Trial Outcomes & Findings for Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers (NCT NCT01434680)

Last Updated: 2017-04-25

Results Overview

Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

992 participants

Primary outcome timeframe

1 month postvaccination (day 29)

Results posted on

2017-04-25

Participant Flow

Subjects were enrolled at eleven sites in Poland.

All enrolled subjects were included in the trial. Data from the group MenC-CRM ROS\_EMV was not included in the primary and secondary analyses as these subjects were initially enrolled in group MenC-CRM ROS, but wrongly vaccinated with MenC-CRM EMV.

Participant milestones

Participant milestones
Measure	MenC-CRM LIQ Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.	MenC-CRM ROS Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.	MenC-CRM EMV Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.	MenC-CRM ROS_EMV Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
Overall Study STARTED	299	268	306	119
Overall Study COMPLETED	296	266	304	119
Overall Study NOT COMPLETED	3	2	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MenC-CRM LIQ Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.	MenC-CRM ROS Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.	MenC-CRM EMV Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
Overall Study Withdrawal by Subject	1	0	2
Overall Study Lost to Follow-up	1	1	0
Overall Study Protocol Violation	1	1	0

Baseline Characteristics

Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenC-CRM LIQ n=299 Participants Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.	MenC-CRM ROS n=268 Participants Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.	MenC-CRM EMV n=306 Participants Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.	MenC-CRM ROS_EMV n=119 Participants Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV	Total n=992 Participants Total of all reporting groups
Age, Continuous	16.4 Months STANDARD_DEVIATION 3.4 • n=5 Participants	16.2 Months STANDARD_DEVIATION 3.2 • n=7 Participants	16.7 Months STANDARD_DEVIATION 3.4 • n=5 Participants	17.2 Months STANDARD_DEVIATION 3.3 • n=4 Participants	16.5 Months STANDARD_DEVIATION 3.3 • n=21 Participants
Sex: Female, Male Female	143 Participants n=5 Participants	131 Participants n=7 Participants	141 Participants n=5 Participants	50 Participants n=4 Participants	465 Participants n=21 Participants
Sex: Female, Male Male	156 Participants n=5 Participants	137 Participants n=7 Participants	165 Participants n=5 Participants	69 Participants n=4 Participants	527 Participants n=21 Participants

PRIMARY outcome

Timeframe: 1 month postvaccination (day 29)

Population: Analysis was done on the per protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.

Outcome measures

Outcome measures
Measure	MenC-CRM LIQ n=283 Participants Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.	MenC-CRM ROS n=259 Participants Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.	MenC-CRM EMV n=281 Participants Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.	MenC-CRM ROS_EMV Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination Day 1	2.1 Titers Interval 2.0 to 2.2	2.16 Titers Interval 2.05 to 2.26	2.15 Titers Interval 2.05 to 2.25	—
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination Day 29	9.84 Titers Interval 8.39 to 12.0	14 Titers Interval 12.0 to 16.0	12 Titers Interval 10.0 to 14.0	—

SECONDARY outcome

Timeframe: 1 month postvaccination (day 29)

Population: Analysis was done on the per protocol (PP) set.

Immunogenicity was measured by hSBA GMTs against N meningitidis type C, approximately 28 days (at day 29) after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM ROS.

Outcome measures

Outcome measures
Measure	MenC-CRM LIQ n=283 Participants Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.	MenC-CRM ROS n=259 Participants Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.	MenC-CRM EMV Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.	MenC-CRM ROS_EMV Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination Day 1	2.1 Titers Interval 2.0 to 2.2	2.16 Titers Interval 2.05 to 2.26	—	—
Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination Day 29	9.84 Titers Interval 8.39 to 12.0	14 Titers Interval 12.0 to 16.0	—	—

SECONDARY outcome

Timeframe: From day 1 through day 7

Population: Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.

Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following a single injection with either MenC-CRM LIQ or MenC-CRM ROS or MenC-CRM EMV. Safety was also assessed in subjects who mistakenly received MenC-CRM EMV instead of MenC-CRM ROS.

Outcome measures

Outcome measures
Measure	MenC-CRM LIQ n=299 Participants Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.	MenC-CRM ROS n=267 Participants Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.	MenC-CRM EMV n=304 Participants Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.	MenC-CRM ROS_EMV n=119 Participants Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Any Local	124 Number of subjects	115 Number of subjects	148 Number of subjects	58 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Injection site Tenderness	88 Number of subjects	64 Number of subjects	101 Number of subjects	41 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Injection site Erythema	222 Number of subjects	200 Number of subjects	211 Number of subjects	81 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Injection site Induration	252 Number of subjects	227 Number of subjects	236 Number of subjects	88 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Any Systemic	163 Number of subjects	140 Number of subjects	155 Number of subjects	60 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Change in Eating habits	87 Number of subjects	68 Number of subjects	83 Number of subjects	26 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Sleepiness	66 Number of subjects	55 Number of subjects	56 Number of subjects	24 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Persistent Crying	45 Number of subjects	41 Number of subjects	36 Number of subjects	15 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Vomiting	9 Number of subjects	11 Number of subjects	7 Number of subjects	4 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Diarrhea	42 Number of subjects	30 Number of subjects	34 Number of subjects	17 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Irritability	101 Number of subjects	76 Number of subjects	87 Number of subjects	32 Number of subjects
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events Fever (≥38°C)	20 Number of subjects	11 Number of subjects	18 Number of subjects	13 Number of subjects

Adverse Events

MenC-CRM LIQ

Serious events: 0 serious events

Other events: 252 other events

Deaths: 0 deaths

MenC-CRM ROS

Serious events: 3 serious events

Other events: 227 other events

Deaths: 0 deaths

MenC-CRM EMV

Serious events: 2 serious events

Other events: 236 other events

Deaths: 0 deaths

MenC-CRM ROS_EMV

Serious events: 1 serious events

Other events: 88 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MenC-CRM LIQ n=299 participants at risk Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.	MenC-CRM ROS n=267 participants at risk Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.	MenC-CRM EMV n=304 participants at risk Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.	MenC-CRM ROS_EMV n=119 participants at risk Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
Gastrointestinal disorders Diarrhea	0.00% 0/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.00% 0/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.33% 1/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.84% 1/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
Gastrointestinal disorders Vomiting	0.00% 0/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.00% 0/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.33% 1/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.00% 0/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
Infections and infestations Gastroenteritis Rotavirus	0.00% 0/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.75% 2/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.00% 0/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.00% 0/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
Infections and infestations Pneumonia	0.00% 0/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.37% 1/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.33% 1/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	0.00% 0/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.

Other adverse events

Other adverse events
Measure	MenC-CRM LIQ n=299 participants at risk Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.	MenC-CRM ROS n=267 participants at risk Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.	MenC-CRM EMV n=304 participants at risk Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.	MenC-CRM ROS_EMV n=119 participants at risk Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
Gastrointestinal disorders Diarrhea	14.7% 44/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	12.0% 32/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	11.8% 36/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	14.3% 17/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
General disorders Crying	15.1% 45/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	15.4% 41/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	11.8% 36/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	12.6% 15/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
General disorders Injection Site Erythema	74.2% 222/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	74.9% 200/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	69.4% 211/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	68.1% 81/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
General disorders Injection Site Induration	84.3% 252/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	85.0% 227/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	77.6% 236/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	73.9% 88/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
General disorders Injection Site Pain	29.4% 88/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	24.0% 64/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	33.2% 101/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	34.5% 41/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
General disorders Irritability	33.8% 101/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	28.5% 76/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	28.6% 87/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	26.9% 32/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
Nervous system disorders Somnolence	22.1% 66/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	20.6% 55/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	18.4% 56/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	20.2% 24/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
Psychiatric disorders Eating Disorder	29.4% 88/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	25.5% 68/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	27.3% 83/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	21.8% 26/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
General disorders Pyrexia	9.0% 27/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	5.6% 15/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	7.6% 23/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	14.3% 17/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
Infections and infestations Respiratory Tract Infection	3.3% 10/299 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	2.6% 7/267 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	3.9% 12/304 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.	5.0% 6/119 • Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination). All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER