Study Evaluating Safety & Immunogenicity of rLP2086 Vacci... | NCT00387725

ID	Type	Description	Link
B1971006	Other Identifier	Alias Study Number

Study Evaluating Safety & Immunogenicity of rLP2086 Vacci... | NCT00387725 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	20ug Experimental	Biological: rLP2086
Group 2	Experimental	60ug Experimental	Biological: rLP2086
Group 3	Experimental	200ug Experimental	Biological: rLP2086
Group 4	Active Comparator	Active comparator	Biological: rLP2086

Name	Type	Description	Arm Group Labels	Other Names
rLP2086	Biological	Vaccine administered at 0, 1, and 6 months	Group 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sydney Children's Hospital		Randwick	New South Wales	2031	Australia
The Children's Hospital at Westmead

Label	URL
To obtain contact information for a study center near you, click here.	View source

Arm/Group Information

ID	Title	Description
FG000	Twinrix	Given on a 0, 1-, 6- month schedule
FG001	Initial Formulation rLP2086 20 mcg	Given on a 0, 1-, 6- month schedule
FG002	Initial Formulation rLP2086 60 mcg	Given on a 0, 1-, 6- month schedule
FG003	Initial Formulation rLP2086 200 mcg	Given on a 0, 1-, 6- month schedule

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00021 subjects FG00116 subjects FG00245 subjects FG00345 subjects
COMPLETED		FG00020 subjects FG00115 subjects FG00243 subjects FG00343 subjects
NOT COMPLETED		FG0001 subjects FG0011 subjects FG0022 subjects FG0032 subjects

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Baseline Characteristics Module

ID	Title	Description
BG000	Twinrix	Given on a 0, 1-, 6- month schedule
BG001	Initial Formulation rLP2086 20 mcg	Given on a 0, 1-, 6- month schedule

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2

Posted

Number

percentage of participants

1 month after Dose 2

ID	Title	Description
OG000	Twinrix	Given on a 0, 1-, 6- month schedule
OG001	Initial Formulation rLP2086 20 mcg	Given on a 0, 1-, 6- month schedule
OG002	Initial Formulation rLP2086 60 mcg	Given on a 0, 1-, 6- month schedule

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Twinrix	Given on a 0, 1-, 6- month schedule

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Pfizer ClinicalTrials.gov Call Center	Pfizer, Inc.	1-800-718-1021		ClinicalTrials.gov_Inquiries@pfizer.com

ID	Term
C484699	factor H-binding protein, Neisseria meningitidis

Title

Denominators