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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00387569




Registration number
NCT00387569
Ethics application status
Date submitted
11/10/2006
Date registered
13/10/2006
Date last updated
8/05/2008

Titles & IDs
Public title
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
Scientific title
A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years
Secondary ID [1] 0 0
6108A1-502
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 - MnB vaccine rLP8026
Other interventions - MnB vaccine rLP8026
Other interventions - MnB vaccine rLP8026

Experimental: Cohort 1 - Experimental (20ug); Active Comparator/Placebo

Experimental: Cohort 2 - Experimental (60ug); Active Comparator/Placebo

Experimental: Cohort 3 - Experimental (200ug); Active Comparator/Placebo


Other interventions: MnB vaccine rLP8026
MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)

Other interventions: MnB vaccine rLP8026
MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)

Other interventions: MnB vaccine rLP8026
MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)

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

Outcomes
Primary outcome [1] 0 0
Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months
Timepoint [1] 0 0
Vaccinations at 0,1,6 months

Eligibility
Key inclusion criteria
Inclusion Criteria

- Aged 18- to 36-months

- Healthy male or female subjects
Minimum age
18 Months
Maximum age
36 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

- Prior vaccination with a serogroup B meningococcal vaccine

- Prior history of any invasive 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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
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)
WA
Recruitment hospital [1] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
6840 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study to assess the safety of an investigational meningitis vaccine in toddlers and their
immune response to it.
Trial website
https://clinicaltrials.gov/show/NCT00387569
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of 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