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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02534935




Registration number
NCT02534935
Ethics application status
Date submitted
23/02/2015
Date registered
28/08/2015
Date last updated
17/06/2020

Titles & IDs
Public title
Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Scientific 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
Secondary ID [1] 0 0
2011-004400-38
Secondary ID [2] 0 0
B1971035
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningococcal B Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - rLP2086 vaccine
Other interventions - Pediatric HAV vaccine

Experimental: rLP2086 vaccine - Arm stratified by age:
=12 to <18 months and =18 to <24 months

Active Comparator: Control - Arm stratified by age:
=12 to <18 months and =18 to <24 months


Other interventions: rLP2086 vaccine
60 mcg or 120mcg at 0, 2 and 6 months

Other interventions: Pediatric HAV vaccine
0.5-mL dose at months 0 and 6. Normal saline at month 2.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
1 month after Vaccination 3
Primary outcome [2] 0 0
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).
Timepoint [2] 0 0
within 7 Days after Vaccination 1
Primary outcome [3] 0 0
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).
Timepoint [3] 0 0
within 7 Days after Vaccination 2
Primary outcome [4] 0 0
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).
Timepoint [4] 0 0
within 7 Days after Vaccination 3
Primary outcome [5] 0 0
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).
Timepoint [5] 0 0
within 7 Days after Vaccination 1
Primary outcome [6] 0 0
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).
Timepoint [6] 0 0
within 7 Days after Vaccination 2
Primary outcome [7] 0 0
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).
Timepoint [7] 0 0
within 7 Days after Vaccination 3
Primary outcome [8] 0 0
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.
Timepoint [8] 0 0
within 30 Days after Vaccination 1
Primary outcome [9] 0 0
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.
Timepoint [9] 0 0
within 30 Days after Vaccination 2
Primary outcome [10] 0 0
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.
Timepoint [10] 0 0
within 30 Days after Vaccination 3
Primary outcome [11] 0 0
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.
Timepoint [11] 0 0
within 30 Days after any Vaccination
Primary outcome [12] 0 0
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.
Timepoint [12] 0 0
From the Vaccination 1 up to 1 month after Vaccination 3
Primary outcome [13] 0 0
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.
Timepoint [13] 0 0
From 1 month after Vaccination 3 up to 6 months after Vaccination 3
Primary outcome [14] 0 0
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC)Throughout the Study - 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.
Timepoint [14] 0 0
From Vaccination 1 up to 6 months after Vaccination 3
Secondary outcome [1] 0 0
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month 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).
Timepoint [1] 0 0
1 Month After Vaccination 3
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
1 month (Mon) after Vaccination (Vac) 2
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3)
Secondary outcome [4] 0 0
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains
Timepoint [4] 0 0
Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3)

Eligibility
Key inclusion criteria
- 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.
Minimum age
12 Months
Maximum age
24 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

- 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Canberra, Garran
Recruitment hospital [2] 0 0
Australian Clinical Research Network (ACRN) - Maroubra
Recruitment hospital [3] 0 0
Maroubra Medical Centre - Maroubra
Recruitment hospital [4] 0 0
Women's And Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Subiaco
Recruitment postcode(s) [1] 0 0
2605 - Canberra, Garran
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Jindrichuv Hradec
Country [2] 0 0
Czechia
State/province [2] 0 0
Praha 6 - Vokovice
Country [3] 0 0
Czechia
State/province [3] 0 0
Tynec Nad Sazavou
Country [4] 0 0
Finland
State/province [4] 0 0
Espoo
Country [5] 0 0
Finland
State/province [5] 0 0
Helsinki
Country [6] 0 0
Finland
State/province [6] 0 0
Jarvenpaa
Country [7] 0 0
Finland
State/province [7] 0 0
Pori
Country [8] 0 0
Finland
State/province [8] 0 0
Tampere
Country [9] 0 0
Finland
State/province [9] 0 0
Turku
Country [10] 0 0
Poland
State/province [10] 0 0
Bydgoszcz
Country [11] 0 0
Poland
State/province [11] 0 0
Debica
Country [12] 0 0
Poland
State/province [12] 0 0
Krakow
Country [13] 0 0
Poland
State/province [13] 0 0
Lodz
Country [14] 0 0
Poland
State/province [14] 0 0
Lublin
Country [15] 0 0
Poland
State/province [15] 0 0
Siemianowice Slaskie
Country [16] 0 0
Poland
State/province [16] 0 0
Trzebnica
Country [17] 0 0
Poland
State/province [17] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02534935
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications