HealthyPhase 3B1971016NCT01352845

A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

A Phase 3 study testing rLP2086 in people with Healthy, run by Pfizer at 58 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated. Read more about this study

Who is it for?: Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: rLP2086
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,301 participants
Where: 58 sitesin 6 countries
Study dates: May 2013to Feb 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subject aged >=18 and <26 years at the time of enrollment.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Negative urine pregnancy test for all female subjects.

Who cannot join

Previous vaccination with any meningococcal serogroup B vaccine.
Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Current chronic use of systemic antibiotics.
Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Trial locations and contacts

58 sites in 6 countries.

Country

City, postcode or hospital

58 sites in 6 countries

United States35 sites

Anaheim Clinical Trials LLC
Anaheim, California, 92801
Bellevue Urgent Care
Bellevue, Nebraska, 68005
Meridian Clinical Research
Bellevue, Nebraska, 68005
Pioneer Clinical Research, LLC
Bellevue, Nebraska, 68005
Community Research
Cincinnati, Ohio, 45227
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
Rapid Medical Research
Cleveland, Ohio, 44122
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049
Research Across America
Dallas, Texas, 75234
Coastal Medical
East Greenwich, Rhode Island, 02818
Broward Research Group
Hollyood, Florida, 33024
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Research Across America
Katy, Texas, 77450
eStudySite
La Mesa, California, 91942
Altus Research Inc.
Lake Worth, Florida, 33461
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, 66219
Central New York Clinical Research
Manlius, New York, 13104
Clinical Research Advantage, Inc./Desert Clinical Research, LLC
Mesa, Arizona, 85213
Benchmark Research
Metairie, Louisiana, 70006
Milford Emergency Associates, Inc.
Milford, Massachusetts, 01757
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Meridian Clinical Research,
Omaha, Nebraska, 68134
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
Benchmark Research
Sacramento, California, 95822
Miami Research Associates
South Miami, Florida, 33143
Premier Clinical Research
Spokane, Washington, 99204-4880
Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
Tempe, Arizona, 85282
Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
Tempe, Arizona, 85283
PEAK Research, LLC
Upper Saint Clair, Pennsylvania, 15241
Omega Medical Research
Warwick, Rhode Island, 02886
Advanced Clinical Research
West Jordan, Utah, 84088
Palm Beach Research Center
West Palm Beach, Florida, 33409

Other trials in United States

Canada9 sites

Dr. Calvin Powell Professional Medical Corporation
Bay Roberts, Newfoundland and Labrador, A0A 1G0
Canadian Center for Vaccinology - IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Milestone Research
London, Ontario, N5W 6A2
McGill University Health Centre - Vaccine Study Centre
Pierrefonds, Quebec, H9H 4Y6
Centre hospitalier universitaire de Québec
Québec, Quebec, G1E 7G9
Pro-Recherche Inc.
Saint Romuald, Quebec, G6W 5M6
Clinique Medicale St-Louis Inc.
Sainte-Foy, Québec, Quebec, G1W 4R4
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, N7T 4X3
Devonshire Clinical Research Inc.
Woodstock, Ontario, N4S 5P5

Other trials in Canada

Spain6 sites

CAP Balenya
Balenya, Barcelona, 08550
Hospital Clinic de Barcelona
Barcelona, 08036
CAP Centelles
Centelles, Barcelona, 08540
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
FOM (Fundacion Oftalmologica del Mediterraneo) - FISABIO
Valencia, Valencia, 46015
CAP El Remei
Vic, Barcelona, 08500

Other trials in Spain

Finland4 sites

Espoo Vaccine Research Clinic
Espoo, 02230
Helsinki South Vaccine Research Clinic
Helsinki, 00100
Kokkola Vaccine Research Clinic
Kokkola, 67100
Seinäjoki Vaccine Research Clinic
Seinäjoki, 60100

Other trials in Finland

Poland3 sites

NZOZ Centrum Medyczne Graniczna Sp. z o.o.
Katowice, 40-018
Specjalistyczna Poradnia Medyczna Przyladek Zdrowia
Krakow, 30-438
NZOZ Salmed s.c.
Łęczna, 21-010

Other trials in Poland

Denmark1 site

Aarhus Universitetshospital Skejby
Aarhus N, 8200

Other trials in Denmark

About this study

Official title: A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered As A 3-dose Regimen In Healthy Young Adults Aged >=18 To <26 Years

Conditions: Healthy
Being tested: rLP2086, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rLP2086Biological
0.5 mL dose, given at 0, 2 and 6 months
PlaceboOther
0.5 mL dose, given at 0, 2 and 6 months

Study groups in NCT01352845
Study group	Role	What they receive
rLP2086	Experimental	Not described Receives: Biological: rLP2086
Control	Placebo comparator	Steril normal saline solution Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1
Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.
Measured: One month after third bivalent rLP2086 vaccination
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Measured: Within 7 days after first vaccination
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Measured: Within 7 days after second vaccination
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Measured: Within 7 days after third vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Measured: Within 7 days after first vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Measured: Within 7 days after second vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Measured: Within 7 days after third vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination
Measured: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination
Measured: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination
Measured: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination
Measured: Within 30 days after any vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase
Measured: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination
Measured: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination
Measured: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination
Measured: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
Measured: Within 30 days after any vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase
Measured: From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase
Measured: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period
Measured: From the first vaccination up to 6 month after the third vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination
Measured: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination
Measured: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination
Measured: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination
Measured: Within 30 days after any vaccination
Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase
Measured: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase
Measured: From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period
Measured: From the first vaccination up to 6 month after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination
Measured: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination
Measured: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination
Measured: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination
Measured: Within 30 days after any vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
Measured: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase
Measured: From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period
Measured: From the first vaccination up to 6 month after the third vaccination the third vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination
Measured: Within 30 minutes after first vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination
Measured: Within 30 minutes after second vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination
Measured: Within 30 minutes after third vaccination
Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase
Measured: From the first vaccination up to 1 month after the third vaccination

Secondary outcomes (10)

Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
Measured: Before first vaccination, 1 month after third vaccination
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Measured: Before first vaccination, 1 month after third vaccination (Vac)
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Measured: Before first vaccination, 1 month after third vaccination
Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1
Measured: Before vaccination 1, 1 Month after Vaccination 2
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1
Measured: One month after second Bivalent rLP2086 vaccination
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Measured: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary endpoint 'Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1'.
Measured: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Measured: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination
Measured: One month after third bivalent rLP2086 vaccination
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Measured: One month after third bivalent rLP2086 vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Feb 2015

First posted12 May 2011 (estimated)
Study startMay 2013
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3,301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01352845
Sponsor's protocol ID: B1971016
Other IDs: 6108A1-2004, 2009-014492-46, 2009
Acronym: B1971016
Status last verified: Jan 2016
First submitted: 11 May 2011
Last updated: 23 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
PubMed 35164991
Beeslaar J, Absalon J, Anderson AS, Eiden JJ, Balmer P, Harris SL, Jones TR, O'Neill RE, Pregaldien JL, Radley D, Maansson R, Ginis J, Srivastava A, Perez JL. MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies. Infect Dis Ther. 2020 Sep;9(3):641-656. doi: 10.1007/s40121-020-00319-0. Epub 2020 Jul 22.
PubMed 32700260
Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17.
PubMed 32681472
Ostergaard L, Vesikari T, Absalon J, Beeslaar J, Ward BJ, Senders S, Eiden JJ, Jansen KU, Anderson AS, York LJ, Jones TR, Harris SL, O'Neill R, Radley D, Maansson R, Pregaldien JL, Ginis J, Staerke NB, Perez JL; B1971009 and B1971016 Trial Investigators. A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults. N Engl J Med. 2017 Dec 14;377(24):2349-2362. doi: 10.1056/NEJMoa1614474.
PubMed 29236639

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered As A 3-dose Regimen In Healthy Young Adults Aged >=18 To <26 Years
ClinicalTrials.gov ID: NCT01352845
Acronym / sponsor ID: B1971016 / B1971016
Conditions: Healthy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,301 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 12 May 2011 (estimated)
Results: Posted 23 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
rLP2086	Experimental	Biological: rLP2086
Control	Placebo comparator	Other: PlaceboSteril normal saline solution

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male or female subject aged >=18 and <26 years at the time of enrollment.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Negative urine pregnancy test for all female subjects.

Key exclusion criteria (8 listed)

Previous vaccination with any meningococcal serogroup B vaccine.
Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rLP20860.5 mL dose, given at 0, 2 and 6 months	Biological	rLP2086
Placebo0.5 mL dose, given at 0, 2 and 6 months	Other	Control

Primary outcome

Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1
Time frame: One month after third bivalent rLP2086 vaccination
Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Time frame: Within 7 days after first vaccination
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Time frame: Within 7 days after second vaccination
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Time frame: Within 7 days after third vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Time frame: Within 7 days after first vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Time frame: Within 7 days after second vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Time frame: Within 7 days after third vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination
Time frame: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination
Time frame: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination
Time frame: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination
Time frame: Within 30 days after any vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase
Time frame: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination
Time frame: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination
Time frame: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination
Time frame: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
Time frame: Within 30 days after any vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase
Time frame: From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase
Time frame: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period
Time frame: From the first vaccination up to 6 month after the third vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination
Time frame: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination
Time frame: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination
Time frame: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination
Time frame: Within 30 days after any vaccination
Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase
Time frame: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase
Time frame: From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period
Time frame: From the first vaccination up to 6 month after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination
Time frame: Within 30 days after first vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination
Time frame: Within 30 days after second vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination
Time frame: Within 30 days after third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination
Time frame: Within 30 days after any vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
Time frame: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase
Time frame: From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period
Time frame: From the first vaccination up to 6 month after the third vaccination the third vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination
Time frame: Within 30 minutes after first vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination
Time frame: Within 30 minutes after second vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination
Time frame: Within 30 minutes after third vaccination
Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase
Time frame: From the first vaccination up to 1 month after the third vaccination

10 secondary outcomes

Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1
Time frame: Before first vaccination, 1 month after third vaccination
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Time frame: Before first vaccination, 1 month after third vaccination (Vac)
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Time frame: Before first vaccination, 1 month after third vaccination
Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1
Time frame: Before vaccination 1, 1 Month after Vaccination 2
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1
Time frame: One month after second Bivalent rLP2086 vaccination
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination
Time frame: One month after third bivalent rLP2086 vaccination
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
Time frame: One month after third bivalent rLP2086 vaccination

Results and safety

Results posted to the registry on 23 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 rLP2086	2,471	1,800
Group 2 Saline	822	619

Primary outcome: Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1

Time frame: One month after third bivalent rLP2086 vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1 rLP2086 n = 1723
Composite hSBA response (N=1664)	84.9 (83.1 to 86.6)
PMB80 [A22] (N=1695)	80.5 (78.6 to 82.4)
PMB2001 [A56] (N=1642)	90.0 (88.4 to 91.4)
PMB2948 [B24] (N=1675)	79.3 (77.3 to 81.2)
PMB2707 [B44] (N=1696)	79.6 (77.6 to 81.5)

Population analysed: Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.

Primary outcome: Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination

Time frame: Within 7 days after first vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1 rLP2086 n = 2425	Group 2 Saline n = 798
Pain at injection site: Any	84.2 (82.7 to 85.6)	11.8 (9.6 to 14.2)
Pain at injection site: Mild	42.3 (40.3 to 44.3)	10.7 (8.6 to 13.0)
Pain at injection site: Moderate	37.1 (35.1 to 39.0)	1.1 (0.5 to 2.1)
Pain at injection site: Severe	4.8 (4.0 to 5.8)	0.0 (0.0 to 0.5)
Redness: Any	13.8 (12.5 to 15.3)	0.6 (0.2 to 1.5)
Redness: Mild	5.8 (4.9 to 6.8)	0.5 (0.1 to 1.3)
Redness: Moderate	7.1 (6.1 to 8.2)	0.0 (0.0 to 0.5)
Redness: Severe	0.9 (0.6 to 1.4)	0.1 (0.0 to 0.7)

Population analysed: Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.

Primary outcome: Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination

Time frame: Within 7 days after second vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1 rLP2086 n = 2076	Group 2 Saline n = 706
Pain at injection site: Any	79.3 (77.5 to 81.1)	7.8 (5.9 to 10.0)
Pain at injection site: Mild	42.2 (40.1 to 44.4)	6.8 (5.1 to 8.9)
Pain at injection site: Moderate	32.7 (30.7 to 34.8)	1.0 (0.4 to 2.0)
Pain at injection site: Severe	4.4 (3.6 to 5.4)	0.0 (0.0 to 0.5)
Redness: Any	11.8 (10.4 to 13.3)	0.3 (0.0 to 1.0)
Redness: Mild	4.6 (3.7 to 5.6)	0.1 (0.0 to 0.8)
Redness: Moderate	6.3 (5.3 to 7.4)	0.0 (0.0 to 0.5)
Redness: Severe	0.9 (0.6 to 1.4)	0.1 (0.0 to 0.8)

Population analysed: Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.

Primary outcome: Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination

Time frame: Within 7 days after third vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1 rLP2086 n = 1823	Group 2 Saline n = 624
Pain at injection site: Any	80.4 (78.5 to 82.2)	6.7 (4.9 to 9.0)
Pain at injection site: Mild	36.1 (33.9 to 38.4)	6.4 (4.6 to 8.6)
Pain at injection site: Moderate	38.9 (36.6 to 41.2)	0.3 (0.0 to 1.2)
Pain at injection site: Severe	5.3 (4.3 to 6.5)	0.0 (0.0 to 0.6)
Redness: Any	17.1 (15.4 to 18.9)	0.2 (0.0 to 0.9)
Redness: Mild	6.2 (5.1 to 7.4)	0.2 (0.0 to 0.9)
Redness: Moderate	8.6 (7.3 to 9.9)	0.0 (0.0 to 0.6)
Redness: Severe	2.3 (1.7 to 3.1)	0.0 (0.0 to 0.6)

Population analysed: Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs/SAEs: recorded from first vaccination through 6 months after third vaccination. Participants recorded pre-specified reactogenicity events (local reactions, systemic events) in electronic diary within 7 days after first, second and third vaccination. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 rLP2086	33 of 2,471 (1.3%)	2,193 of 2,471 (88.7%)	Not reported
Group 2 Saline	11 of 822 (1.3%)	567 of 822 (69%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35164991Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
Derived from this study: PubMed 32700260Beeslaar J, Absalon J, Anderson AS, Eiden JJ, Balmer P, Harris SL, Jones TR, O'Neill RE, Pregaldien JL, Radley D, Maansson R, Ginis J, Srivastava A, Perez JL. MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies. Infect Dis Ther. 2020 Sep;9(3):641-656. doi: 10.1007/s40121-020-00319-0. Epub 2020 Jul 22.
Derived from this study: PubMed 32681472Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17.
Derived from this study: PubMed 29236639Ostergaard L, Vesikari T, Absalon J, Beeslaar J, Ward BJ, Senders S, Eiden JJ, Jansen KU, Anderson AS, York LJ, Jones TR, Harris SL, O'Neill R, Radley D, Maansson R, Pregaldien JL, Ginis J, Staerke NB, Perez JL; B1971009 and B1971016 Trial Investigators. A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults. N Engl J Med. 2017 Dec 14;377(24):2349-2362. doi: 10.1056/NEJMoa1614474.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

58 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rLP2086 in people with Healthy, run by Pfizer at 58 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Canada, Spain, Finland, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1 (time frame: One month after third bivalent rLP2086 vaccination). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01352845, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.