Meningococcal B DiseasePhase 2NCT02534935

Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.

A Phase 2 study testing rLP2086 vaccine and Pediatric HAV vaccine in people with Meningococcal B Disease, run by Pfizer at 25 sites in 4 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 investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months. Read more about this study

Who is it for?: Ages 12 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Meningococcal B Disease
What is being tested?: rLP2086 vaccine and Pediatric HAV vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 396 participants
Where: 25 sitesin 4 countries
Study dates: 31 Aug 2015to 17 Mar 2020
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 12 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female subject aged 12 to <15 months or 18 to <24 months during sentinel-cohort enrollment, Or,12 to <24 months during expanded-cohort enrollment.
Subjects must have received all vaccinations in the relevant National Immunization Program (NIP) for their age group.
Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.

Who cannot join

Previous vaccination with any meningococcal serogroup B vaccine.
Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.
Contraindication to vaccination with any HAV vaccine or known latex allergy.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
A known or suspected disorder 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 or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included.

Show all 12Show fewer

History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
Significant neurologic disorder or history of seizure (excluding simple febrile seizure).
Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.
Current chronic use of systemic antibiotics.
Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.
Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Trial locations and contacts

25 sites in 4 countries.

Country

City, postcode or hospital

25 sites in 4 countries

Poland8 sites

NZOZ Vitamed
Bydgoszcz, 85-079
Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek
Dębica, 39-200
Indywidualna Specjalistyczna Praktyka Lekarska Hanna Czajka
Krakow, 31-302
Specjalistyczna Praktyka Lekarska GRAVITA
Lodz, 91-347
NZOZ Praktyka Lekarza Rodzinnego Eskulap sp. z o.o
Lublin, 20-044
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
Siemianowice Śląskie, 41-103
Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy Oddzial Pediatryczny
Trzebnica, 55-100
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu Klinika Pediatrii i Chorob
Wroclaw, 50-368

Other trials in Poland

Finland7 sites

Espoo Vaccine Research Clinic
Espoo, 02230
Helsinki South Vaccine Research Clinic
Helsinki, 00100
Helsinki East Vaccine Research Clinic
Helsinki, 00930
Jarvenpaa Vaccine Research Center
Jarvenpaa, 04400
Pori Vaccine Research Clinic
Pori, 28100
Tampere Vaccine Research Clinic
Tampere, 33100
Turku Vaccine Research Clinic
Turku, 20520

Other trials in Finland

Australia6 sites

The Canberra Hospital
Canberra, Garran, Australian Capital Territory, 2605
Australian Clinical Research Network (ACRN)
Maroubra, New South Wales, 2035
Maroubra Medical Centre
Maroubra, New South Wales, 2035
Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital
Nedlands, Western Australia, 6009
Women's And Children's Hospital
North Adelaide, South Australia, 5006
Murdoch Children's Research Institute
Parkville, Victoria, 3052

Other trials in Australia

Czechia4 sites

Ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, 377 01
Samostatna ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, 377 01
Medicentrum 6 s.r.o
Praha 6 - Vokovice, 160 00
Prakticky Lekar Pro Deti A Mladez
Týnec nad Sázavou, 257 41

Other trials in Czechia

About this study

Official title: A PHASE 2, RANDOMIZED, CONTROLLED, OBSERVER-BLINDED STUDY CONDUCTED TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A NEISSERIA MENINGITIDIS SEROGROUP B BIVALENT RECOMBINANT LIPOPROTEIN 2086 VACCINE (BIVALENT RLP2086) WHEN ADMINISTERED TO HEALTHY TODDLERS AGED 12 TO <18 MONTHS OR 18 TO <24 MONTHS, AND THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086

Conditions: Meningococcal B Disease
Being tested: rLP2086 vaccine, Pediatric HAV vaccine
Keywords: Phase 2 Immunogenicity, Safety, Tolerability Study, rLP2086 Vaccine, Healthy Toddlers, Neisseria meningitidis, Duration of Immunogenicity

What participants receive

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

rLP2086 vaccineBiological
60 mcg or 120mcg at 0, 2 and 6 months
Pediatric HAV vaccineBiological
0.5-mL dose at months 0 and 6. Normal saline at month 2.

Study groups in NCT02534935
Study group	Role	What they receive
rLP2086 vaccine	Experimental	Arm stratified by age: ≥12 to <18 months and ≥18 to <24 months Receives: Biological: rLP2086 vaccine
Control	Active comparator	Arm stratified by age: ≥12 to <18 months and ≥18 to <24 months Receives: Biological: Pediatric HAV vaccine

What is being measured

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

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).
Measured: 1 month after Vaccination 3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1
Local reactions included tenderness at injection site, swelling and redness collected by using an electronic diary (e-diary). Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 centimeter [cm]), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Measured: within 7 Days after Vaccination 1
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2
Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Measured: within 7 Days after Vaccination 2
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3
Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Measured: within 7 Days after Vaccination 3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1
Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).
Measured: within 7 Days after Vaccination 1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2
Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).
Measured: within 7 Days after Vaccination 2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3
Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).
Measured: within 7 Days after Vaccination 3
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Measured: within 30 Days after Vaccination 1
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Measured: within 30 Days after Vaccination 2
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Measured: within 30 Days after Vaccination 3
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
Measured: within 30 Days after any Vaccination
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
Measured: From the Vaccination 1 up to 1 month after Vaccination 3
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
Measured: From 1 month after Vaccination 3 up to 6 months after Vaccination 3
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
Measured: From Vaccination 1 up to 6 months after Vaccination 3

Secondary outcomes (11)

Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).
Measured: 1, 6, 12, 24 months after Vaccination 3
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).
Measured: 1 month (Mon) after Vaccination (Vac) 2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains
Measured: Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains
Measured: Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination
Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain at injection site was graded as: mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity). A caliper was used to measure the redness or swelling area. Caliper units were converted to centimeters (cm) according to 1 caliper unit = 0.5 cm. Redness and swelling were graded as: none (0 cm) mild (0.5-2.0 cm), moderate (>=2.0 to 7.0 cm) and severe (>7.0 cm).
Measured: Within 7 days after booster vaccination
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as a temperature of greater than or equal to (>=) 38.0 degree Celsius and was graded as 38.0 degree Celsius (C) to 38.4 degree C, 38.5 degree C to 38.9 degree C, 39.0 degree C to 39.4 degree C, 39.5 degree C to 40.0 degree C, >40.0 degree C. Vomiting was graded as mild (1 to 2 times in 24 hours), moderate (>2 times in 24 hours) and severe (requires IV hydration). Diarrhea was graded as mild (2 to 3 loose stools in 24 hours), moderate (4 to 5 loose stools in 24 hours), and severe (6 or more loose stools in 24 hours). Fatigue, headache, muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). The use and type of antipyretic medication was also recorded in the e-diary daily.
Measured: Within 7 days after booster vaccination
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination
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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
Measured: Booster vaccination to 1 month after booster vaccination (T1), 1 month after booster vaccination to 6 months after booster vaccination (T2) and booster vaccination through 6 months after booster vaccination (T3)
Percentage of Participants With at Least 1 Adverse Event (AE) From Booster Vaccination to 1 Month After Booster Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Measured: Booster vaccination up to 1 month after booster vaccination
Percentage of Participants With Immediate Adverse Event (IAE) After Booster Vaccination
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Measured: Within 30 minutes after booster vaccination
Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. The LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44.
Measured: Before booster vaccination and 1 month after booster vaccination
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination
The LLOQ was 1:16 for A22, 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Measured: Before booster vaccination and 1 month after booster vaccination

Timeline

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

31 Aug 201517 Mar 2020

First posted28 Aug 2015 (estimated)
Study start31 Aug 2015
Primary completion21 Aug 2017
Study completion17 Mar 2020

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 (1)Papers the sponsor has linked to this study.
Other trials for Meningococcal B DiseaseStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 396 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02534935
Sponsor's protocol ID: B1971035
Other IDs: 2011-004400-38
Status last verified: Aug 2021
First submitted: 23 Feb 2015
Last updated: 27 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Marshall HS, Vesikari T, Richmond PC, Wysocki J, Szenborn L, Beeslaar J, Maguire JD, Balmer P, O'Neill R, Anderson AS, Pregaldien JL, Maansson R, Jiang HQ, Perez JL. Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1-9 years: two phase 2 randomised, controlled, observer-blinded studies. Lancet Infect Dis. 2023 Jan;23(1):103-116. doi: 10.1016/S1473-3099(22)00424-8. Epub 2022 Sep 7.
PubMed 36087588

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

RecruitingPhase 4
Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases
Autoimmune Rheumatologic Disease
Active, not recruitingPhase 4
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
Meningitis, Meningococcal
Active, not recruitingPhase 3
Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections
Gonorrhea, Sexually Transmitted Infection
RecruitingPhase 4
Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons
Meningococcal Meningitis, Serogroup B, Transgender Persons
RecruitingPhase 1
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
Diphtheria, Tetanus and Acellular Pertussis, Epidemic Meningitis

All Meningococcal B Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 2, RANDOMIZED, CONTROLLED, OBSERVER-BLINDED STUDY CONDUCTED TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A NEISSERIA MENINGITIDIS SEROGROUP B BIVALENT RECOMBINANT LIPOPROTEIN 2086 VACCINE (BIVALENT RLP2086) WHEN ADMINISTERED TO HEALTHY TODDLERS AGED 12 TO <18 MONTHS OR 18 TO <24 MONTHS, AND THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086
ClinicalTrials.gov ID: NCT02534935
Acronym / sponsor ID: B1971035
Conditions: Meningococcal B Disease
Keywords: Phase 2 Immunogenicity, Safety, Tolerability Study, rLP2086 Vaccine, Healthy Toddlers, Neisseria meningitidis, Duration of Immunogenicity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 396 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 31 Aug 2015 (actual)
Primary completion: 21 Aug 2017 (actual)
Study completion: 17 Mar 2020 (actual)
First posted: 28 Aug 2015 (estimated)
Results: Posted 17 Apr 2018

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: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
rLP2086 vaccine	Experimental	Biological: rLP2086 vaccineArm stratified by age: ≥12 to <18 months and ≥18 to <24 months
Control	Active comparator	Biological: Pediatric HAV vaccineArm stratified by age: ≥12 to <18 months and ≥18 to <24 months

Who may qualify

Ages: 12 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male or female subject aged 12 to <15 months or 18 to <24 months during sentinel-cohort enrollment, Or,12 to <24 months during expanded-cohort enrollment.
Subjects must have received all vaccinations in the relevant National Immunization Program (NIP) for their age group.
Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.

Key exclusion criteria (12 listed)

Previous vaccination with any meningococcal serogroup B vaccine.
Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.
Contraindication to vaccination with any HAV vaccine or known latex allergy.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

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
rLP2086 vaccine60 mcg or 120mcg at 0, 2 and 6 months	Biological	rLP2086 vaccine
Pediatric HAV vaccine0.5-mL dose at months 0 and 6. Normal saline at month 2.	Biological	Control

Primary outcome

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3
Time frame: 1 month after Vaccination 3
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1
Time frame: within 7 Days after Vaccination 1
Local reactions included tenderness at injection site, swelling and redness collected by using an electronic diary (e-diary). Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 centimeter [cm]), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2
Time frame: within 7 Days after Vaccination 2
Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3
Time frame: within 7 Days after Vaccination 3
Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1
Time frame: within 7 Days after Vaccination 1
Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2
Time frame: within 7 Days after Vaccination 2
Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3
Time frame: within 7 Days after Vaccination 3
Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1
Time frame: within 30 Days after Vaccination 1
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2
Time frame: within 30 Days after Vaccination 2
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3
Time frame: within 30 Days after Vaccination 3
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination
Time frame: within 30 Days after any Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase
Time frame: From the Vaccination 1 up to 1 month after Vaccination 3
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase
Time frame: From 1 month after Vaccination 3 up to 6 months after Vaccination 3
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3
Time frame: From Vaccination 1 up to 6 months after Vaccination 3
An AE was any untoward medical occurrence in a participant who received investigational product 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/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC 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.

11 secondary outcomes

Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3
Time frame: 1, 6, 12, 24 months after Vaccination 3
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2
Time frame: 1 month (Mon) after Vaccination (Vac) 2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains
Time frame: Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains
Time frame: Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination
Time frame: Within 7 days after booster vaccination
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination
Time frame: Within 7 days after booster vaccination
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination
Time frame: Booster vaccination to 1 month after booster vaccination (T1), 1 month after booster vaccination to 6 months after booster vaccination (T2) and booster vaccination through 6 months after booster vaccination (T3)
Percentage of Participants With at Least 1 Adverse Event (AE) From Booster Vaccination to 1 Month After Booster Vaccination
Time frame: Booster vaccination up to 1 month after booster vaccination
Percentage of Participants With Immediate Adverse Event (IAE) After Booster Vaccination
Time frame: Within 30 minutes after booster vaccination
Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination
Time frame: Before booster vaccination and 1 month after booster vaccination
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination
Time frame: Before booster vaccination and 1 month after booster vaccination

Results and safety

Results posted to the registry on 17 Apr 2018, 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: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)	44	44
Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)	220	210
Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1	132	127

Primary outcome: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3

Time frame: 1 month after Vaccination 3. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n = 9	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n = 11	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n = 47	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n = 51	Group 3: HAV/Saline (>=12 Months to <18 Months) n = 31	Group 3: HAV/Saline (>=18 Months to <24 Months) n = 30
PMB80 [A22]	88.9 (51.8 to 99.7)	90.9 (58.7 to 99.8)	91.1 (78.8 to 97.5)	88.2 (76.1 to 95.6)	3.2 (0.1 to 16.7)	6.9 (0.8 to 22.8)
PMB2001 [A56]	100.0 (66.4 to 100.0)	100.0 (69.2 to 100.0)	100.0 (92.5 to 100.0)	100.0 (92.6 to 100.0)	0.0 (0.0 to 14.2)	3.3 (0.1 to 17.2)
PMB2948 [B24]	88.9 (51.8 to 99.7)	81.8 (48.2 to 97.7)	71.1 (55.7 to 83.6)	72.0 (57.5 to 83.8)	3.2 (0.1 to 16.7)	6.9 (0.8 to 22.8)
PMB2707 [B44]	88.9 (51.8 to 99.7)	90.0 (55.5 to 99.7)	87.2 (74.3 to 95.2)	85.1 (71.7 to 93.8)	0.0 (0.0 to 14.2)	0.0 (0.0 to 11.6)

Population analysed: All eligible participants randomized to study received,scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here,overall number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.

Primary outcome: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1

Time frame: within 7 Days after Vaccination 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n = 22	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n = 22	Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) n = 44	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n = 110	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n = 110	Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) n = 220	Group 3: HAV/Saline (>=12 Months to <18 Months) n = 66	Group 3: HAV/Saline (>=18 Months to <24 Months) n = 66	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n = 132
Tenderness at injection site: Any	68.2 (45.1 to 86.1)	50.0 (28.2 to 71.8)	59.1 (43.2 to 73.7)	50.9 (41.2 to 60.6)	64.5 (54.9 to 73.4)	57.7 (50.9 to 64.3)	15.2 (7.5 to 26.1)	19.7 (10.9 to 31.3)	17.4 (11.4 to 25.0)
Tenderness at injection site: Mild	45.5 (24.4 to 67.8)	27.3 (10.7 to 50.2)	36.4 (22.4 to 52.2)	27.3 (19.2 to 36.6)	34.5 (25.7 to 44.2)	30.9 (24.9 to 37.5)	12.1 (5.4 to 22.5)	19.7 (10.9 to 31.3)	15.9 (10.1 to 23.3)
Tenderness at injection site: Moderate	22.7 (7.8 to 45.4)	18.2 (5.2 to 40.3)	20.5 (9.8 to 35.3)	20.9 (13.7 to 29.7)	24.5 (16.8 to 33.7)	22.7 (17.4 to 28.8)	3.0 (0.4 to 10.5)	0.0 (0.0 to 5.4)	1.5 (0.2 to 5.4)
Tenderness at injection site: Severe	0.0 (0.0 to 15.4)	4.5 (0.1 to 22.8)	2.3 (0.1 to 12.0)	2.7 (0.6 to 7.8)	5.5 (2.0 to 11.5)	4.1 (1.9 to 7.6)	0.0 (0.0 to 5.4)	0.0 (0.0 to 5.4)	0.0 (0.0 to 2.8)
Redness: Any

Primary outcome: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2

Time frame: within 7 Days after Vaccination 2. Number (95% Confidence Interval). Unit: percentage of Participants

Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n = 22	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n = 22	Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) n = 44	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n = 105	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n = 107	Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) n = 212	Group 3: HAV/Saline (>=12 Months to <18 Months) n = 63	Group 3: HAV/Saline (>=18 Months to <24 Months) n = 65	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n = 128
Tenderness at injection site: Any	45.5 (24.4 to 67.8)	50.0 (28.2 to 71.8)	47.7 (32.5 to 63.3)	45.7 (36.0 to 55.7)	60.7 (50.8 to 70.0)	53.3 (46.3 to 60.2)	14.3 (6.7 to 25.4)	15.4 (7.6 to 26.5)	14.8 (9.2 to 22.2)
Tenderness at injection site: Mild	31.8 (13.9 to 54.9)	40.9 (20.7 to 63.6)	36.4 (22.4 to 52.2)	31.4 (22.7 to 41.2)	32.7 (24.0 to 42.5)	32.1 (25.8 to 38.8)	12.7 (5.6 to 23.5)	15.4 (7.6 to 26.5)	14.1 (8.6 to 21.3)
Tenderness at injection site: Moderate	13.6 (2.9 to 34.9)	9.1 (1.1 to 29.2)	11.4 (3.8 to 24.6)	12.4 (6.8 to 20.2)	24.3 (16.5 to 33.5)	18.4 (13.4 to 24.3)	1.6 (0.0 to 8.5)	0.0 (0.0 to 5.5)	0.8 (0.0 to 4.3)
Tenderness at injection site: Severe	0.0 (0.0 to 15.4)	0.0 (0.0 to 15.4)	0.0 (0.0 to 8.0)	1.9 (0.2 to 6.7)	3.7 (1.0 to 9.3)	2.8 (1.0 to 6.1)	0.0 (0.0 to 5.7)	0.0 (0.0 to 5.5)	0.0 (0.0 to 2.8)
Redness: Any

Primary outcome: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3

Time frame: within 7 Days after Vaccination 3. Number (95% Confidence Interval). Unit: percentage of Participants

Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n = 22	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n = 22	Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) n = 44	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n = 104	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n = 108	Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) n = 212	Group 3: HAV/Saline (>=12 Months to <18 Months) n = 65	Group 3: HAV/Saline (>=18 Months to <24 Months) n = 63	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n = 128
Tenderness at injection site: Any	54.5 (32.2 to 75.6)	59.1 (36.4 to 79.3)	56.8 (41.0 to 71.7)	51.9 (41.9 to 61.8)	62.0 (52.2 to 71.2)	57.1 (50.1 to 63.8)	16.9 (8.8 to 28.3)	14.3 (6.7 to 25.4)	15.6 (9.8 to 23.1)
Tenderness at injection site: Mild	22.7 (7.8 to 45.4)	40.9 (20.7 to 63.6)	31.8 (18.6 to 47.6)	29.8 (21.2 to 39.6)	34.3 (25.4 to 44.0)	32.1 (25.8 to 38.8)	12.3 (5.5 to 22.8)	12.7 (5.6 to 23.5)	12.5 (7.3 to 19.5)
Tenderness at injection site: Moderate	31.8 (13.9 to 54.9)	18.2 (5.2 to 40.3)	25.0 (13.2 to 40.3)	17.3 (10.6 to 26.0)	22.2 (14.8 to 31.2)	19.8 (14.7 to 25.8)	4.6 (1.0 to 12.9)	1.6 (0.0 to 8.5)	3.1 (0.9 to 7.8)
Tenderness at injection site: Severe	0.0 (0.0 to 15.4)	0.0 (0.0 to 15.4)	0.0 (0.0 to 8.0)	4.8 (1.6 to 10.9)	5.6 (2.1 to 11.7)	5.2 (2.6 to 9.1)	0.0 (0.0 to 5.5)	0.0 (0.0 to 5.7)	0.0 (0.0 to 2.8)
Redness: Any

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1	4 of 44 (9.1%)	43 of 44 (97.7%)	0 of 44
Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1	19 of 220 (8.6%)	209 of 220 (95%)	0 of 220
Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1	8 of 132 (6.1%)	113 of 132 (85.6%)	0 of 132
120-mcg Bivalent rLP2086: Stage 2 Booster Phase	2 of 147 (1.4%)	121 of 147 (82.3%)	0 of 147
Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up	3 of 220 (1.4%)	0 of 220 (0%)	0 of 220
Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up	0 of 132 (0%)	0 of 132 (0%)	0 of 132

Limitations and caveats (from the sponsor): The immunogenicity data at 36 and 48 months after vaccination 3 was not collected due to change in planned analysis as per latest protocol amendment, according to which blood draw of participants at 36 and 48 months after Vaccination 3 was removed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36087588Marshall HS, Vesikari T, Richmond PC, Wysocki J, Szenborn L, Beeslaar J, Maguire JD, Balmer P, O'Neill R, Anderson AS, Pregaldien JL, Maansson R, Jiang HQ, Perez JL. Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1-9 years: two phase 2 randomised, controlled, observer-blinded studies. Lancet Infect Dis. 2023 Jan;23(1):103-116. doi: 10.1016/S1473-3099(22)00424-8. Epub 2022 Sep 7.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Meningococcal B Disease

RecruitingPhase 4
Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases
Autoimmune Rheumatologic Disease
Active, not recruitingPhase 4
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
Meningitis, Meningococcal
Active, not recruitingPhase 3
Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections
Gonorrhea, Sexually Transmitted Infection
RecruitingPhase 4
Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons
Meningococcal Meningitis, Serogroup B, Transgender Persons
RecruitingPhase 1
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
Diphtheria, Tetanus and Acellular Pertussis, Epidemic Meningitis

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

25 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rLP2086 vaccine and Pediatric HAV vaccine in people with Meningococcal B Disease, run by Pfizer at 25 sites in 4 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 12 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 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Poland, Finland, Australia, Czechia. 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. 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 17 Apr 2018). 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 Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3 (time frame: 1 month after Vaccination 3). The study lists 14 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 NCT02534935, which also lists 1 linked publication.

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 27 Sep 2021.