Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children

October 29, 2019 updated by: GlaxoSmithKline

Non-inferiority of GSK Biologicals' Meningococcal Vaccine (GSK134612) Compared to Licensed MenC-CRM197 Conjugate Vaccine in Healthy Children

The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study has 2 study groups. One group will receive one dose of GSK Biologicals' vaccine GSK 134612 and the other group will receive one dose of licensed MenC-CRM197 vaccine. All subjects will have 2 blood samples taken: just before vaccination and one month after vaccination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
414

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Draguignan, France, 83300
        • GSK Investigational Site
      • Laon, France, 02000
        • GSK Investigational Site
      • Le Havre, France, 76600
        • GSK Investigational Site
      • Lingolsheim, France, 67380
        • GSK Investigational Site
      • Miribel, France, 01700
        • GSK Investigational Site
      • Nice, France, 06300
        • GSK Investigational Site
      • Paris, France, 75015
        • GSK Investigational Site
      • Saint Laurent du Var, France, 06700
        • GSK Investigational Site
      • Tours, France, 37000
        • GSK Investigational Site
      • Vaulx en Velin, France, 69120
        • GSK Investigational Site
      • Vence, France, 06140
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10315
        • GSK Investigational Site
      • Berlin, Germany, 13055
        • GSK Investigational Site
      • Berlin, Germany, 14197
        • GSK Investigational Site
      • Berlin, Germany, 10627
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Tettnang, Baden-Wuerttemberg, Germany, 88069
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Germany, 81735
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81241
        • GSK Investigational Site
      • Noerdlingen, Bayern, Germany, 86720
        • GSK Investigational Site
      • Olching, Bayern, Germany, 82140
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Detmold, Nordrhein-Westfalen, Germany, 32756
        • GSK Investigational Site
      • Espelkamp, Nordrhein-Westfalen, Germany, 32339
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, Germany, 47574
        • GSK Investigational Site
      • Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
        • GSK Investigational Site
      • Hille, Nordrhein-Westfalen, Germany, 32479
        • GSK Investigational Site
      • Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
        • GSK Investigational Site
      • Solingen, Nordrhein-Westfalen, Germany, 42719
        • GSK Investigational Site
      • Velbert, Nordrhein-Westfalen, Germany, 42551
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Frankenthal, Rheinland-Pfalz, Germany, 67227
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54290
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects whose parents/guardians, the investigator believes can and will comply with the requirements of the protocol.
  • A male or female between, and including, 2 and 10 years of age at the time of the vaccination.
  • Written informed consent obtained from the parent(s) or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the study vaccine dose, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose..
  • Administration of a vaccine not foreseen by the study protocol during the period starting from one month before the dose of the study vaccine and ending 30 days after.
  • Concurrently participating in another clinical study or planned participation 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.
  • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W-135 and/or Y (for subjects below 6 years) or within the last five years (for subjects 6 years old and above).
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and/or Y.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment
  • Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccine dose or planned administration during the study period.

Exclusion criteria for specified regions in France

  • Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135, or
  • Subjects living in a geographic area in France where local outbreak with meningococcal serogroup C has occurred and would thus be likely to participate in a vaccination campaign against meningococcal serogroup C.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Nimenrix Group
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
Biological: GSK Biologicals' meningococcal vaccine GSK134612
Intramuscular administration, 1 dose
ACTIVE_COMPARATOR: Menjugate Group
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
Biological: Menjugate
Intramuscular administration, 1 dose
Other Names:
  • MenC-CRM197vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody
Time Frame: One month after vaccination (Month 1)
Vaccine response to MenC was defined as: -for initially seronegative subjects [i.e. rSBA-MenC titer below (<) 1:8], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
One month after vaccination (Month 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time Frame: During the 31-day (Days 0-30) post-vaccination period
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During the 31-day (Days 0-30) post-vaccination period
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
Time Frame: Prior to (Month 0) and one month after vaccination (Month 1)
Antibody titers were presented as geometric mean titers (GMTs).
Prior to (Month 0) and one month after vaccination (Month 1)
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
Time Frame: Prior to (Month 0) and one month after vaccination (Month 1)
Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations were presented as geometric mean concentrations (GMCs) and tabulated as micrograms per milliliter (μg/mL).
Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms
Time Frame: During the 4-day (Days 0-3) post-vaccination period
Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = cried when limb was moved/spontaneously painful. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 30 millimeters (mm).
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms
Time Frame: During the 4-day (Days 0-3) post-vaccination period
Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 50 millimeters (mm).
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Time Frame: During the 4-day (Days 0-3) post-vaccination period
Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Time Frame: During the 4-day (Days 0-3) post-vaccination period
Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Specific Adverse Events
Time Frame: Up to 6 months after vaccination (Month 6)
Specific AEs included: - rash (hives, idiopathic thrombocytopenic purpura, petechiae); - new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies); - conditions prompting emergency room (ER) visits.
Up to 6 months after vaccination (Month 6)
Number of Subjects With Any Serious Adverse Events (SAEs)
Time Frame: Up to six months after vaccination (Month 6)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Up to six months after vaccination (Month 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 111414
  • 2007-007837-38 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Dataset Specification
    Information identifier: 111414
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: 111414
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 111414
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: 111414
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 111414
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: 111414
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: 111414
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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