Trial Outcomes & Findings for A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults (NCT NCT00474487)

Last Updated: 2014-04-21

Results Overview

Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2831 participants

Primary outcome timeframe

Days 1 to 7

Results posted on

2014-04-21

Participant Flow

Subjects were enrolled at 3 centers in Argentina and Colombia.

All subjects enrolled were included in the trial.

Participant milestones

Participant milestones
Measure	Novartis MenACWY Vaccine (19 to 55 Years) One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.	Novartis MenACWY Vaccine (56 to 65 Years) One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.	Licensed Conjugate Vaccine (19 to 55 Years) One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).	Licensed Polysaccharide Vaccine (56 to 65 Years) One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
Overall Study STARTED	1606	217	899	109
Overall Study COMPLETED	1576	215	885	109
Overall Study NOT COMPLETED	30	2	14	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Novartis MenACWY Vaccine (19 to 55 Years) One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.	Novartis MenACWY Vaccine (56 to 65 Years) One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.	Licensed Conjugate Vaccine (19 to 55 Years) One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
Overall Study Withdrawal by Subject	6	0	0
Overall Study Lost to Follow-up	20	1	7
Overall Study Inappropriate enrollment	4	0	7
Overall Study Death	0	1	0

Baseline Characteristics

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Novartis MenACWY Vaccine (19 to 55 Years) n=1606 Participants One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.	Novartis MenACWY Vaccine (56 to 65 Years) n=217 Participants One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.	Licensed Conjugate Vaccine (19 to 55 Years) n=899 Participants One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).	Licensed Polysaccharide Vaccine (56 to 65 Years) n=109 Participants One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.	Total n=2831 Participants Total of all reporting groups
Age, Continuous	34.6 Years STANDARD_DEVIATION 10.1 • n=5 Participants	60.1 Years STANDARD_DEVIATION 2.7 • n=7 Participants	34.8 Years STANDARD_DEVIATION 10.4 • n=5 Participants	60.1 Years STANDARD_DEVIATION 2.6 • n=4 Participants	37.6 Years STANDARD_DEVIATION 12.6 • n=21 Participants
Sex: Female, Male Female	1092 Participants n=5 Participants	163 Participants n=7 Participants	627 Participants n=5 Participants	79 Participants n=4 Participants	1961 Participants n=21 Participants
Sex: Female, Male Male	514 Participants n=5 Participants	54 Participants n=7 Participants	272 Participants n=5 Participants	30 Participants n=4 Participants	870 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Subjects n=5 Participants	1 Subjects n=7 Participants	1 Subjects n=5 Participants	0 Subjects n=4 Participants	3 Subjects n=21 Participants
Race/Ethnicity, Customized Black	135 Subjects n=5 Participants	18 Subjects n=7 Participants	109 Subjects n=5 Participants	8 Subjects n=4 Participants	270 Subjects n=21 Participants
Race/Ethnicity, Customized Caucasian	249 Subjects n=5 Participants	38 Subjects n=7 Participants	127 Subjects n=5 Participants	23 Subjects n=4 Participants	437 Subjects n=21 Participants
Race/Ethnicity, Customized Hispanic	1217 Subjects n=5 Participants	158 Subjects n=7 Participants	658 Subjects n=5 Participants	77 Subjects n=4 Participants	2110 Subjects n=21 Participants
Race/Ethnicity, Customized Other	4 Subjects n=5 Participants	2 Subjects n=7 Participants	3 Subjects n=5 Participants	1 Subjects n=4 Participants	10 Subjects n=21 Participants
Race/Ethnicity, Customized Not Available	0 Subjects n=5 Participants	0 Subjects n=7 Participants	1 Subjects n=5 Participants	0 Subjects n=4 Participants	1 Subjects n=21 Participants

PRIMARY outcome

Timeframe: Days 1 to 7

Population: The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.

Outcome measures

Outcome measures
Measure	Novartis MenACWY Vaccine n=1588 Participants One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Licensed Conjugate Vaccine n=882 Participants One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years	95 Subjects	46 Subjects

SECONDARY outcome

Timeframe: 1 month postvaccination

Population: The analysis was performed on the per-protocol (PP) population.

Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years). Seroresponse: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

Outcome measures

Outcome measures
Measure	Novartis MenACWY Vaccine n=179 Participants One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Licensed Conjugate Vaccine n=182 Participants One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population Seroresponders in serogroup A	78 Percentage of subjects Interval 71.0 to 84.0	77 Percentage of subjects Interval 71.0 to 83.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population Seroresponders in serogroup C (N= 180, 183)	83 Percentage of subjects Interval 76.0 to 88.0	81 Percentage of subjects Interval 74.0 to 86.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population Seroresponders in serogroup W (N= 178, 180)	66 Percentage of subjects Interval 58.0 to 73.0	53 Percentage of subjects Interval 46.0 to 61.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population Seroresponders in serogroup Y (N= 181, 182)	80 Percentage of subjects Interval 74.0 to 86.0	58 Percentage of subjects Interval 51.0 to 65.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population hSBA ≥1:8 in serogroup A	81 Percentage of subjects Interval 74.0 to 86.0	80 Percentage of subjects Interval 74.0 to 86.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population hSBA ≥1:8 in serogroup C (N= 180, 183)	88 Percentage of subjects Interval 82.0 to 92.0	92 Percentage of subjects Interval 87.0 to 96.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population hSBA ≥1:8 in serogroup W (N= 178, 180)	98 Percentage of subjects Interval 95.0 to 100.0	93 Percentage of subjects Interval 89.0 to 97.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population hSBA ≥1:8 in serogroup Y (N= 181, 182)	88 Percentage of subjects Interval 82.0 to 92.0	76 Percentage of subjects Interval 70.0 to 82.0

SECONDARY outcome

Timeframe: 1 month postvaccination

Population: The analysis was performed on the per-protocol (PP) population.

Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years). Seroresponse: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

Outcome measures

Outcome measures
Measure	Novartis MenACWY Vaccine n=83 Participants One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Licensed Conjugate Vaccine n=41 Participants One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population Seroresponders in serogroup Y (N= 84, 41)	77 Percentage of subjects Interval 67.0 to 86.0	54 Percentage of subjects Interval 37.0 to 69.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population hSBA ≥1:8 in serogroup W (N= 82, 39)	94 Percentage of subjects Interval 86.0 to 98.0	95 Percentage of subjects Interval 83.0 to 99.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population Seroresponders in serogroup A	86 Percentage of subjects Interval 76.0 to 92.0	61 Percentage of subjects Interval 45.0 to 76.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population Seroresponders in serogroup C (N= 84, 41)	83 Percentage of subjects Interval 74.0 to 91.0	73 Percentage of subjects Interval 57.0 to 86.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population Seroresponders in serogroup W (N= 82, 39)	61 Percentage of subjects Interval 50.0 to 72.0	54 Percentage of subjects Interval 37.0 to 70.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population hSBA ≥1:8 in serogroup A	87 Percentage of subjects Interval 78.0 to 93.0	63 Percentage of subjects Interval 47.0 to 78.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population hSBA ≥1:8 in serogroup C (N= 84, 41)	90 Percentage of subjects Interval 82.0 to 96.0	83 Percentage of subjects Interval 68.0 to 93.0
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population hSBA ≥1:8 in serogroup Y (N= 84, 41)	88 Percentage of subjects Interval 79.0 to 94.0	68 Percentage of subjects Interval 52.0 to 82.0

SECONDARY outcome

Timeframe: 1 month postvaccination

Population: The analysis was performed on the per-protocol (PP) population.

Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age.

Outcome measures

Outcome measures
Measure	Novartis MenACWY Vaccine n=179 Participants One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Licensed Conjugate Vaccine n=182 Participants One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population Serogroup A	77 Titers Interval 57.0 to 105.0	52 Titers Interval 38.0 to 70.0
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population Serogroup C (N=180, 183)	114 Titers Interval 84.0 to 153.0	88 Titers Interval 65.0 to 118.0
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population Serogroup W (N=178, 180)	159 Titers Interval 123.0 to 205.0	112 Titers Interval 87.0 to 144.0
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population Serogroup Y (N=181, 182)	95 Titers Interval 70.0 to 127.0	40 Titers Interval 30.0 to 54.0

SECONDARY outcome

Timeframe: 1 month postvaccination

Population: The analysis was performed on the per-protocol (PP) population.

Outcome measures

Outcome measures
Measure	Novartis MenACWY Vaccine n=83 Participants One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Licensed Conjugate Vaccine n=41 Participants One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population Serogroup A	111 Titers Interval 70.0 to 175.0	21 Titers Interval 11.0 to 39.0
Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population Serogroup C (N=84, 41)	196 Titers Interval 125.0 to 306.0	86 Titers Interval 45.0 to 163.0
Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population Serogroup W (N=82, 39)	164 Titers Interval 112.0 to 240.0	132 Titers Interval 76.0 to 229.0
Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population Serogroup Y (N=84, 41)	121 Titers Interval 76.0 to 193.0	28 Titers Interval 15.0 to 55.0

SECONDARY outcome

Timeframe: Days 1 to 7

Population: The analysis was performed on the safety population.

Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years).

Outcome measures

Outcome measures
Measure	Novartis MenACWY Vaccine n=1588 Participants One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Licensed Conjugate Vaccine n=882 Participants One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Induration	179 Subjects	115 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Any systemic reaction	616 Subjects	375 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Any local reaction	729 Subjects	439 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Pain	632 Subjects	392 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Erythema	207 Subjects	105 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Chills	124 Subjects	70 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Nausea	112 Subjects	77 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Malaise	309 Subjects	186 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Myalgia	197 Subjects	131 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Arthralgia	118 Subjects	76 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Headache	421 Subjects	254 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Rash	53 Subjects	22 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Fever ≥38°C (N= 1587, 882)	56 Subjects	31 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Any Other Reaction	280 Subjects	162 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Analgesic/Antipyretic Med. Used (N=1588, 881)	250 Subjects	148 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years Stayed Home (N= 1585, 880)	75 Subjects	46 Subjects

SECONDARY outcome

Timeframe: Days 1 to 7

Population: The analysis was done on the safety population.

Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years).

Outcome measures

Outcome measures
Measure	Novartis MenACWY Vaccine n=216 Participants One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Licensed Conjugate Vaccine n=109 Participants One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Headache	52 Subjects	30 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Rash	10 Subjects	2 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Any local reaction	92 Subjects	44 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Pain	69 Subjects	34 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Erythema	41 Subjects	13 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Induration	39 Subjects	17 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Any systemic reaction	84 Subjects	44 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Chills	26 Subjects	6 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Nausea	20 Subjects	8 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Malaise	50 Subjects	20 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Myalgia	39 Subjects	11 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Arthralgia	25 Subjects	11 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Fever ≥38°C	6 Subjects	3 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Any other reaction	29 Subjects	15 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Analgesic/Antipyretic Med. Used	25 Subjects	14 Subjects
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years Stayed Home (N= 214, 108)	14 Subjects	6 Subjects

Adverse Events

Novartis MenACWY Vaccine (19 to 55 Years)

Serious events: 11 serious events

Other events: 955 other events

Deaths: 0 deaths

Novartis MenACWY Vaccine (56 to 65 Years)

Serious events: 1 serious events

Other events: 124 other events

Deaths: 0 deaths

Licensed Conjugate Vaccine (19 to 55 Years)

Serious events: 8 serious events

Other events: 561 other events

Deaths: 0 deaths

Licensed Polysaccharide Vaccine (56 to 65 Years)

Serious events: 1 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Novartis MenACWY Vaccine (19 to 55 Years) n=1588 participants at risk One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Novartis MenACWY Vaccine (56 to 65 Years) n=216 participants at risk One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Licensed Conjugate Vaccine (19 to 55 Years) n=882 participants at risk One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly in ages 19 to 55 years.	Licensed Polysaccharide Vaccine (56 to 65 Years) n=109 participants at risk One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly (Ages 56 to 65 Years)
General disorders Injection site pain	39.8% 632/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	31.9% 69/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	44.4% 392/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	31.2% 34/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
General disorders Injection site erythema	13.0% 207/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	19.0% 41/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	11.9% 105/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	11.9% 13/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
General disorders Injection site induration	11.3% 179/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	18.1% 39/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	13.0% 115/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	15.6% 17/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
General disorders Chills	7.8% 124/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	12.0% 26/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	7.9% 70/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	5.5% 6/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Gastrointestinal disorders Nausea	7.1% 112/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	9.3% 20/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	8.7% 77/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	7.3% 8/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
General disorders Malaise	19.5% 309/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	23.1% 50/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	21.1% 186/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	18.3% 20/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Musculoskeletal and connective tissue disorders Myalgia	12.4% 197/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	18.1% 39/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	14.9% 131/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	10.1% 11/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 118/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	11.6% 25/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	8.6% 76/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	10.1% 11/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Nervous system disorders Headache	26.5% 421/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	24.1% 52/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	28.8% 254/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	27.5% 30/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Novartis MenACWY Vaccine (19 to 55 Years) n=1588 participants at risk One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Novartis MenACWY Vaccine (56 to 65 Years) n=216 participants at risk One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Licensed Conjugate Vaccine (19 to 55 Years) n=882 participants at risk One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly in ages 19 to 55 years.	Licensed Polysaccharide Vaccine (56 to 65 Years) n=109 participants at risk One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly (Ages 56 to 65 Years)
Gastrointestinal disorders Abdominal Pain	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.11% 1/882 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
General disorders Generalised Oedema	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.11% 1/882 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Infections and infestations Appendicitis	0.06% 1/1588 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Infections and infestations Cellulitis	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.11% 1/882 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Infections and infestations Herpes Zoster	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.11% 1/882 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Infections and infestations HIV Infection	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.11% 1/882 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Infections and infestations Pelvic Inflammatory disease	0.06% 1/1588 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Infections and infestations Pyometra	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.92% 1/109 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.11% 1/882 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Injury, poisoning and procedural complications Arthropod Sting	0.06% 1/1588 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Injury, poisoning and procedural complications Upper Limb Fracture	0.06% 1/1588 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.11% 1/882 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Nervous system disorders Syncope	0.06% 1/1588 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.19% 3/1588 • Number of events 3 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Renal and urinary disorders Haematuria	0.06% 1/1588 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.11% 1/882 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Surgical and medical procedures Nephrectomy	0.06% 1/1588 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.11% 1/882 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Vascular disorders Deep Vein Thrombosis	0.06% 1/1588 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/216 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.
Vascular disorders Hypovolaemic Shock	0.00% 0/1588 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.46% 1/216 • Number of events 1 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/882 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.	0.00% 0/109 • Serious adverse events were collected from study day 1 to 180. The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.