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Clinical Trial Results:
A Phase 2, Randomized, Placebo-Controlled, Single-blind Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Administered in Either 2- or 3-Dose Regimens in Healthy Subjects Aged ≥ 11 to <19 Years

Summary
EudraCT number	2009-014493-18
Trial protocol	SE CZ ES PL DE FI DK
Global end of trial date	18 Sep 2012

Results information
Results version number	v1(current)
This version publication date	29 Jun 2016
First version publication date	01 Aug 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

B1971012 (6108A1-2003-EU)

ISRCTN number

US NCT number

NCT01299480

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

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

Public contact

Clinical Trials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.govCallCenter@pfizer.com

Scientific contact

Clinical Trials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.govCallCenter@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

03 Dec 2013

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

18 Sep 2012

Was the trial ended prematurely?

Main objective of the trial

Co-Primary Objectives: To assess the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the third vaccination with bivalent rLP2086 vaccine among group 1 subjects. To assess the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the third vaccination with bivalent rLP2086 vaccine among group 2 subjects.

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

03 Mar 2011

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

6 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 239

Country: Number of subjects enrolled

Spain: 176

Country: Number of subjects enrolled

Sweden: 133

Country: Number of subjects enrolled

Czech Republic: 330

Country: Number of subjects enrolled

Denmark: 302

Country: Number of subjects enrolled

Finland: 368

Country: Number of subjects enrolled

Germany: 164

Worldwide total number of subjects

1712

EEA total number of subjects

1712

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)

220

Adolescents (12-17 years)

1325

Adults (18-64 years)

167

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 1714 subjects were enrolled in this study. Of these, 1 subject was not randomized but was vaccinated with Saline at Injection 1. This subject was included in safety population and not intent-to-treat population.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Subject

Are arms mutually exclusive

Yes

Group 1:rLP2086(0-, 1-, 6-Month) + Saline(2-Month)

Arm description

Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.

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-, 1-, 6- month schedule.

Investigational medicinal product name

Saline (0.9% sodium chloride)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.9% saline on a 2- month schedule.

Group 2:rLP2086(0-, 2-, 6-Month) +Saline(1-Month)

Arm description

Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.

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.

Investigational medicinal product name

Saline (0.9% sodium chloride)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.9% saline on a 1- month schedule.

Group 3:rLP2086(0-, 6-Month) +Saline(1-, 2-Month)

Arm description

Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.

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-, 6- month schedule.

Investigational medicinal product name

Saline (0.9% sodium chloride)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.9% saline on a 1-, 2-month schedule.

Group 4:rLP2086(0-, 2-Month) + Saline(1-, 6-Month)

Arm description

Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.

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- month schedule.

Investigational medicinal product name

Saline (0.9% sodium chloride)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.9% saline on a 1-, 6-month schedule.

Group 5:rLP2086(2-, 6-Month) + Saline(0-, 1-Month)

Arm description

Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.

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 on a 2-, 6- month schedule.

Investigational medicinal product name

Saline (0.9% sodium chloride)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.9% saline on a 0-, 1-month schedule.

Number of subjects in period 1	Group 1:rLP2086(0-, 1-, 6-Month) + Saline(2-Month)	Group 2:rLP2086(0-, 2-, 6-Month) +Saline(1-Month)	Group 3:rLP2086(0-, 6-Month) +Saline(1-, 2-Month)	Group 4:rLP2086(0-, 2-Month) + Saline(1-, 6-Month)	Group 5:rLP2086(2-, 6-Month) + Saline(0-, 1-Month)
Started	427	430	426	285	144
Randomized and Treated	427	430	426	285	143
Completed	385	395	386	261	123
Not completed	42	35	40	24	21
Withdrawal due to pregnancy	-	1	1	-	-
Consent withdrawn by subject	3	4	7	3	4
Physician decision	1	1	-	2	-
Adverse event	6	4	5	4	-
Treated but not randomized	-	-	-	-	1
No longer willing to participate	19	17	14	13	10
Unspecified	3	2	3	-	3
Protocol Violation	7	5	8	1	1
Lost to follow-up	3	1	2	1	2

Baseline characteristics

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Reporting group title

Overall Study

Reporting group description

Baseline characteristics are represented for safety population.

Reporting group values	Overall Study	Total
Number of subjects	1712	1712
Age categorical
Some subjects randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One subject was not randomized but received Saline at Injection 1 and was included in Group 5. Subjects have been presented as per actual administration schedule received.
Units: Subjects
11- less than (<) 14 years	627	627
14 - <19 years	1085	1085
Gender categorical
Units: Subjects
Female	870	870
Male	842	842

Subject analysis set title

Group 1:rLP2086(0 -,1-,6- Month) +Saline(2-Month):Safety

Subject analysis set type

Safety analysis

Subject analysis set description

Randomized to receive rLP2086 on a 0-, 1-, 6-month and 0.9% normal saline on a 2- month schedule.

Subject analysis set title

Group 2:rLP2086(0-,2-,6-Month)+Saline(1- Month):Safety

Subject analysis set type

Safety analysis

Subject analysis set description

Randomized to receive rLP2086 on a 0-, 2-, 6-month and 0.9% normal saline on a 1- month schedule.

Subject analysis set title

Group 3: rLP2086(0-, 6-Month) +Saline(1-,2-Month):Safety

Subject analysis set type

Safety analysis

Subject analysis set description

Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.

Subject analysis set title

Group 4:rLP2086(0-,2- Month) +Saline(1-,6-Month):Safety

Subject analysis set type

Safety analysis

Subject analysis set description

Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.

Subject analysis set title

Group 5:rLP2086(2-,6- Month)+ Saline(0-,1- Month): Safety

Subject analysis set type

Safety analysis

Subject analysis set description

Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.

Subject analysis sets values	Group 1:rLP2086(0 -,1-,6- Month) +Saline(2-Month):Safety	Group 2:rLP2086(0-,2-,6-Month)+Saline(1- Month):Safety	Group 3: rLP2086(0-, 6-Month) +Saline(1-,2-Month):Safety	Group 4:rLP2086(0-,2- Month) +Saline(1-,6-Month):Safety	Group 5:rLP2086(2-,6- Month)+ Saline(0-,1- Month): Safety
Number of subjects	426	414	451	277	144
Age categorical
Some subjects randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One subject was not randomized but received Saline at Injection 1 and was included in Group 5. Subjects have been presented as per actual administration schedule received.
Units: Subjects
11- less than (<) 14 years	155	154	164	101	53
14 - <19 years	271	260	287	176	91
Age continuous
Units:
	( )	( )	( )	( )	( )
Gender categorical
Units: Subjects
Female	212	217	227	135	79
Male	214	197	224	142	65

End points

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Reporting group title

Group 1:rLP2086(0-, 1-, 6-Month) + Saline(2-Month)

Reporting group description

Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.

Reporting group title

Group 2:rLP2086(0-, 2-, 6-Month) +Saline(1-Month)

Reporting group description

Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.

Reporting group title

Group 3:rLP2086(0-, 6-Month) +Saline(1-, 2-Month)

Reporting group description

Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.

Reporting group title

Group 4:rLP2086(0-, 2-Month) + Saline(1-, 6-Month)

Reporting group description

Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.

Reporting group title

Group 5:rLP2086(2-, 6-Month) + Saline(0-, 1-Month)

Reporting group description

Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.

Subject analysis set title

Group 1:rLP2086(0 -,1-,6- Month) +Saline(2-Month):Safety

Subject analysis set type

Safety analysis

Subject analysis set description

Randomized to receive rLP2086 on a 0-, 1-, 6-month and 0.9% normal saline on a 2- month schedule.

Subject analysis set title

Group 2:rLP2086(0-,2-,6-Month)+Saline(1- Month):Safety

Subject analysis set type

Safety analysis

Subject analysis set description

Randomized to receive rLP2086 on a 0-, 2-, 6-month and 0.9% normal saline on a 1- month schedule.

Subject analysis set title

Group 3: rLP2086(0-, 6-Month) +Saline(1-,2-Month):Safety

Subject analysis set type

Safety analysis

Subject analysis set description

Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.

Subject analysis set title

Group 4:rLP2086(0-,2- Month) +Saline(1-,6-Month):Safety

Subject analysis set type

Safety analysis

Subject analysis set description

Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.

Subject analysis set title

Group 5:rLP2086(2-,6- Month)+ Saline(0-,1- Month): Safety

Subject analysis set type

Safety analysis

Subject analysis set description

Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.

Primary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Subjects

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End point title

Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Subjects ^[1] ^[2]

End point description

End point type

Primary

End point timeframe

1 month after Injection 4

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 in the form of attachment.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to be reported for reporting group Group 1: rLP2086(0-, 1-, 6-Month) + Saline(2-Month) and Group 2: rLP2086(0-, 2-, 6-Month) +Saline(1-Month) only.

End point values	Group 1:rLP2086(0-, 1-, 6-Month) + Saline(2-Month)	Group 2:rLP2086(0-, 2-, 6-Month) +Saline(1-Month)
Number of subjects analysed	365	360
Units: percentage of subjects
number (not applicable)
PMB80 [A22] 1:8 (N=360,357)	91.7	95
PMB2001 [A56] 1:8 (N=362, 359)	99.4	98.9
PMB2948 [B24] 1:8 (N=354, 354)	89	88.4
PMB2707 [B44] 1:8 (N=356, 352)	88.5	86.1

Attachments

Statistical Analysis for Primary Endpoint

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting At Least 1 Adverse Event (AE)

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End point title

Percentage of Subjects Reporting At Least 1 Adverse Event (AE) ^[3]

End point description

Some subjects randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One subject was not randomized but received Saline at Injection 1 and was included in Group 5. Subjects have been presented as per actual administration schedule received.

End point type

Primary

End point timeframe

Injection 1 up to 1 month after Injection 4

Notes
[3] - 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	Group 1:rLP2086(0 -,1-,6- Month) +Saline(2-Month):Safety	Group 2:rLP2086(0-,2-,6-Month)+Saline(1- Month):Safety	Group 3: rLP2086(0-, 6-Month) +Saline(1-,2-Month):Safety	Group 4:rLP2086(0-,2- Month) +Saline(1-,6-Month):Safety	Group 5:rLP2086(2-,6- Month)+ Saline(0-,1- Month): Safety
Number of subjects analysed	426	414	451	277	144
Units: percentage of subjects
number (not applicable)	36.9	35.7	35.5	35.7	37.5

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving hSBA Titer >=LLOQ: Group 3 Subjects

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End point title

Percentage of Subjects Achieving hSBA Titer >=LLOQ: Group 3 Subjects ^[4]

End point description

End point type

Secondary

End point timeframe

1 month after Injection 4

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint was planned to be reported for reporting group Group 3:rLP2086(0-, 6-Month) +Saline(1-, 2-Month) only.

End point values	Group 3:rLP2086(0-, 6-Month) +Saline(1-, 2-Month)
Number of subjects analysed	371
Units: percentage of subjects
number (not applicable)
PMB80 [A22] 1:8 (N=369)	93.5
PMB2001 [A56] 1: 8 (N=370)	98.4
PMB2948 [B24] 1:8 (N=359)	81.1
PMB2707 [B44] 1:8 (N=356)	77.5

Attachments

Statistical Analysis for Secondary Endpoint

No statistical analyses for this end point

Secondary: Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)

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End point title

Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)

End point description

End point type

Secondary

End point timeframe

Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4

End point values	Group 1:rLP2086(0-, 1-, 6-Month) + Saline(2-Month)	Group 2:rLP2086(0-, 2-, 6-Month) +Saline(1-Month)	Group 3:rLP2086(0-, 6-Month) +Saline(1-, 2-Month)	Group 4:rLP2086(0-, 2-Month) + Saline(1-, 6-Month)	Group 5:rLP2086(2-, 6-Month) + Saline(0-, 1-Month)
Number of subjects analysed	365	360	371	241	113
Units: Titer
geometric mean (confidence interval 95%)
Before Inj1: PMB80 [A22]; N=356,352,364,235,108	7.1 (6.41 to 7.87)	6.3 (5.72 to 6.95)	6.4 (5.84 to 7.02)	6.4 (5.66 to 7.22)	6.8 (5.59 to 8.3)
1M aft Inj2: PMB80 [A22]; N=351,345,351,224,110	24.4 (21.25 to 27.94)	10.7 (9.44 to 12.09)	12 (10.58 to 13.6)	13.3 (11.21 to 15.76)	7.1 (5.86 to 8.48)
1M aft Inj3: PMB80 [A22]; N=332,344,340,238,102	17.7 (15.28 to 20.47)	32.9 (29.34 to 36.92)	10.3 (9.09 to 11.68)	37.1 (32.23 to 42.76)	16 (12.15 to 21.06)
1M aft Inj4: PMB80 [A22]; N=360,357,369,234,111	55.1 (48.87 to 62.07)	56.3 (50.91 to 62.27)	48.4 (43.45 to 53.86)	14.2 (12.08 to 16.73)	39.6 (32.31 to 48.46)
Before Inj1: PMB2001 [A56]; N=350,348,355,231,107	6.8 (6.06 to 7.64)	6.1 (5.54 to 6.77)	6.7 (6 to 7.48)	6.3 (5.54 to 7.15)	6.2 (5.1 to 7.47)
1M aft Inj2: PMB2001 [A56]; N=353,329,335,218,102	77.3 (68.54 to 87.12)	17 (14.56 to 19.96)	18.5 (15.81 to 21.63)	17.7 (14.45 to 21.58)	6.8 (5.52 to 8.36)
1M aft Inj3: PMB2001 [A56]; N=329,339,320,240,102	48.3 (41.96 to 55.5)	94.6 (84.64 to 105.68)	15.1 (12.89 to 17.74)	104.9 (93.16 to 118.05)	26.8 (19.48 to 36.92)
1M aft Inj4: PMB2001 [A56]; N=362,359,370,228,113	152.9 (137.23 to 170.47)	155.6 (140.39 to 172.38)	125.6 (112.59 to 140.17)	26.5 (22.24 to 31.58)	111.8 (92.73 to 134.9)
Before Inj1: PMB2948 [B24]; N=362,356,369,241,112	5.3 (4.93 to 5.75)	5.1 (4.77 to 5.52)	5 (4.7 to 5.38)	4.9 (4.49 to 5.24)	5.1 (4.51 to 5.82)
1M aft Inj2: PMB2948 [B24]; N=344,345,352,223,110	13.8 (12.15 to 15.57)	8.2 (7.38 to 9.21)	9.2 (8.2 to 10.28)	9.8 (8.39 to 11.35)	5.3 (4.7 to 6.08)
1M aft Inj3: PMB2948 [B24]; N=328,337,340,237,102	11 (9.61 to 12.5)	14.9 (13.2 to 16.73)	7.5 (6.75 to 8.35)	17.7 (15.24 to 20.49)	12.6 (10.01 to 15.89)
1M aft Inj4: PMB2948 [B24]; N=354,354,359,228,110	29.1 (25.88 to 32.66)	25.6 (23.03 to 28.45)	20.6 (18.38 to 23.18)	8 (7.01 to 9.24)	14.7 (12.01 to 18.1)
Before Inj1: PMB2707 [B44]; N=363,357,370,241,113	4.4 (4.18 to 4.54)	4.5 (4.24 to 4.67)	4.5 (4.26 to 4.7)	4.6 (4.28 to 4.9)	4.4 (4.04 to 4.76)
1M aft Inj2: PMB2707 [B44]; N=341,345,349,225,111	13.1 (11.29 to 15.11)	5.5 (5.04 to 6.01)	5.7 (5.19 to 6.3)	5.9 (5.19 to 6.74)	4.4 (4.04 to 4.77)
1M aft Inj3: PMB2707 [B44]; N=333,331,341,234,105	8.4 (7.4 to 9.6)	15.5 (13.51 to 17.87)	5.2 (4.78 to 5.68)	19.1 (16.03 to 22.78)	6.8 (5.45 to 8.55)
1M aft Inj4: PMB2707 [B44]; N=356,352,356,230,111	40.3 (35.16 to 46.11)	35 (30.63 to 39.91)	22.5 (19.6 to 25.72)	6.2 (5.52 to 7.07)	17.8 (14.12 to 22.42)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving hSBA Titer >=LLOQ

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End point title

Percentage of Subjects Achieving hSBA Titer >=LLOQ

End point description

End point type

Secondary

End point timeframe

Before Injection 1, 1 Month after Injection 2, 3, 4

End point values	Group 1:rLP2086(0-, 1-, 6-Month) + Saline(2-Month)	Group 2:rLP2086(0-, 2-, 6-Month) +Saline(1-Month)	Group 3:rLP2086(0-, 6-Month) +Saline(1-, 2-Month)	Group 4:rLP2086(0-, 2-Month) + Saline(1-, 6-Month)	Group 5:rLP2086(2-, 6-Month) + Saline(0-, 1-Month)
Number of subjects analysed	365	360	371	241	113
Units: percentage of subjects
number (not applicable)
Before Inj1: PMB80[A22] 1:8; N=356,352,364,235,108	28.1	21.9	24.7	22.6	25
1M aft Inj2:PMB80[A22]1:8; N=351,345,351,224,110	74.6	46.7	51.3	52.2	28.2
1M aft Inj3:PMB80[A22]1:8; N=332,344,340,238,102	63	88.7	44.7	90.8	55.9
1M aft Inj4:PMB80[A22]1:8; N=360,357,369,234,111	91.7	95	93.5	57.7	91.9
Before Inj1:PMB2001[A56]1:8; N=350,348,355,231,107	20.9	18.7	21.7	19	17.8
1M aft Inj2:PMB2001[A56]1:8; N=353,329,335,218,102	96.6	56.2	58.8	56	22.5
1M aft Inj3;PMB2001[A56]1:8; N=329,339,320,240,102	89.1	97.9	50.6	100	67.6
1M aft Inj4:PMB2001[A56]1:8; N=362,359,370,228,113	99.4	98.9	98.4	76.8	99.1
Before Inj1:PMB2948[B24]1:8; N=362,356,369,241,112	16.3	13.8	13	11.2	14.3
1M aft Inj2:PMB2948[B24]1:8; N=344,345,352,223,110	62.2	39.4	43.8	45.3	18.2
1M aft Inj3:PMB2948[B24]1:8; N=328,337,340,237,102	50.6	70.3	35.6	73	56.9
1M aft Inj4:PMB2948[B24]1:8; N=354,354,359,228,110	89	88.4	81.1	35.5	69.1
Before Inj1:PMB2707[B44]1:8; N=363,357,370,241,113	5.2	6.2	6.2	7.5	4.4
1M aft Inj2:PMB2707[B44]1:8; N=341,345,349,225,111	54	15.7	17.8	18.2	4.5
1M aft Inj3:PMB2707[B44]1:8; N=333,331,341,234,105	35.4	61.9	12.6	70.1	23.8
1M aft Inj4:PMB2707[B44]1:8; N=356,352,356,230,111	88.5	86.1	77.5	23.9	73

No statistical analyses for this end point

Secondary: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

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End point title

Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

End point description

End point type

Secondary

End point timeframe

Before Injection 1, 1 Month after Injection 2, 3, 4

End point values	Group 1:rLP2086(0-, 1-, 6-Month) + Saline(2-Month)	Group 2:rLP2086(0-, 2-, 6-Month) +Saline(1-Month)	Group 3:rLP2086(0-, 6-Month) +Saline(1-, 2-Month)	Group 4:rLP2086(0-, 2-Month) + Saline(1-, 6-Month)	Group 5:rLP2086(2-, 6-Month) + Saline(0-, 1-Month)
Number of subjects analysed	365	360	371	241	113
Units: percentage of subjects
number (not applicable)
Before Inj1:PMB80[A22] 1:4; N=356,352,364,235,108	28.9	23.9	26.4	23.8	25.9
Before Inj1:PMB80[A22] 1:16; N=356,352,364,235,108	27.2	20.5	22.8	22.1	24.1
Before Inj1:PMB80[A22] 1:32; N=356,352,364,235,108	18.3	14.5	13.5	13.2	15.7
Before Inj1:PMB80[A22] 1:64; N=356,352,364,235,108	7.6	6.5	4.7	6.8	7.4
Before Inj1:PMB80[A22]1:128; N=356,352,364,235,108	1.4	2.3	1.6	2.6	1.9
1M aft Inj2:PMB80[A22] 1:4; N=351,345,351,224,110	74.9	47.8	51.3	52.2	29.1
1M aft Inj2:PMB80[A22] 1:16; N=351,345,351,224,110	73.5	45.8	50.7	51.8	27.3
1M aft Inj2:PMB80[A22] 1:32; N=351,345,351,224,110	58.4	28.7	34.5	37.9	18.2
1M aft Inj2:PMB80[A22] 1:64; N=351,345,351,224,110	30.8	14.5	14.5	19.6	6.4
1M aft Inj2:PMB80[A22]1:128; N=351,345,351,224,110	14.8	5.2	5.7	8.5	0.9
1M aft Inj3:PMB80[A22] 1:4; N=332,344,340,238,102	63.6	88.7	45.6	90.8	55.9
1M aft Inj3:PMB80[A22]1:16; N=332,344,340,238,102	62.3	88.1	42.4	90.8	55.9
1M aft Inj3:PMB80[A22]1:32; N=332,344,340,238,102	47.3	69.5	30.6	70.6	45.1
1M aft Inj3:PMB80[A22]1:64; N=332,344,340,238,102	22.3	35.8	12.4	39.1	22.5
1M aft Inj3:PMB80[A22]1:128; N=332,344,340,238,102	11.7	14.8	4.4	19.7	14.7
1M aft Inj4:PMB80[A22] 1:4; N=360,357,369,234,111	91.9	95	94	58.1	91.9
1M aft Inj4:PMB80[A22] 1:16; N=360,357,369,234,111	91.4	95	93.2	56	91
1M aft Inj4:PMB80[A22] 1:32; N=360,357,369,234,111	84.2	86.6	81.8	38	74.8
1M aft Inj4:PMB80[A22] 1:64;N=360,357,369,234,111	61.9	63.9	53.9	19.2	42.3
1M aft Inj4:PMB80[A22]1:128; N=360,357,369,234,111	31.7	32.5	25.7	8.5	20.7
Before Inj1:PMB2001[A56] 1:4;N=350,348,355,231,107	25.1	22.1	25.1	25.5	25.2
Before Inj1:PMB2001[A56]1:16;N=350,348,355,231,107	20	18.1	20.3	19	16.8
Before Inj1:PMB2001[A56]1:32;N=350,348,355,231,107	18	14.1	17.2	15.6	15.9
Before Inj1:PMB2001[A56]1:64;N=350,348,355,231,107	11.7	7.5	10.7	8.7	8.4
Before Inj1: PMB2001 1:128;N=350,348,355,231,107	4.3	2.3	3.7	2.6	2.8
1M aft Inj2:PMB2001[A56] 1:4;N=353,329,335,218,102	96.6	61.4	63.3	60.1	25.5
1M aft Inj2:PMB2001[A56]1:16;N=353,329,335,218,102	96.3	55	57.9	55.5	21.6
1M aft Inj2:PMB2001[A56]1:32;N=353,329,335,218,102	87.8	48	50.1	47.2	17.6
1M aft Inj2:PMB2001[A56]1:64;N=353,329,335,218,102	72.8	27.4	31	29.8	10.8
1M aft Inj2:PMB2001 1:128;N=353,329,335,218,102	41.1	14.3	14.9	15.6	2.9
1M aft Inj3:PMB2001[A56] 1:4;N=329,339,320,240,102	91.5	98.5	54.4	100	72.5
1M aft Inj3:PMB2001[A56]1:16;N=329,339,320,240,102	87.8	97.9	50	99.2	65.7
1M aft Inj3:PMB2001[A56]1:32;N=329,339,320,240,102	79.9	94.1	43.8	95	55.9
1M aft Inj3:PMB2001[A56]1:64;N=329,339,320,240,102	52.9	79.1	28.4	81.7	39.2
1M aft Inj3:PMB2001 1:128;N=329,339,320,240,102	26.7	50.4	13.1	57.1	22.5
1M aft Inj4:PMB2001[A56] 1:4;N=362,359,370,228,113	99.7	99.2	98.9	79.8	99.1
1M aft Inj4:PMB2001[A56]1:16;N=362,359,370,228,113	99.2	98.9	98.4	74.6	99.1
1M aft Inj4:PMB2001[A56]1:32;N=362,359,370,228,113	95.3	96.1	94.6	59.6	92.9
1M aft Inj4:PMB2001[A56]1:64;N=362,359,370,228,113	87.8	91.1	83.8	34.2	85
1M aft Inj4:PMB2001 1:128;N=362,359,370,228,113	72.4	73.5	65.9	15.8	60.2
Before Inj1:PMB2948[B24]1:4;N=362,356,369,241,112	18.5	15.4	14.4	13.3	16.1
Before Inj1:PMB2948[B24]1:16;N=362,356,369,241,112	12.7	11.5	10.8	8.7	12.5
Before Inj1:PMB2948[B24]1:32;N=362,356,369,241,112	7.2	6.2	6	5	4.5
Before Inj1:PMB2948[B24]1:64;N=362,356,369,241,112	2.8	3.1	2.2	2.1	2.7
Before Inj1:PMB2948 1:128;N=362,356,369,241,112	1.4	0.8	0.5	0.8	1.8
1M aft Inj2:PMB2948[B24]1:4;N=344,345,352,223,110	66.3	42.3	45.7	47.1	20
1M aft Inj2:PMB2948[B24]1:16;N=344,345,352,223,110	57.6	32.8	39.5	40.4	14.5
1M aft Inj2:PMB2948[B24]1:32;N=344,345,352,223,110	34.9	18.6	23.3	24.7	5.5
1M aft Inj2:PMB2948[B24]1:64;N=344,345,352,223,110	14	9	8.8	11.7	3.6
1M aft Inj2:PMB2948 1:128;N=344,345,352,223,110	6.1	3.5	2.6	4.5	0
1M aft Inj3:PMB2948[B24]1:4;N=328,337,340,237,102	52.1	72.1	37.6	75.5	57.8
1M aft Inj3:PMB2948[B24]1:16;N=328,337,340,237,102	45.1	63.5	29.7	67.1	52.9
1M aft Inj3:PMB2948[B24]1:32;N=328,337,340,237,102	23.8	32	15.9	43.5	32.4
1M aft Inj3:PMB2948[B24]1:64;N=328,337,340,237,102	15.5	13.6	5	19.4	15.7
1M aft Inj3:PMB2948 1:128;N=328,337,340,237,102	6.7	6.5	2.6	8.4	6.9
1M aft Inj4:PMB2948[B24]1:4;N=354,354,359,228,110	90.1	90.1	83	38.2	70.9
1M aft Inj4:PMB2948[B24]1:16;N=354,354,359,228,110	82.8	83.6	73.8	32.9	64.5
1M aft Inj4:PMB2948[B24]1:32;N=354,354,359,228,110	60.7	56.2	47.1	18	33.6
1M aft Inj4:PMB2948[B24]1:64;N=354,354,359,228,110	33.3	26.6	22.6	10.5	12.7
1M aft Inj4:PMB2948 1:128;N=354,354,359,228,110	13	10.5	7.2	3.1	6.4
Before Inj1:PMB2707[B44]1:4;N=363,357,370,241,113	7.7	7.8	7.8	8.3	7.1
Before Inj1:PMB2707[B44]1:16;N=363,357,370,241,113	3.6	5	4.9	6.6	4.4
Before Inj1:PMB2707[B44]1:32;N=363,357,370,241,113	3	2.5	3.5	2.9	3.5
Before Inj1:PMB2707[B44]1:64;N=363,357,370,241,113	0.6	1.4	1.4	1.2	0.9
Before Inj1:PMB2707 1:128;N=363,357,370,241,113	0	0.3	0.3	0.8	0
1M aftInj2:PMB2707[B44]1:4;N=341,345,349,225,111	57.5	17.7	20.6	20.4	5.4
1M aft Inj2:PMB2707[B44]1:16;N=341,345,349,225,111	47.2	13.6	14	14.2	4.5
1M aft Inj2:PMB2707[B44]1:32;N=341,345,349,225,111	32	9.9	8.3	9.8	3.6
1M aft Inj2:PMB2707[B44]1:64;N=341,345,349,225,111	18.8	4.1	5.2	6.2	0.9
1M aft Inj2:PMB2707 1:128;N=341,345,349,225,111	10	1.7	3.7	4	0
1M aft Inj3:PMB2707[B44]1:4;N=333,331,341,234,105	39	65.9	15.5	73.5	28.6
1M aft Inj3:PMB2707[B44]1:16;N=333,331,341,234,105	30.3	58.6	10.9	64.5	21
1M aft Inj3:PMB2707[B44]1:32;N=333,331,341,234,105	18.6	39	5.9	42.3	13.3
1M aft Inj3:PMB2707[B44]1:64;N=333,331,341,234,105	11.4	22.7	3.8	24.4	7.6
1M aft Inj3:PMB2707 1:128;N=333,331,341,234,105	6.3	7.9	2.6	14.1	3.8
1M aft Inj4:PMB2707[B44]1:4;N=356,352,356,230,111	89.3	87.8	78.9	26.1	73
1M aft Inj4:PMB2707[B44]1:16;N=356,352,356,230,111	84.8	83.8	70.8	19.1	66.7
1M aft Inj4:PMB2707[B44]1:32;N=356,352,356,230,111	68.5	65.3	49.2	10	39.6
1M aft Inj4:PMB2707[B44]1:64;N=356,352,356,230,111	46.6	42.3	27.8	5.2	20.7
1M aft Inj4:PMB2707 1:128;N=356,352,356,230,111	27.5	22.7	13.8	3.9	9

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Achieving At Least 4-fold Increase in hSBA Titer

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End point title

Percentage of Subjects Achieving At Least 4-fold Increase in hSBA Titer

End point description

Results were not reported because a decision was made a priori to remove the endpoint as a secondary outcome measure.

End point type

Other pre-specified

End point timeframe

1 month after Injection 2, 3, 4

End point values	Group 1:rLP2086(0-, 1-, 6-Month) + Saline(2-Month)	Group 2:rLP2086(0-, 2-, 6-Month) +Saline(1-Month)	Group 3:rLP2086(0-, 6-Month) +Saline(1-, 2-Month)	Group 4:rLP2086(0-, 2-Month) + Saline(1-, 6-Month)	Group 5:rLP2086(2-, 6-Month) + Saline(0-, 1-Month)
Number of subjects analysed	0 ^[5]	0 ^[6]	0 ^[7]	0 ^[8]	0 ^[9]
Units: percentage of subjects
number (not applicable)

Notes
[5] - Results not reported because the endpoint was removed as a secondary endpoint.
[6] - Results not reported because the endpoint was removed as a secondary endpoint.
[7] - Results not reported because the endpoint was removed as a secondary endpoint.
[8] - Results not reported because the endpoint was removed as a secondary endpoint.
[9] - Results not reported because the endpoint was removed as a secondary endpoint.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

AE reported from Injection 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline). SAE reported from Injection 1 to 6 months after last of investigational product (bivalent rLP2086/saline)

Adverse event reporting additional description

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

15.1

Reporting group title

Group 1:rLP2086(0-,1-,6- Month)+Saline(2-Month)

Reporting group description

Randomized to receive rLP2086 and 0.9% normal saline.

Reporting group title

Group 2:rLP2086(0 -,2-,6-Month) +Saline(1-Month)

Reporting group description

Randomized to receive rLP2086 and 0.9% normal saline.

Reporting group title

Group 3: rLP2086(0- ,6-Month) +Saline(1-,2-Month)

Reporting group description

Randomized to receive rLP2086 and 0.9% normal saline.

Reporting group title

Group 4: rLP2086(0-,2-Month) +Saline(1-,6 - Month)

Reporting group description

Randomized to receive rLP2086 and 0.9% normal saline.

Reporting group title

Group 5: rLP2086(2- ,6-Month)+ Saline(0-, 1-Month)

Reporting group description

Randomized to receive rLP2086 and 0.9% normal saline.

Serious adverse events	Group 1:rLP2086(0-,1-,6- Month)+Saline(2-Month)	Group 2:rLP2086(0 -,2-,6-Month) +Saline(1-Month)	Group 3: rLP2086(0- ,6-Month) +Saline(1-,2-Month)	Group 4: rLP2086(0-,2-Month) +Saline(1-,6 - Month)	Group 5: rLP2086(2- ,6-Month)+ Saline(0-, 1-Month)
Total subjects affected by serious adverse events
subjects affected / exposed	12 / 426 (2.82%)	14 / 414 (3.38%)	7 / 451 (1.55%)	7 / 277 (2.53%)	3 / 144 (2.08%)
number of deaths (all causes)	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
General disorders and administration site conditions
Chills
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Hypersensitivity
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	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
Reproductive system and breast disorders
Ovarian cyst
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	1 / 451 (0.22%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Respiratory, thoracic and mediastinal disorders
Allergic cough
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Injury, poisoning and procedural complications
Concussion
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	1 / 451 (0.22%)	1 / 277 (0.36%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	1 / 451 (0.22%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bone contusion
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	0 / 451 (0.00%)	1 / 277 (0.36%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Clavicle fracture
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	0 / 451 (0.00%)	1 / 277 (0.36%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Femur fracture
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Foreign body
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Hand fracture
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	0 / 451 (0.00%)	1 / 277 (0.36%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Head injury
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Lower limb fracture
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	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
Near drowning
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	1 / 451 (0.22%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Poisoning
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Radius fracture
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Skeletal injury
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	1 / 144 (0.69%)
occurrences causally related to treatment / all	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
Nervous system disorders
Headache
subjects affected / exposed	0 / 426 (0.00%)	2 / 414 (0.48%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Migraine
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	1 / 451 (0.22%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Aphthous stomatitis
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Constipation
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Crohn's disease
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Gastritis
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Vomiting
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hyperbilirubinaemia
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	1 / 451 (0.22%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Skin and subcutaneous tissue disorders
Dermatitis contact
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Urticaria
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	0 / 451 (0.00%)	1 / 277 (0.36%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 426 (0.00%)	2 / 414 (0.48%)	1 / 451 (0.22%)	1 / 277 (0.36%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	2 / 426 (0.47%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acute sinusitis
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	0 / 451 (0.00%)	1 / 277 (0.36%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Infectious mononucleosis
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	0 / 451 (0.00%)	1 / 277 (0.36%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Localised infection
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Tonsillitis streptococcal
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Urethritis
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	1 / 451 (0.22%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Urinary tract infection
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	1 / 451 (0.22%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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
Type 2 diabetes mellitus
subjects affected / exposed	0 / 426 (0.00%)	0 / 414 (0.00%)	1 / 451 (0.22%)	0 / 277 (0.00%)	0 / 144 (0.00%)
occurrences causally related to treatment / all	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

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	Group 1:rLP2086(0-,1-,6- Month)+Saline(2-Month)	Group 2:rLP2086(0 -,2-,6-Month) +Saline(1-Month)	Group 3: rLP2086(0- ,6-Month) +Saline(1-,2-Month)	Group 4: rLP2086(0-,2-Month) +Saline(1-,6 - Month)	Group 5: rLP2086(2- ,6-Month)+ Saline(0-, 1-Month)
Total subjects affected by non serious adverse events
subjects affected / exposed	113 / 426 (26.53%)	115 / 414 (27.78%)	114 / 451 (25.28%)	72 / 277 (25.99%)	43 / 144 (29.86%)
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	2 / 426 (0.47%)	10 / 414 (2.42%)	3 / 451 (0.67%)	5 / 277 (1.81%)	0 / 144 (0.00%)
occurrences all number	2	11	3	6	0
Fall
subjects affected / exposed	1 / 426 (0.23%)	2 / 414 (0.48%)	4 / 451 (0.89%)	1 / 277 (0.36%)	2 / 144 (1.39%)
occurrences all number	1	2	4	1	2
Foot fracture
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	0 / 451 (0.00%)	1 / 277 (0.36%)	2 / 144 (1.39%)
occurrences all number	1	0	0	1	2
Nervous system disorders
Headache
subjects affected / exposed	13 / 426 (3.05%)	12 / 414 (2.90%)	11 / 451 (2.44%)	6 / 277 (2.17%)	6 / 144 (4.17%)
occurrences all number	13	13	11	7	6
General disorders and administration site conditions
Injection site pain
subjects affected / exposed	6 / 426 (1.41%)	4 / 414 (0.97%)	3 / 451 (0.67%)	6 / 277 (2.17%)	1 / 144 (0.69%)
occurrences all number	6	4	3	6	1
Pyrexia
subjects affected / exposed	7 / 426 (1.64%)	3 / 414 (0.72%)	4 / 451 (0.89%)	3 / 277 (1.08%)	3 / 144 (2.08%)
occurrences all number	7	3	4	3	3
Fatigue
subjects affected / exposed	5 / 426 (1.17%)	5 / 414 (1.21%)	1 / 451 (0.22%)	2 / 277 (0.72%)	2 / 144 (1.39%)
occurrences all number	5	5	1	2	2
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	2 / 451 (0.44%)	0 / 277 (0.00%)	2 / 144 (1.39%)
occurrences all number	1	0	2	0	2
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed	0 / 426 (0.00%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	1	0	0	2
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	4 / 426 (0.94%)	7 / 414 (1.69%)	2 / 451 (0.44%)	1 / 277 (0.36%)	2 / 144 (1.39%)
occurrences all number	5	7	2	1	2
Infections and infestations
Nasopharyngitis
subjects affected / exposed	43 / 426 (10.09%)	32 / 414 (7.73%)	25 / 451 (5.54%)	21 / 277 (7.58%)	8 / 144 (5.56%)
occurrences all number	56	33	31	27	10
Pharyngitis
subjects affected / exposed	20 / 426 (4.69%)	21 / 414 (5.07%)	20 / 451 (4.43%)	14 / 277 (5.05%)	7 / 144 (4.86%)
occurrences all number	20	23	26	15	8
Upper respiratory tract infection
subjects affected / exposed	9 / 426 (2.11%)	14 / 414 (3.38%)	12 / 451 (2.66%)	6 / 277 (2.17%)	3 / 144 (2.08%)
occurrences all number	9	15	13	6	3
Gastroenteritis
subjects affected / exposed	10 / 426 (2.35%)	10 / 414 (2.42%)	14 / 451 (3.10%)	6 / 277 (2.17%)	3 / 144 (2.08%)
occurrences all number	10	12	14	6	3
Tonsillitis
subjects affected / exposed	10 / 426 (2.35%)	11 / 414 (2.66%)	9 / 451 (2.00%)	8 / 277 (2.89%)	2 / 144 (1.39%)
occurrences all number	13	12	9	8	2
Sinusitis
subjects affected / exposed	7 / 426 (1.64%)	6 / 414 (1.45%)	7 / 451 (1.55%)	2 / 277 (0.72%)	3 / 144 (2.08%)
occurrences all number	7	6	8	2	5
Bronchitis
subjects affected / exposed	4 / 426 (0.94%)	5 / 414 (1.21%)	9 / 451 (2.00%)	0 / 277 (0.00%)	2 / 144 (1.39%)
occurrences all number	4	5	9	0	2
Urinary tract infection
subjects affected / exposed	5 / 426 (1.17%)	4 / 414 (0.97%)	4 / 451 (0.89%)	2 / 277 (0.72%)	1 / 144 (0.69%)
occurrences all number	5	4	4	2	1
Rhinitis
subjects affected / exposed	3 / 426 (0.70%)	4 / 414 (0.97%)	3 / 451 (0.67%)	3 / 277 (1.08%)	2 / 144 (1.39%)
occurrences all number	3	4	3	4	3
Otitis media
subjects affected / exposed	0 / 426 (0.00%)	3 / 414 (0.72%)	4 / 451 (0.89%)	0 / 277 (0.00%)	2 / 144 (1.39%)
occurrences all number	0	3	5	0	2
Acute tonsillitis
subjects affected / exposed	0 / 426 (0.00%)	4 / 414 (0.97%)	1 / 451 (0.22%)	3 / 277 (1.08%)	0 / 144 (0.00%)
occurrences all number	0	4	1	4	0
Tracheitis
subjects affected / exposed	1 / 426 (0.23%)	0 / 414 (0.00%)	5 / 451 (1.11%)	0 / 277 (0.00%)	2 / 144 (1.39%)
occurrences all number	1	0	5	0	2
Gastroenteritis viral
subjects affected / exposed	2 / 426 (0.47%)	1 / 414 (0.24%)	0 / 451 (0.00%)	0 / 277 (0.00%)	2 / 144 (1.39%)
occurrences all number	2	1	0	0	2

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Were there any global substantial amendments to the protocol? Yes

19 Oct 2010

1- The study design was changed, with vaccinations given at 0, 1, 2, and 6 months; previously vaccinations were designated to be given at 0, 2, 6, and 12 months. 2-The primary objective became 2 coprimary objectives. 3- Endpoints have been updated to reflect objectives. 4- Inclusion/ exclusion have also been updated. 5- Safety section became the current sponsor template text. 6- Statistics section updated to reflect the changes in objectives and endpoints. 7- Biological sample wording had been clarified. 8- Protocol text was updated to match the current template. 8- Protocol text was updated to match the current template.

15 Jul 2011

1-Visit windows for Visits 2, 3, and 5 at month 1, month 2 and month 5 updated to 28-132 days, 56-160 days and 105-156 days to allow subjects to continue in the study following the delay of study immunizations due to the study pause. 2- Duration of subject participation updated to 17 months and duration of study updated to 20 months. 3- Clinical experience has been updated. 4- Exclusion criteria added to exclude family members of study site and sponsor personnel. 5- Unscheduled telephone contact was added.

23 Apr 2012

Protocol text was amended to address following changes in safety reporting: 1- Revision of section on ongoing safety reviews performed. 2- Text had been amended to address changes in safety reporting exposure during pregnancy. 3- Medication errors language was updated to align with sponsor SOP. 4- Adverse Event Reporting section was updated due to alignment with sponsor SOP guidance and US FDA Final Rule. 5- Active reporting period and necessity to report all SAEs post- active reporting period clarifying language was added to align with sponsor SOP and Final Rule. Vaccine study reporting period language was also added. 6- Definition of AE was updated to align under sponsor SOP guidance, including addition of medication error. 7- Clarification was added regarding persistent or significant disability/incapacity in serious adverse events section to align under Final Rule definition 8- Medical device reporting criteria was clarified to align with EU and US legislation. 9- Causality Assessment section was updated to align with sponsor SOP guidance. 10- Minor administrative corrections were done.

24 Apr 2012

1- Immunogenicity exploratory objective and endpoints were added to be consistent with Phase 2/3 program. 2- Safety endpoints were updated to be consistent with Phase 3 program. 3- A clarification was added regarding exploratory analysis which was already performed. 4- Language was inserted to confirm sera drawn without prior vaccination which was not be assayed or analyzed.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
01 Jul 2011	Injections were temporarily paused during investigation of a suspected unexpected serious adverse reaction (SUSAR). A comprehensive review of the case was performed by Pfizer’s risk management committee (RMC), which recommended resumption of study immunization. The external data monitoring committee (EDMC) reviewed the case and agreed with the recommendation of the RMC that vaccinations were safe to resume without change to the benefit-risk profile. Subsequently, a decision was made to resume study immunizations.	01 Nov 2011

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 Trial Results:
A Phase 2, Randomized, Placebo-Controlled, Single-blind Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Administered in Either 2- or 3-Dose Regimens in Healthy Subjects Aged ≥ 11 to <19 Years

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Trial information

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Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Subjects

Primary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Subjects

Primary: Percentage of Subjects Reporting At Least 1 Adverse Event (AE)

Primary: Percentage of Subjects Reporting At Least 1 Adverse Event (AE)

Secondary: Percentage of Subjects Achieving hSBA Titer >=LLOQ: Group 3 Subjects

Secondary: Percentage of Subjects Achieving hSBA Titer >=LLOQ: Group 3 Subjects

Secondary: Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)

Secondary: Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)

Secondary: Percentage of Subjects Achieving hSBA Titer >=LLOQ

Secondary: Percentage of Subjects Achieving hSBA Titer >=LLOQ

Secondary: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

Secondary: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

Other pre-specified: Percentage of Subjects Achieving At Least 4-fold Increase in hSBA Titer

Other pre-specified: Percentage of Subjects Achieving At Least 4-fold Increase in hSBA Titer

Adverse events

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Substantial protocol amendments (globally)

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Clinical trials

Clinical Trial Results: A Phase 2, Randomized, Placebo-Controlled, Single-blind Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Administered in Either 2- or 3-Dose Regimens in Healthy Subjects Aged ≥ 11 to <19 Years

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Subjects

Primary: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Subjects

Primary: Percentage of Subjects Reporting At Least 1 Adverse Event (AE)

Primary: Percentage of Subjects Reporting At Least 1 Adverse Event (AE)

Secondary: Percentage of Subjects Achieving hSBA Titer >=LLOQ: Group 3 Subjects

Secondary: Percentage of Subjects Achieving hSBA Titer >=LLOQ: Group 3 Subjects

Secondary: Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)

Secondary: Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)

Secondary: Percentage of Subjects Achieving hSBA Titer >=LLOQ

Secondary: Percentage of Subjects Achieving hSBA Titer >=LLOQ

Secondary: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

Secondary: Percentage of Subjects With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

Other pre-specified: Percentage of Subjects Achieving At Least 4-fold Increase in hSBA Titer

Other pre-specified: Percentage of Subjects Achieving At Least 4-fold Increase in hSBA Titer

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2, Randomized, Placebo-Controlled, Single-blind Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Administered in Either 2- or 3-Dose Regimens in Healthy Subjects Aged ≥ 11 to <19 Years