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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02534935
Ethics application status
Date submitted
23/02/2015
Date registered
28/08/2015

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
Treatment: Other - rLP2086 vaccine
Treatment: Other - 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


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

Treatment: Other: Pediatric HAV vaccine
0.5-mL dose at months 0 and 6. Normal saline at month 2.
Intervention code [1] 0 0
Treatment: Other
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
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
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
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
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
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
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
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
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
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
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
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
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
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) From Vaccination 1 up to 6 Months After Vaccination 3
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 at 1, 6, 12, and 24 Months After Vaccination 3
Timepoint [1] 0 0
1, 6, 12, 24 months 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
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), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)
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), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)
Secondary outcome [5] 0 0
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination
Timepoint [5] 0 0
Within 7 days after booster vaccination
Secondary outcome [6] 0 0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination
Timepoint [6] 0 0
Within 7 days after booster vaccination
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
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)
Secondary outcome [8] 0 0
Percentage of Participants With at Least 1 Adverse Event (AE) From Booster Vaccination to 1 Month After Booster Vaccination
Timepoint [8] 0 0
Booster vaccination up to 1 month after booster vaccination
Secondary outcome [9] 0 0
Percentage of Participants With Immediate Adverse Event (IAE) After Booster Vaccination
Timepoint [9] 0 0
Within 30 minutes after booster vaccination
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Before booster vaccination and 1 month after booster vaccination
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Before booster vaccination and 1 month after booster vaccination

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
Sex
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
31/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/03/2020
Sample size
Target
Accrual to date
Final
396
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
Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital - Nedlands
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
6009 - Nedlands
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02534935