Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00808028




Registration number
NCT00808028
Ethics application status
Date submitted
12/12/2008
Date registered
15/12/2008
Date last updated
14/04/2015

Titles & IDs
Public title
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
Scientific title
A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years
Secondary ID [1] 0 0
B1971005
Secondary ID [2] 0 0
6108A1-2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningitis, Meningococcal 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - meningococcal B rLP2086 vaccine.
Treatment: Other - meningococcal B rLP2086 vaccine.
Treatment: Other - meningococcal B rLP2086 vaccine.
Other interventions - normal saline (placebo)

Experimental: 1 - dose level 1 rLP2086 vaccine

Experimental: 2 - dose level 2 rLP2086 vaccine

Experimental: 3 - dose level 3 rLP2086 vaccine

Placebo comparator: 4 - normal saline (placebo)


Treatment: Other: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

Treatment: Other: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

Treatment: Other: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

Other interventions: normal saline (placebo)
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
Timepoint [1] 0 0
Before vaccination 1 up to 1 month after vaccination 2
Primary outcome [2] 0 0
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
Timepoint [2] 0 0
Before vaccination 1 up to 1 month after vaccination 3
Primary outcome [3] 0 0
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Timepoint [3] 0 0
Vaccination 1 upto 1 Month after vaccination 3
Primary outcome [4] 0 0
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
Timepoint [4] 0 0
6 month after vaccination 3 up to 48 months
Secondary outcome [1] 0 0
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
Timepoint [1] 0 0
1 month before vaccination 1, 1 month after vaccination 2, 3

Eligibility
Key inclusion criteria
* Healthy male or female subjects between the ages of >=11 and <=18 years at the time of enrollment.
* Negative urine pregnancy test for all female subjects.
* Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
Minimum age
11 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of any invasive meningococcal disease.
* A previous anaphylactic or severe vaccine-associated adverse reaction.
* Any clinically significant chronic disease.
* A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
* Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

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?



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
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
538
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Queensland Paediatric Infectious Diseases (QPID) Laboratory - Herston
Recruitment hospital [2] 0 0
Department of Paediatrics, Women's & Children's Hospital - North Adelaide
Recruitment hospital [3] 0 0
Royal Children's Hospital - Carlton
Recruitment hospital [4] 0 0
Children's Clinical Research Facility, Vaccine Trials Group (VTG), - Subiaco
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Poland
State/province [1] 0 0
Debica
Country [2] 0 0
Poland
State/province [2] 0 0
Krakow
Country [3] 0 0
Poland
State/province [3] 0 0
Leczna
Country [4] 0 0
Poland
State/province [4] 0 0
Lodz
Country [5] 0 0
Poland
State/province [5] 0 0
Lubartow
Country [6] 0 0
Poland
State/province [6] 0 0
Lublin
Country [7] 0 0
Poland
State/province [7] 0 0
Melno
Country [8] 0 0
Poland
State/province [8] 0 0
Oborniki Slaskie
Country [9] 0 0
Poland
State/province [9] 0 0
Poznan
Country [10] 0 0
Poland
State/province [10] 0 0
Siemianowice Slaskie
Country [11] 0 0
Poland
State/province [11] 0 0
Torun
Country [12] 0 0
Poland
State/province [12] 0 0
Trzebnica
Country [13] 0 0
Poland
State/province [13] 0 0
Wroclaw
Country [14] 0 0
Spain
State/province [14] 0 0
La Coruna
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Spain
State/province [16] 0 0
Pontevedra
Country [17] 0 0
Spain
State/province [17] 0 0
Almeria
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Valencia

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00808028