Trial Outcomes & Findings for Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine (NCT NCT02639351)

NCT ID: NCT02639351

Last Updated: 2019-06-28

Results Overview

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature greater than or equal to (≥) 38 degrees Celsius (°C), as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 80 participants
• Primary outcome timeframe: Within 30 minutes of vaccination (Min) at Day 1
• Results posted on: 2019-06-28

Participant Flow

80 subjects were recruited from 1 site in Germany.

Participant milestones

Measure	LHD153R Formulation 1 Group Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group Healthy subjects aged 18 to 45 years who received a single dose of Meningococcal C-CRM conjugate vaccine (MenC-CRM).
Overall Study STARTED	16	16	16	16	16
Overall Study COMPLETED	16	16	16	16	16
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine

Baseline characteristics by cohort

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.	Total n=80 Participants Total of all reporting groups
Age, Continuous	36.8 Years STANDARD_DEVIATION 7.51 • n=93 Participants	33.8 Years STANDARD_DEVIATION 6.89 • n=4 Participants	34.9 Years STANDARD_DEVIATION 5.18 • n=27 Participants	34.4 Years STANDARD_DEVIATION 6.72 • n=483 Participants	34.4 Years STANDARD_DEVIATION 7.85 • n=36 Participants	34.9 Years STANDARD_DEVIATION 6.79 • n=10 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants	6 Participants n=483 Participants	6 Participants n=36 Participants	24 Participants n=10 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	12 Participants n=4 Participants	11 Participants n=27 Participants	10 Participants n=483 Participants	10 Participants n=36 Participants	56 Participants n=10 Participants
Race/Ethnicity, Customized White	16 Participants n=93 Participants	16 Participants n=4 Participants	15 Participants n=27 Participants	16 Participants n=483 Participants	16 Participants n=36 Participants	79 Participants n=10 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants

PRIMARY outcome

Timeframe: Within 30 minutes of vaccination (Min) at Day 1

Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms.

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature greater than or equal to (≥) 38 degrees Celsius (°C), as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Erythema	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Induration	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Pain	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Arthralgia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Diarrhea	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Fever	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Headache	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Loss of Appetite	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Myalgia	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Urticaria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Vomiting	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Swelling	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Chills	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Fatigue	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Nausea	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) Any Rash	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination)

Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported local and systemic symptoms

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Any Solicited Local and Systemic AEs Any Induration	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Swelling	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Arthralgia	0 Participants	1 Participants	0 Participants	4 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Diarrhea	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Fever	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Headache	3 Participants	6 Participants	3 Participants	5 Participants	8 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Myalgia	0 Participants	1 Participants	0 Participants	3 Participants	2 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Rash	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Urticaria	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Vomiting	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Analgesic/Antipyretics Use	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Erythema	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Pain	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Chills	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Fatigue	3 Participants	2 Participants	3 Participants	5 Participants	3 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Loss of Appetite	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Nausea	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 5 to Day 8

Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Any Solicited Local and Systemic AEs Any Erythema	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Induration	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Pain	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Swelling	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Arthralgia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Fatigue	1 Participants	1 Participants	0 Participants	4 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Fever	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Headache	4 Participants	3 Participants	2 Participants	5 Participants	2 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Loss of Appetite	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Myalgia	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Rash	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Urticaria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Vomiting	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Analgesic/Antipyretics Use	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Chills	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Diarrhea	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Nausea	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 8 to Day 14

Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Any Solicited Local and Systemic AEs Any Vomiting	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Pain	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Headache	4 Participants	1 Participants	1 Participants	2 Participants	4 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Loss of Appetite	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Nausea	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Rash	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Urticaria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Analgesic/Antipyretics Use	1 Participants	2 Participants	0 Participants	3 Participants	1 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Chills	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Diarrhea	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Erythema	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Induration	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Swelling	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Arthralgia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Fatigue	2 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Fever	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Myalgia	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 8 (excluding 30 minutes immediately after vaccination)

Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Any Solicited Local and Systemic AEs Any Pain	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Swelling	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Arthralgia	0 Participants	1 Participants	0 Participants	4 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Chills	0 Participants	1 Participants	1 Participants	4 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Diarrhea	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Fatigue	3 Participants	2 Participants	3 Participants	6 Participants	3 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Fever	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Headache	5 Participants	7 Participants	5 Participants	5 Participants	10 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Loss of Appetite	0 Participants	1 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Myalgia	0 Participants	1 Participants	0 Participants	5 Participants	2 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Nausea	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Vomiting	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Analgesic/Antipyretics Use	2 Participants	3 Participants	1 Participants	3 Participants	1 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Erythema	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Induration	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Rash	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Urticaria	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 14 (excluding 30 minutes immediately after any vaccination)

Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and provided post-vaccination solicited local and systemic symptoms data

Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Any Solicited Local and Systemic AEs Any Erythema	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Induration	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Pain	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Swelling	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Arthralgia	1 Participants	1 Participants	0 Participants	4 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Chills	0 Participants	1 Participants	1 Participants	4 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Diarrhea	1 Participants	0 Participants	1 Participants	3 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Fever	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Headache	6 Participants	7 Participants	5 Participants	5 Participants	10 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Rash	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Vomiting	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Analgesic/Antipyretics Use	2 Participants	3 Participants	1 Participants	4 Participants	1 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Fatigue	3 Participants	2 Participants	3 Participants	6 Participants	3 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Loss of Appetite	1 Participants	1 Participants	2 Participants	4 Participants	0 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Myalgia	1 Participants	1 Participants	0 Participants	5 Participants	2 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Nausea	1 Participants	2 Participants	1 Participants	3 Participants	1 Participants
Number of Subjects With Any Solicited Local and Systemic AEs Any Urticaria	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 29

Population: Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and provided post-vaccination unsolicited adverse event data.

An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes intercurrent illnesses or injuries and exacerbation of pre-existing conditions. Unsolicited adverse event were defined as symptoms that were not solicited using a Subject Diary and that were spontaneously communicated by a subject who has signed the informed consent. Unsolicited AEs were collected through the Day 29 visit and the analysis was performed for Day 1-29 time frame, instead of Day 1-14 as required by protocol.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Any Unsolicited AEs	4 Participants	2 Participants	1 Participants	4 Participants	4 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 366

Population: Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and had post-vaccination unsolicited adverse events data. Data for this endpoint was analyzed from Day 1 to study termination (Day 366). Data from day of signed informed consent till Day 1(as per protocol) were not collected.

SAEs are untoward medical occurrences that at any dose resulted in death,was life-threatening,required/prolonged hospitalization,persistent/significant disability/incapacity,congenital anomaly/in important & significant medical event that could jeopardize the subject/could required intervention to prevent one of the other outcomes mentioned above.MAAEs are AEs that lead to a visit to a healthcare provider.NOCDs are adverse events that represent new diagnosis of a chronic medical condition that was not present/suspected in a subject prior to study enrolment.AESIs were defined according to MedDRA preferred terms.Certain AESIs are monitored after administration of immunostimulatory agents.These are pre-defined & include AEs in the SOCs of Gastrointestinal disorders,Liver disorders,Metabolic diseases,Musculo-skeletal disorders,Neuroinflammatory disorders,Skin disorders,Vasculitides & others.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Any Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Study Withdrawal, New Onset of Chronic Disease (NOCDs) and Adverse Events of Special Interest (AESIs). Any MAAEs	6 Participants	9 Participants	5 Participants	8 Participants	8 Participants
Number of Subjects With Any Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Study Withdrawal, New Onset of Chronic Disease (NOCDs) and Adverse Events of Special Interest (AESIs). Any AEs leading to withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Study Withdrawal, New Onset of Chronic Disease (NOCDs) and Adverse Events of Special Interest (AESIs). Any NOCDs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Study Withdrawal, New Onset of Chronic Disease (NOCDs) and Adverse Events of Special Interest (AESIs). Any AESIs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Study Withdrawal, New Onset of Chronic Disease (NOCDs) and Adverse Events of Special Interest (AESIs). Any SAEs	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 29

Population: Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and had post-vaccination unsolicited adverse event data.

SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastrointestinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Any SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Any AESIs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Any MAAEs	2 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Any AEs leading to withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Any NOCDs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 29 up to study end (Day 366)

Population: Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and had post-vaccination unsolicited adverse events data.

SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastroin-testinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Any AEs leading to withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Any NOCDs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Any AESIs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Any SAEs	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. Any MAAEs	5 Participants	9 Participants	5 Participants	5 Participants	8 Participants

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in millimoles per liter (mmol/L).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. Na	138.07 mmol/L Standard Deviation 1.226	136.77 mmol/L Standard Deviation 1.514	136.73 mmol/L Standard Deviation 1.891	138.29 mmol/L Standard Deviation 1.875	137.06 mmol/L Standard Deviation 1.821
Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. K	4.253 mmol/L Standard Deviation 0.325	4.176 mmol/L Standard Deviation 0.162	4.185 mmol/L Standard Deviation 0.346	3.962 mmol/L Standard Deviation 0.178	4.253 mmol/L Standard Deviation 0.253
Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. Cl	104.25 mmol/L Standard Deviation 1.382	103.94 mmol/L Standard Deviation 2.057	103.91 mmol/L Standard Deviation 1.973	104.99 mmol/L Standard Deviation 2.168	104.03 mmol/L Standard Deviation 2.120
Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. BUN	4.545 mmol/L Standard Deviation 1.085	5.048 mmol/L Standard Deviation 1.422	5.247 mmol/L Standard Deviation 1.039	4.616 mmol/L Standard Deviation 0.930	4.606 mmol/L Standard Deviation 1.327
Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. Bicarbonate	25.42 mmol/L Standard Deviation 1.638	25.75 mmol/L Standard Deviation 1.293	27.09 mmol/L Standard Deviation 2.180	26.64 mmol/L Standard Deviation 1.944	25.98 mmol/L Standard Deviation 1.749

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters Na	-0.34 Difference of mmol/L Standard Deviation 1.051	0.45 Difference of mmol/L Standard Deviation 1.693	-0.33 Difference of mmol/L Standard Deviation 2.097	-0.86 Difference of mmol/L Standard Deviation 1.744	-0.09 Difference of mmol/L Standard Deviation 2.020
Changes in Clinical Serum Chemistry Parameters K	0.002 Difference of mmol/L Standard Deviation 0.361	0.043 Difference of mmol/L Standard Deviation 0.205	0.100 Difference of mmol/L Standard Deviation 0.310	0.028 Difference of mmol/L Standard Deviation 0.208	0.178 Difference of mmol/L Standard Deviation 0.254
Changes in Clinical Serum Chemistry Parameters Cl	-0.55 Difference of mmol/L Standard Deviation 1.526	-0.32 Difference of mmol/L Standard Deviation 2.005	-0.74 Difference of mmol/L Standard Deviation 2.080	-1.06 Difference of mmol/L Standard Deviation 2.828	-0.10 Difference of mmol/L Standard Deviation 2.122
Changes in Clinical Serum Chemistry Parameters BUN	-0.209 Difference of mmol/L Standard Deviation 0.944	-0.911 Difference of mmol/L Standard Deviation 0.838	-0.949 Difference of mmol/L Standard Deviation 0.940	-0.556 Difference of mmol/L Standard Deviation 0.493	-0.433 Difference of mmol/L Standard Deviation 0.616
Changes in Clinical Serum Chemistry Parameters Bicarbonate	0.09 Difference of mmol/L Standard Deviation 1.080	0.51 Difference of mmol/L Standard Deviation 1.381	0.88 Difference of mmol/L Standard Deviation 1.690	0.41 Difference of mmol/L Standard Deviation 1.413	0.66 Difference of mmol/L Standard Deviation 1.733

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data.

Analysis was performed on blood samples collected at Day 8 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters Na	-0.39 Difference of mmol/L Standard Deviation 2.129	0.08 Difference of mmol/L Standard Deviation 2.066	0.68 Difference of mmol/L Standard Deviation 1.951	-0.61 Difference of mmol/L Standard Deviation 2.305	0.11 Difference of mmol/L Standard Deviation 1.676
Changes in Clinical Serum Chemistry Parameters Bicarbonate	1.20 Difference of mmol/L Standard Deviation 1.747	1.00 Difference of mmol/L Standard Deviation 1.485	0.14 Difference of mmol/L Standard Deviation 1.614	0.82 Difference of mmol/L Standard Deviation 1.633	0.41 Difference of mmol/L Standard Deviation 2.117
Changes in Clinical Serum Chemistry Parameters K	-0.030 Difference of mmol/L Standard Deviation 0.302	0.233 Difference of mmol/L Standard Deviation 0.274	0.143 Difference of mmol/L Standard Deviation 0.322	0.128 Difference of mmol/L Standard Deviation 0.137	0.071 Difference of mmol/L Standard Deviation 0.208
Changes in Clinical Serum Chemistry Parameters Cl	-1.37 Difference of mmol/L Standard Deviation 1.740	-0.28 Difference of mmol/L Standard Deviation 2.467	0.27 Difference of mmol/L Standard Deviation 2.265	-1.73 Difference of mmol/L Standard Deviation 4.390	-1.30 Difference of mmol/L Standard Deviation 2.642
Changes in Clinical Serum Chemistry Parameters BUN	0.125 Difference of mmol/L Standard Deviation 1.177	-0.507 Difference of mmol/L Standard Deviation 0.758	-0.128 Difference of mmol/L Standard Deviation 1.236	0.144 Difference of mmol/L Standard Deviation 1.144	0.003 Difference of mmol/L Standard Deviation 0.909

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 29 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters Na	0.06 Difference of mmol/L Standard Deviation 1.834	1.11 Difference of mmol/L Standard Deviation 1.993	1.66 Difference of mmol/L Standard Deviation 2.317	0.09 Difference of mmol/L Standard Deviation 1.880	0.76 Difference of mmol/L Standard Deviation 1.926
Changes in Clinical Serum Chemistry Parameters K	-0.008 Difference of mmol/L Standard Deviation 0.426	0.290 Difference of mmol/L Standard Deviation 0.369	0.147 Difference of mmol/L Standard Deviation 0.377	0.204 Difference of mmol/L Standard Deviation 0.255	0.109 Difference of mmol/L Standard Deviation 0.299
Changes in Clinical Serum Chemistry Parameters Cl	-1.02 Difference of mmol/L Standard Deviation 2.144	-0.34 Difference of mmol/L Standard Deviation 2.379	-1.38 Difference of mmol/L Standard Deviation 1.438	-1.21 Difference of mmol/L Standard Deviation 1.870	-1.03 Difference of mmol/L Standard Deviation 1.862
Changes in Clinical Serum Chemistry Parameters BUN	0.500 Difference of mmol/L Standard Deviation 1.199	-0.103 Difference of mmol/L Standard Deviation 1.180	0.021 Difference of mmol/L Standard Deviation 1.214	0.476 Difference of mmol/L Standard Deviation 0.784	0.216 Difference of mmol/L Standard Deviation 1.023
Changes in Clinical Serum Chemistry Parameters Bicarbonate	0.64 Difference of mmol/L Standard Deviation 1.672	2.66 Difference of mmol/L Standard Deviation 1.787	2.01 Difference of mmol/L Standard Deviation 2.158	0.52 Difference of mmol/L Standard Deviation 2.030	1.27 Difference of mmol/L Standard Deviation 2.340

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: Creatinine (CREA) in micro mole per liter (μmol/L)

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Clinical Serum Chemistry Parameters-Creatinine	77.52 μmol/L Standard Deviation 12.517	72.25 μmol/L Standard Deviation 12.336	80.43 μmol/L Standard Deviation 10.086	74.43 μmol/L Standard Deviation 13.459	74.29 μmol/L Standard Deviation 9.206

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters	0.64 Difference of μmol/L Standard Deviation 3.393	2.59 Difference of μmol/L Standard Deviation 2.622	0.21 Difference of μmol/L Standard Deviation 7.479	-0.50 Difference of μmol/L Standard Deviation 4.654	1.41 Difference of μmol/L Standard Deviation 4.663

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 8 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters	3.61 Difference of μmol/L Standard Deviation 5.109	3.48 Difference of μmol/L Standard Deviation 5.377	2.49 Difference of μmol/L Standard Deviation 4.936	2.03 Difference of μmol/L Standard Deviation 5.052	2.40 Difference of μmol/L Standard Deviation 3.440

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 29 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters	4.51 Difference of μmol/L Standard Deviation 4.557	5.68 Difference of μmol/L Standard Deviation 5.878	3.09 Difference of μmol/L Standard Deviation 6.345	1.72 Difference of μmol/L Standard Deviation 4.906	3.24 Difference of μmol/L Standard Deviation 6.355

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: ALT and AST in International Units per liter (IU/L).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ALT	26.75 IU/L Standard Deviation 11.906	20.17 IU/L Standard Deviation 9.875	21.14 IU/L Standard Deviation 7.920	22.97 IU/L Standard Deviation 8.747	25.86 IU/L Standard Deviation 12.631
Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) AST	23.30 IU/L Standard Deviation 5.880	25.01 IU/L Standard Deviation 5.058	24.11 IU/L Standard Deviation 4.809	23.08 IU/L Standard Deviation 6.592	24.84 IU/L Standard Deviation 5.771

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters AST	-2.41 Difference of IU/L Standard Deviation 2.461	-2.82 Difference of IU/L Standard Deviation 2.451	-3.07 Difference of IU/L Standard Deviation 3.280	-1.98 Difference of IU/L Standard Deviation 3.391	-1.44 Difference of IU/L Standard Deviation 2.590
Changes in Clinical Serum Chemistry Parameters ALT	-2.29 Difference of IU/L Standard Deviation 3.044	-1.28 Difference of IU/L Standard Deviation 1.563	-1.40 Difference of IU/L Standard Deviation 2.892	-1.19 Difference of IU/L Standard Deviation 3.969	0.23 Difference of IU/L Standard Deviation 2.569

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 8 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters ALT	0.70 Difference of IU/L Standard Deviation 5.806	2.08 Difference of IU/L Standard Deviation 5.027	0.47 Difference of IU/L Standard Deviation 4.580	1.03 Difference of IU/L Standard Deviation 6.764	1.88 Difference of IU/L Standard Deviation 4.150
Changes in Clinical Serum Chemistry Parameters AST	2.58 Difference of IU/L Standard Deviation 4.930	2.47 Difference of IU/L Standard Deviation 13.382	0.21 Difference of IU/L Standard Deviation 6.431	0.43 Difference of IU/L Standard Deviation 6.743	0.00 Difference of IU/L Standard Deviation 4.103

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 29 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters ALT	-2.15 Difference of IU/L Standard Deviation 9.553	2.36 Difference of IU/L Standard Deviation 6.040	5.99 Difference of IU/L Standard Deviation 10.114	0.91 Difference of IU/L Standard Deviation 7.192	3.78 Difference of IU/L Standard Deviation 8.382
Changes in Clinical Serum Chemistry Parameters AST	0.56 Difference of IU/L Standard Deviation 6.031	1.88 Difference of IU/L Standard Deviation 16.060	2.24 Difference of IU/L Standard Deviation 5.948	-0.74 Difference of IU/L Standard Deviation 6.674	2.61 Difference of IU/L Standard Deviation 6.823

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: CRP in milligram per liter (mg/L).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=15 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP)	1.382 mg/L Standard Deviation 3.353	0.928 mg/L Standard Deviation 0.663	1.049 mg/L Standard Deviation 1.003	2.337 mg/L Standard Deviation 3.718	1.243 mg/L Standard Deviation 1.340

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=15 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters	-0.148 Difference of mg/L Standard Deviation 1.334	0.888 Difference of mg/L Standard Deviation 2.177	0.439 Difference of mg/L Standard Deviation 1.015	1.646 Difference of mg/L Standard Deviation 4.231	0.239 Difference of mg/L Standard Deviation 0.777

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 8 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=15 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters	-0.393 Difference of mg/L Standard Deviation 3.260	0.339 Difference of mg/L Standard Deviation 0.878	-0.057 Difference of mg/L Standard Deviation 0.830	7.736 Difference of mg/L Standard Deviation 30.996	0.153 Difference of mg/L Standard Deviation 0.934

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 29 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=15 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Clinical Serum Chemistry Parameters	-0.202 Difference of mg/L Standard Deviation 3.195	0.348 Difference of mg/L Standard Deviation 0.849	0.200 Difference of mg/L Standard Deviation 0.535	1.075 Difference of mg/L Standard Deviation 8.004	-0.058 Difference of mg/L Standard Deviation 0.948

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9 cells per liter (10^9/L)

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. Basophil	0.033 10^9/L Standard Deviation 0.015	0.034 10^9/L Standard Deviation 0.020	0.033 10^9/L Standard Deviation 0.014	0.030 10^9/L Standard Deviation 0.014	0.029 10^9/L Standard Deviation 0.012
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. Eosinophils	0.128 10^9/L Standard Deviation 0.065	0.183 10^9/L Standard Deviation 0.127	0.184 10^9/L Standard Deviation 0.114	0.150 10^9/L Standard Deviation 0.105	0.234 10^9/L Standard Deviation 0.136
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. Leukocytes	6.150 10^9/L Standard Deviation 2.116	5.278 10^9/L Standard Deviation 1.170	6.085 10^9/L Standard Deviation 1.720	6.031 10^9/L Standard Deviation 1.560	6.383 10^9/L Standard Deviation 1.347
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. Lymphocytes	1.653 10^9/L Standard Deviation 0.453	1.764 10^9/L Standard Deviation 0.425	0.425 10^9/L Standard Deviation 0.562	1.751 10^9/L Standard Deviation 0.332	1.868 10^9/L Standard Deviation 0.413
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. Monocytes	0.413 10^9/L Standard Deviation 0.110	0.365 10^9/L Standard Deviation 0.108	0.428 10^9/L Standard Deviation 0.114	0.398 10^9/L Standard Deviation 0.090	0.451 10^9/L Standard Deviation 0.115
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. Neutrophils	3.811 10^9/L Standard Deviation 1.865	2.833 10^9/L Standard Deviation 0.712	3.502 10^9/L Standard Deviation 1.157	3.618 10^9/L Standard Deviation 1.372	3.692 10^9/L Standard Deviation 1.095
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. Platelets	203.9 10^9/L Standard Deviation 37.90	208.3 10^9/L Standard Deviation 38.82	239.9 10^9/L Standard Deviation 60.28	197.8 10^9/L Standard Deviation 45.04	224.0 10^9/L Standard Deviation 50.46

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters Eosinophils	0.015 Difference of 10^9/L Standard Deviation 0.045	-0.018 Difference of 10^9/L Standard Deviation 0.057	-0.009 Difference of 10^9/L Standard Deviation 0.041	-0.016 Difference of 10^9/L Standard Deviation 0.050	0.016 Difference of 10^9/L Standard Deviation 0.052
Changes in Hematology Parameters Leukocytes	0.853 Difference of 10^9/L Standard Deviation 1.442	0.923 Difference of 10^9/L Standard Deviation 1.291	0.584 Difference of 10^9/L Standard Deviation 1.048	0.294 Difference of 10^9/L Standard Deviation 1.531	0.621 Difference of 10^9/L Standard Deviation 0.968
Changes in Hematology Parameters Lymphocytes	0.077 Difference of 10^9/L Standard Deviation 0.314	-0.147 Difference of 10^9/L Standard Deviation 0.533	-0.302 Difference of 10^9/L Standard Deviation 0.358	-0.197 Difference of 10^9/L Standard Deviation 0.397	0.000 Difference of 10^9/L Standard Deviation 0.246
Changes in Hematology Parameters Monocytes	0.075 Difference of 10^9/L Standard Deviation 0.068	0.053 Difference of 10^9/L Standard Deviation 0.102	0.049 Difference of 10^9/L Standard Deviation 0.084	0.051 Difference of 10^9/L Standard Deviation 0.102	0.040 Difference of 10^9/L Standard Deviation 0.078
Changes in Hematology Parameters Neutrophils	0.686 Difference of 10^9/L Standard Deviation 1.436	1.044 Difference of 10^9/L Standard Deviation 0.945	0.863 Difference of 10^9/L Standard Deviation 0.851	0.451 Difference of 10^9/L Standard Deviation 1.182	0.558 Difference of 10^9/L Standard Deviation 0.873
Changes in Hematology Parameters Platelets	-2.5 Difference of 10^9/L Standard Deviation 11.08	-0.6 Difference of 10^9/L Standard Deviation 15.19	-0.1 Difference of 10^9/L Standard Deviation 12.75	-2.3 Difference of 10^9/L Standard Deviation 9.74	-0.8 Difference of 10^9/L Standard Deviation 14.20
Changes in Hematology Parameters Basophils	0.000 Difference of 10^9/L Standard Deviation 0.014	0.000 Difference of 10^9/L Standard Deviation 0.009	-0.003 Difference of 10^9/L Standard Deviation 0.009	0.004 Difference of 10^9/L Standard Deviation 0.014	0.001 Difference of 10^9/L Standard Deviation 0.011

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 8 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters Basophils	-0.001 Difference of 10^9/L Standard Deviation 0.016	0.004 Difference of 10^9/L Standard Deviation 0.010	-0.002 Difference of 10^9/L Standard Deviation 0.014	0.006 Difference of 10^9/L Standard Deviation 0.013	0.006 Difference of 10^9/L Standard Deviation 0.016
Changes in Hematology Parameters Eosinophils	0.044 Difference of 10^9/L Standard Deviation 0.048	-0.006 Difference of 10^9/L Standard Deviation 0.059	-0.013 Difference of 10^9/L Standard Deviation 0.058	0.025 Difference of 10^9/L Standard Deviation 0.064	0.033 Difference of 10^9/L Standard Deviation 0.074
Changes in Hematology Parameters Leukocytes	0.123 Difference of 10^9/L Standard Deviation 1.624	0.086 Difference of 10^9/L Standard Deviation 0.968	-0.417 Difference of 10^9/L Standard Deviation 1.161	-0.451 Difference of 10^9/L Standard Deviation 1.245	0.074 Difference of 10^9/L Standard Deviation 0.978
Changes in Hematology Parameters Lymphocytes	0.333 Difference of 10^9/L Standard Deviation 0.416	0.029 Difference of 10^9/L Standard Deviation 0.404	-0.007 Difference of 10^9/L Standard Deviation 0.476	0.115 Difference of 10^9/L Standard Deviation 0.349	0.025 Difference of 10^9/L Standard Deviation 0.339
Changes in Hematology Parameters Monocytes	0.004 Difference of 10^9/L Standard Deviation 0.086	-0.001 Difference of 10^9/L Standard Deviation 0.069	-0.053 Difference of 10^9/L Standard Deviation 0.087	-0.016 Difference of 10^9/L Standard Deviation 0.097	0.027 Difference of 10^9/L Standard Deviation 0.081
Changes in Hematology Parameters Neutrophils	-0.256 Difference of 10^9/L Standard Deviation 1.567	0.048 Difference of 10^9/L Standard Deviation 0.640	-0.342 Difference of 10^9/L Standard Deviation 0.854	-0.603 Difference of 10^9/L Standard Deviation 1.184	-0.031 Difference of 10^9/L Standard Deviation 1.015
Changes in Hematology Parameters Platelets	28.2 Difference of 10^9/L Standard Deviation 27.77	25.3 Difference of 10^9/L Standard Deviation 16.19	13.1 Difference of 10^9/L Standard Deviation 28.34	17.9 Difference of 10^9/L Standard Deviation 16.39	22.4 Difference of 10^9/L Standard Deviation 22.90

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 29 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters Basophils	0.007 Difference of 10^9/L Standard Deviation 0.012	0.002 Difference of 10^9/L Standard Deviation 0.010	0.003 Difference of 10^9/L Standard Deviation 0.011	0.006 Difference of 10^9/L Standard Deviation 0.012	0.004 Difference of 10^9/L Standard Deviation 0.013
Changes in Hematology Parameters Eosinophils	0.039 Difference of 10^9/L Standard Deviation 0.063	-0.014 Difference of 10^9/L Standard Deviation 0.107	0.027 Difference of 10^9/L Standard Deviation 0.078	0.020 Difference of 10^9/L Standard Deviation 0.052	0.018 Difference of 10^9/L Standard Deviation 0.063
Changes in Hematology Parameters Leukocytes	0.136 Difference of 10^9/L Standard Deviation 1.637	0.328 Difference of 10^9/L Standard Deviation 0.781	-0.023 Difference of 10^9/L Standard Deviation 1.442	-0.212 Difference of 10^9/L Standard Deviation 1.264	-0.086 Difference of 10^9/L Standard Deviation 1.161
Changes in Hematology Parameters Lymphocytes	0.294 Difference of 10^9/L Standard Deviation 0.506	0.038 Difference of 10^9/L Standard Deviation 0.476	-0.041 Difference of 10^9/L Standard Deviation 0.451	0.122 Difference of 10^9/L Standard Deviation 0.429	0.105 Difference of 10^9/L Standard Deviation 0.268
Changes in Hematology Parameters Monocytes	0.079 Difference of 10^9/L Standard Deviation 0.109	0.025 Difference of 10^9/L Standard Deviation 0.090	-0.002 Difference of 10^9/L Standard Deviation 0.098	-0.028 Difference of 10^9/L Standard Deviation 0.099	0.019 Difference of 10^9/L Standard Deviation 0.092
Changes in Hematology Parameters Neutrophiles	-0.276 Difference of 10^9/L Standard Deviation 1.431	0.277 Difference of 10^9/L Standard Deviation 0.611	-0.016 Difference of 10^9/L Standard Deviation 0.970	-0.355 Difference of 10^9/L Standard Deviation 1.228	-0.234 Difference of 10^9/L Standard Deviation 1.091
Changes in Hematology Parameters Platelets	19.6 Difference of 10^9/L Standard Deviation 33.37	24.5 Difference of 10^9/L Standard Deviation 15.30	6.6 Difference of 10^9/L Standard Deviation 15.68	10.1 Difference of 10^9/L Standard Deviation 16.55	11.1 Difference of 10^9/L Standard Deviation 22.47

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: RBC in 10^12 cells per liter (10^12/L).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Hematology Parameters- Red Blood Cells (RBC)	4.777 10^12/L Standard Deviation 0.358	4.598 10^12/L Standard Deviation 0.377	4.724 10^12/L Standard Deviation 0.492	4.676 10^12/L Standard Deviation 0.362	4.773 10^12/L Standard Deviation 0.315

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters	0.024 Difference of 10^12/L Standard Deviation 0.146	0.064 Difference of 10^12/L Standard Deviation 0.198	0.139 Difference of 10^12/L Standard Deviation 0.167	0.019 Difference of 10^12/L Standard Deviation 0.205	0.069 Difference of 10^12/L Standard Deviation 0.174

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 8 for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters	0.058 Difference of 10^12/L Standard Deviation 0.171	0.102 Difference of 10^12/L Standard Deviation 0.256	0.014 Difference of 10^12/L Standard Deviation 0.216	0.008 Difference of 10^12/L Standard Deviation 0.144	0.061 Difference of 10^12/L Standard Deviation 0.211

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 29 for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters	0.094 Difference of 10^12/L Standard Deviation 0.239	0.209 Difference of 10^12/L Standard Deviation 0.187	0.197 Difference of 10^12/L Standard Deviation 0.208	-0.001 Difference of 10^12/L Standard Deviation 0.200	0.052 Difference of 10^12/L Standard Deviation 0.199

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: hematocrit in liter per liter (L/L).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Hematology Parameters- Hematocrit	0.428 L/L Standard Deviation 0.026	0.415 L/L Standard Deviation 0.032	0.409 L/L Standard Deviation 0.029	0.411 L/L Standard Deviation 0.033	0.424 L/L Standard Deviation 0.029

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters	0.002 Difference of L/L Standard Deviation 0.013	0.002 Difference of L/L Standard Deviation 0.017	0.013 Difference of L/L Standard Deviation 0.017	-0.001 Difference of L/L Standard Deviation 0.019	0.006 Difference of L/L Standard Deviation 0.018

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 8 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters	0.006 Difference of L/L Standard Deviation 0.015	0.010 Difference of L/L Standard Deviation 0.022	0.002 Difference of L/L Standard Deviation 0.018	-0.001 Difference of L/L Standard Deviation 0.011	0.005 Difference of L/L Standard Deviation 0.019

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 29 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters	0.008 Difference of L/L Standard Deviation 0.023	0.021 Difference of L/L Standard Deviation 0.017	0.021 Difference of L/L Standard Deviation 0.019	0.001 Difference of L/L Standard Deviation 0.016	0.007 Difference of L/L Standard Deviation 0.016

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: HGB in gram per liter (g/L).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Hematology Parameters- Hemoglobin (HGB)	144.3 g/L Standard Deviation 8.50	139.2 g/L Standard Deviation 11.35	137.1 g/L Standard Deviation 11.47	139.3 g/L Standard Deviation 13.15	143.5 g/L Standard Deviation 10.85

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters	1.6 Difference of g/L Standard Deviation 3.67	2.3 Difference of g/L Standard Deviation 5.43	4.6 Difference of g/L Standard Deviation 4.18	0.6 Difference of g/L Standard Deviation 5.70	2.3 Difference of g/L Standard Deviation 4.51

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 8 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters	1.5 Difference of g/L Standard Deviation 5.07	3.8 Difference of g/L Standard Deviation 7.04	1.4 Difference of g/L Standard Deviation 6.15	2.8 Difference of g/L Standard Deviation 4.02	2.8 Difference of g/L Standard Deviation 4.99

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on blood samples collected at Day 29 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Hematology Parameters	1.2 Difference of g/L Standard Deviation 5.33	5.4 Difference of g/L Standard Deviation 5.55	5.4 Difference of g/L Standard Deviation 5.25	3.1 Difference of g/L Standard Deviation 4.22	1.6 Difference of g/L Standard Deviation 5.03

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on urine samples collected at Day 1 (pre-dose) for the following parameter: Urine RBC in microliters (μL).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC)	2.8 μL Standard Deviation 6.82	1.3 μL Standard Deviation 3.42	7.2 μL Standard Deviation 13.41	20.0 μL Standard Deviation 20.0	6.9 μL Standard Deviation 17.02

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Urinalysis Parameters	-1.6 Difference of μL Standard Deviation 4.37	4.1 Difference of μL Standard Deviation 10.52	5.9 Difference of μL Standard Deviation 26.28	-14.7 Difference of μL Standard Deviation 58.15	-5.6 Difference of μL Standard Deviation 13.65

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on urine samples collected at Day 8 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Urinalysis Parameters	-0.6 Difference of μL Standard Deviation 2.50	1.6 Difference of μL Standard Deviation 5.69	-5.0 Difference of μL Standard Deviation 12.65	-8.4 Difference of μL Standard Deviation 69.92	0.0 Difference of μL Standard Deviation 0.00

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on urine samples collected at Day 29 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Urinalysis Parameters	-1.3 Difference of μL Standard Deviation 3.42	3.1 Difference of μL Standard Deviation 8.14	-1.3 Difference of μL Standard Deviation 17.46	-14.7 Difference of μL Standard Deviation 64.92	-3.8 Difference of μL Standard Deviation 12.58

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Urinalysis Parameters- Urine Glucose	0.0 mmol/L Standard Deviation 0.00	0.0 mmol/L Standard Deviation 0.00	0.0 mmol/L Standard Deviation 0.00	0.0 mmol/L Standard Deviation 0.00	0.0 mmol/L Standard Deviation 0.00

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.

Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Urinalysis Parameters	0 Difference of mmol/L Standard Deviation 0	0 Difference of mmol/L Standard Deviation 0	0 Difference of mmol/L Standard Deviation 0	0 Difference of mmol/L Standard Deviation 0	0 Difference of mmol/L Standard Deviation 0

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.

Analysis was performed on urine samples collected at Day 8 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Urinalysis Parameters	0.0 Difference of mmol/L Standard Deviation 0.00	0.0 Difference of mmol/L Standard Deviation 0.00	0.0 Difference of mmol/L Standard Deviation 0.00	0.0 Difference of mmol/L Standard Deviation 0.00	0.0 Difference of mmol/L Standard Deviation 0.00

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.

Analysis was performed on urine samples collected at Day 29 (post-dose) for the following parameter: Urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Urinalysis Parameters	0.0 Difference of mmol/L Standard Deviation 0.00	0.0 Difference of mmol/L Standard Deviation 0.00	0.0 Difference of mmol/L Standard Deviation 0.00	0.0 Difference of mmol/L Standard Deviation 0.00	0.0 Difference of mmol/L Standard Deviation 0.00

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.

The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Absolute Values for Urinalysis Parameters- Urine Protein	0.000 g/L Standard Deviation 0.000	0.000 g/L Standard Deviation 0.000	0.000 g/L Standard Deviation 0.000	0.000 g/L Standard Deviation 0.000	0.000 g/L Standard Deviation 0.000

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on urine samples collected at day 1 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 1 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Urinalysis Parameters	0 Difference of g/L Standard Deviation 0	0 Difference of g/L Standard Deviation 0	0 Difference of g/L Standard Deviation 0	0 Difference of g/L Standard Deviation 0	0 Difference of g/L Standard Deviation 0

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the safety set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on urine samples collected at day 8 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 8 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Urinalysis Parameters	0.000 Difference of g/L Standard Deviation 0.000	0.000 Difference of g/L Standard Deviation 0.000	0.000 Difference of g/L Standard Deviation 0.000	0.047 Difference of g/L Standard Deviation 0.188	0.000 Difference of g/L Standard Deviation 0.000

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

Analysis was performed on urine samples collected at day 29 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 29 (post-dose) results.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Changes in Urinalysis Parameters	0.000 Difference of g/L Standard Deviation 0.000	0.000 Difference of g/L Standard Deviation 0.000	0.000 Difference of g/L Standard Deviation 0.000	0.000 Difference of g/L Standard Deviation 0.000	0.000 Difference of g/L Standard Deviation 0.000

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · Normal	2 Participants	4 Participants	1 Participants	2 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · Low	1 Participants	1 Participants	3 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Normal	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · Normal	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Normal	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · High	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · No change	15 Participants	16 Participants	16 Participants	15 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · No change	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · Normal	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · No change	16 Participants	16 Participants	15 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Normal	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Low	1 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · No change	15 Participants	14 Participants	15 Participants	13 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · Normal	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · High	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · No change	16 Participants	14 Participants	15 Participants	14 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · Normal	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · Low	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · No change	16 Participants	15 Participants	15 Participants	15 Participants	14 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Normal	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · High	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · No change	16 Participants	16 Participants	14 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · Normal	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · High	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · No change	16 Participants	16 Participants	15 Participants	16 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · Normal	0 Participants	4 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · No change	15 Participants	11 Participants	13 Participants	15 Participants	13 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · Normal	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · No change	15 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · Normal	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · High	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · Low	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · No change	16 Participants	14 Participants	15 Participants	15 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · No change	16 Participants	15 Participants	15 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · High	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · High	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · No change	16 Participants	16 Participants	15 Participants	16 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · High	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · No change	16 Participants	16 Participants	16 Participants	16 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Normal	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · High	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · No change	14 Participants	15 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · Normal	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · Low	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · No change	15 Participants	15 Participants	14 Participants	15 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · Low	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · No change	14 Participants	11 Participants	15 Participants	13 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · Normal	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · No change	13 Participants	15 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Low	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · No change	16 Participants	14 Participants	15 Participants	15 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · Normal	1 Participants	0 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · High	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · No change	15 Participants	15 Participants	13 Participants	12 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · No change	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · No change	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Abnormal Laboratory Parameter Values BUN · No change	15 Participants	15 Participants	15 Participants	14 Participants	14 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Normal	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · High	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · No change	15 Participants	16 Participants	16 Participants	14 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · High	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · No change	16 Participants	15 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · No change	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Normal	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · High	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Low	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · Normal	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · High	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · No change	15 Participants	15 Participants	16 Participants	12 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · Normal	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · High	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · Low	1 Participants	0 Participants	0 Participants	4 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · No change	15 Participants	15 Participants	15 Participants	11 Participants	13 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · High	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · No change	15 Participants	16 Participants	15 Participants	16 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · Normal	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · No change	16 Participants	16 Participants	15 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · Normal	0 Participants	3 Participants	4 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · Low	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · No change	13 Participants	10 Participants	9 Participants	12 Participants	13 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · Normal	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · No change	15 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · Normal	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · High	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · No change	16 Participants	15 Participants	16 Participants	16 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · Normal	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · Low	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · No change	16 Participants	15 Participants	14 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · High	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · No change	16 Participants	16 Participants	16 Participants	16 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · Normal	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · Low	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · No change	16 Participants	16 Participants	15 Participants	15 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Normal	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · High	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Low	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · No change	14 Participants	15 Participants	14 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · Normal	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · High	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · Low	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · No change	15 Participants	15 Participants	13 Participants	16 Participants	13 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · Normal	1 Participants	3 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · Low	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · No change	14 Participants	12 Participants	15 Participants	15 Participants	14 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · Normal	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · High	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · Low	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · No change	15 Participants	15 Participants	15 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Normal	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · No change	16 Participants	15 Participants	15 Participants	14 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · Normal	1 Participants	1 Participants	4 Participants	3 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · High	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · No change	15 Participants	13 Participants	12 Participants	12 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · No change	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · High	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · No change	16 Participants	16 Participants	16 Participants	15 Participants	16 Participants

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Normal	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · High	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · No change	15 Participants	16 Participants	14 Participants	15 Participants	14 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · High	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · No change	16 Participants	15 Participants	14 Participants	16 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · Normal	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · High	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Bicarbonate · No change	16 Participants	14 Participants	13 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Normal	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · High	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Low	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · No change	15 Participants	14 Participants	14 Participants	15 Participants	13 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · Normal	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · High	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CRP · No change	15 Participants	16 Participants	16 Participants	12 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · Normal	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · Low	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Cl · No change	15 Participants	14 Participants	15 Participants	14 Participants	13 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · High	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · No change	16 Participants	16 Participants	15 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · Normal	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · High	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values K · No change	16 Participants	15 Participants	15 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · Normal	0 Participants	5 Participants	5 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · Low	2 Participants	2 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Na · No change	14 Participants	9 Participants	11 Participants	14 Participants	12 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · Normal	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · High	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Basophils · No change	15 Participants	15 Participants	16 Participants	15 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · Normal	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · High	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · Low	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Eosinophils · No change	16 Participants	14 Participants	15 Participants	15 Participants	14 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · Normal	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · High	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values RBC · No change	16 Participants	14 Participants	13 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · High	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hematocrit · No change	15 Participants	14 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · Normal	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · High	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Hemoglobin · No change	15 Participants	16 Participants	15 Participants	15 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Normal	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · High	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · No change	14 Participants	16 Participants	15 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · Normal	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · Low	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Lymphocytes · No change	14 Participants	15 Participants	15 Participants	16 Participants	14 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · Normal	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Monocytes · No change	14 Participants	13 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · Normal	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · High	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Neutrophils · No change	14 Participants	16 Participants	15 Participants	15 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Normal	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · High	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Low	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · No change	15 Participants	15 Participants	14 Participants	13 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · Normal	2 Participants	1 Participants	4 Participants	4 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · High	0 Participants	3 Participants	2 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine RBC · No change	14 Participants	12 Participants	10 Participants	10 Participants	14 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Glucose · No change	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · Normal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · Low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Urine Protein · No change	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants

PRIMARY outcome

Timeframe: At Day 1 (post-dose)

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 1	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · None	16 Participants	16 Participants	16 Participants	15 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 1	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · None	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · None	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · None	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · None	12 Participants	13 Participants	12 Participants	8 Participants	13 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 1	4 Participants	3 Participants	4 Participants	8 Participants	3 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · None	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · None	15 Participants	15 Participants	16 Participants	15 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 3	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 8

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · None	15 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · None	16 Participants	15 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · None	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · None	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · None	9 Participants	12 Participants	8 Participants	12 Participants	13 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 1	7 Participants	4 Participants	7 Participants	4 Participants	3 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 2	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · None	15 Participants	15 Participants	15 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 1	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · None	16 Participants	16 Participants	16 Participants	15 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data

The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Number of Subjects With Abnormal Laboratory Parameter Values ALT · None	16 Participants	16 Participants	14 Participants	15 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 1	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values ALT · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · None	16 Participants	15 Participants	14 Participants	16 Participants	15 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 1	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values AST · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · None	16 Participants	16 Participants	15 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 1	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values BUN · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · None	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values CREA · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · None	10 Participants	14 Participants	13 Participants	11 Participants	10 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 1	6 Participants	2 Participants	3 Participants	5 Participants	6 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values HGB · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · None	16 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Leukocytes · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · None	15 Participants	16 Participants	16 Participants	16 Participants	16 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Parameter Values Platelets · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 1 (pre-dose)

Population: Analysis was performed on the Per Protocol Set (PPS) which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unbliding or analysis.

The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC)	11.40 Titer Interval 6.23 to 20.86	8.52 Titer Interval 4.66 to 15.59	6.09 Titer Interval 3.33 to 11.13	5.23 Titer Interval 2.86 to 9.57	6.17 Titer Interval 3.37 to 11.28

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unbliding or analysis.

The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
hSBA GMTs Against N. Meningitidis Serogroup C (MenC)	96.61 Titer Interval 34.97 to 266.89	55.05 Titer Interval 20.19 to 150.06	101.77 Titer Interval 37.34 to 277.39	56.31 Titer Interval 20.55 to 154.29	70.38 Titer Interval 25.83 to 191.79

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.

GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup	8.70 Ratio Interval 2.77 to 27.36	6.52 Ratio Interval 2.08 to 20.51	16.56 Ratio Interval 5.27 to 52.07	10.57 Ratio Interval 3.36 to 33.23	11.32 Ratio Interval 3.6 to 35.57

SECONDARY outcome

Timeframe: At Day 8 and Day 181

Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.

The antibody concentrations were assessed by hSBA directed against MenC and expressed as GMTs.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
hSBA GMTs Against N. Meningitidis Serogroup C (MenC) Day 8	30.86 Titer Interval 12.61 to 75.5	12.18 Titer Interval 5.04 to 29.47	13.58 Titer Interval 5.61 to 32.87	15.47 Titer Interval 6.2 to 38.65	21.30 Titer Interval 8.8 to 51.53
hSBA GMTs Against N. Meningitidis Serogroup C (MenC) Day 181	98.79 Titer Interval 49.66 to 196.52	68.89 Titer Interval 34.94 to 135.83	83.59 Titer Interval 42.4 to 164.78	63.13 Titer Interval 31.91 to 124.91	59.67 Titer Interval 29.61 to 120.27

SECONDARY outcome

Timeframe: At Day 8 and Day 181

Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.

GMR of GMTs of antibodies against MenC serogroup was evaluated at Day 8 and Day 181 relative to Day 1 (pre-dose).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup Day 8/Day 1	2.93 Ratio Interval 1.07 to 8.03	1.47 Ratio Interval 0.54 to 4.02	2.16 Ratio Interval 0.79 to 5.91	2.64 Ratio Interval 0.93 to 7.48	3.35 Ratio Interval 1.22 to 9.17
GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup Day 181/Day 1	9.29 Ratio Interval 3.98 to 21.69	8.30 Ratio Interval 3.55 to 19.37	13.40 Ratio Interval 5.74 to 31.28	11.51 Ratio Interval 4.93 to 26.87	9.53 Ratio Interval 3.97 to 22.87

SECONDARY outcome

Timeframe: At Day 8, Day 29 and Day 181

Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.

The percentage of subjects who achieved hSBA seroresponse against MenC serogroup was evaluated at Day 8, Day 29 and Day 181 after vaccination. Seroresponse was defined as a post vaccination hSBA ≥ 8 for subjects with a baseline hSBA lower than (<) 4 or had an increase of at least 4 times the baseline hSBA level for subjects with pre vaccination hSBA ≥ 4.

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). Day 8	31.3 Percentage of subjects Interval 11.0 to 58.7	37.5 Percentage of subjects Interval 15.2 to 64.6	31.3 Percentage of subjects Interval 11.0 to 58.7	33.3 Percentage of subjects Interval 11.8 to 61.6	37.5 Percentage of subjects Interval 15.2 to 64.6
Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). Day 29	75.0 Percentage of subjects Interval 47.6 to 92.7	56.3 Percentage of subjects Interval 29.9 to 80.2	81.3 Percentage of subjects Interval 54.4 to 96.0	68.8 Percentage of subjects Interval 41.3 to 89.0	75.0 Percentage of subjects Interval 47.6 to 92.7
Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). Day 181	75.0 Percentage of subjects Interval 47.6 to 92.7	56.3 Percentage of subjects Interval 29.9 to 80.2	87.5 Percentage of subjects Interval 61.7 to 98.4	75.0 Percentage of subjects Interval 47.6 to 92.7	80.0 Percentage of subjects Interval 51.9 to 95.7

SECONDARY outcome

Timeframe: At Day 1 (pre-dose), Day 8, Day 29 and Day 181

Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.

The antibody concentrations were assessed by ELISA and expressed as Geometric Mean Concentrations (GMCs) in microgram per mililiter (μg/mL).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) Day 1 (pre-dose)	0.287 μg/mL Interval 0.124 to 0.664	0.407 μg/mL Interval 0.176 to 0.942	0.207 μg/mL Interval 0.089 to 0.479	0.107 μg/mL Interval 0.046 to 0.249	0.199 μg/mL Interval 0.086 to 0.462
Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) Day 8	2.005 μg/mL Interval 0.98 to 4.101	2.169 μg/mL Interval 1.052 to 4.472	1.668 μg/mL Interval 0.817 to 3.406	2.897 μg/mL Interval 1.4 to 5.997	1.445 μg/mL Interval 0.708 to 2.951
Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) Day 29	15.946 μg/mL Interval 9.265 to 27.444	12.753 μg/mL Interval 7.364 to 22.086	19.322 μg/mL Interval 11.242 to 33.21	21.944 μg/mL Interval 12.636 to 38.107	9.207 μg/mL Interval 5.356 to 15.827
Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) Day 181	5.201 μg/mL Interval 3.218 to 8.406	5.556 μg/mL Interval 3.419 to 9.027	7.131 μg/mL Interval 4.416 to 11.513	7.570 μg/mL Interval 4.644 to 12.339	3.432 μg/mL Interval 2.093 to 5.628

SECONDARY outcome

Timeframe: At Day 8, Day 29 and Day 181

Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.

The percentage of subjects with at least a 4-fold increase in antibody concentrations to MenC serogroup as measured by ELISA were analysed at day 8, 29 and 181 relative to Day 1 (pre-dose).

Outcome measures

Measure	LHD153R Formulation 1 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 Participants Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA Day 8	68.8 Percentage of subjects Interval 41.3 to 89.0	50.0 Percentage of subjects Interval 24.7 to 75.3	68.8 Percentage of subjects Interval 41.3 to 89.0	68.8 Percentage of subjects Interval 41.3 to 89.0	62.5 Percentage of subjects Interval 35.4 to 84.8
Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA Day 29	93.8 Percentage of subjects Interval 69.8 to 99.8	81.3 Percentage of subjects Interval 54.4 to 96.0	100.0 Percentage of subjects Interval 79.4 to 100.0	100.0 Percentage of subjects Interval 79.4 to 100.0	87.5 Percentage of subjects Interval 61.7 to 98.4
Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA Day 181	87.5 Percentage of subjects Interval 61.7 to 98.4	75.0 Percentage of subjects Interval 47.6 to 92.7	100.0 Percentage of subjects Interval 79.4 to 100.0	100.0 Percentage of subjects Interval 79.4 to 100.0	86.7 Percentage of subjects Interval 59.5 to 98.3

Adverse Events

LHD153R Formulation 1 Group

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

LHD153R Formulation 2 Group

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

LHD153R Formulation 3 Group

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

LHD153R Formulation 4 Group

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

MenC Group

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	LHD153R Formulation 1 Group n=16 participants at risk Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 participants at risk Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 participants at risk Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 participants at risk Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 participants at risk Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Injury, poisoning and procedural complications Joint injury	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).

Other adverse events

Measure	LHD153R Formulation 1 Group n=16 participants at risk Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R.	LHD153R Formulation 2 Group n=16 participants at risk Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R.	LHD153R Formulation 3 Group n=16 participants at risk Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R.	LHD153R Formulation 4 Group n=16 participants at risk Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.	MenC Group n=16 participants at risk Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Gastrointestinal disorders Dysphagia	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Gastrointestinal disorders Toothache	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Chest discomfort	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Bronchitis	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Conjunctivitis	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Gastroenteritis	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Gastroenteritis norovirus	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Herpes virus infection	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Hordeolum	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Nasopharyngitis	18.8% 3/16 • Number of events 4 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	18.8% 3/16 • Number of events 4 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	18.8% 3/16 • Number of events 4 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Pneumonia	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Sinusitis	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Tinea pedis	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Tonsillitis	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Tooth infection	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Upper respiratory tract infection	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Infections and infestations Urinary tract infection	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Induration	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Pain	100.0% 16/16 • Number of events 214 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	100.0% 16/16 • Number of events 216 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	100.0% 16/16 • Number of events 213 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	100.0% 16/16 • Number of events 216 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	100.0% 16/16 • Number of events 210 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Swelling	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 4 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Injury, poisoning and procedural complications Concussion	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Injury, poisoning and procedural complications Joint injury	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Injury, poisoning and procedural complications Ligament sprain	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Injury, poisoning and procedural complications Sunburn	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Musculoskeletal and connective tissue disorders Back pain	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Musculoskeletal and connective tissue disorders Neck pain	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Nervous system disorders Dizziness	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Nervous system disorders Headache	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Reproductive system and breast disorders Vaginal discharge	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Skin and subcutaneous tissue disorders Dandruff	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Skin and subcutaneous tissue disorders Pityriasis rosea	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Arthralgia	6.2% 1/16 • Number of events 3 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	25.0% 4/16 • Number of events 6 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Chills	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 4 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	25.0% 4/16 • Number of events 9 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Diarrhea	6.2% 1/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	18.8% 3/16 • Number of events 5 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Fatigue	18.8% 3/16 • Number of events 10 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 10 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	18.8% 3/16 • Number of events 3 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	37.5% 6/16 • Number of events 25 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	18.8% 3/16 • Number of events 3 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Fever	6.2% 1/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 11 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Headache	37.5% 6/16 • Number of events 13 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	43.8% 7/16 • Number of events 21 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	31.2% 5/16 • Number of events 8 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	31.2% 5/16 • Number of events 18 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	62.5% 10/16 • Number of events 15 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Loss of Appetite	6.2% 1/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 3 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	25.0% 4/16 • Number of events 15 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Myalgia	6.2% 1/16 • Number of events 3 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 3 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	31.2% 5/16 • Number of events 12 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	18.8% 3/16 • Number of events 3 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Nausea	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 4 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 2 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	18.8% 3/16 • Number of events 7 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Rash	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Urticaria	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).
General disorders Vomiting	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	6.2% 1/16 • Number of events 1 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	12.5% 2/16 • Number of events 3 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).	0.00% 0/16 • Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: kt144805@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER