NCT01641042

Brief Summary

The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2012

Geographic Reach
2 countries

16 active sites

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

First Submitted

Initial submission to the registry

July 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 10, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2015

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 18, 2017

Completed
Last Updated

October 18, 2017

Status Verified

March 1, 2017

Enrollment Period

2.1 years

First QC Date

July 12, 2012

Results QC Date

September 21, 2017

Last Update Submit

September 21, 2017

Conditions

Infections, Meningococcal

Keywords

Meningococcal vaccinesVaccines, conjugateNeisseria meningitidisImmunocompromised patient

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies

    Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects \[i.e. pre-vaccination rSBA antibody titers below (\<) 1:8\] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).

    One month after the first vaccine dose (at Month 1)

  • Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies

    Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).

    One month after the first vaccine dose (at Month 1)

Secondary Outcomes (19)

  • Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies

    One month after the second vaccine dose (At Month 3)

  • Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies

    One month after the second vaccine dose (At Month 3)

  • Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values

    At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

  • Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values

    Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3

  • Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens

    At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

  • +14 more secondary outcomes

Study Arms (2)

Healthy Group

EXPERIMENTAL

The subjects in the Healthy group will be age-matched to the subjects in the At-risk group. Subjects will receive 2 doses of the investigational vaccine.

Biological: Meningococcal vaccine GSK134612

At-risk Group

EXPERIMENTAL

This group includes subjects with medical conditions placing them at an increased risk for meningococcal disease. Subjects will receive 2 doses of the investigational vaccine.

Biological: Meningococcal vaccine GSK134612

Interventions

Meningococcal vaccine GSK134612BIOLOGICAL

2 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.

At-risk GroupHealthy Group

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
  • A male or female 1 to 17 years of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if
  • the subject has practiced adequate contraception for one month (30 days) prior to the first vaccine dose, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception from administration of the first vaccine dose until 2 months after administration of the second vaccine dose.
  • Healthy subject as established by medical history and clinical examination before entering into the study.
  • Age-matched to a subject from the At-risk group according to age strata 1-5 years, 6-10 years and 11 to 17 years.

You may not qualify if:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (until the phone contact at Month 8).
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before administration of each study vaccine dose until 30 days after administration of each study vaccine dose. Administration of licensed inactivated influenza vaccines is allowed as per local recommendations.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of meningococcal disease.
  • Any confirmed or suspected Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine until one month after the second dose of study vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine including latex.
  • Major congenital defects.
  • History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
  • Acute disease and/or fever at the time of enrolment.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Vaccination against meningococcal disease of any serogroup
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

GSK Investigational Site

Antioch, California, 94509, United States

Location

GSK Investigational Site

Daly City, California, 94015, United States

Location

GSK Investigational Site

Fremont, California, 94538, United States

Location

GSK Investigational Site

Hayward, California, 94545, United States

Location

GSK Investigational Site

Oakland, California, 94611, United States

Location

GSK Investigational Site

Redwood City, California, 94063, United States

Location

GSK Investigational Site

Roseville, California, 95661, United States

Location

GSK Investigational Site

Sacramento, California, 95815, United States

Location

GSK Investigational Site

Sacramento, California, 95823, United States

Location

GSK Investigational Site

Santa Clara, California, 95051, United States

Location

GSK Investigational Site

Santa Rosa, California, 95403, United States

Location

GSK Investigational Site

Vallejo, California, 94589, United States

Location

GSK Investigational Site

Durham, North Carolina, 27704, United States

Location

GSK Investigational Site

Durham, North Carolina, 27705, United States

Location

GSK Investigational Site

Brno, 613 00, Czechia

Location

GSK Investigational Site

Hradec Králové, 500 02, Czechia

Location

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 16, 2012

Study Start

September 10, 2012

Primary Completion

October 10, 2014

Study Completion

March 3, 2015

Last Updated

October 18, 2017

Results First Posted

October 18, 2017

Record last verified: 2017-03

Locations

US(14)CZ(2)