on Day 57.

Investigational medicinal product name

Ad26.COV2.S

Investigational medicinal product code

JNJ-78436735

Other name

Ad26COVS1, VAC31518

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received single dose of Ad26.COV2.S 1.25*10^10 vp administered as IM injection on Day 1 and Ad26.COV.S 2.5*10^10 vp as a booster vaccination on Day 184.

Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo

Arm description

Subjects received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 57. Subjects were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Subjects received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.

Arm type

Experimental

Investigational medicinal product name

Ad26.COV2.S

Investigational medicinal product code

JNJ-78436735

Other name

Ad26COVS1, VAC31518

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received single dose of Ad26.COV2.S 0.625*10^10 vp administered as IM injection on Day 1 and Ad26.COV.S 2.5*10^10 vp as a booster vaccination on Day 184.

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received placebo matching to Ad26.COV2.S 0.625*10^10 administered as IM injection on Day 57.

Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp

Arm description

Subjects received a single dose of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Arm type

Experimental

Investigational medicinal product name

Ad26.COV2.S

Investigational medicinal product code

JNJ-78436735

Other name

Ad26COVS1, VAC31518

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 2 doses of Ad26.COV2.S 2.5*10^10 administered as IM injection on Day 1 and Day 57.

Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp

Arm description

Subjects received a single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Arm type

Experimental

Investigational medicinal product name

Ad26.COV2.S

Investigational medicinal product code

JNJ-78436735

Other name

Ad26COVS1, VAC31518

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 2 doses of Ad26.COV2.S 1.25*10^10 vp dministered as IM injection on Day 1 and Day 57.

Group 6: Ad26.COV2.S 0.625*10^10 vp+Ad26.COV2.S 0.625*10^10 vp

Arm description

Subjects received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Subjects were unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Arm type

Experimental

Investigational medicinal product name

Ad26.COV2.S

Investigational medicinal product code

JNJ-78436735

Other name

Ad26COVS1, VAC31518

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 2 doses Ad26.COV2.S 0.625*10^10 vp administered as IM injection on Day 1 and Day 57.

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 sponsor was unblinded at the time of the primary analysis, then the blind was maintained at a participant and study site level up to the unblinding visit.

Number of subjects in period 1	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Started	51	50	51	49	49	49
Completed	49	46	50	45	47	45
Not completed	2	4	1	4	2	4
Adverse event, serious fatal	-	1	-	-	-	-
Consent withdrawn by subject	1	2	-	2	1	1
Other	1	-	1	1	-	2
Lost to follow-up	-	1	-	1	1	1

Baseline characteristics

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Reporting group title

Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo

Reporting group description

Reporting group title

Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo

Reporting group description

Reporting group title

Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo

Reporting group description

Reporting group title

Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp

Reporting group description

Reporting group title

Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp

Reporting group description

Reporting group title

Group 6: Ad26.COV2.S 0.625*10^10 vp+Ad26.COV2.S 0.625*10^10 vp

Reporting group description

Subjects received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Subjects were unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Reporting group values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp	Total
Number of subjects	51	50	51	49	49	49	299
Title for AgeCategorical
Units: subjects
Children (2-11 years)	0	0	0	0	0	0	0
Adolescents (12-17 years)	51	50	51	49	49	49	299
Adults (18-64 years)	0	0	0	0	0	0	0
From 65 to 84 years	0	0	0	0	0	0	0
85 years and over	0	0	0	0	0	0	0
Title for AgeContinuous
Units: years
arithmetic mean (standard deviation)	14.1 ( 1.87 )	14 ( 1.82 )	14.3 ( 1.76 )	14.4 ( 1.75 )	14.2 ( 1.8 )	14.1 ( 1.84 )	-
Title for Gender
Units: subjects
Female	22	22	21	20	21	20	126
Male	29	28	30	29	28	29	173

End points

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Reporting group title

Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo

Reporting group description

Reporting group title

Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo

Reporting group description

Reporting group title

Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo

Reporting group description

Reporting group title

Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp

Reporting group description

Reporting group title

Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp

Reporting group description

Reporting group title

Group 6: Ad26.COV2.S 0.625*10^10 vp+Ad26.COV2.S 0.625*10^10 vp

Reporting group description

Subjects received a single dose of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Subjects were unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1

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End point title

Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1 ^[1]

End point description

End point type

Primary

End point timeframe

7 days post-dose 1 on Day 1 (Day 8)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	51	50	51	49	49	49
Units: subjects	13	16	17	11	12	15

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2

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End point title

Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2 ^[2]

End point description

An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as local (at the injection site) AEs for which subjects were specifically asked and which were noted by subjects in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, swelling at the vaccination site. Safety analysis set included all subjects with at least one vaccine administration documented. Here "N" number of subjects that started the Arm, signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.

End point type

Primary

End point timeframe

7 days post-dose 2 on Day 57 (Day 64)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	51	50	50	47	49	48
Units: subjects	8	10	3	16	9	10

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Systemic AEs at 7 Days Post-dose 1

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End point title

Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Systemic AEs at 7 Days Post-dose 1 ^[3]

End point description

An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which subjects were specifically asked and which were noted by subjects in their reactogenicity diary for 7 days post each vaccination. Subjects were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia. Safety analysis set included all subjects with at least one vaccine administration documented.

End point type

Primary

End point timeframe

7 days post-dose 1 on Day 1 (Day 8)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	51	50	51	49	49	49
Units: subjects	20	13	18	14	16	16

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Systemic AEs at 7 Days Post-dose 2

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End point title

Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Systemic AEs at 7 Days Post-dose 2 ^[4]

End point description

An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which subjects were specifically asked and which were noted by subjects in their reactogenicity diary for 7 days post each vaccination. Subjects were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia. Safety analysis set included all subjects with at least one vaccine administration documented. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.

End point type

Primary

End point timeframe

7 days post-dose 2 on Day 57 (Day 64)

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	51	50	50	47	49	48
Units: subjects	11	10	4	14	10	11

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Unsolicited AEs at 28 Days Post-dose 2

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End point title

Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Unsolicited AEs at 28 Days Post-dose 2 ^[5]

End point description

An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the subjects were not specifically questioned in the subject's reactogenicity diary. Safety analysis set included all subjects with at least one vaccine administration documented. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.

End point type

Primary

End point timeframe

28 days post-dose 2 on Day 57 (Day 85)

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	51	50	50	47	49	48
Units: subjects	7	7	8	7	7	9

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Unsolicited AEs at 28 Days Post-dose 1

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End point title

Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Unsolicited AEs at 28 Days Post-dose 1 ^[6]

End point description

An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination were also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the subjects were not specifically questioned in the subject's reactogenicity diary. Safety analysis set included all subjects with at least one vaccine administration documented.

End point type

Primary

End point timeframe

28 days post-dose 1 on Day 1 (Day 29)

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	51	50	51	49	49	49
Units: subjects	9	9	5	3	8	10

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with MAAEs 6 Months Post-Dose 2

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End point title

Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with MAAEs 6 Months Post-Dose 2 ^[7]

End point description

MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not to be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. Safety analysis set included all subjects with at least one vaccine administration documented. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.

End point type

Primary

End point timeframe

From the first vaccination (Day 1) until 6 months post-dose 2 on Day 57 (Up to Day 240)

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	51	50	50	47	49	48
Units: subjects	4	6	2	2	4	5

No statistical analyses for this end point

Primary: Groups 1, 2, and 3: Number of Subjects with MAAEs Leading to Discontinuation

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End point title

Groups 1, 2, and 3: Number of Subjects with MAAEs Leading to Discontinuation ^[8] ^[9]

End point description

Number of subjects with MAAEs leading to discontinuation were reported. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. Safety analysis set included all subjects with at least one vaccine administration documented.

End point type

Primary

End point timeframe

From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for rest of the arms were reported as separate end points.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Number of subjects analysed	51	50	51
Units: subjects	0	0	0

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1

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End point title

Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1 ^[10]

End point description

End point type

Primary

End point timeframe

From the first vaccination (Day 1) until 6 months post-dose 1 on Day 1 (Up to Day 184)

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	51	50	51	49	49	49
Units: subjects	2	0	0	1	0	5

No statistical analyses for this end point

Primary: Groups 1, 2, and 3: Number of Subjects with Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C])

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End point title

Groups 1, 2, and 3: Number of Subjects with Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C]) ^[11] ^[12]

End point description

Number of subjects with AESI (including MIS-C) were reported. Thrombotic events (suspected deep vessel venous or arterial thrombotic events); Thrombocytopenia (platelet count below 150,000/μL) and MIS-C (a subject <21 years with fever, evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement [cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological]; & No alternative diagnoses; & Positive for coronavirus disease 2019 [COVID-19] infection by Real-time reverse transcriptase-polymerase chain reaction [RT-PCR], serology, or antigen test; or COVID-19 exposure within 4 weeks prior to symptoms) were considered AESIs in this study. Safety analyses set included subjects who had at least one vaccine administration. Here "N" signifies the number of subjects evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.

End point type

Primary

End point timeframe

From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for rest of the arms were reported as separate end points.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Number of subjects analysed	13	18	15
Units: subjects	0	0	0

No statistical analyses for this end point

Primary: Groups 4, 5 and 6: Number of Subjects with SAEs

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End point title

Groups 4, 5 and 6: Number of Subjects with SAEs ^[13] ^[14]

End point description

SAE were defined as any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Safety analysis set included all subjects with at least one vaccine administration documented.

End point type

Primary

End point timeframe

From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for rest of the arms were reported as separate end points.

End point values	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	49	49	49
Units: subjects	0	1	0

No statistical analyses for this end point

Primary: Groups 1, 2, and 3: Number of Subjects with Serious Adverse Events (SAEs)

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End point title

Groups 1, 2, and 3: Number of Subjects with Serious Adverse Events (SAEs) ^[15] ^[16]

End point description

End point type

Primary

End point timeframe

From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for rest of the arms were reported as separate end points.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Number of subjects analysed	51	50	51
Units: subjects	1	1	0

No statistical analyses for this end point

Primary: Groups 4, 5 and 6: Number of Subjects with MAAEs Leading to Discontinuation

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End point title

Groups 4, 5 and 6: Number of Subjects with MAAEs Leading to Discontinuation ^[17] ^[18]

End point description

End point type

Primary

End point timeframe

From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for rest of the arms were reported as separate end points.

End point values	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	49	49	49
Units: subjects	0	0	0

No statistical analyses for this end point

Primary: Groups 4, 5 and 6: Number of Subjects with AESI (Including MIS-C)

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End point title

Groups 4, 5 and 6: Number of Subjects with AESI (Including MIS-C) ^[19] ^[20]

End point description

Number of subjects with AESI (including MIS-C) were reported. Thrombotic events (suspected deep vessel venous or arterial thrombotic events); Thrombocytopenia (platelet count below 150,000/μL) and MIS-C (a subject <21 years with fever, evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement [cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological]; & No alternative diagnoses; & Positive for coronavirus disease 2019 [COVID-19] infection by RT-PCR, serology, or antigen test; or COVID-19 exposure within 4 weeks prior to symptoms) were considered as AESIs in this study. Safety analyses set included all subjects with at least one vaccine administration documented. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.

End point type

Primary

End point timeframe

From first vaccination up to Day 240 (6 months after second vaccination on Day 57)

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for rest of the arms were reported as separate end points.

End point values	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	46	47	47
Units: subjects	0	0	0

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2

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End point title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2 ^[21]

End point description

Serological response to vaccination were measured by S-ELISA (ELISA Units/mL [EU/mL]) at 14 days post-dose 2. For Vaccine-specific responses, a subject was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. The PPI set included all randomized and vaccinated subjects for whom immunogenicity data were available excluding data from subjects with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.

End point type

Primary

End point timeframe

14 days post-dose 2 on Day 57 (Day 71)

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	38	31	38	30	32	37
Units: EU/mL
geometric mean (confidence interval 95%)	4923 (3329 to 7282)	4679 (2748 to 7967)	4043 (2480 to 6590)	8958 (6333 to 12671)	8716 (6577 to 11550)	6522 (4461 to 9533)

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days Post-dose 1

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End point title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days Post-dose 1 ^[22]

End point description

Serological response to vaccination were measured by S-ELISA (ELISA Units/mL [EU/mL]) at 28 days post-dose 1. For Vaccine-specific responses, a subject was defined as a responder if: 1. a baseline sample value of less than or equal to the lower limit of quantification (<=LLOQ) and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. The Per Protocol Immunogenicity (PPI) set included all randomized and vaccinated subjects for whom immunogenicity data were available excluding data from subjects with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.

End point type

Primary

End point timeframe

28 days post-dose 1 on Day 1 (Day 29)

Notes
[22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	44	42	43	35	39	41
Units: ELISA Unit/milliliter (EU/mL)
geometric mean (confidence interval 95%)	6533 (4341 to 9831)	7812 (5120 to 11920)	5881 (3719 to 9302)	9273 (5596 to 15366)	6758 (4344 to 10513)	6069 (3780 to 9745)

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1

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End point title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1 ^[23]

End point description

Serological response to vaccination were measured by VNA titers 28 days post-dose 1. For Vaccine-specific responses, a subject was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. The PPI set included all randomized and vaccinated subjects for whom immunogenicity data were available excluding data from subjects with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.

End point type

Primary

End point timeframe

28 days post-dose 1 (Day 29)

Notes
[23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	43	42	42	35	39	41
Units: 50% inhibitory concentration (IC50)
geometric mean (confidence interval 95%)	1325 (792 to 2216)	1754 (988 to 3113)	1392 (806 to 2403)	2038 (1065 to 3897)	1878 (1089 to 3240)	1455 (864 to 2449)

No statistical analyses for this end point

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2

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End point title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2 ^[24]

End point description

Serological response to vaccination will be measured by VNA titers 14 days post-dose 2. For Vaccine-specific responses, a subject was defined as a responder if: 1. a baseline sample value <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. The PPI set included all randomized and vaccinated subjects for whom immunogenicity data were available excluding data from subjects with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.

End point type

Primary

End point timeframe

14 days post-dose 2 on Day 57 (Day 71)

Notes
[24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical testing was done. Only descriptive statistics was performed.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	38	31	38	30	32	37
Units: subjects
geometric mean (confidence interval 95%)	1187 (698 to 2018)	1094 (517 to 2315)	864 (471 to 1583)	2386 (1453 to 3917)	2670 (1816 to 3925)	1742 (1064 to 2852)

No statistical analyses for this end point

Secondary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or individual SARS-CoV-2 S Proteins as Assessed by ELISA

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End point title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or individual SARS-CoV-2 S Proteins as Assessed by ELISA

End point description

Serological response to vaccination measured by binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 S proteins as assessed by ELISA were reported. For Vaccine-specific responses, a subject was defined as responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. The PPI set included all randomized and vaccinated subjects for whom immunogenicity data were available excluding data from subjects with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints. Here "99999" signifies that the data were not collected or analyzed for the specified category.

End point type

Secondary

End point timeframe

Groups 1-3: Days 1, 29, 57, 71, 184, 198, and 366; Groups 4-6: Days 1, 29, 57, 71 and 240

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	51	50	51	49	49	49
Units: EU/mL
geometric mean (confidence interval 95%)
Day 1 (n=51, 50, 51, 49, 48, 49)	255 (148 to 438)	297 (156 to 563)	338 (189 to 605)	256 (144 to 455)	200 (117 to 341)	282 (151 to 528)
Day 29 (n=44, 42, 43, 35, 39, 41)	6533 (4341 to 9831)	7812 (5120 to 11920)	5881 (3719 to 9302)	9273 (5596 to 15366)	6758 (4344 to 10513)	6069 (3780 to 9745)
Day 57 (n=41, 40, 41, 33, 38, 38)	5629 (3896 to 8133)	7450 (4934 to 11249)	4554 (2922 to 7099)	7034 (4542 to 10891)	5650 (3798 to 8405)	4817 (3009 to 7710)
Day 71 (n=38, 31, 38, 30, 32, 37)	4923 (3329 to 7282)	4679 (2748 to 7967)	4043 (2480 to 6590)	8958 (6333 to 12671)	8716 (6577 to 11550)	6522 (4461 to 9533)
Day 184 (n=19, 11, 19, 0, 0, 0 )	4131 (2431 to 7021)	4765 (2048 to 11087)	3861 (1826 to 8165)	99999 (9999 to 99999)	99999 (9999 to 99999)	99999 (9999 to 99999)
Day 198 (n=27, 21, 31, 0, 0, 0)	6782 (5230 to 8795)	7656 (5317 to 11026)	10506 (8227 to 13417)	99999 (9999 to 99999)	99999 (9999 to 99999)	99999 (9999 to 99999)
Day 240 (n=0, 0, 0, 14, 16, 22)	99999 (9999 to 99999)	99999 (9999 to 99999)	99999 (9999 to 99999)	4994 (3144 to 7932)	5338 (3039 to 9377)	3877 (2390 to 6289)
Day 366 (25, 18, 31, 0, 0, 0)	5087 (3809 to 6793)	4934 (2856 to 8526)	6585 (4907 to 8838)	99999 (9999 to 99999)	99999 (9999 to 99999)	99999 (9999 to 99999)

No statistical analyses for this end point

Secondary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2

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End point title

Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2

End point description

Serological response to vaccination measured by neutralizing antibody titers to SARS-CoV-2 (VNA) were reported. For Vaccine-specific responses, a subject was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. The PPI set included all randomized and vaccinated subjects for whom immunogenicity data were available excluding data from subjects with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number analyzed) signifies number of subjects analyzed at specified timepoints. Here "99999" signifies that the data were not collected or analyzed for the specified arm. "-99" signifies a value <LLOQ.

End point type

Secondary

End point timeframe

Groups 1-3: Days 1, 29, 57, 71, 184, 198 and 366; Groups 4-6: Days 1, 29, 57, 71 and 240

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo	Group 4: Ad26.COV2.S 2.510^10 vp + Ad26.COV2.S 2.510^10 vp	Group 5: Ad26.COV2.S 1.2510^10 vp + Ad26.COV2.S 1.2510^10 vp	Group 6: Ad26.COV2.S 0.62510^10 vp+Ad26.COV2.S 0.62510^10 vp
Number of subjects analysed	51	50	50	48	48	49
Units: IC50
geometric mean (confidence interval 95%)
Day 1 (n=51, 50, 50, 48, 48, 49))	105 (-99 to 163)	149 (88 to 250)	114 (-99 to 186)	112 (-99 to 184)	83 (-99 to 121)	127 (77 to 210)
Day 29 (n= 43, 42, 42, 35, 39, 41)	1325 (792 to 2216)	1754 (988 to 3113)	1392 (806 to 2403)	2038 (1065 to 3897)	1878 (1089 to 3240)	1455 (864 to 2449)
Day 57 (n=41, 40, 41, 33, 38, 38)	1197 (710 to 2020)	1743 (992 to 3065)	993 (570 to 1730)	1662 (923 to 2992)	1434 (847 to 2427)	1188 (649 to 2173)
Day 71 (n= 38, 31, 38, 30, 32, 37)	1187 (698 to 2018)	1094 (517 to 2315)	864 (471 to 1583)	2386 (1453 to 3917)	2670 (1816 to 3925)	1742 (1064 to 2852)
Day 184 (n=19, 11, 19, 0, 0, 0)	1358 (773 to 2386)	1702 (462 to 6273)	860 (326 to 2267)	99999 (-99999 to 99999)	99999 (-99999 to 99999)	99999 (-99999 to 99999)
Day 198 (n=27, 21, 31, 0, 0, 0)	2496 (1760 to 3539)	2547 (1223 to 5303)	4083 (3006 to 5547)	99999 (-99999 to 99999)	99999 (-99999 to 99999)	99999 (-99999 to 99999)
Day 240 (n= 0, 0, 0, 14, 16, 22)	99999 (-99999 to 99999)	99999 (-99999 to 99999)	99999 (-99999 to 99999)	1867 (944 to 3692)	1900 (1035 to 3489)	1134 (548 to 2347)
Day 366 (n=25,18, 31, 0, 0, 0)	1809 (1231 to 2656)	1783 (691 to 4599)	2274 (1521 to 3401)	99999 (-99999 to 99999)	99999 (-99999 to 99999)	99999 (-99999 to 99999)

No statistical analyses for this end point

Secondary: Groups 1, 2 and 3: Number of Subjects with Solicited Local AEs for 7 Days Post-booster Vaccination

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End point title

Groups 1, 2 and 3: Number of Subjects with Solicited Local AEs for 7 Days Post-booster Vaccination ^[25]

End point description

Solicited local AEs are pre-defined local (at the injection site) AEs for which subjects are specifically asked and which are noted by subjects in their reactogenicity diary for 7 days post booster vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination. Safety analyses set included all subjects with at least one vaccine administration documented. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point type

Secondary

End point timeframe

From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184)

Notes
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Number of subjects analysed	51	48	49
Units: subjects	19	16	17

No statistical analyses for this end point

Secondary: Groups 1, 2 and 3: Number of Subjects with MAAEs Until 6 Months Post-booster Vaccination

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End point title

Groups 1, 2 and 3: Number of Subjects with MAAEs Until 6 Months Post-booster Vaccination ^[26]

End point description

MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. Safety analyses set included all subjects with at least one vaccine administration documented. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point type

Secondary

End point timeframe

From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)

Notes
[26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Number of subjects analysed	51	48	49
Units: subjects	1	2	2

No statistical analyses for this end point

Secondary: Groups 1, 2 and 3: Number of Subjects with Unsolicited AEs for 28 Days Post-booster Vaccination

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End point title

Groups 1, 2 and 3: Number of Subjects with Unsolicited AEs for 28 Days Post-booster Vaccination ^[27]

End point description

Unsolicited AEs were all AEs for which the subject was not specifically questioned in the subject's reactogenicity diary. Safety analyses set included all subjects with at least one vaccine administration documented. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point type

Secondary

End point timeframe

From first vaccination on Day 1 up to Day 212 (28 days after booster Vaccination on Day 184)

Notes
[27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Number of subjects analysed	51	48	49
Units: subjects	6	8	10

No statistical analyses for this end point

Secondary: Groups 1, 2 and 3: Number of Subjects with Solicited Systemic AEs for 7 Days Post-booster Vaccination

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End point title

Groups 1, 2 and 3: Number of Subjects with Solicited Systemic AEs for 7 Days Post-booster Vaccination ^[28]

End point description

Subjects were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, and myalgia and pyrexia. Safety analyses set included all subjects with at least one vaccine administration documented. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point type

Secondary

End point timeframe

From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184)

Notes
[28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Number of subjects analysed	51	48	49
Units: Subjects	16	14	15

No statistical analyses for this end point

Secondary: Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers

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End point title

Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers ^[29]

End point description

Serological response to post-booster vaccination measured by binding (S-ELISA and/or equivalent assay) antibody titers were reported. For Vaccine-specific responses, a subject was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. PPI set: All randomized and vaccinated participants with available immunogenicity data excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point type

Secondary

End point timeframe

Days 184, 198 and 366

Notes
[29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Number of subjects analysed	27	21	31
Units: EU/mL
geometric mean (confidence interval 95%)
Day 184 (n=19, 11, 19)	4131 (2431 to 7021)	4765 (2048 to 11087)	3861 (1826 to 8165)
Day 198 (n=27, 21, 31)	6782 (5230 to 8795)	7656 (5317 to 11026)	10506 (8227 to 13417)
Day 366 (n=25, 18, 31)	5087 (3809 to 6793)	4934 (2856 to 8526)	6585 (4907 to 8838)

No statistical analyses for this end point

Secondary: Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers

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End point title

Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers ^[30]

End point description

Serological response to post-booster vaccination measured by neutralizing (VNA) antibody titers were reported. For Vaccine-specific responses, a subject was defined as a responder if: 1. a baseline sample value of <=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly >LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. PPI set: All randomized and vaccinated participants with available immunogenicity data excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point type

Secondary

End point timeframe

Days 184, 198 and 366

Notes
[30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.

End point values	Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Number of subjects analysed	27	21	31
Units: IC50
geometric mean (confidence interval 95%)
Day 184 (n=19, 11, 19)	1358 (773 to 2386)	1702 (462 to 6273)	860 (326 to 2267)
Day 198 (n=27, 21, 31)	2496 (1760 to 3539)	2547 (1223 to 5303)	4083 (3006 to 5547)
Day 366 (n=25, 18, 31)	1809 (1231 to 2656)	1783 (691 to 4599)	2274 (1521 to 3401)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Groups 1 to 3:From first vaccination on Day 1 until 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4 to 6:From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)

Adverse event reporting additional description

Safety analyses included all subjects with at least one vaccine administration documented.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

Group 1: Ad26.COV2.S 2.5*10^10 + Placebo

Reporting group description

Subjects received single dose of Ad26.COV.S 2.5*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5*10^10 vp on Day 57. Subjects were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Subjects received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.

Reporting group title

Group 2: Ad26.COV2.S 1.25*10^10 + Placebo

Reporting group description

Participants received single dose of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25*10^10 vp on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.

Reporting group title

Group 3: Ad26.COV2.S 0.625*10^10 + Placebo

Reporting group description

Participants received single dose of Ad26.COV2.S 0.625*10^10 virus particle (vp) as intramuscular (IM) injection on Day 1 and placebo matching to Ad26.COV2.S 0.625*10^10 vp on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5*10^10 vp on Day 184.

Reporting group title

Group 4: Ad26.COV2.S 2.5*10^10 + Ad26.COV2.S 2.5*10^10

Reporting group description

Participants received 2-doses of Ad26.COV2.S 2.5*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Reporting group title

Group 5: Ad26.COV2.S 1.25*10^10 + Ad26.COV2.S 1.25*10^10

Reporting group description

Participants received 2-doses of Ad26.COV2.S 1.25*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination

Reporting group title

Group 6: Ad26.COV2.S 0.625*10^10 + Ad26.COV2.S 0.625*10^10

Reporting group description

Participants received 2-doses of Ad26.COV2.S 0.625*10^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.

Serious adverse events	Group 1: Ad26.COV2.S 2.5*10^10 + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 + Placebo	Group 4: Ad26.COV2.S 2.510^10 + Ad26.COV2.S 2.510^10	Group 5: Ad26.COV2.S 1.2510^10 + Ad26.COV2.S 1.2510^10	Group 6: Ad26.COV2.S 0.62510^10 + Ad26.COV2.S 0.62510^10
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 51 (1.96%)	1 / 50 (2.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	1 / 49 (2.04%)	0 / 49 (0.00%)
number of deaths (all causes)	0	1	0	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Femur Fracture
subjects affected / exposed	1 / 51 (1.96%)	0 / 50 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 49 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	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
Intentional Overdose
subjects affected / exposed	0 / 51 (0.00%)	1 / 50 (2.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	0 / 49 (0.00%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Vaginal Cyst Excision
subjects affected / exposed	0 / 51 (0.00%)	0 / 50 (0.00%)	0 / 51 (0.00%)	0 / 49 (0.00%)	1 / 49 (2.04%)	0 / 49 (0.00%)
occurrences causally related to treatment / all	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

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

Non-serious adverse events	Group 1: Ad26.COV2.S 2.5*10^10 + Placebo	Group 2: Ad26.COV2.S 1.25*10^10 + Placebo	Group 3: Ad26.COV2.S 0.625*10^10 + Placebo	Group 4: Ad26.COV2.S 2.510^10 + Ad26.COV2.S 2.510^10	Group 5: Ad26.COV2.S 1.2510^10 + Ad26.COV2.S 1.2510^10	Group 6: Ad26.COV2.S 0.62510^10 + Ad26.COV2.S 0.62510^10
Total subjects affected by non serious adverse events
subjects affected / exposed	35 / 51 (68.63%)	32 / 50 (64.00%)	34 / 51 (66.67%)	26 / 49 (53.06%)	29 / 49 (59.18%)	35 / 49 (71.43%)
Nervous system disorders
Headache(Solicited)
subjects affected / exposed	16 / 51 (31.37%)	20 / 50 (40.00%)	17 / 51 (33.33%)	12 / 49 (24.49%)	17 / 49 (34.69%)	16 / 49 (32.65%)
occurrences all number	28	26	20	17	21	18
General disorders and administration site conditions
Vaccination Site Swelling(Solicited)
subjects affected / exposed	5 / 51 (9.80%)	7 / 50 (14.00%)	3 / 51 (5.88%)	4 / 49 (8.16%)	2 / 49 (4.08%)	4 / 49 (8.16%)
occurrences all number	7	8	3	4	2	5
Vaccination Site Pain(Solicited)
subjects affected / exposed	23 / 51 (45.10%)	22 / 50 (44.00%)	24 / 51 (47.06%)	19 / 49 (38.78%)	15 / 49 (30.61%)	19 / 49 (38.78%)
occurrences all number	38	39	34	26	18	22
Vaccination Site Erythema(Solicited)
subjects affected / exposed	4 / 51 (7.84%)	5 / 50 (10.00%)	2 / 51 (3.92%)	3 / 49 (6.12%)	4 / 49 (8.16%)	3 / 49 (6.12%)
occurrences all number	4	8	2	3	4	3
Fatigue(Solicited)
subjects affected / exposed	20 / 51 (39.22%)	11 / 50 (22.00%)	12 / 51 (23.53%)	16 / 49 (32.65%)	10 / 49 (20.41%)	14 / 49 (28.57%)
occurrences all number	26	17	14	21	11	16
Pyrexia(Solicited)
subjects affected / exposed	10 / 51 (19.61%)	2 / 50 (4.00%)	7 / 51 (13.73%)	7 / 49 (14.29%)	2 / 49 (4.08%)	5 / 49 (10.20%)
occurrences all number	12	4	7	7	2	5
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	3 / 51 (5.88%)	2 / 50 (4.00%)	1 / 51 (1.96%)	0 / 49 (0.00%)	0 / 49 (0.00%)	2 / 49 (4.08%)
occurrences all number	3	2	1	0	0	2
Nausea(Solicited)
subjects affected / exposed	8 / 51 (15.69%)	5 / 50 (10.00%)	11 / 51 (21.57%)	6 / 49 (12.24%)	7 / 49 (14.29%)	2 / 49 (4.08%)
occurrences all number	8	6	13	7	8	3
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	2 / 51 (3.92%)	1 / 50 (2.00%)	1 / 51 (1.96%)	1 / 49 (2.04%)	3 / 49 (6.12%)	0 / 49 (0.00%)
occurrences all number	2	1	1	1	3	0
Musculoskeletal and connective tissue disorders
Myalgia(Solicited)
subjects affected / exposed	18 / 51 (35.29%)	11 / 50 (22.00%)	14 / 51 (27.45%)	13 / 49 (26.53%)	9 / 49 (18.37%)	5 / 49 (10.20%)
occurrences all number	21	15	18	16	11	6
Infections and infestations
Gastroenteritis
subjects affected / exposed	2 / 51 (3.92%)	3 / 50 (6.00%)	0 / 51 (0.00%)	1 / 49 (2.04%)	2 / 49 (4.08%)	3 / 49 (6.12%)
occurrences all number	2	4	0	1	2	3
Covid-19
subjects affected / exposed	7 / 51 (13.73%)	4 / 50 (8.00%)	4 / 51 (7.84%)	4 / 49 (8.16%)	7 / 49 (14.29%)	6 / 49 (12.24%)
occurrences all number	7	4	4	4	7	6
Upper Respiratory Tract Infection
subjects affected / exposed	2 / 51 (3.92%)	5 / 50 (10.00%)	2 / 51 (3.92%)	0 / 49 (0.00%)	0 / 49 (0.00%)	4 / 49 (8.16%)
occurrences all number	2	7	2	0	0	6
Rhinitis
subjects affected / exposed	3 / 51 (5.88%)	1 / 50 (2.00%)	1 / 51 (1.96%)	0 / 49 (0.00%)	1 / 49 (2.04%)	1 / 49 (2.04%)
occurrences all number	3	1	1	0	1	1
Influenza
subjects affected / exposed	5 / 51 (9.80%)	3 / 50 (6.00%)	6 / 51 (11.76%)	2 / 49 (4.08%)	0 / 49 (0.00%)	5 / 49 (10.20%)
occurrences all number	6	3	10	3	0	5

More information

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Were there any global substantial amendments to the protocol? Yes

15 Aug 2022

The overall rationale for the protocol amendment 4 was the removal of Part 2 of this study. The Part 1 of Study VAC31518COV3006 has been ongoing since 29 September 2021. Since the start of enrollment, there has been a slower than desired participant enrollment rate mainly due to the success of the national vaccination programs in the countries where Part 1 is being conducted and a high number of participants being seropositive for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) at screening/randomization. Thus, the current design of Part 2 in vaccine naïve participants is no longer feasible nor relevant and will, therefore, be removed from this study. However, Part 1 will continue as planned and the results may yield a preferred dose to be used in potential future studies.

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

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Clinical trials

Clinical Trial Results: A Randomized, Observer-blind, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive (HORIZON 2)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Systemic AEs at 7 Days Post-dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Systemic AEs at 7 Days Post-dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Systemic AEs at 7 Days Post-dose 2

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Solicited Systemic AEs at 7 Days Post-dose 2

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Unsolicited AEs at 28 Days Post-dose 2

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Unsolicited AEs at 28 Days Post-dose 2

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Unsolicited AEs at 28 Days Post-dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Unsolicited AEs at 28 Days Post-dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with MAAEs 6 Months Post-Dose 2

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with MAAEs 6 Months Post-Dose 2

Primary: Groups 1, 2, and 3: Number of Subjects with MAAEs Leading to Discontinuation

Primary: Groups 1, 2, and 3: Number of Subjects with MAAEs Leading to Discontinuation

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1

Primary: Groups 1, 2, and 3: Number of Subjects with Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C])

Primary: Groups 1, 2, and 3: Number of Subjects with Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C])

Primary: Groups 4, 5 and 6: Number of Subjects with SAEs

Primary: Groups 4, 5 and 6: Number of Subjects with SAEs

Primary: Groups 1, 2, and 3: Number of Subjects with Serious Adverse Events (SAEs)

Primary: Groups 1, 2, and 3: Number of Subjects with Serious Adverse Events (SAEs)

Primary: Groups 4, 5 and 6: Number of Subjects with MAAEs Leading to Discontinuation

Primary: Groups 4, 5 and 6: Number of Subjects with MAAEs Leading to Discontinuation

Primary: Groups 4, 5 and 6: Number of Subjects with AESI (Including MIS-C)

Primary: Groups 4, 5 and 6: Number of Subjects with AESI (Including MIS-C)

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days Post-dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days Post-dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2

Primary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2

Secondary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or individual SARS-CoV-2 S Proteins as Assessed by ELISA

Secondary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or individual SARS-CoV-2 S Proteins as Assessed by ELISA

Secondary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2

Secondary: Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2

Secondary: Groups 1, 2 and 3: Number of Subjects with Solicited Local AEs for 7 Days Post-booster Vaccination

Secondary: Groups 1, 2 and 3: Number of Subjects with Solicited Local AEs for 7 Days Post-booster Vaccination

Secondary: Groups 1, 2 and 3: Number of Subjects with MAAEs Until 6 Months Post-booster Vaccination

Secondary: Groups 1, 2 and 3: Number of Subjects with MAAEs Until 6 Months Post-booster Vaccination

Secondary: Groups 1, 2 and 3: Number of Subjects with Unsolicited AEs for 28 Days Post-booster Vaccination

Secondary: Groups 1, 2 and 3: Number of Subjects with Unsolicited AEs for 28 Days Post-booster Vaccination

Secondary: Groups 1, 2 and 3: Number of Subjects with Solicited Systemic AEs for 7 Days Post-booster Vaccination

Secondary: Groups 1, 2 and 3: Number of Subjects with Solicited Systemic AEs for 7 Days Post-booster Vaccination

Secondary: Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers

Secondary: Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers

Secondary: Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers

Secondary: Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
A Randomized, Observer-blind, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive (HORIZON 2)