A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01352793
• Collaborator: (none)
• Enrollment: 5,715
• Locations: 86
• Arms: 2
• Duration (Months): 22
• Patients Per Site: 66.5
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

Condition or Disease	Intervention/Treatment	Phase
Meningitis, Meningococcal	Biological: rLP2086 vaccine; Biological: control	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 5715 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rLP2086 vaccine rLP2086 vaccine	Biological: rLP2086 vaccine; 120 mcg, 3 doses, at month 0, 2, and 6.
Other: control The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.	Biological: control; HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study [Vaccination 1 up to 6 months after Vaccination 3]

   An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.

2. Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 [Within 30 days after Vaccination 1]

   A medically attended AE was defined as a non-serious AE that required medical attention.

3. Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 [Within 30 days after Vaccination 2]

   A medically attended AE was defined as a non-serious AE that required medical attention.

4. Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 [Within 30 days after Vaccination 3]

   A medically attended AE was defined as a non-serious AE that required medical attention.

Secondary Outcome Measures

1. Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods [Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)]

   An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

2. Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods [Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)]

   A medically attended AE was defined as a non-serious AE that required medical attention.

3. Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods [Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)]

   A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

4. Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods [Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)]

   An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

5. Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination [Within 30 minutes after Vaccination 1, 2, 3]

   An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

6. Number of Days Participant Missed School or Work Due to Adverse Events (AEs) [Vaccination 1 up to 1 month after Vaccination 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy subjects aged 10 to 25 years.

Exclusion Criteria:

• Previous vaccination with Hepatitis A virus vaccine

• Previous vaccination with investigational meningococcal B vaccine

• History of culture-proven N. meningitidis serogroup B disease

• Any neuroinflammatory or autoimmune condition

• Any immune defect that would prevent an effective response to the study vaccine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Accelovance,Inc.	Huntsville	Alabama	United States	35802
2	Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC	Chandler	Arizona	United States	85224
3	Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC	Chandler	Arizona	United States	85224
4	Cassidy Medical Group/Clinical Research Advantage	Tempe	Arizona	United States	85282
5	Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC	Tempe	Arizona	United States	85282
6	Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address	Tempe	Arizona	United States	85282
7	Harrisburg Family Medical Center	Harrisburg	Arkansas	United States	72432
8	Accelovance. Inc	San Diego	California	United States	92108
9	Benchmark Research	San Francisco	California	United States	94102
10	Cassidy Medical Group/Clinical Research Advantage	Vista	California	United States	92083
11	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
12	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
13	Optimal Research, LLC	Melbourne	Florida	United States	32934
14	Accelovance	Melbourne	Florida	United States	32935
15	Miami Research Associates	South Miami	Florida	United States	33143
16	Accelovance,Inc.	Mishawaka	Indiana	United States	46545
17	Clinical Research Advantage,Inc/Ridge Family Practice	Council Bluffs	Iowa	United States	51503
18	Kentucky Pediatric/Adult Research	Bardstown	Kentucky	United States	40004
19	Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP	Fremont	Nebraska	United States	68025
20	Prairie Fields Family Medicine/Clinical Research Advantage	Fremont	Nebraska	United States	68025
21	Rochester Clinical Research, Inc.	Rochester	New York	United States	14609
22	Rapid Medical Research. Inc.	Cleveland	Ohio	United States	44122
23	Ohio Pediatric Research Association	Dayton	Ohio	United States	45414
24	Coastal Carolina Research Center	Mt. Pleasant	South Carolina	United States	29464
25	PMG Research of Bristol	Bristol	Tennessee	United States	37620
26	Benchmark Research	Austin	Texas	United States	78705
27	Tekton Research	Austin	Texas	United States	78745
28	Research Across America	Dallas	Texas	United States	75234
29	Benchmark Research	Fort Worth	Texas	United States	76135
30	West Houston Clinical Research Service	Houston	Texas	United States	77055
31	Research Across America	Katy	Texas	United States	77450
32	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
33	J. Lewis Research, Inc. - Foothill Family Clinic	Salt Lake City	Utah	United States	84109
34	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah	United States	84121
35	Jean Brown Research	Salt Lake City	Utah	United States	84124
36	J. Lewis Research, Inc. - Jordan River Family Medicine	South Jordan	Utah	United States	84095
37	Advanced Clinical Research	West Jordan	Utah	United States	84088
38	PI-Coor Clinical Research, LLC	Burke	Virginia	United States	22015
39	Pediatric Research of Charlottesville	Charlottesville	Virginia	United States	22902
40	Australian Clinical Research Network	Maroubra	New South Wales	Australia	2035
41	The Children's Hospital at Westmead	Westmead	New South Wales	Australia	2145
42	AusTrials Pty Ltd	Sherwood	Queensland	Australia	4075
43	Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics	North Adelaide	South Australia	Australia	5006
44	Telethon Institute for Child Health Research	Subiaco		Australia	6008
45	Centro De Investigacion Clinica Del Sur	Temuco	Araucania	Chile	4781156
46	Hospital Clinico de la Pontificia Universidad Catolica de Chile/	Santiago	Region Metropolitana	Chile	8330034
47	Centro de Estudios de Vacunas, CESFAM Gabriela Mistral	Santiago	Region Metropolitana	Chile	886000
48	Cesfam Dr. Jose Symon Ojeda	Conchali	Santiago	Chile	8550442
49	Hospital Luis Calvo Mackenna	Santiago		Chile	7500539
50	Ordinace praktickeho lekare pro deti a dorost	Jindrichuv Hradec		Czech Republic	377 01
51	Samostatna ordinace praktickeho lekare pro deti a dorost	Jindrichuv Hradec		Czech Republic	377 01
52	Samostatna ordinace praktickeho lekare pro deti a dorost	Jindrichuv Hradec		Czech Republic	37701
53	Ordinace praktickeho lekare pro deti a dorost	Plzen		Czech Republic	30138
54	Ordinace praktickeho lekare pro deti a dorost	Praha 2		Czech Republic	120 00
55	Prakticky Lekar Pro Deti a Mladez	Tynec nad Sazavou		Czech Republic	257 41
56	Aarhus Universitetshospital, Skejby	Aarhus N		Denmark	8200
57	Eraarst Kersti Veidrik Ou	Rakvere		Estonia	44316
58	Innomedica OU	Tallinn		Estonia	10117
59	Merekivi Perearstid OU	Tallinn		Estonia	10617
60	Merelahe Family Doctors Centre	Tallinn		Estonia	10617
61	Pori Vaccine Research Clinic	Pori		Finland	28100
62	Tampere Vaccine Research Clinic	Tampere		Finland	33100
63	Turku Vaccine Research Clinic	Turku		Finland	20520
64	Clinical Trial Center North	Hamburg		Germany	20246
65	Clinical Trial Center North GmbH & Co.KG	Hamburg		Germany	20251
66	Bernhard Nocht Centre for Clinical Trials (BNCCT)	Hamburg		Germany	20359
67	Juliusspital Wuerzburg	Wuerzburg		Germany	97070
68	JSC "InMedica"	Kaunas		Lithuania	48259
69	Saules Family Medicine Centre	Kaunas		Lithuania	LT-49449
70	Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases	Kaunas		Lithuania	LT47116
71	LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE	Kaunas		Lithuania	LT50009
72	Centro poliklinika, Public Institution	Vilnius		Lithuania	LT01117
73	Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek	Debica		Poland	39-200
74	Krakowski Szpital Specjalistyczny im Jana Pawla II	Krakow		Poland	31-202
75	Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska	Krakow		Poland	31-302
76	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny	Lubartow		Poland	21-100
77	NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak	Oborniki Slaskie		Poland	55-120
78	Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu	Poznan		Poland	61-709
79	NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska	Siemianowice Slaskie		Poland	41-103
80	NZOZ Nasz Lekarz	Torun		Poland	87-100
81	Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny	Trzebnica		Poland	55-100
82	Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu	Wroclaw		Poland	50-345
83	Instituto Hispalense de Pediatria	Sevilla		Spain	41014
84	Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir	Valencia		Spain	46001
85	Vaccinenheten Barn- och ungdomsmedicinska kliniken	Malmo	SE	Sweden	205 02
86	Norrlands Universitetssjukhus, Institution för Pediatrik	Umeå		Sweden	90185

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01352793
• Other Study ID Numbers: B1971014; 2009-015198-11; 6108A1-3003
• First Posted: May 12, 2011
• Last Update Posted: Mar 11, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Pfizer: phase 3 safety study; 5700 healthy subjects; 3 vaccine doses at month 0; 2; and 6; control HAV/saline/HAV
• Additional relevant MeSH terms: Meningitis, Meningococcal; Meningitis

Study Results

Participant Flow

Pre-assignment Detail	A total of 5712 participants in 12 countries were enrolled in this study. Of these, 8 participants were randomized but did not receive study vaccination.

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Period Title: Overall Study
STARTED	3804	1908
Vaccination 1	3796	1908
Vaccination 2	3530	1806
Vaccination 3	3314	1710
COMPLETED	3219	1663
NOT COMPLETED	585	245

Baseline Characteristics

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV	Total
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month	Total of all reporting groups
Overall Participants	3804	1908	5712
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	17.4 (4.6)	17.4 (4.6)	17.4 (4.6)
Sex: Female, Male (Count of Participants)
Female	1962 51.6%	994 52.1%	2956 51.8%
Male	1842 48.4%	914 47.9%	2756 48.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study
Description	An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Time Frame	Vaccination 1 up to 6 months after Vaccination 3

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Measure Participants	3796	1908
Number (95% Confidence Interval) [percentage of participants]	1.55 0%	2.52 0.1%

2. Primary Outcome

Title	Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
Description	A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame	Within 30 days after Vaccination 1

Outcome Measure Data

Analysis Population Description

Vaccination 1 safety population included all participants who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2.

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Measure Participants	3796	1908
Number (95% Confidence Interval) [percentage of participants]	7.03 0.2%	6.13 0.3%

3. Primary Outcome

Title	Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
Description	A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame	Within 30 days after Vaccination 2

Outcome Measure Data

Analysis Population Description

Vaccination 2 safety population included all participants who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3.

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Measure Participants	3529	1806
Number (95% Confidence Interval) [percentage of participants]	5.50 0.1%	6.09 0.3%

4. Primary Outcome

Title	Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3
Description	A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame	Within 30 days after Vaccination 3

Outcome Measure Data

Analysis Population Description

Vaccination 3 safety population included all participants who received the third dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available from Vaccination 3 to post Vaccination 3 follow-up visit (1 month after Vaccination 3).

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Measure Participants	3313	1710
Number (95% Confidence Interval) [percentage of participants]	5.34 0.1%	5.50 0.3%

5. Secondary Outcome

Title	Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
Description	An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time Frame	Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Measure Participants	3796	1908
30 days after Vaccination 1 (N=3796, 1908)	0.18 0%	0.42 0%
30 days after Vaccination 2 (N=3529, 1806)	0.17 0%	0.44 0%
30 days after Vaccination 3 (N=3313, 1710)	0.33 0%	0.12 0%
30 days after any vaccination (N=3796, 1908)	0.61 0%	0.94 0%
Vaccination phase (N=3796, 1908)	1.16 0%	1.83 0.1%
Follow-up phase (N=3400, 1733)	0.44 0%	0.87 0%

6. Secondary Outcome

Title	Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
Description	A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame	Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Measure Participants	3796	1908
30 days after any vaccination (N=3796, 1908)	14.38 0.4%	14.57 0.8%
Vaccination phase (N=3796, 1908)	24.60 0.6%	24.53 1.3%
Follow-up phase (N=3400, 1733)	11.24 0.3%	11.43 0.6%
Throughout study (N=3796, 1908)	29.00 0.8%	29.04 1.5%

7. Secondary Outcome

Title	Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
Description	A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time Frame	Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Measure Participants	3796	1908
30 days after Vaccination 1 (N=3796, 1908)	0.21 0%	0.10 0%
30 days after Vaccination 2 (N=3529, 1806)	0.17 0%	0.33 0%
30 days after Vaccination 3 (N=3313, 1710)	0.09 0%	0.12 0%
30 days after any vaccination (N=3796, 1908)	0.45 0%	0.52 0%
Vaccination phase (N=3796, 1908)	1.03 0%	1.05 0.1%
Follow-up phase (N=3400, 1733)	0.44 0%	0.52 0%
Throughout study (N=3796, 1908)	1.40 0%	1.52 0.1%

8. Secondary Outcome

Title	Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
Description	An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time Frame	Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Measure Participants	3796	1908
30 days after Vaccination 1 (N=3796, 1908)	31.48 0.8%	19.03 1%
30 days after Vaccination 2 (N=3529, 1806)	20.37 0.5%	12.35 0.6%
30 days after Vaccination 3 (N=3313, 1710)	15.00 0.4%	10.76 0.6%
30 days after any vaccination (N=3796, 1908)	43.02 1.1%	31.45 1.6%
Vaccination phase (N=3796, 1908)	51.08 1.3%	42.51 2.2%

9. Secondary Outcome

Title	Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
Description	An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time Frame	Within 30 minutes after Vaccination 1, 2, 3

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Measure Participants	3796	1908
Vaccination 1 (N=3796, 1908)	1.05 0%	0.84 0%
Vaccination 2 (N=3529, 1806)	0.54 0%	0.06 0%
Vaccination 3 (N=3313, 1710)	0.45 0%	0.41 0%

10. Secondary Outcome

Title	Number of Days Participant Missed School or Work Due to Adverse Events (AEs)
Time Frame	Vaccination 1 up to 1 month after Vaccination 3

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.

Arm/Group Title	Group 1: rLP2086	Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule	Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
Measure Participants	3796	1908
Median (Full Range) [days]	3.0 (7.01)	3.0 (9.67)

Adverse Events

Time Frame	AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
Adverse Event Reporting Description	SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
Arm/Group Title	Group 1: rLP2086		Group 2: HAV/Saline/HAV
Arm/Group Description	Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule		Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
All Cause Mortality
	Group 1: rLP2086		Group 2: HAV/Saline/HAV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1: rLP2086		Group 2: HAV/Saline/HAV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/3796 (1.6%)		48/1908 (2.5%)
Blood and lymphatic system disorders
Neutropenia	1/3796 (0%)		0/1908 (0%)
Endocrine disorders
Autoimmune thyroiditis	1/3796 (0%)		0/1908 (0%)
Hyperprolactinaemia	0/3796 (0%)		1/1908 (0.1%)
Hypothalamo-pituitary disorder	1/3796 (0%)		0/1908 (0%)
Gastrointestinal disorders
Abdominal pain	0/3796 (0%)		2/1908 (0.1%)
Constipation	0/3796 (0%)		1/1908 (0.1%)
Duodenal perforation	0/3796 (0%)		1/1908 (0.1%)
Duodenal ulcer perforation	0/3796 (0%)		1/1908 (0.1%)
Enteritis	1/3796 (0%)		0/1908 (0%)
Hepatobiliary disorders
Biliary dyskinesia	1/3796 (0%)		0/1908 (0%)
Immune system disorders
Allergy to arthropod sting	0/3796 (0%)		2/1908 (0.1%)
Anaphylactic reaction	1/3796 (0%)		0/1908 (0%)
Drug hypersensitivity	1/3796 (0%)		0/1908 (0%)
Infections and infestations
Appendicitis	3/3796 (0.1%)		4/1908 (0.2%)
Gastroenteritis	0/3796 (0%)		3/1908 (0.2%)
Peritonsillar abscess	2/3796 (0.1%)		1/1908 (0.1%)
Meningitis viral	2/3796 (0.1%)		0/1908 (0%)
Abdominal abscess	0/3796 (0%)		1/1908 (0.1%)
Acute tonsillitis	0/3796 (0%)		1/1908 (0.1%)
Breast abscess	1/3796 (0%)		0/1908 (0%)
Carbuncle	1/3796 (0%)		0/1908 (0%)
Cellulitis	1/3796 (0%)		0/1908 (0%)
Cystitis	1/3796 (0%)		0/1908 (0%)
Gastrointestinal viral infection	1/3796 (0%)		0/1908 (0%)
Meningitis enterococcal	0/3796 (0%)		1/1908 (0.1%)
Meningitis enteroviral	1/3796 (0%)		0/1908 (0%)
Pertussis	1/3796 (0%)		0/1908 (0%)
Pilonidal cyst	1/3796 (0%)		0/1908 (0%)
Pneumonia	1/3796 (0%)		0/1908 (0%)
Postoperative wound infection	1/3796 (0%)		0/1908 (0%)
Rectal abscess	0/3796 (0%)		1/1908 (0.1%)
Salpingitis	1/3796 (0%)		0/1908 (0%)
Tick-borne viral encephalitis	1/3796 (0%)		0/1908 (0%)
Pyelonephritis	1/3796 (0%)		1/1908 (0.1%)
Injury, poisoning and procedural complications
Concussion	1/3796 (0%)		2/1908 (0.1%)
Intentional overdose	2/3796 (0.1%)		0/1908 (0%)
Cartilage injury	0/3796 (0%)		1/1908 (0.1%)
Clavicle fracture	0/3796 (0%)		1/1908 (0.1%)
Contusion	1/3796 (0%)		0/1908 (0%)
Craniocerebral injury	1/3796 (0%)		0/1908 (0%)
Fibula fracture	1/3796 (0%)		0/1908 (0%)
Forearm fracture	1/3796 (0%)		0/1908 (0%)
Gun shot wound	1/3796 (0%)		0/1908 (0%)
Head injury	1/3796 (0%)		0/1908 (0%)
Heat stroke	1/3796 (0%)		0/1908 (0%)
Jaw fracture	1/3796 (0%)		0/1908 (0%)
Lower limb fracture	0/3796 (0%)		1/1908 (0.1%)
Overdose	1/3796 (0%)		0/1908 (0%)
Snake bite	0/3796 (0%)		1/1908 (0.1%)
Spinal compression fracture	0/3796 (0%)		1/1908 (0.1%)
Traumatic intracranial haemorrhage	0/3796 (0%)		1/1908 (0.1%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	0/3796 (0%)		1/1908 (0.1%)
Type 1 diabetes mellitus	0/3796 (0%)		1/1908 (0.1%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/3796 (0%)		1/1908 (0.1%)
Osteochondrosis	1/3796 (0%)		0/1908 (0%)
Pain in extremity	0/3796 (0%)		1/1908 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central Nervous System germinoma	0/3796 (0%)		1/1908 (0.1%)
Nervous system disorders
Migraine	1/3796 (0%)		1/1908 (0.1%)
Multiple sclerosis	1/3796 (0%)		1/1908 (0.1%)
Convulsion	0/3796 (0%)		1/1908 (0.1%)
Demyelination	0/3796 (0%)		1/1908 (0.1%)
Headache	1/3796 (0%)		0/1908 (0%)
Meningism	1/3796 (0%)		0/1908 (0%)
Neuralgia	0/3796 (0%)		1/1908 (0.1%)
Radicular syndrome	0/3796 (0%)		1/1908 (0.1%)
Tension headache	0/3796 (0%)		1/1908 (0.1%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	2/3796 (0.1%)		3/1908 (0.2%)
Abortion missed	1/3796 (0%)		0/1908 (0%)
Ectopic pregnancy	0/3796 (0%)		1/1908 (0.1%)
Psychiatric disorders
Suicidal ideation	3/3796 (0.1%)		1/1908 (0.1%)
Depression	0/3796 (0%)		3/1908 (0.2%)
Major depression	1/3796 (0%)		1/1908 (0.1%)
Substance abuse	2/3796 (0.1%)		0/1908 (0%)
Attention deficit or hyperactivity disorder	1/3796 (0%)		0/1908 (0%)
Psychotic disorder	1/3796 (0%)		0/1908 (0%)
Schizoaffective disorder	1/3796 (0%)		0/1908 (0%)
Renal and urinary disorders
Renal tubular necrosis	0/3796 (0%)		1/1908 (0.1%)
Reproductive system and breast disorders
Menorrhagia	1/3796 (0%)		0/1908 (0%)
Testicular torsion	0/3796 (0%)		1/1908 (0.1%)
Respiratory, thoracic and mediastinal disorders
Asthma	3/3796 (0.1%)		0/1908 (0%)
Hyperventilation	1/3796 (0%)		0/1908 (0%)
Status asthmaticus	0/3796 (0%)		1/1908 (0.1%)
Skin and subcutaneous tissue disorders
Ingrowing nail	1/3796 (0%)		0/1908 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: rLP2086		Group 2: HAV/Saline/HAV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1671/3796 (44%)		640/1908 (33.5%)
Gastrointestinal disorders
Nausea	89/3796 (2.3%)		33/1908 (1.7%)
Vomiting	60/3796 (1.6%)		27/1908 (1.4%)
Abdominal pain	47/3796 (1.2%)		32/1908 (1.7%)
Diarrhoea	42/3796 (1.1%)		17/1908 (0.9%)
General disorders
Injection site pain	722/3796 (19%)		149/1908 (7.8%)
Pyrexia	237/3796 (6.2%)		44/1908 (2.3%)
Injection site erythema	142/3796 (3.7%)		6/1908 (0.3%)
Vaccination site pain	126/3796 (3.3%)		9/1908 (0.5%)
Fatigue	82/3796 (2.2%)		19/1908 (1%)
Injection site swelling	84/3796 (2.2%)		6/1908 (0.3%)
Infections and infestations
Upper respiratory tract infection	157/3796 (4.1%)		87/1908 (4.6%)
Nasopharyngitis	149/3796 (3.9%)		84/1908 (4.4%)
Pharyngitis	75/3796 (2%)		47/1908 (2.5%)
Gastroenteritis	64/3796 (1.7%)		38/1908 (2%)
Bronchitis	65/3796 (1.7%)		36/1908 (1.9%)
Sinusitis	54/3796 (1.4%)		33/1908 (1.7%)
Urinary tract infection	50/3796 (1.3%)		24/1908 (1.3%)
Pharyngitis streptococcal	45/3796 (1.2%)		22/1908 (1.2%)
Tonsillitis	38/3796 (1%)		21/1908 (1.1%)
Viral pharyngitis	41/3796 (1.1%)		13/1908 (0.7%)
Injury, poisoning and procedural complications
Ligament sprain	60/3796 (1.6%)		30/1908 (1.6%)
Contusion	50/3796 (1.3%)		23/1908 (1.2%)
Fall	38/3796 (1%)		24/1908 (1.3%)
Musculoskeletal and connective tissue disorders
Pain in extremity	76/3796 (2%)		26/1908 (1.4%)
Back pain	49/3796 (1.3%)		26/1908 (1.4%)
Arthralgia	40/3796 (1.1%)		27/1908 (1.4%)
Nervous system disorders
Headache	249/3796 (6.6%)		102/1908 (5.3%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	83/3796 (2.2%)		41/1908 (2.1%)
Cough	73/3796 (1.9%)		34/1908 (1.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.