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)
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Summary
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EudraCT number |
2020-005720-11 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
14 Aug 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Mar 2024
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First version publication date |
06 Mar 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
VAC31518COV3006
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05007080 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen Vaccines & Prevention B.V.
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Sponsor organisation address |
Newtonweg 1, Leiden, Netherlands, 2333 CP
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Public contact |
Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-002880-PIP01-20 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Aug 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Aug 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Sep 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Argentina: 35
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Country: Number of subjects enrolled |
Brazil: 55
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Country: Number of subjects enrolled |
India: 108
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Country: Number of subjects enrolled |
Mexico: 37
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Country: Number of subjects enrolled |
South Africa: 64
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Worldwide total number of subjects |
299
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
299
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Pre-assignment
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind [1] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received placebo matching to Ad26.COV2.S 2.5*10^10 vp administered as IM injection on Day 57.
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Investigational medicinal product name |
Ad26.COV2.S
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Investigational medicinal product code |
JNJ-78436735
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Other name |
Ad26COVS1, VAC31518
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received placebo matching to Ad26.COV2.S 1.25*10^10 administered as IM injection on Day 57.
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Investigational medicinal product name |
Ad26.COV2.S
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Investigational medicinal product code |
JNJ-78436735
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Other name |
Ad26COVS1, VAC31518
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Arm title
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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
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Investigational medicinal product code |
JNJ-78436735
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Other name |
Ad26COVS1, VAC31518
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received placebo matching to Ad26.COV2.S 0.625*10^10 administered as IM injection on Day 57.
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Arm title
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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
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Investigational medicinal product code |
JNJ-78436735
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Other name |
Ad26COVS1, VAC31518
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Arm title
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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
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Investigational medicinal product code |
JNJ-78436735
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Other name |
Ad26COVS1, VAC31518
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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Arm title
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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
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Investigational medicinal product code |
JNJ-78436735
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Other name |
Ad26COVS1, VAC31518
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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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.
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| 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. |
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Baseline characteristics reporting groups
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Reporting group title |
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
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Reporting group 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
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Reporting group 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
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Reporting group 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
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Reporting group 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
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Reporting group 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 6: Ad26.COV2.S 0.625*10^10 vp+Ad26.COV2.S 0.625*10^10 vp
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
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||
Reporting group 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. | ||
Reporting group title |
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
|
||
Reporting group 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. | ||
Reporting group title |
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
|
||
Reporting group 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. | ||
Reporting group title |
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
|
||
Reporting group 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. | ||
Reporting group title |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
|
||
Reporting group 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. | ||
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. | ||
|
||||||||||||||||||||||
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 [1] | |||||||||||||||||||||
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 [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. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||
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 [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 pre-defined 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.
|
|||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||
End point timeframe |
7 days post-dose 1 on Day 1 (Day 8)
|
|||||||||||||||||||||
| 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. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||
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. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||
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. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||
End point title |
Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Unsolicited AEs at 28 Days Post-dose 1 [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 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 [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. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||
End point title |
Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with Unsolicited AEs at 28 Days Post-dose 2 [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 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 [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. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
|||||||||||||
End point title |
Groups 1, 2, and 3: Number of Subjects with MAAEs Leading to Discontinuation [7] [8] | ||||||||||||
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 [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. [8] - 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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
||||||||||||||||||||||
End point title |
Groups 1, 2, 3, 4, 5 and 6: Number of Subjects with MAAEs 6 Months Post-Dose 2 [9] | |||||||||||||||||||||
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 [9] - 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. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
||||||||||||||||||||||
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 |
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.
|
|||||||||||||||||||||
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. |
||||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
|||||||||||||
End point title |
Groups 4, 5 and 6: Number of Subjects with SAEs [11] [12] | ||||||||||||
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 [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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Groups 1, 2, and 3: Number of Subjects with Serious Adverse Events (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 366 (6 months after booster vaccination on Day 184)
|
||||||||||||
| 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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Groups 4, 5 and 6: Number of Subjects with MAAEs Leading to Discontinuation [15] [16] | ||||||||||||
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 240 (6 months after second vaccination on Day 57)
|
||||||||||||
| 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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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]) [17] [18] | ||||||||||||
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 [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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||
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 [19] | ||||||||||||||||||||||||||||
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 [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. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
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 [20] | ||||||||||||||||||||||||||||
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 [20] - 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. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||
End point title |
Groups 4, 5 and 6: Number of Subjects with AESI (Including MIS-C) [21] [22] | ||||||||||||
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 [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. [22] - 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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
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)
|
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| 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. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
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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.
|
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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
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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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.
|
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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
|
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|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Groups 1, 2 and 3: Number of Subjects with Solicited Systemic AEs for 7 Days Post-booster Vaccination [26] | ||||||||||||
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 [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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Groups 1, 2 and 3: Number of Subjects with MAAEs Until 6 Months Post-booster Vaccination [28] | ||||||||||||
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 [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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
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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.
|
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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. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
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|
Adverse events information
|
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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)
|
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Adverse event reporting additional description |
Safety analyses included all subjects with at least one vaccine administration documented.
|
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.0
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Reporting groups
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Reporting group title |
Group 1: Ad26.COV2.S 2.5*10^10 + Placebo
|
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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
|
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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
|
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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
|
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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
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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
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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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. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
