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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00387725




Registration number
NCT00387725
Ethics application status
Date submitted
11/10/2006
Date registered
13/10/2006
Date last updated
21/11/2014

Titles & IDs
Public title
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
Scientific title
A Randomized, Observer-blinded, Parallel-group, Active-control, Phase ½ Trial Of The Safety, Immunogenicity, And Tolerability Of 20 Mg, 60 Mg, And 200 Mg Of Meningococcal Group B Rlp2086 Vaccine In Healthy Children And Adolescents Aged 8 To 14 Years
Secondary ID [1] 0 0
B1971006
Secondary ID [2] 0 0
6108A1-501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

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

Experimental: Group A - 20ug Experimental

Experimental: Group 2 - 60ug Experimental

Experimental: Group 3 - 200ug Experimental

Active Comparator: Group 4 - Active comparator


Other interventions: rLP2086
Vaccine administered at 0, 1, and 6 months

Other interventions: rLP2086
Vaccine administered at 0, 1, and 6 months

Other interventions: rLP2086
Vaccine administered at 0, 1, and 6 months

Other interventions: rLP2086
Vaccine administered at 0, 1, and 6 months
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2
Timepoint [1] 0 0
1 month after Dose 2
Primary outcome [2] 0 0
Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3
Timepoint [2] 0 0
1 month after Dose 3
Primary outcome [3] 0 0
Percentage of Participants With at Least One Adverse Event (AE)
Timepoint [3] 0 0
Dose 1 up to 1 month after Dose 3

Eligibility
Key inclusion criteria
Inclusion Criteria

- Aged 8 to 14 years at the time of enrollment.

- Healthy male or female subjects

- Negative urine pregnancy test for female subjects
Minimum age
8 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Prior vaccination with a meningococcal B vaccine

- Prior meningococcal disease

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 assessing the outcomes
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
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
Accrual to date
Final
127
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Herston
Recruitment hospital [4] 0 0
Princess Margaret Hospital for Children - Subiaco
Recruitment hospital [5] 0 0
Sir Albert Sakzewski Virus Research Centre (SASVRC) - Herston
Recruitment hospital [6] 0 0
Women's & Children's Hospital - North Adelaide
Recruitment hospital [7] 0 0
The Telethon Institute for Child Health Research - Subiaco
Recruitment hospital [8] 0 0
National Centre for Immunisation - Westmead
Recruitment hospital [9] 0 0
Department of Paediatrics and Child Health - Woden
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4006 - Herston
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment postcode(s) [5] 0 0
QLD 4006 - Herston
Recruitment postcode(s) [6] 0 0
SA 5006 - North Adelaide
Recruitment postcode(s) [7] 0 0
WA 6008 - Subiaco
Recruitment postcode(s) [8] 0 0
NSW 2145 - Westmead
Recruitment postcode(s) [9] 0 0
ACT 2606 - Woden

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

Ethics approval
Ethics application status

Summary
Brief summary
Study to evaluate the safety of an investigational meningitis vaccine and the immune response
to it in adolescents
Trial website
https://clinicaltrials.gov/ct2/show/NCT00387725
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00387725