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NCT00387725 Clinical Trial

Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00387725
Other study ID # 6108A1-501
Secondary ID B1971006
Status Completed
Phase Phase 2
First received October 11, 2006
Last updated November 14, 2014
Start date November 2006
Est. completion date February 2008

Study information
Verified date November 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial Summary

Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents

Recruitment information / eligibility
Status Completed
Enrollment 127
Est. completion date February 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 14 Years
Eligibility 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

Exclusion Criteria:

Exclusion Criteria

- Prior vaccination with a meningococcal B vaccine

- Prior meningococcal disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• rLP2086
Vaccine administered at 0, 1, and 6 months
• rLP2086
Vaccine administered at 0, 1, and 6 months
• rLP2086
Vaccine administered at 0, 1, and 6 months
• rLP2086
Vaccine administered at 0, 1, and 6 months

Locations
Country Name City State
Australia Royal Children's Hospital Herston Queensland
Australia Sir Albert Sakzewski Virus Research Centre (SASVRC) Herston
Australia Women's & Children's Hospital North Adelaide
Australia Sydney Children's Hospital Randwick New South Wales
Australia Princess Margaret Hospital for Children Subiaco Western Australia
Australia The Telethon Institute for Child Health Research Subiaco
Australia National Centre for Immunisation Westmead
Australia The Children's Hospital at Westmead Westmead New South Wales
Australia Department of Paediatrics and Child Health Woden

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 1 month after Dose 2 No
Primary Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 1 month after Dose 3 No
Primary Percentage of Participants With at Least One Adverse Event (AE) Dose 1 up to 1 month after Dose 3 Yes
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