Trial Outcomes & Findings for Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women (NCT NCT04766086)

NCT ID: NCT04766086

Last Updated: 2024-05-24

Results Overview

Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter \[cm\]). Grading: Grade 1/mild (greater than \[\>\] 2.0 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 306 participants
• Primary outcome timeframe: Day 1 (day of vaccination) to Day 7
• Results posted on: 2024-05-24

Participant Flow

Healthy non-pregnant female participants aged 18-49 years, were randomized to receive multivalent group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) and tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap), or GBS6 and placebo, or placebo and Tdap.

A total of 306 participants were enrolled and randomized in the study, of whom 304 were vaccinated.

Participant milestones

Measure	GBS6 + Tdap Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
Overall Study STARTED	103	99	104
Overall Study Vaccinated	102	99	103
Overall Study COMPLETED	99	93	98
Overall Study NOT COMPLETED	4	6	6

Reasons for withdrawal

Measure	GBS6 + Tdap Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
Overall Study Lost to Follow-up	3	5	3
Overall Study Withdrawal by Subject	1	1	2
Overall Study Other	0	0	1

Baseline Characteristics

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

Baseline characteristics by cohort

Measure	GBS6 + Tdap n=102 Participants Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo n=99 Participants Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap n=103 Participants Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Total n=304 Participants Total of all reporting groups
Age, Continuous	35.4 Years STANDARD_DEVIATION 8.54 • n=5 Participants	34.8 Years STANDARD_DEVIATION 8.60 • n=7 Participants	35.5 Years STANDARD_DEVIATION 8.59 • n=5 Participants	35.3 Years STANDARD_DEVIATION 8.55 • n=4 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	99 Participants n=7 Participants	103 Participants n=5 Participants	304 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants	36 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=5 Participants	86 Participants n=7 Participants	86 Participants n=5 Participants	265 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	56 Participants n=4 Participants
Race (NIH/OMB) White	80 Participants n=5 Participants	68 Participants n=7 Participants	75 Participants n=5 Participants	223 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) to Day 7

Population: Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.0 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

Outcome measures

Measure	GBS6 + Tdap n=102 Participants Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo n=98 Participants Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap n=103 Participants Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Pain at injection site: Any	39.2 Percentage of participants Interval 29.7 to 49.4	45.9 Percentage of participants Interval 35.8 to 56.3	33.0 Percentage of participants Interval 24.1 to 43.0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Pain at injection site: Mild	27.5 Percentage of participants Interval 19.1 to 37.2	35.7 Percentage of participants Interval 26.3 to 46.0	26.2 Percentage of participants Interval 18.0 to 35.8
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Pain at injection site: Moderate	11.8 Percentage of participants Interval 6.2 to 19.6	9.2 Percentage of participants Interval 4.3 to 16.7	6.8 Percentage of participants Interval 2.8 to 13.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Pain at injection site: Severe	0 Percentage of participants Interval 0.0 to 3.6	1.0 Percentage of participants Interval 0.0 to 5.6	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Pain at injection site: Grade 4	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Erythema/redness: Any	7.8 Percentage of participants Interval 3.4 to 14.9	2.0 Percentage of participants Interval 0.2 to 7.2	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Erythema/redness: Mild	4.9 Percentage of participants Interval 1.6 to 11.1	1.0 Percentage of participants Interval 0.0 to 5.6	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Erythema/redness: Severe	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Erythema/redness: Grade 4	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Induration/swelling: Any	3.9 Percentage of participants Interval 1.1 to 9.7	4.1 Percentage of participants Interval 1.1 to 10.1	1.9 Percentage of participants Interval 0.2 to 6.8
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Induration/swelling: Mild	1.0 Percentage of participants Interval 0.0 to 5.3	2.0 Percentage of participants Interval 0.2 to 7.2	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Induration/swelling: Moderate	2.9 Percentage of participants Interval 0.6 to 8.4	2.0 Percentage of participants Interval 0.2 to 7.2	1.9 Percentage of participants Interval 0.2 to 6.8
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Induration/swelling: Severe	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Erythema/redness: Moderate	2.9 Percentage of participants Interval 0.6 to 8.4	1.0 Percentage of participants Interval 0.0 to 5.6	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination Induration/swelling: Grade 4	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) to Day 7

Population: Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment.

Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, chills, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.

Outcome measures

Measure	GBS6 + Tdap n=102 Participants Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo n=99 Participants Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap n=103 Participants Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Fever: >= 38.0°C	1.0 Percentage of participants Interval 0.0 to 5.3	4.0 Percentage of participants Interval 1.1 to 10.1	2.9 Percentage of participants Interval 0.6 to 8.3
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Fever: 38.0°C to 38.4°C	0 Percentage of participants Interval 0.0 to 3.6	2.0 Percentage of participants Interval 0.2 to 7.2	2.9 Percentage of participants Interval 0.6 to 8.3
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Fever: >40.0°C	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Nausea/vomiting: Any	14.7 Percentage of participants Interval 8.5 to 23.1	17.2 Percentage of participants Interval 10.4 to 26.3	14.6 Percentage of participants Interval 8.4 to 22.9
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Nausea/vomiting: Severe	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Diarrhea: Mild	15.7 Percentage of participants Interval 9.2 to 24.2	11.1 Percentage of participants Interval 5.7 to 19.2	13.6 Percentage of participants Interval 7.6 to 21.8
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Diarrhea: Moderate	3.9 Percentage of participants Interval 1.1 to 9.7	4.0 Percentage of participants Interval 1.1 to 10.1	7.8 Percentage of participants Interval 3.4 to 14.7
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Diarrhea: Severe	0 Percentage of participants Interval 0.0 to 3.6	1.0 Percentage of participants Interval 0.0 to 5.6	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Headache: Any	35.3 Percentage of participants Interval 26.1 to 45.4	48.5 Percentage of participants Interval 38.3 to 58.7	38.8 Percentage of participants Interval 29.4 to 48.9
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Headache: Severe	1.0 Percentage of participants Interval 0.0 to 5.3	1.0 Percentage of participants Interval 0.0 to 5.5	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Headache: Grade 4	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Fatigue/tiredness: Any	51.0 Percentage of participants Interval 40.9 to 61.0	50.5 Percentage of participants Interval 40.7 to 61.3	46.6 Percentage of participants Interval 36.7 to 56.7
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Fatigue/tiredness: Mild	29.4 Percentage of participants Interval 20.8 to 39.3	21.2 Percentage of participants Interval 13.8 to 30.9	19.4 Percentage of participants Interval 12.3 to 28.4
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Fatigue/tiredness: Moderate	20.6 Percentage of participants Interval 13.2 to 29.7	24.2 Percentage of participants Interval 16.4 to 34.2	26.2 Percentage of participants Interval 18.0 to 35.8
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Fatigue/tiredness: Severe	1.0 Percentage of participants Interval 0.0 to 5.3	5.1 Percentage of participants Interval 1.7 to 11.5	1.0 Percentage of participants Interval 0.0 to 5.3
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Muscle pain: Any	30.4 Percentage of participants Interval 21.7 to 40.3	24.2 Percentage of participants Interval 16.4 to 34.2	26.2 Percentage of participants Interval 18.0 to 35.8
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Muscle pain: Mild	14.7 Percentage of participants Interval 8.5 to 23.1	13.1 Percentage of participants Interval 7.3 to 21.6	14.6 Percentage of participants Interval 8.4 to 22.9
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Joint pain: Any	17.6 Percentage of participants Interval 10.8 to 26.4	15.2 Percentage of participants Interval 8.8 to 24.0	12.6 Percentage of participants Interval 6.9 to 20.6
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Joint pain: Mild	9.8 Percentage of participants Interval 4.8 to 17.3	10.1 Percentage of participants Interval 5.0 to 18.0	5.8 Percentage of participants Interval 2.2 to 12.2
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Fever: >38.4°C to 38.9°C	1.0 Percentage of participants Interval 0.0 to 5.3	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Fever: >38.9°C to 40.0°C	0 Percentage of participants Interval 0.0 to 3.6	2.0 Percentage of participants Interval 0.2 to 7.2	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Nausea/vomiting: Mild	7.8 Percentage of participants Interval 3.4 to 14.9	12.1 Percentage of participants Interval 6.5 to 20.4	12.6 Percentage of participants Interval 6.9 to 20.6
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Nausea/vomiting: Moderate	6.9 Percentage of participants Interval 2.8 to 13.6	5.1 Percentage of participants Interval 1.7 to 11.5	1.9 Percentage of participants Interval 0.2 to 6.8
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Nausea/vomiting: Grade 4	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Diarrhea: Any	19.6 Percentage of participants Interval 12.4 to 28.6	16.2 Percentage of participants Interval 9.2 to 25.2	21.4 Percentage of participants Interval 13.9 to 30.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Diarrhea: Grade 4	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Headache: Mild	23.5 Percentage of participants Interval 15.7 to 33.0	34.3 Percentage of participants Interval 25.1 to 44.6	26.2 Percentage of participants Interval 18.0 to 35.8
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Headache: Moderate	10.8 Percentage of participants Interval 5.5 to 18.5	13.1 Percentage of participants Interval 7.2 to 21.4	12.6 Percentage of participants Interval 6.9 to 20.6
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Fatigue/tiredness: Grade 4	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Muscle pain: Moderate	15.7 Percentage of participants Interval 9.2 to 24.2	10.1 Percentage of participants Interval 5.0 to 18.0	11.7 Percentage of participants Interval 6.2 to 19.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Muscle pain: Severe	0 Percentage of participants Interval 0.0 to 3.6	1.0 Percentage of participants Interval 0.0 to 5.6	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Muscle pain: Grade 4	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Joint pain: Moderate	7.8 Percentage of participants Interval 3.4 to 14.9	3.0 Percentage of participants Interval 0.6 to 8.7	6.8 Percentage of participants Interval 2.8 to 13.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Joint pain: Severe	0 Percentage of participants Interval 0.0 to 3.6	2.0 Percentage of participants Interval 0.2 to 7.2	0 Percentage of participants Interval 0.0 to 3.5
Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination Joint pain: Grade 4	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 1 Month post-vaccination

Population: Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment.

An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. In this outcome measure results excluded data for local reactions and systemic events.

Outcome measures

Measure	GBS6 + Tdap n=102 Participants Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo n=99 Participants Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap n=103 Participants Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Vaccination	5.9 Percentage of participants Interval 2.2 to 12.4	8.1 Percentage of participants Interval 3.6 to 15.3	3.9 Percentage of participants Interval 1.1 to 9.6

PRIMARY outcome

Timeframe: Day 1 (day of vaccination) through 6 Months post-vaccination

Population: Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment.

A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

Outcome measures

Measure	GBS6 + Tdap n=102 Participants Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo n=99 Participants Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap n=103 Participants Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 6 Months After Vaccination MAEs	4.9 Percentage of participants Interval 1.6 to 11.1	4.0 Percentage of participants Interval 1.1 to 10.0	6.8 Percentage of participants Interval 2.8 to 13.5
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 6 Months After Vaccination SAEs	0 Percentage of participants Interval 0.0 to 3.6	0 Percentage of participants Interval 0.0 to 3.7	1.0 Percentage of participants Interval 0.0 to 5.3

PRIMARY outcome

Timeframe: 1 Month after Vaccination (Day 1, day of vaccination)

Population: Evaluable immunogenicity population included all participants who were eligible, received all doses of the investigational products to which they were randomized, had blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month postvaccination visit, and had no major protocol violations.

IU/mL stands for international units per milliliter.

Outcome measures

Measure	GBS6 + Tdap n=99 Participants Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo n=101 Participants Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
Percentage of Participants Achieving Anti-tetanus Toxoid (Anti-TTd) and Anti-diphtheria Toxoid (Anti-DTd) Antibody Concentration >=0.1 IU/mL at 1 Month After Vaccination: GBS6 + Tdap and Placebo + Tdap Groups Anti-DTd	100.0 Percentage of participants Interval 96.3 to 100.0	100.0 Percentage of participants Interval 96.4 to 100.0	—
Percentage of Participants Achieving Anti-tetanus Toxoid (Anti-TTd) and Anti-diphtheria Toxoid (Anti-DTd) Antibody Concentration >=0.1 IU/mL at 1 Month After Vaccination: GBS6 + Tdap and Placebo + Tdap Groups Anti-TTd	100.0 Percentage of participants Interval 96.3 to 100.0	100.0 Percentage of participants Interval 96.4 to 100.0	—

PRIMARY outcome

Timeframe: 1 Month after Vaccination (Day 1, day of vaccination)

Population: Evaluable immunogenicity population included all participants who were eligible, received all doses of the investigational products to which they were randomized, had blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month postvaccination visit, and had no major protocol violations.

GMCs of anti-PT, anti-FHA, and anti-PRN was reported as descriptive data for the GBS6 +Tdap and placebo + Tdap groups, along with associated 2-sided 95% confidence interval. GMR for anti-PT, anti-FHA and anti-PRN antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data.

Outcome measures

Measure	GBS6 + Tdap n=99 Participants Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo n=101 Participants Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
Geometric Mean Concentration (GMC) of Anti-Pertussis Toxin (PT), Anti-Filamentous Hemagglutinin (FHA), and Anti-Pertactin (PRN) Antibodies; GMR of Anti-PT, Anti-FHA, and Anti-PRN for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination GMC of Anti-PT antibodies	17.975 Endotoxin units per milliliter (EU/mL) Interval 14.519 to 22.254	32.916 Endotoxin units per milliliter (EU/mL) Interval 26.641 to 40.668	—
Geometric Mean Concentration (GMC) of Anti-Pertussis Toxin (PT), Anti-Filamentous Hemagglutinin (FHA), and Anti-Pertactin (PRN) Antibodies; GMR of Anti-PT, Anti-FHA, and Anti-PRN for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination GMC of Anti-FHA antibodies	108.377 Endotoxin units per milliliter (EU/mL) Interval 93.479 to 125.65	191.140 Endotoxin units per milliliter (EU/mL) Interval 161.964 to 225.571	—
Geometric Mean Concentration (GMC) of Anti-Pertussis Toxin (PT), Anti-Filamentous Hemagglutinin (FHA), and Anti-Pertactin (PRN) Antibodies; GMR of Anti-PT, Anti-FHA, and Anti-PRN for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination GMC of Anti-PRN antibodies	158.887 Endotoxin units per milliliter (EU/mL) Interval 132.346 to 190.751	270.294 Endotoxin units per milliliter (EU/mL) Interval 222.691 to 328.072	—

PRIMARY outcome

Timeframe: 1 Month after Vaccination (Day 1, day of vaccination)

Population: Evaluable immunogenicity population evaluated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here, "Number analyzed" signifies number of participants with valid and determinate assay results for the serotype at the specified time point.

GBS CPS serotype-specific IgG GMCs (Ia, Ib, II, III, IV, V) were reported as descriptive data for the GBS6+Tdap and GBS6+placebo groups, along with associated 2-sided 95% confidence interval. GMR of GBS CPS serotype-specific IgG antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data.

Outcome measures

Measure	GBS6 + Tdap n=99 Participants Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo n=94 Participants Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination III	3.521 mcg/mL Interval 2.107 to 5.885	5.547 mcg/mL Interval 3.239 to 9.5	—
GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination IV	6.065 mcg/mL Interval 4.097 to 8.98	4.115 mcg/mL Interval 2.746 to 6.167	—
GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination Ia	13.015 mcg/mL Interval 7.095 to 23.874	14.616 mcg/mL Interval 7.965 to 26.821	—
GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination Ib	2.421 mcg/mL Interval 1.322 to 4.431	2.106 mcg/mL Interval 1.037 to 4.278	—
GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination II	63.656 mcg/mL Interval 40.279 to 100.6	61.709 mcg/mL Interval 39.961 to 95.291	—
GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination V	1.307 mcg/mL Interval 0.722 to 2.363	2.337 mcg/mL Interval 1.209 to 4.517	—

Adverse Events

GBS6 + Tdap

Serious events: 0 serious events

Other events: 81 other events

Deaths: 0 deaths

GBS6 + Placebo

Serious events: 0 serious events

Other events: 71 other events

Deaths: 0 deaths

Placebo + Tdap

Serious events: 1 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Measure	GBS6 + Tdap n=102 participants at risk Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo n=99 participants at risk Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap n=103 participants at risk Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
Hepatobiliary disorders Bile duct stone	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.

Other adverse events

Measure	GBS6 + Tdap n=102 participants at risk Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter \[mL\]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.	GBS6 + Placebo n=99 participants at risk Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.	Placebo + Tdap n=103 participants at risk Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Cardiac disorders Tachycardia	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Gastrointestinal disorders Tooth impacted	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
General disorders Axillary pain	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Infections and infestations Bacterial vaginosis	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Infections and infestations COVID-19	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	2.0% 2/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Infections and infestations Ear infection	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Infections and infestations Gingivitis	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Infections and infestations Influenza	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Infections and infestations Otitis media	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Infections and infestations Post procedural infection	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Infections and infestations Sinusitis	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Infections and infestations Upper respiratory tract infection	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Injury, poisoning and procedural complications Epicondylitis	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Investigations Blood pressure increased	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Metabolism and nutrition disorders Abnormal weight gain	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Nervous system disorders Headache	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Nervous system disorders Nerve compression	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Nervous system disorders Presyncope	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Psychiatric disorders Anxiety	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Psychiatric disorders Attention deficit hyperactivity disorder	0.00% 0/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.97% 1/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Psychiatric disorders Depression	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.0% 1/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 2/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Vascular disorders Hypertension	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Gastrointestinal disorders Diarrhoea (DIARRHEA)	19.6% 20/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	16.2% 16/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	21.4% 22/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Gastrointestinal disorders Vomiting (NAUSEA/VOMITING)	14.7% 15/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	17.2% 17/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	14.6% 15/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
General disorders Fatigue (FATIGUE)	51.0% 52/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	50.5% 50/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	46.6% 48/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
General disorders Injection site erythema (REDNESS)	7.8% 8/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	2.0% 2/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	0.00% 0/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
General disorders Injection site pain (PAIN)	39.2% 40/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	45.5% 45/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	33.0% 34/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
General disorders Injection site swelling (SWELLING)	3.9% 4/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	4.0% 4/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	1.9% 2/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
General disorders Pyrexia (FEVER)	0.98% 1/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	4.0% 4/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	2.9% 3/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Musculoskeletal and connective tissue disorders Arthralgia (JOINT PAIN)	17.6% 18/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	15.2% 15/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	12.6% 13/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Musculoskeletal and connective tissue disorders Myalgia (MUSCLE PAIN)	30.4% 31/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	24.2% 24/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	26.2% 27/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
Nervous system disorders Headache (HEADACHE)	35.3% 36/102 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	48.5% 48/99 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.	38.8% 40/103 • Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1] All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER