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Clinical Trial Results:
A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60 µg, 120 µg, and 200 µg in Healthy Adolescents Aged 11 to 18 Years

Summary
EudraCT number	2008-007789-51
Trial protocol	PL ES Outside EU/EEA
Global end of trial date	27 Mar 2014

Results information
Results version number	v1(current)
This version publication date	29 Jun 2016
First version publication date	29 Jul 2015
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

6108A1-2001-WW

ISRCTN number

US NCT number

NCT00808028

WHO universal trial number (UTN)

Other trial identifiers

Alias: B1971005

Sponsor organisation name

Pfizer Inc

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer Clinical Trials.gov Call Centre, Pfizer Inc, 001 45678899, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer Clinical Trials.gov Call Centre, Pfizer Inc, 001 45678899, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-001037-PIP02-11

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

28 May 2015

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

27 Mar 2014

Was the trial ended prematurely?

Main objective of the trial

To assess the immunogenicity of 60 microgram (mcg), 120 mcg, and 200 mcg recombinant lipoprotein 2086 (rLP2086) vaccine as measured by serum bactericidal assays (SBA) performed with MnB strains expressing LP2086 subfamily A and B proteins in healthy adolescents aged 11 to 18 years.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

09 Feb 2009

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy

Long term follow-up duration

48 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Spain: 89

Country: Number of subjects enrolled

Australia: 139

Country: Number of subjects enrolled

Poland: 311

Worldwide total number of subjects

539

EEA total number of subjects

400

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

443

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

This study was conducted at 25 sites in 3 countries. Study start date was 9 February 2009 and end date was 27 March 2014.

Period 1 title

Stage 1 (6 months)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Subject

Are arms mutually exclusive

Yes

Control- Stage 1

Arm description

Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.

Arm type

Placebo

Investigational medicinal product name

Normal Saline

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received normal saline on a 0, 2-, 6-month schedule.

rLP2086 60 mcg- Stage 1

Arm description

Given on a 0, 2-, 6-month schedule in Stage 1.

Arm type

Experimental

Investigational medicinal product name

Bivalent Recombinant lipoprotein 2086 (rLP2086)

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received rLP2086 60 mcg on a 0-, 2-, 6- month schedule.

rLP2086 120 mcg- Stage 1

Arm description

Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.

Arm type

Experimental

Investigational medicinal product name

Bivalent Recombinant lipoprotein 2086 (rLP2086)

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received rLP2086 120 mcg on a 0-, 2-, 6- month schedule.

rLP2086 200 mcg- Stage 1

Arm description

Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.

Arm type

Experimental

Investigational medicinal product name

Bivalent Recombinant lipoprotein 2086 (rLP2086)

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received rLP2086 200 mcg on a 0-, 2-, 6- month schedule.

Number of subjects in period 1	Control- Stage 1	rLP2086 60 mcg- Stage 1	rLP2086 120 mcg- Stage 1	rLP2086 200 mcg- Stage 1
Started	121	22	198	198
Completed	116	21	191	183
Not completed	5	1	7	15
Consent withdrawn by subject	3	-	2	5
Adverse Event	-	-	1	2
Parent/legal guardian request	-	1	1	3
Unspecified	1	-	2	4
Protocol Violation	-	-	-	1
Lost to follow-up	1	-	1	-

Period 2 title

Stage 2 (Followed up to 48 Months )

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Control- Stage 2

Arm description

Follow-up to 48 months.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

rLP2086 120 mcg- Stage 2

Arm description

Follow-up to 48 months.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

rLP2086 200 mcg- Stage 2

Arm description

Follow-up to 48 months.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 2 ^[1]	Control- Stage 2	rLP2086 120 mcg- Stage 2	rLP2086 200 mcg- Stage 2
Started	80	170	151
Completed	69	141	128
Not completed	11	29	23
Consent withdrawn by subject	6	9	11
Adverse Event	1	1	-
Failed to return	2	5	4
Death	-	1	-
Non-compliance	-	1	-
Protocol Violation	-	1	-
Unspecified	-	1	1
Lost to follow-up	2	8	7
Parent's or guardian request	-	2	-

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Out of 511 completed subjects in Stage 1, 89 did not enter Stage 2.

Baseline characteristics

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Reporting group title

Control- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.

Reporting group title

rLP2086 60 mcg- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1.

Reporting group title

rLP2086 120 mcg- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.

Reporting group title

rLP2086 200 mcg- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.

Reporting group values	Control- Stage 1	rLP2086 60 mcg- Stage 1	rLP2086 120 mcg- Stage 1	rLP2086 200 mcg- Stage 1	Total
Number of subjects	121	22	198	198	539
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	13.8 ± 2.05	13.3 ± 1.84	14.3 ± 2.11	14 ± 2.01	-
Gender categorical
Units: Subjects
Female	61	11	113	103	288
Male	60	11	85	95	251

End points

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Reporting group title

Control- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.

Reporting group title

rLP2086 60 mcg- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1.

Reporting group title

rLP2086 120 mcg- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.

Reporting group title

rLP2086 200 mcg- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.

Reporting group title

Control- Stage 2

Reporting group description

Follow-up to 48 months.

Reporting group title

rLP2086 120 mcg- Stage 2

Reporting group description

Follow-up to 48 months.

Reporting group title

rLP2086 200 mcg- Stage 2

Reporting group description

Follow-up to 48 months.

Primary: Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before vaccination 1 up to 1 month after vaccination 2

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End point title

Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before vaccination 1 up to 1 month after vaccination 2 ^[1]

End point description

Modified- Intent-to-treat (mITT) population included all randomized subjects who received at least 1 vaccination and had at least 1 valid and determinate assay result.

End point type

Primary

End point timeframe

Before vaccination 1 up to 1 month after vaccination 2

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical analysis has been provided separately as an attachment.

End point values	Control- Stage 1	rLP2086 60 mcg- Stage 1	rLP2086 120 mcg- Stage 1	rLP2086 200 mcg- Stage 1
Number of subjects analysed	119 ^[2]	22 ^[3]	195 ^[4]	192 ^[5]
Units: Titer
number (not applicable)
Subfamily A Strain A05 (N=80, 18, 115, 106)	1.3	88.9	83.5	87.7
Subfamily B Strain B02 (N= 84, 21, 121, 114)	0	71.4	59.5	59.6

Attachments

Statistical analysis for Endpoint 1

Notes
[2] - Subjects evaluable for this measure during specified time period.
[3] - Subjects evaluable for this measure during specified time period.
[4] - Subjects evaluable for this measure during specified time period.
[5] - Subjects evaluable for this measure during specified time period.

No statistical analyses for this end point

Primary: Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3

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End point title

Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 ^[6]

End point description

mITT population included all randomized subjects who received at least 1 vaccination and had at least 1 valid and determinate assay result.

End point type

Primary

End point timeframe

Before vaccination 1 up to 1 month after vaccination 3

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical analysis has been provided separately as an attachment.

End point values	Control- Stage 1	rLP2086 60 mcg- Stage 1	rLP2086 120 mcg- Stage 1	rLP2086 200 mcg- Stage 1
Number of subjects analysed	119 ^[7]	22 ^[8]	195 ^[9]	192 ^[10]
Units: percentage of subjects
number (not applicable)
Subfamily A Strain A05 (N=73, 19, 111,100)	5.5	89.5	92.8	94
Subfamily B Strain B02 (N=79, 21, 112,105)	1.3	81	86.6	84.8

Attachments

Statistical Analysis for Endpoint 2

Notes
[7] - Subjects evaluable for this measure during specified time period.
[8] - Subjects evaluable for this measure during specified time period.
[9] - Subjects evaluable for this measure during specified time period.
[10] - Subjects evaluable for this measure during specified time period.

No statistical analyses for this end point

Primary: Percentage of Subjects With Atleast One Adverse Event (AE): Stage 1

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End point title

Percentage of Subjects With Atleast One Adverse Event (AE): Stage 1 ^[11]

End point description

Safety population included subjects who received at least 1 dose of study vaccine.

End point type

Primary

End point timeframe

Vaccination 1 upto 1 Month after vaccination 3

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.

End point values	Control- Stage 1	rLP2086 60 mcg- Stage 1	rLP2086 120 mcg- Stage 1	rLP2086 200 mcg- Stage 1
Number of subjects analysed	121	22	198	195
Units: percentage of subjects
number (not applicable)
Stage 1: Vaccination phase	44.6	81.8	38.9	47.2
Stage 1: 6-month follow up	4.1	18.2	1.5	2.6

No statistical analyses for this end point

Primary: Percentage of Subjects With Atleast One Adverse Event: Stage 2

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End point title

Percentage of Subjects With Atleast One Adverse Event: Stage 2 ^[12]

End point description

Safety population included subjects who received at least 1 dose of study vaccine.

End point type

Primary

End point timeframe

6 month after vaccination 3 up to 48 months

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.

End point values	Control- Stage 2	rLP2086 120 mcg- Stage 2	rLP2086 200 mcg- Stage 2
Number of subjects analysed	80	170	151
Units: percentage of subjects
number (not applicable)	2.5	4.1	2

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level

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End point title

Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level

End point description

mITT population included all randomized subjects who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those subjects who were evaluable for this measure during specified time period.

End point type

Secondary

End point timeframe

1 month before vaccination 1, 1 month after vaccination 2, 3

End point values	Control- Stage 1	rLP2086 60 mcg- Stage 1	rLP2086 120 mcg- Stage 1	rLP2086 200 mcg- Stage 1
Number of subjects analysed	119	22	195	192
Units: percentage of subjects
number (not applicable)
A04 Predose 1;1:32 (N= 64, 15, 90, 92)	10.9	0	10	12
A04 Predose 1;1:64 (N= 64, 15, 90, 92)	3.1	0	7.8	5.4
A04 Predose 1;1:128 (N= 64, 15, 90, 92)	0	0	1.1	0
A04 1-month postdose 2;1:32 (N= 69, 21, 115, 115)	4.3	95.2	98.3	91.3
A04 1-month postdose 2;1:64 (N= 69, 21, 115, 115)	1.4	85.7	82.6	72.2
A04 1-month postdose 2;1:128 (N=69, 21, 115, 115)	1.4	52.4	44.3	42.6
A04 1-month postdose 3; 1:32 (N= 57, 19, 108, 99)	8.8	94.7	100	99
A04 1-month postdose 3; 1:64 (N= 57, 19, 108, 99)	5.3	94.7	95.4	90.9
A04 1-month postdose 3; 1:128 (N= 57, 19, 108, 99	3.5	68.4	67.6	67.7
A05 Predose 1;1:16 (N= 81, 21, 122, 114)	12.3	4.8	9	6.1
A05 Predose 1;1:32 (N= 81, 21, 122, 114)	7.4	4.8	5.7	4.4
A05 Predose 1;1:64 (N= 81, 21, 122, 114)	4.9	0	2.5	1.8
A05 Predose 1;1:128 (N= 81, 21, 122, 114)	1.2	0	0.8	0
A05 1-month postdose 2;1:16 (N= 83, 18, 118, 110)	7.2	88.9	89	90.9
A05 1-month postdose 2;1:32 (N= 83, 18, 118, 110)	3.6	88.9	85.6	81.8
A05 1-month postdose 2;1:64 (N= 83, 18, 118, 110)	1.2	83.3	59.3	64.5
A05 1-month postdose 2;1:128 (N= 83, 18, 118, 110	0	33.3	28	40
A05 1-month postdose 3;1:16 (N= 76, 20, 114, 104	11.8	90	96.5	96.2
A05 1-month postdose 3;1:32 (N= 76, 20, 114, 10	7.9	90	94.7	95.2
A05 1-month postdose 3;1:64 (N= 76, 20, 114, 10	3.9	85	89.5	87.5
A05 1-month postdose 3;1:128 (N= 76, 20, 114, 104	1.3	40	68.4	60.6
A56 Predose 1;1:16 (N= 80, 21, 119, 115)	10	4.8	7.6	6.1
A56 Predose 1;1:32 (N= 80, 21, 119, 115)	7.5	4.8	5	4.3
A56 Predose 1;1:64 (N= 80, 21, 119, 115)	2.5	0	0.8	3.5
A56 Predose 1;1:128 (N= 80, 21, 119, 115)	1.3	0	0	0
A56 1-month postdose 2;1:16 (N= 81, 20, 117, 10	12.3	85	94.9	96.3
A56 1-month postdose 2;1:32 (N= 81, 20, 117, 107)	11.1	85	90.6	88.8
A56 1-month postdose 2;1:64 (N= 81, 20, 117, 107)	9.9	80	80.3	71
A56 1-month postdose 2;1:128 (N=81, 20, 117, 107)	2.5	45	39.3	45.8
A56 1-month postdose 3 ;1:16 (N=78, 21, 114, 112)	11.5	95.2	97.4	95.5
A56 1-month postdose 3;1:32 (N= 78, 21, 114, 112)	9	85.7	93.9	93.8
A56 1-month postdose 3;1:64 (N= 78, 21, 114, 112)	3.8	71.4	91.2	84.8
A56 1-month postdose 3;1:128 (N= 78, 21, 114, 112)	2.6	61.9	74.6	67
B02 Predose 1;1:16 (N= 84, 22, 124, 118)	3.6	0	1.6	2.5
B02 Predose 1;1:32 (N= 84, 22, 124, 118)	1.2	0	0.8	1.7
B02 Predose 1;1:64 (N= 84, 22, 124, 118)	0	0	0.8	0
B02 Predose 1;1:128 (N= 84, 22, 124, 118)	0	0	0.8	0
B02 1-month postdose 2 ;1:16 (N= 84, 21, 122, 114)	1.2	76.2	68.9	65.8
B02 1-month postdose 2 ;1:32 (N= 84, 21, 122, 114)	0	57.1	45.9	48.2
B02 1-month postdose 2 ;1:64 (N= 84, 21, 122, 114)	0	42.9	25.4	21.9
B02 1-month postdose 2;1:128 (N= 84, 21, 122, 114)	0	14.3	7.4	8.8
B02 1-month postdose 3 ;1:16 (N= 79, 21, 113, 105)	3.8	85.7	90.3	85.7
B02 1-month postdose 3 ;1:32 (N= 79, 21, 113, 105)	1.3	81	78.8	79
B02 1-month postdose 3 ;1:64 (N= 79, 21, 113, 105)	0	57.1	52.2	60
B02 1-month postdose 3;1:128 (N= 79, 21, 113, 105)	0	42.9	19.5	19
B03 Predose 1;1:16 (N= 83, 22, 118, 117)	2.4	0	2.5	2.6
B03 Predose 1;1:32 (N= 83, 22, 118, 117)	2.4	0	2.5	2.6
B03 Predose 1;1:64 (N= 83, 22, 118, 117)	1.2	0	0	0.9
B03 Predose 1;1:128 (N= 83, 22, 118, 117)	0	0	0	0
B03 1-month postdose 2;1:16 (N= 84, 19, 102, 96)	2.4	21.1	32.4	30.2
B03 1-month postdose 2;1:32 (N= 84, 19, 102, 96)	2.4	21.1	30.4	28.1
B03 1-month postdose 2;1:64 (N= 84, 19, 102, 96)	1.2	5.3	22.5	19.8
B03 1-month postdose 2;1:128 (N= 84, 19, 102, 96)	0	0	10.8	8.3
B03 1-month postdose 3;1:16 (N= 68, 15, 86, 81)	5.9	53.3	75.6	67.9
B03 1-month postdose 3;1:32 (N= 68, 15, 86, 81)	4.4	53.3	75.6	66.7
B03 1-month postdose 3;1:64 (N= 68, 15, 86, 81)	1.5	46.7	60.5	58
B03 1-month postdose 3;1:128 (N= 68, 15, 86, 81)	0	26.7	27.9	24.7
B44 Predose 1 ;1:8 (N= 81, 22, 120, 116)	2.5	0	3.3	2.6
B44 Predose 1 ;1:16 (N= 81, 22, 120, 116)	1.2	0	1.7	2.6
B44 Predose 1 ;1:32 (N= 81, 22, 120, 116)	0	0	0	1.7
B44 Predose 1 ;1:64 (N= 81, 22, 120, 116)	0	0	0	0.9
B44 Predose 1 ;1:128 (N= 81, 22, 120, 116)	0	0	0	0.9
B44 1-month postdose 2;1:8 (n= 81, 21, 115, 106)	1.2	61.9	68.7	70.8
B44 1-month postdose 2;1:16 (N= 81, 21, 115, 106)	0	61.9	60.9	64.2
B44 1-month postdose 2;1:32 (N= 81, 21, 115, 106)	0	47.6	43.5	42.5
B44 1-month postdose 2;1:64 (N= 81, 21, 115, 106)	0	23.8	22.6	25.5
B44 1-month postdose 2;1:128 (N= 81, 21, 115, 106)	0	0	6.1	11.3
B44 1-month postdose 3;1:8 (N= 83, 21, 115, 111)	4.8	76.2	88.7	86.5
B44 1-month postdose 3; 1:16 (N= 83, 21, 115, 111)	1.2	76.2	86.1	85.6
B44 1-month postdose 3;1:32 (N= 83, 21, 115, 111)	0	76.2	80.9	80.2
B44 1-month postdose 3;1:64 (N= 83, 21, 115, 111)	0	47.6	53.9	61.3
B44 1-month postdose 3;1:128 (N= 83, 21, 115, 111)	0	9.5	22.6	19.8

No statistical analyses for this end point

Other pre-specified: Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B

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End point title

Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B

End point description

mITT population included all randomized subjects who received at least 1 vaccination and had at least 1 valid and determinate assay result.

End point type

Other pre-specified

End point timeframe

Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3

End point values	Control- Stage 1	rLP2086 60 mcg- Stage 1	rLP2086 120 mcg- Stage 1	rLP2086 200 mcg- Stage 1
Number of subjects analysed	119 ^[13]	22 ^[14]	195 ^[15]	192 ^[16]
Units: Titer
geometric mean (confidence interval 95%)
Subfamily(Sf) A Predose 1(N=106, 22, 156, 173)	3.6 (2.6 to 5.1)	4.3 (1.6 to 11.7)	7.2 (5.3 to 9.8)	4.9 (3.8 to 6.4)
Sf A 1-month postdose 2(N=104, 22, 168, 166)	4.9 (3.5 to 6.9)	984.6 (663.8 to 1460.4)	1115.5 (962.8 to 1292.5)	1285.8 (1082.3 to 1527.7)
Sf A 1-month postdose 3(N=98, 20, 158, 148)	5.8 (3.9 to 8.5)	3120.3 (1959.5 to 4968.8)	2289.5 (1967 to 2664.9)	2342.6 (2003.9 to 2738.5)
Sf B Predose 1(N=106, 22, 155, 172)	3.5 (2.6 to 4.6)	4.2 (1.4 to 12.7)	5.4 (4.1 to 7.2)	3.9 (3 to 5)
Sf B 1-month postdose 2(N=104, 22, 168, 166)	3.7 (2.7 to 5)	405.8 (298.74 to 551.4)	816.5 (701 to 951.1)	852 (729.1 to 995.6)
Sf B 1-month postdose 3(N=98, 20, 158, 148)	4.1 (2.9 to 5.7)	3264.2 (2502.3 to 4258.1)	2246.8 (1988.1 to 2539.2)	2553.3 (2256 to 2889.7)

Notes
[13] - Subjects evaluable for this measure during specified time period.
[14] - Subjects evaluable for this measure during specified time period.
[15] - Subjects evaluable for this measure during specified time period.
[16] - Subjects evaluable for this measure during specified time period.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

AE reported from Vaccination 1 up to 48 months after vaccincation 3 and SAE reported from Vaccination 1 up to 48 months after vaccination 1

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.0

Reporting group title

Control- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1.

Reporting group title

rLP2086 60 microgram (mcg)- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1 .

Reporting group title

rLP2086 120 mcg- Stage 1

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1.

Reporting group title

rLP2086 200 mcg- Stage 1

Reporting group description

Given on a 0, 2-, 6- month schedule in Stage 1.

Reporting group title

Control-Stage 1 Follow-up

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1.

Reporting group title

rLP2086 60 mcg- Stage 1 Follow up

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1.

Reporting group title

rLP2086 120 mcg- Stage 1 Follow up

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1.

Reporting group title

rLP2086 200 mcg-Stage 1 Follow up

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1

Reporting group title

Control- Stage 2

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1, werethen followed up to 6 monthsin Stage 1 and further up to 48 months in Stage 2.

Reporting group title

rLP2086 120 mcg- Stage 2

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2.

Reporting group title

rLP2086 200 mcg- Stage 2

Reporting group description

Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2.

Serious adverse events	Control- Stage 1	rLP2086 60 microgram (mcg)- Stage 1	rLP2086 120 mcg- Stage 1	rLP2086 200 mcg- Stage 1	Control-Stage 1 Follow-up	rLP2086 60 mcg- Stage 1 Follow up	rLP2086 120 mcg- Stage 1 Follow up	rLP2086 200 mcg-Stage 1 Follow up	Control- Stage 2	rLP2086 120 mcg- Stage 2	rLP2086 200 mcg- Stage 2
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 121 (2.48%)	1 / 22 (4.55%)	3 / 198 (1.52%)	8 / 195 (4.10%)	0 / 121 (0.00%)	1 / 22 (4.55%)	1 / 198 (0.51%)	2 / 195 (1.03%)	1 / 80 (1.25%)	6 / 170 (3.53%)	3 / 151 (1.99%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar tumour
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
CNS germinoma
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	1 / 170 (0.59%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Abdominal injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chest injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Concussion
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Jaw fracture
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Limb injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	1 / 170 (0.59%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	1 / 170 (0.59%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	1 / 151 (0.66%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	1 / 170 (0.59%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Headache
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Lymphadenitis
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Ovarian cyst
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cough
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rhinitis allergic
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	1 / 170 (0.59%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mononucleosis syndrome
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eczema impetiginous
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	1 / 170 (0.59%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	1 / 80 (1.25%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pilonidal cyst
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	1 / 151 (0.66%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	1 / 170 (0.59%)	0 / 151 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis streptococcal
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	1 / 151 (0.66%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Control- Stage 1	rLP2086 60 microgram (mcg)- Stage 1	rLP2086 120 mcg- Stage 1	rLP2086 200 mcg- Stage 1	Control-Stage 1 Follow-up	rLP2086 60 mcg- Stage 1 Follow up	rLP2086 120 mcg- Stage 1 Follow up	rLP2086 200 mcg-Stage 1 Follow up	Control- Stage 2	rLP2086 120 mcg- Stage 2	rLP2086 200 mcg- Stage 2
Total subjects affected by non serious adverse events
subjects affected / exposed	54 / 121 (44.63%)	18 / 22 (81.82%)	75 / 198 (37.88%)	91 / 195 (46.67%)	5 / 121 (4.13%)	3 / 22 (13.64%)	2 / 198 (1.01%)	4 / 195 (2.05%)	1 / 80 (1.25%)	1 / 170 (0.59%)	0 / 151 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
General disorders and administration site conditions
Influenza like illness
subjects affected / exposed	4 / 121 (3.31%)	1 / 22 (4.55%)	2 / 198 (1.01%)	4 / 195 (2.05%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	4	1	2	4	0	0	0	0	0	0	0
Injection site pain
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	3 / 195 (1.54%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	3	0	0	0	0	0	0	0
Pyrexia
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	2 / 195 (1.03%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	2	0	0	0	0	0	0	0
Injection site swelling
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	2	1	0	0	0	0	0	0	0
Chest pain
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Hypothermia
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Injection site dermatitis
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Injection site erythema
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Injection site haematoma
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Injection site pallor
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Injection site paraesthesia
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Injection site pruritus
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Vaccination site pallor
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Vessel puncture site haematoma
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Immune system disorders
Allergy to animal
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Allergy to chemicals
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Seasonal allergy
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	2 / 121 (1.65%)	0 / 22 (0.00%)	0 / 198 (0.00%)	2 / 195 (1.03%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	2	0	0	2	0	0	0	0	0	0	0
Penile discharge
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	4 / 121 (3.31%)	2 / 22 (9.09%)	2 / 198 (1.01%)	4 / 195 (2.05%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	4	2	2	4	0	0	0	0	0	0	0
Rhinorrhoea
subjects affected / exposed	6 / 121 (4.96%)	0 / 22 (0.00%)	3 / 198 (1.52%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	6	0	4	1	0	0	0	0	0	0	0
Cough
subjects affected / exposed	3 / 121 (2.48%)	1 / 22 (4.55%)	2 / 198 (1.01%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	3	1	2	1	0	0	0	0	0	0	0
Asthma
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	2 / 198 (1.01%)	2 / 195 (1.03%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	4	2	0	0	0	0	0	0	0
Rhinitis allergic
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	2	1	0	0	0	0	0	0	0
Asthma exercise induced
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Epistaxis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Psychiatric disorders
Abnormal behaviour
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Investigations
Blood iron decreased
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	2 / 198 (1.01%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0
Electrocardiogram QT prolonged
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	0	0	0
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	2 / 121 (1.65%)	1 / 22 (4.55%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	2	1	1	0	0	0	0	0	0	0	0
Thermal burn
subjects affected / exposed	1 / 121 (0.83%)	1 / 22 (4.55%)	1 / 198 (0.51%)	1 / 195 (0.51%)	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	1	1	1	1	0	0	0	0	0	0
Skin laceration
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	2 / 195 (1.03%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	2	0	0	0	0	0	0	0
Arthropod bite
subjects affected / exposed	1 / 121 (0.83%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0
Concussion
subjects affected / exposed	2 / 121 (1.65%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0
Foot fracture
subjects affected / exposed	1 / 121 (0.83%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0
Joint sprain
subjects affected / exposed	1 / 121 (0.83%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0
Procedural pain
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	2 / 198 (1.01%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0
Radius fracture
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	2	0	1	0	0	0	0	0	0	0
Road traffic accident
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0
Soft tissue injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	2 / 195 (1.03%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	2	0	0	0	1	0	0	0
Whiplash injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0
Wrist fracture
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0
Ankle fracture
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0
Back injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Chemical burn of skin
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Chest injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Foreign body
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Head injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0	0	0
Ligament injury
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Poisoning
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Post concussion syndrome
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Post procedural haematoma
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Skeletal injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Ulna fracture
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Hand fracture
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Limb injury
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Upper limb fracture
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Congenital, familial and genetic disorders
Factor V Leiden mutation
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	1 / 170 (0.59%)	0 / 151 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Cardiac disorders
Palpitations
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	8 / 121 (6.61%)	2 / 22 (9.09%)	3 / 198 (1.52%)	2 / 195 (1.03%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	10	2	4	2	0	0	0	0	0	0	0
Syncope
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	4 / 195 (2.05%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	4	0	0	0	0	0	0	0
Migraine
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	2	0	0	0	0	0	0	0
Burning sensation mucosal
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Presyncope
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Tremor
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	2	0	0	1	0	0	0	0	0	0	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Vertigo
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Eye disorders
Conjunctivitis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	3 / 198 (1.52%)	2 / 195 (1.03%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	3	2	0	0	0	0	0	0	0
Eye inflammation
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Eyelid cyst
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Photophobia
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	2 / 121 (1.65%)	0 / 22 (0.00%)	2 / 198 (1.01%)	3 / 195 (1.54%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	2	0	2	3	0	0	0	0	0	0	0
Diarrhoea
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	1 / 198 (0.51%)	4 / 195 (2.05%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	1	4	0	0	0	0	0	0	0
Dyspepsia
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0
Glossodynia
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0
Dental caries
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Food poisoning
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Gingivitis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Inguinal hernia
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Irritable bowel syndrome
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Mouth ulceration
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Tooth impacted
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Toothache
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Vomiting
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	1	1	0	0	0	0	0	0	0
Acne
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	1	0	0	0	1	0	0	0
Dermatitis allergic
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0
Scar
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0
Alopecia
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Dermatitis atopic
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Dermatitis contact
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Drug eruption
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0
Hangnail
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Ingrowing nail
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Photosensitivity reaction
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Rash
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0
Urticaria
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	1	1	0	0	0	0	0	0	0
Back pain
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0
Arthropathy
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Costochondritis
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Muscle contracture
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Myalgia
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0
Neck pain
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Pain in extremity
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Tendonitis
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Torticollis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Rheumatoid arthritis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	1 / 80 (1.25%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	20 / 121 (16.53%)	13 / 22 (59.09%)	28 / 198 (14.14%)	21 / 195 (10.77%)	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	27	16	35	29	0	1	0	0	0	0	0
Pharyngitis
subjects affected / exposed	5 / 121 (4.13%)	0 / 22 (0.00%)	4 / 198 (2.02%)	10 / 195 (5.13%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	5	0	4	11	0	0	0	0	0	0	0
Tonsillitis
subjects affected / exposed	1 / 121 (0.83%)	1 / 22 (4.55%)	5 / 198 (2.53%)	7 / 195 (3.59%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	1	5	11	0	0	0	0	0	0	0
Gastroenteritis
subjects affected / exposed	3 / 121 (2.48%)	0 / 22 (0.00%)	5 / 198 (2.53%)	4 / 195 (2.05%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	3	0	6	4	0	0	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	8 / 198 (4.04%)	3 / 195 (1.54%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	9	3	0	0	0	0	0	0	0
Bronchitis
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	3 / 198 (1.52%)	4 / 195 (2.05%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	3	5	0	0	0	0	0	0	0
Respiratory tract infection
subjects affected / exposed	4 / 121 (3.31%)	0 / 22 (0.00%)	2 / 198 (1.01%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	4	0	2	1	0	0	0	0	0	0	0
Rhinitis
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	4 / 198 (2.02%)	2 / 195 (1.03%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	4	2	0	0	0	0	0	0	0
Viral infection
subjects affected / exposed	2 / 121 (1.65%)	4 / 22 (18.18%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	2	4	1	0	0	0	0	0	0	0	0
Ear infection
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	2 / 195 (1.03%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	2	0	0	0	0	0	0	0
Influenza
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	1	1	0	0	0	0	0	0	0
Laryngitis
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	1	1	0	0	0	0	0	0	0
Lower respiratory tract infection
subjects affected / exposed	3 / 121 (2.48%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	3	0	0	0	0	0	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	3 / 195 (1.54%)	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	3	1	0	0	0	0	0	0
Acute tonsillitis
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0
H1N1 influenza
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0
Mumps
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	2 / 198 (1.01%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0
Otitis media
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	1	0	1	0	0	0	0	0
Respiratory tract infection viral
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0
Sinusitis
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0
Acarodermatitis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Cellulitis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Gastritis viral
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Gastroenteritis viral
subjects affected / exposed	0 / 121 (0.00%)	1 / 22 (4.55%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	0	0
Herpes simplex
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Impetigo
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Pertussis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Pneumonia
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Pulpitis dental
subjects affected / exposed	1 / 121 (0.83%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Pyelonephritis
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Subcutaneous abscess
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	1 / 198 (0.51%)	0 / 195 (0.00%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	1 / 195 (0.51%)	0 / 121 (0.00%)	0 / 22 (0.00%)	0 / 198 (0.00%)	0 / 195 (0.00%)	0 / 80 (0.00%)	0 / 170 (0.00%)	0 / 151 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

05 Nov 2008

1- The stopping rules for moderate systemic reactions and chills of any severity were removed.

16 Sep 2009

1- Pregnancy testing at each visit of stage 2 was added. 2- Study visit procedures were updated to reflect that investigators should inquire about autoimmune diseases at the 6-month safety follow-up of stage 1 and at each visit throughout stage 2.

16 Nov 2009

1- The window for the third vaccination was broadened to 9 months. The vaccination schedule was changed to 0, 2, and 6 to 9 months. 2- The window for the immunogenicity blood collection 24 months postdose 3 and following was broadened from 2 to 3 months.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
22 Oct 2009	A serious adverse event (SAE) characterized by severe headache and vomiting occurred in a subject during stage 1 of the study. This event was considered possibly related to study vaccine and triggered a protocol-defined study pause.	-

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60 µg, 120 µg, and 200 µg in Healthy Adolescents Aged 11 to 18 Years

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before vaccination 1 up to 1 month after vaccination 2

Primary: Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before vaccination 1 up to 1 month after vaccination 2

Primary: Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3

Primary: Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3

Primary: Percentage of Subjects With Atleast One Adverse Event (AE): Stage 1

Primary: Percentage of Subjects With Atleast One Adverse Event (AE): Stage 1

Primary: Percentage of Subjects With Atleast One Adverse Event: Stage 2

Primary: Percentage of Subjects With Atleast One Adverse Event: Stage 2

Secondary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level

Secondary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level

Other pre-specified: Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B

Other pre-specified: Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Outside EU/EEA

Clinical trials

Clinical Trial Results: A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60 µg, 120 µg, and 200 µg in Healthy Adolescents Aged 11 to 18 Years

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before vaccination 1 up to 1 month after vaccination 2

Primary: Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before vaccination 1 up to 1 month after vaccination 2

Primary: Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3

Primary: Percentage of Subjects With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3

Primary: Percentage of Subjects With Atleast One Adverse Event (AE): Stage 1

Primary: Percentage of Subjects With Atleast One Adverse Event (AE): Stage 1

Primary: Percentage of Subjects With Atleast One Adverse Event: Stage 2

Primary: Percentage of Subjects With Atleast One Adverse Event: Stage 2

Secondary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level

Secondary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level

Other pre-specified: Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B

Other pre-specified: Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60 µg, 120 µg, and 200 µg in Healthy Adolescents Aged 11 to 18 Years