Meningitis, MeningococcalPhase 2NCT00808028

A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

A Phase 2 study testing meningococcal B rLP2086 vaccine. in people with Meningitis, Meningococcal, run by Pfizer at 27 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old. Read more about this study

Who is it for?: Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Meningitis, Meningococcal
What is being tested?: meningococcal B rLP2086 vaccine.
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 538 participants
Where: 27 sitesin 3 countries
Study dates: Feb 2009to Mar 2014
Phase: Phase 2
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 11 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy male or female subjects between the ages of >=11 and <=18 years at the time of enrollment.
Negative urine pregnancy test for all female subjects.
Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.

Who cannot join

History of any invasive meningococcal disease.
A previous anaphylactic or severe vaccine-associated adverse reaction.
Any clinically significant chronic disease.
A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

Trial locations and contacts

27 sites in 3 countries.

Country

City, postcode or hospital

27 sites in 3 countries

Poland16 sites

ZOZ w Debicy, Poradnia Chorob Zakaznych
Dębica, 39-200
SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
Krakow, 31-202
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
Krakow, 31-503
NZOZ Salmed
Łęczna, 21-010
Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
Lodz, 91-347
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
Lodz, 91-347
SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14
Lubartów, 21-100
Eskulap Sp. z o. o., ul. Weteranow 46
Lublin, 20-044
SP ZOZ, Poradnia Dziecieca w Grucie
Mełno, 86-330
NZOZ Pratyka Lekarza Rodzinnego Alina Grocka-Wlazlak
Oborniki Śląskie, 55-120
Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno-Zakazny A
Poznan, 61-734
NZLA Michalkowice, Jarosz i Partnerzy
Siemianowice Śląskie, 41-03
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia
Torun, 87-100
Oddzial Dzieciecy Szpital im. Swietej Jadwigi Slaskiej
Trzebnica, 55-100
Klinika Pediatrii i Chorob Infekcyjnych
Wroclaw, 50-345
Samodzielny Publiczny Szpital Kliniczny Nr 1
Wroclaw, 50-345

Other trials in Poland

Spain7 sites

Clinica Virgen del Mar
Almería, 04120
Hospital General de Cataluna
Barcelona, 08195
Hospital U. de Getafe
Getafe, Madrid, 28905
Hospital U. 12 de Octubre
Madrid, Madrid, 28041
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, La Coruna, 15706
Centro de Salud Nazaret
Valencia, 46024
Complexo Hospitalario Xeral-Cies de Vigo
Vigo, Pontevedra, 36204

Other trials in Spain

Australia4 sites

Royal Children's Hospital
Carlton, Victoria, 3053
Queensland Paediatric Infectious Diseases (QPID) Laboratory
Herston, Queensland, 4029
Department of Paediatrics, Women's & Children's Hospital
North Adelaide, South Australia, 5006
Children's Clinical Research Facility, Vaccine Trials Group (VTG),
Subiaco, Western Australia, 6008

Other trials in Australia

About this study

Official title: A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years

The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

Conditions: Meningitis, Meningococcal
Being tested: meningococcal B rLP2086 vaccine., normal saline (placebo)
Medical subject headings: Meningitis, Meningococcal

What participants receive

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

meningococcal B rLP2086 vaccine.Biological
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
meningococcal B rLP2086 vaccine.Biological
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
meningococcal B rLP2086 vaccine.Biological
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
normal saline (placebo)Other
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

Study groups in NCT00808028
Study group	Role	What they receive
1	Experimental	dose level 1 rLP2086 vaccine Receives: Biological: meningococcal B rLP2086 vaccine.
2	Experimental	dose level 2 rLP2086 vaccine Receives: Biological: meningococcal B rLP2086 vaccine.
3	Experimental	dose level 3 rLP2086 vaccine Receives: Biological: meningococcal B rLP2086 vaccine.
4	Placebo comparator	normal saline (placebo) Receives: Other: normal saline (placebo)

What is being measured

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

Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
Measured: Before vaccination 1 up to 1 month after vaccination 2
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
Measured: Before vaccination 1 up to 1 month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Measured: Vaccination 1 upto 1 Month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
Measured: 6 month after vaccination 3 up to 48 months

Secondary outcomes (1)

Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
Measured: 1 month before vaccination 1, 1 month after vaccination 2, 3

Timeline

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

Feb 2009Mar 2014

First posted15 Dec 2008 (estimated)
Study startFeb 2009
Primary completionMar 2014
Study completionMar 2014

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 Meningitis, MeningococcalStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Enrolment: 538 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00808028
Sponsor's protocol ID: 6108A1-2001
Other IDs: B1971005, 2008-007789-51, 2008
Status last verified: Mar 2015
First submitted: 12 Dec 2008
Last updated: 14 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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, 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
Marshall HS, Richmond PC, Beeslaar J, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Lee SS, Perez JL; 6108A12001 Study Investigators. Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2017 Jan;17(1):58-67. doi: 10.1016/S1473-3099(16)30314-0. Epub 2016 Oct 11.
PubMed 27745812
Richmond PC, Marshall HS, Nissen MD, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Beeslaar J, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Perez JL; 2001 Study Investigators. Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012 Aug;12(8):597-607. doi: 10.1016/S1473-3099(12)70087-7. Epub 2012 May 7.
PubMed 22569484

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?

See locations

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
Active, not recruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
Epidemic Meningitis, Meningococcal Vaccines
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months
Epidemic Meningitis, Meningococcal Vaccines

All Meningitis, Meningococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years
ClinicalTrials.gov ID: NCT00808028
Acronym / sponsor ID: 6108A1-2001
Conditions: Meningitis, Meningococcal
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 538 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 15 Dec 2008 (estimated)
Results: Posted 14 Apr 2015

Clinical summary

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

The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Number of arms: 4

Arm	Type	Receives
1	Experimental	Biological: meningococcal B rLP2086 vaccine.dose level 1 rLP2086 vaccine
2	Experimental	Biological: meningococcal B rLP2086 vaccine.dose level 2 rLP2086 vaccine
3	Experimental	Biological: meningococcal B rLP2086 vaccine.dose level 3 rLP2086 vaccine
4	Placebo comparator	Other: normal saline (placebo)normal saline (placebo)

Who may qualify

Ages: 11 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Healthy male or female subjects between the ages of >=11 and <=18 years at the time of enrollment.
Negative urine pregnancy test for all female subjects.
Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.

Key exclusion criteria (5 listed)

History of any invasive meningococcal disease.
A previous anaphylactic or severe vaccine-associated adverse reaction.
Any clinically significant chronic disease.
A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

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
meningococcal B rLP2086 vaccine.vaccine, 0.5 mL, 0 - 2 - 6 to 9 months	Biological	1
meningococcal B rLP2086 vaccine.vaccine, 0.5 mL, 0 - 2 - 6 to 9 months	Biological	2
meningococcal B rLP2086 vaccine.vaccine, 0.5 mL, 0 - 2 - 6 to 9 months	Biological	3
normal saline (placebo)vaccine, 0.5 mL, 0 - 2 - 6 to 9 months	Other	4

Primary outcome

Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
Time frame: Before vaccination 1 up to 1 month after vaccination 2
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
Time frame: Before vaccination 1 up to 1 month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Time frame: Vaccination 1 upto 1 Month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
Time frame: 6 month after vaccination 3 up to 48 months

1 secondary outcome

Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
Time frame: 1 month before vaccination 1, 1 month after vaccination 2, 3

Results and safety

Results posted to the registry on 14 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	121	116
rLP2086 60 Microgram (mcg)	22	21
rLP2086 120 mcg	198	191
rLP2086 200 mcg	198	183

Primary outcome: Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2

Time frame: Before vaccination 1 up to 1 month after vaccination 2. Number. Unit: Percentage of participants

Measure	Control-Stage 1 n = 119	rLP2086 60 mcg- Stage 1 n = 22	rLP2086 120 mcg- Stage 1 n = 195	rLP2086 200 mcg- Stage 1 n = 192
Subfamily A Strain A05 (N= 80, 18, 115, 106)	1.3	88.9	83.5	87.7
Subfamily B Strain B02 (N= 84, 21, 121, 114)	0.0	71.4	59.5	59.6

Control-Stage 1: p >0.9999, Binomial Distribution
rLP2086 60 mcg- Stage 1: p = 0.0007, Binomial Distribution
rLP2086 120 mcg- Stage 1: p <0.0001, Binomial Distribution

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

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

Time frame: Before vaccination 1 up to 1 month after vaccination 3. Number. Unit: Percentage of participants

Measure	Control-Stage 1 n = 119	rLP2086 60 mcg- Stage 1 n = 22	rLP2086 120 mcg- Stage 1 n = 195	rLP2086 200 mcg- Stage 1 n = 192
Subfamily A Strain A05 (N= 73, 19, 111,100)	5.5	89.5	92.8	94.0
Subfamily B Strain B02 (N= 79, 21, 112,105)	1.3	81.0	86.6	84.8

Control-Stage 1: p >0.9999, Binomial Distribution
rLP2086 60 mcg- Stage 1: p = 0.0004, Binomial Distribution
rLP2086 120 mcg- Stage 1: p <0.0001, Binomial Distribution

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

Time frame: Vaccination 1 upto 1 Month after vaccination 3. Number. Unit: Percentage of participants

Measure	Control-Stage 1 n = 121	rLP2086 60 mcg- Stage 1 n = 22	rLP2086 120 mcg- Stage 1 n = 198	rLP2086 200 mcg- Stage 1 n = 195
Stage 1: Vaccination phase	44.6	81.8	38.9	47.2
Stage 1: 6-month follow up phase	4.1	18.2	1.5	2.6

Population analysed: Safety population included participants who received at least 1 dose of study vaccine.

Primary outcome: Percentage of Participants With Atleast One Adverse Event (AE): Stage 2

Time frame: 6 month after vaccination 3 up to 48 months. Number. Unit: Percentage of participants

Measure	Control- Stage 2 n = 80	rLP2086 120 mcg- Stage 2 n = 170	rLP2086 200 mcg- Stage 2 n = 151
Value	2.5	4.1	2.0

Population analysed: Safety population included participants who received at least 1 dose of study vaccine.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AE reported from Vaccination 1 upto 48 months after vaccincation 3 and SAE reported from Vaccination 1 upto 48 months after vaccincation 3. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control- Stage 1	3 of 121 (2.5%)	54 of 121 (44.6%)	Not reported
rLP2086 60 mcg- Stage 1	1 of 22 (4.5%)	18 of 22 (81.8%)	Not reported
rLP2086 120 mcg- Stage 1	3 of 198 (1.5%)	75 of 198 (37.9%)	Not reported
rLP2086 200 mcg- Stage 1	8 of 195 (4.1%)	91 of 195 (46.7%)	Not reported
Control-Stage 1 Follow-up	0 of 121 (0%)	5 of 121 (4.1%)	Not reported
rLP2086 60 mcg- Stage 1 Follow up	1 of 22 (4.5%)	3 of 22 (13.6%)	Not reported
rLP2086 120 mcg- Stage 1 Follow up	1 of 198 (0.5%)	2 of 198 (1%)	Not reported
rLP2086 200 mcg- Stage 1 Follow up	2 of 195 (1%)	4 of 195 (2.1%)	Not reported
Control-Stage 2	1 of 80 (1.3%)	1 of 80 (1.3%)	Not reported
rLP2086 120 mcg- Stage 2	6 of 170 (3.5%)	1 of 170 (0.6%)	Not reported
rLP2086 200 mcg- Stage 2	3 of 151 (2%)	0 of 151 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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 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 27745812Marshall HS, Richmond PC, Beeslaar J, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Lee SS, Perez JL; 6108A12001 Study Investigators. Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2017 Jan;17(1):58-67. doi: 10.1016/S1473-3099(16)30314-0. Epub 2016 Oct 11.
Derived from this study: PubMed 22569484Richmond PC, Marshall HS, Nissen MD, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Beeslaar J, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Perez JL; 2001 Study Investigators. Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012 Aug;12(8):597-607. doi: 10.1016/S1473-3099(12)70087-7. Epub 2012 May 7.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Meningitis, Meningococcal

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
Active, not recruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
Epidemic Meningitis, Meningococcal Vaccines
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months
Epidemic Meningitis, Meningococcal Vaccines

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

27 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing meningococcal B rLP2086 vaccine. in people with Meningitis, Meningococcal, run by Pfizer at 27 sites in 3 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 5 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Poland, Spain, Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Apr 2015). 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 at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 (time frame: Before vaccination 1 up to 1 month after vaccination 2). The study lists 4 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 NCT00808028, 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 14 Apr 2015.