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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - rLP2086
Treatment: Other - rLP2086
Treatment: Other - rLP2086
Treatment: Other - rLP2086

Experimental: Group A - 20ug Experimental

Experimental: Group 2 - 60ug Experimental

Experimental: Group 3 - 200ug Experimental

Active comparator: Group 4 - Active comparator


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

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

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

Treatment: Other: rLP2086
Vaccine administered at 0, 1, and 6 months
Intervention code [1] 0 0
Treatment: Other
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
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/NCT00387725