Trial Outcomes & Findings for The Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose (NCT NCT04977479)

NCT ID: NCT04977479

Last Updated: 2023-10-16

Results Overview

Proportion of participants who had recurrent systemic allergic reaction following active COVID-19 vaccine dose in this study. Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where Grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate) = mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4 = severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5 = death. Systemic allergic reaction was defined as CoFAR grade 1 reaction with elevated tryptase or CoFAR Grade ≥ 2 reaction irrespective of tryptase levels.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Within the 3-hour post-vaccine observation period
• Results posted on: 2023-10-16

Participant Flow

Three participants withdrew prior to start of study. One participant was ineligible due to partial 2nd vaccine dose pre-enrollment outside of the study

Participant milestones

Measure	Blinded Active Vaccine 2 Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly followed by a wash out period of 24 hours then crossover to receive placebo (0.3 mL normal saline) intramuscularly.	Blinded Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the placebo (0.3 mL normal saline) intramuscularly followed by a wash out period of 24 hours then crossover to receive the active mRNA COVID-19 vaccine (0.3mL) intramuscularly.	Open-Label Booster Vaccine Participants who did not suffer from a COFAR grade 3 or higher reaction after blinded active vaccine 2 were offered to receive booster dose of the active mRNA COVID-19 vaccine (0.3 mL) intramuscularly 5 months later.
First Period of Crossover STARTED	8	8	0
First Period of Crossover COMPLETED	8	8	0
First Period of Crossover NOT COMPLETED	0	0	0
Washout Period STARTED	8	8	0
Washout Period COMPLETED	8	8	0
Washout Period NOT COMPLETED	0	0	0
Second Period of Crossover STARTED	8	8	0
Second Period of Crossover COMPLETED	8	8	0
Second Period of Crossover NOT COMPLETED	0	0	0
Open Label STARTED	0	0	16
Open Label COMPLETED	0	0	16
Open Label NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose

Baseline characteristics by cohort

Measure	Blinded Active Vaccine 2 n=8 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly followed by a wash out period of 24 hours then crossover to receive placebo (0.3 mL normal saline) intramuscularly.	Blinded Placebo n=8 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the placebo (0.3 mL normal saline) intramuscularly followed by a wash out period of 24 hours then crossover to receive the active mRNA COVID-19 vaccine (0.3mL) intramuscularly.	Total n=16 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included participants who received the active study vaccine in the crossover phase as pre-specified in the protocol to only collect and report data from the active vaccination.

Proportion of participants who had recurrent systemic allergic reaction following active COVID-19 vaccine dose in this study. Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where Grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate) = mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4 = severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5 = death.

Systemic allergic reaction was defined as CoFAR grade 1 reaction with elevated tryptase or CoFAR Grade ≥ 2 reaction irrespective of tryptase levels.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants Who Had Recurrent Systemic Allergic Reaction to Vaccine	0.125 Proportion of participants Interval 0.016 to 0.383	—

PRIMARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included participants who received both active study vaccines in the crossover phase and the booster dose in the open label phase

Proportion of participants who had recurrent systemic allergic reaction following active COVID-19 vaccine dose in this study. Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where

Grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate) = mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4 = severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5 = death.

Systemic allergic reaction was defined as CoFAR grade 1 reaction with elevated tryptase or CoFAR Grade ≥ 2 reaction irrespective of tryptase levels.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants Who Had Recurrent Systemic Allergic Reaction to Vaccine	0.125 Proportion of participants Interval 0.016 to 0.383	—

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included participants who received the active study vaccine in the crossover phase as pre-specified in the protocol to only collect and report data from the active vaccination.

Proportion of participants who developed severe systemic allergic reaction following active COVID-19 vaccine dose in this study. Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where

Grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate) = mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4 = severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5 = death.

Severe systemic allergic reaction was defined as CoFAR Grade ≥ 3 reaction, regardless of tryptase levels.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants Who Developed Severe Systemic Allergic Reaction to Vaccine	0 Proportion of participants Interval 0.0 to 0.206	—

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included those who had a systemic allergic reaction following 1st dose of an mRNA vaccine before study and received both active study active vaccines

Proportion of participants who developed severe systemic allergic reaction following active COVID-19 vaccine dose in this study. Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where

Grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate) = mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4 = severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5 = death.

Severe systemic allergic reaction was defined as CoFAR Grade ≥ 3 reaction, regardless of tryptase levels.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants Who Developed Severe Systemic Allergic Reaction to Vaccine	0.062 Proportion of participants Interval 0.002 to 0.302	—

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included participants who received the active study vaccine in the crossover phase as pre-specified in the protocol to only collect and report data from the active vaccination.

Proportion of participants who developed mild or moderate systemic allergic reaction following active COVID-19 vaccine dose in this study. Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where

Grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate) = mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4 = severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5 = death

Mild to moderate systemic allergic reaction was defined as CoFAR Grade 1 or 2 regardless of tryptase level.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants Who Developed Mild or Moderate Systemic Allergic Reaction Following Active Vaccine Dose	0.188 Proportion of participants Interval 0.04 to 0.456	—

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included those who had a systemic allergic reaction following 1st dose of an mRNA vaccine before study and received both active study active vaccines

Proportion of participants who had recurrent systemic allergic reaction following active COVID-19 vaccine dose in this study. Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); grade 2 (moderate) = mild symptoms involving =2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to tr

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants Who Developed Mild or Moderate Systemic Allergic Reaction Following Active Vaccine Dose	0.062 Proportion of participants Interval 0.002 to 0.302	—

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included participants who received the active study vaccine in the crossover phase as pre-specified in the protocol to only collect and report data from the active vaccination.

Proportion of participants with anaphylactic reactions (Levels 1-3) per Brighton Collaboration Criteria to the COVID-19 vaccine after previously demonstrating a systemic allergic reaction to their first full dose of the COVID-19 vaccine. Anaphylaxis was defined using the Brighton Collaboration Criteria as a clinical syndrome characterized by a sudden onset and rapid progression of signs and symptoms involving ≥2 organ systems including skin, cardiovascular, respiratory, gastrointestinal or tryptase elevation (>upper normal limit). Only specific clinical features from these organ systems meet major and/or minor criteria to provide level of diagnostic certainty for anaphylactic reaction. Reaction meeting levels 1-3 diagnostic certainty are consistent with anaphylaxis

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants Who Developed Anaphylactic Reaction Following Active Dose Delivered	0.062 Proportion of participants Interval 0.002 to 0.302	—

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included those who had a systemic allergic reaction following 1st dose of an mRNA vaccine before study and received both active study active vaccines

Proportion of participants with anaphylactic reactions (Levels 1-3) per Brighton Collaboration Criteria to the COVID-19 vaccine after previously demonstrating a systemic allergic reaction to their first full dose of the COVID-19 vaccine. Anaphylaxis was defined using the Brighton Collaboration Criteria as a clinical syndrome characterized by a sudden onset and rapid progression of signs and symptoms involving ≥2 organ systems including skin, cardiovascular, respiratory, gastrointestinal or tryptase elevation (>upper normal limit). Only specific clinical features from these organ systems meet major and/or minor criteria to provide level of diagnostic certainty for anaphylactic reaction. Reaction meeting levels 1-3 diagnostic certainty are consistent with anaphylaxis.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants Who Developed Anaphylactic Reaction Following Active Vaccine Dose	0.062 Proportion of participants Interval 0.002 to 0.302	—

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included the proportion of participants who had a systemic allergic reaction after receiving the active study vaccine compared to the proportion who had a systemic allergic reaction after receiving placebo during the crossover phase of the study.

Participants with recurrent systemic allergic reaction following active vaccine dose in this study compared with reaction in placebo. Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where Grade 1 (mild)= mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate)= mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4= severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5= death Systemic allergic reaction was defined as CoFAR grade 1 reaction with elevated tryptase or CoFAR Grade ≥ 2 reaction irrespective of tryptase level. Outcome was calculated as risk difference estimation.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants Who Had Recurrent Systemic Allergic Reaction Following Active Vaccine Dose Compared With Rate of Reaction in Placebo	0.125 Proportion of participants Interval -0.134 to 0.383	0 Proportion of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included participants who received the active study vaccine in the crossover phase as pre-specified in the protocol to only collect and report data from the active vaccination.

Proportion of participants with less severe allergic reaction to the vaccine dose in this study than recorded reaction to the first full COVID-19 vaccine dose (pre-study). Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where

Grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate) = mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4 = severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5 = death.

Systemic allergic reaction was defined as CoFAR grade 1 reaction with elevated tryptase or CoFAR Grade ≥ 2 reaction irrespective of tryptase levels.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants With Less Severe Allergic Reaction to the Vaccine Dose Delivered in This Study Than Recorded Reaction to the First Full COVID-19 Vaccine Dose	0.188 Proportion of participants Interval 0.04 to 0.456	—

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included those who had a systemic allergic reaction following 1st dose of an mRNA vaccine before study and received both active study active vaccines (blinded and open-label)

Proportion of participants with less severe allergic reaction to the vaccine dose in this study than recorded reaction to the first full COVID-19 vaccine dose (pre-study). Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where

Grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate) = mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4 = severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5 = death.

Systemic allergic reaction was defined as CoFAR grade 1 reaction with elevated tryptase or CoFAR Grade ≥ 2 reaction irrespective of tryptase levels.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants With Less Severe Allergic Reaction to the Vaccine Dose Delivered in This Study Than Recorded Reaction to the First Full COVID-19 Vaccine Dose	0.062 Proportion of participants Interval 0.002 to 0.302	—

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included participants who received the active study vaccine in the crossover phase as pre-specified in the protocol to only collect and report data from the active vaccination.

"Proportion of participants with more severe allergic reaction to the vaccine dose in this study than recorded reaction to the first full COVID-19 vaccine dose (pre-study). Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where

Grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate) = mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4 = severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5 = death

Systemic allergic reaction was defined as CoFAR grade 1 reaction with elevated tryptase or CoFAR Grade ≥ 2 reaction irrespective of tryptase levels.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants With More Severe Systemic Allergic Reaction to the Vaccine Dose Delivered in This Study Than Recorded Reaction to the First Full Vaccine Dose	0 Proportion of participants Interval 0.0 to 0.206	—

SECONDARY outcome

Timeframe: Within the 3-hour post-vaccine observation period

Population: The analysis included those who had a systemic allergic reaction following 1st dose of an mRNA vaccine before study and received both active study active vaccines (blinded and open-label)

"Proportion of participants with more severe allergic reaction to the vaccine dose in this study than recorded reaction to the first full COVID-19 vaccine dose (pre-study). Allergic reactions were graded using Consortium of Food Allergy Research (CoFAR) grading scale (Version 3.0) where

Grade 1 (mild) = mild symptoms involving one organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 2 (moderate) = mild symptoms involving ≥2 organ system (skin, conjunctiva, upper respiratory or gastrointestinal); Grade 3 (severe)= moderate to severe cardiovascular, lower respiratory or gastrointestinal symptoms, responsive to treatment and/or without end-organ dysfunction; Grade 4 = severe cardiovascular or lower respiratory symptoms, with end-organ dysfunction and/or refractory to treatment; and Grade 5 = death.

Systemic allergic reaction was defined as CoFAR grade 1 reaction with elevated tryptase or CoFAR Grade ≥ 2 reaction irrespective of tryptase levels.

Outcome measures

Measure	Blinded Active Vaccine 2 n=16 Participants Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose placebo (0.3 mL normal saline) intramuscularly in the crossover phase of the study.
Proportion of Participants With More Severe Systemic Allergic Reaction to the Vaccine Dose Delivered in This Study Than Recorded Reaction to the First Full Vaccine Dose	0 Proportion of participants Interval 0.0 to 0.206	—

Adverse Events

Blinded Active Vaccine 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Open-Label Booster Vaccine

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Overall Study

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Blinded Active Vaccine 2 n=16 participants at risk Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly	Placebo n=16 participants at risk Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of placebo (0.3 mL normal saline) intramuscularly.	Open-Label Booster Vaccine n=16 participants at risk Participants who did not suffer from a COFAR grade 3 or higher reaction after blinded active vaccine 2 were offered to receive booster dose of the active mRNA COVID-19 vaccine (0.3 mL) intramuscularly 5 months later.	Overall Study n=16 participants at risk Participants who experienced a systemic allergic reaction after receiving their first full dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine receives one dose of the active mRNA COVID-19 vaccine (0.3mL) intramuscularly or placebo (0.3 mL normal saline) intramuscularly in the crossover phase of study.
General disorders Injection site oedema	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Injection site pain	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	87.5% 14/16 • Number of events 15 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	87.5% 14/16 • Number of events 16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Blood and lymphatic system disorders Anaemia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	25.0% 4/16 • Number of events 5 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Cardiac disorders Palpitations	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	25.0% 4/16 • Number of events 6 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 4 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Cardiac disorders Sinus tachycardia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	31.2% 5/16 • Number of events 5 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	50.0% 8/16 • Number of events 12 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Cardiac disorders Tachycardia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Ear and labyrinth disorders Tinnitus	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Eye disorders Eye irritation	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Eye disorders Lacrimation increased	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Eye disorders Vision blurred	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Gastrointestinal disorders Abdominal distension	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Gastrointestinal disorders Abdominal hernia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Gastrointestinal disorders Abdominal pain	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 4 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	37.5% 6/16 • Number of events 6 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Gastrointestinal disorders Dry mouth	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Gastrointestinal disorders Dysphagia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 5 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Gastrointestinal disorders Nausea	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	43.8% 7/16 • Number of events 9 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	50.0% 8/16 • Number of events 11 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Gastrointestinal disorders Proctitis	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Gastrointestinal disorders Toothache	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Gastrointestinal disorders Vomiting	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Application site pruritus	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Chest discomfort	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	37.5% 6/16 • Number of events 8 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Chest pain	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Chills	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	43.8% 7/16 • Number of events 8 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	50.0% 8/16 • Number of events 15 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Discomfort	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Facial pain	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Fatigue	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	81.2% 13/16 • Number of events 15 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	75.0% 12/16 • Number of events 16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Feeling abnormal	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Feeling hot	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Gait disturbance	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Injection site erythema	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	62.5% 10/16 • Number of events 14 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	50.0% 8/16 • Number of events 11 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Injection site induration	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	56.2% 9/16 • Number of events 10 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Injection site pruritus	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Injection site reaction	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Injection site warmth	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Non-cardiac chest pain	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Pyrexia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Tenderness	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
General disorders Vessel puncture site bruise	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Immune system disorders Anaphylactic reaction	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Immune system disorders Food allergy	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Immune system disorders Hypersensitivity	18.8% 3/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Infections and infestations Body tinea	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Infections and infestations Bronchitis	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Infections and infestations Corona virus infection	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Infections and infestations Gastroenteritis	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Infections and infestations Otitis externa	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Infections and infestations Pneumonia viral	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Infections and infestations Upper respiratory tract infection	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Infections and infestations Viral infection	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Injury, poisoning and procedural complications Contusion	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Injury, poisoning and procedural complications Exposure to communicable disease	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Injury, poisoning and procedural complications Injury	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Investigations Blood pressure increased	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	56.2% 9/16 • Number of events 9 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	68.8% 11/16 • Number of events 19 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Investigations Eosinophil count increased	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Investigations Lymphocyte count decreased	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	50.0% 8/16 • Number of events 9 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Investigations Lymphocyte count increased	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Investigations Neutrophil count decreased	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Investigations Neutrophil count increased	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Investigations Platelet count decreased	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Investigations White blood cell count decreased	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	25.0% 4/16 • Number of events 4 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Investigations White blood cell count increased	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Metabolism and nutrition disorders Polydipsia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	25.0% 4/16 • Number of events 4 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	37.5% 6/16 • Number of events 8 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	56.2% 9/16 • Number of events 9 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	43.8% 7/16 • Number of events 9 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Disturbance in attention	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Dizziness	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	37.5% 6/16 • Number of events 6 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	56.2% 9/16 • Number of events 12 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Dysgeusia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Headache	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	75.0% 12/16 • Number of events 14 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	75.0% 12/16 • Number of events 13 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Hypoaesthesia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Migraine	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Nerve compression	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Paraesthesia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	37.5% 6/16 • Number of events 6 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	43.8% 7/16 • Number of events 9 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Parosmia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Presyncope	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Nervous system disorders Taste disorder	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Psychiatric disorders Restlessness	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Renal and urinary disorders Micturition urgency	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Reproductive system and breast disorders Pelvic pain	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	31.2% 5/16 • Number of events 6 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	25.0% 4/16 • Number of events 5 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 4 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 4 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	37.5% 6/16 • Number of events 7 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	37.5% 6/16 • Number of events 7 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	25.0% 4/16 • Number of events 4 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	25.0% 4/16 • Number of events 4 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	25.0% 4/16 • Number of events 6 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Skin and subcutaneous tissue disorders Mechanical urticaria	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 2 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	62.5% 10/16 • Number of events 17 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 5 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Social circumstances Bereavement	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Surgical and medical procedures Catheter management	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Vascular disorders Flushing	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	12.5% 2/16 • Number of events 3 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 4 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Vascular disorders Haematoma	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Vascular disorders Hypertension	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	18.8% 3/16 • Number of events 5 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.
Vascular disorders Hypotension	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	6.2% 1/16 • Number of events 1 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.	0.00% 0/16 • Blinded Active Vaccine 2 & Placebo - Within 3-hour post-vaccination Overall Study - up to 17 months post intervention in the crossover phase Open-Label Booster Vaccine - up to 11 months post vaccine administration Adverse events associated with the crossover phase have been grouped under 'Overall Study' due to the brief washout period between the active vaccine and the placebo.

Additional Information

Pamela Frischmeyer-Guerrerio

National Institute of Allergy and Infectious Diseases

Phone: 301-402-9782

Email: pamela.guerrerio@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place