NCT00387569

Brief Summary

A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 8, 2008

Status Verified

May 1, 2008

Enrollment Period

1.4 years

First QC Date

October 11, 2006

Last Update Submit

May 6, 2008

Conditions

Healthy

Keywords

ToddlersVaccineSafety

Outcome Measures

Primary Outcomes (1)

  • Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months

    Vaccinations at 0,1,6 months

Study Arms (3)

Cohort 1

EXPERIMENTAL

Experimental (20ug); Active Comparator/Placebo

Biological: MnB vaccine rLP8026

Cohort 2

EXPERIMENTAL

Experimental (60ug); Active Comparator/Placebo

Biological: MnB vaccine rLP8026

Cohort 3

EXPERIMENTAL

Experimental (200ug); Active Comparator/Placebo

Biological: MnB vaccine rLP8026

Interventions

MnB vaccine rLP8026BIOLOGICAL

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

Cohort 1

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 18- to 36-months
  • Healthy male or female subjects

You may not qualify if:

  • Prior vaccination with a serogroup B meningococcal vaccine
  • Prior history of any invasive meningococcal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Perth, Western Australia, 6840, Australia

Location

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Australia, medinfo@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 11, 2006

First Posted

October 13, 2006

Study Start

October 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

May 8, 2008

Record last verified: 2008-05

Locations

AU(1)