Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
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
2 other identifiers
interventional
127
1 country
9
Brief Summary
Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 healthy
Started Nov 2006
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2006
CompletedFirst Posted
Study publicly available on registry
October 13, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
November 21, 2014
CompletedNovember 21, 2014
November 1, 2014
1.2 years
October 11, 2006
November 14, 2014
November 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2
1 month after Dose 2
Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3
1 month after Dose 3
Percentage of Participants With at Least One Adverse Event (AE)
Dose 1 up to 1 month after Dose 3
Study Arms (4)
Group A
EXPERIMENTAL20ug Experimental
Group 2
EXPERIMENTAL60ug Experimental
Group 3
EXPERIMENTAL200ug Experimental
Group 4
ACTIVE COMPARATORActive comparator
Interventions
Eligibility Criteria
You may qualify if:
- Aged 8 to 14 years at the time of enrollment.
- Healthy male or female subjects
- Negative urine pregnancy test for female subjects
You may not qualify if:
- Prior vaccination with a meningococcal B vaccine
- Prior meningococcal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (9)
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
Royal Children's Hospital
Herston, Queensland, 4006, Australia
Princess Margaret Hospital for Children
Subiaco, Western Australia, 6008, Australia
Sir Albert Sakzewski Virus Research Centre (SASVRC)
Herston, QLD 4006, Australia
Women's & Children's Hospital
North Adelaide, SA 5006, Australia
The Telethon Institute for Child Health Research
Subiaco, WA 6008, Australia
National Centre for Immunisation
Westmead, NSW 2145, Australia
Department of Paediatrics and Child Health
Woden, ACT 2606, Australia
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2006
First Posted
October 13, 2006
Study Start
November 1, 2006
Primary Completion
January 1, 2008
Study Completion
February 1, 2008
Last Updated
November 21, 2014
Results First Posted
November 21, 2014
Record last verified: 2014-11