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Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.

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ClinicalTrials.gov Identifier: NCT00471081
Recruitment Status : Completed
First Posted : May 9, 2007
Results First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.

Condition or disease Intervention/treatment Phase
Infections, Meningococcal Biological: Meningococcal vaccine GSK134612 Phase 2

Detailed Description:
The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion & Exclusion criteria.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study to Assess Immunogenicity, Reactogenicity and Safety of Primary Vaccination With GSK Biologicals' MenACWY Vaccine (GSK134612) Given as 1 or 2 Doses to Healthy Toddlers 9-12 Months of Age
Study Start Date : July 5, 2007
Actual Primary Completion Date : October 23, 2008
Actual Study Completion Date : November 26, 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Single dose GSK134612.
Biological: Meningococcal vaccine GSK134612
One or 2 intramuscular injections.

Experimental: Group B
Two doses of GSK134612.
Biological: Meningococcal vaccine GSK134612
One or 2 intramuscular injections.




Primary Outcome Measures :
  1. Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value [ Time Frame: One month after the last dose (at Month 4) ]
    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.


Secondary Outcome Measures :
  1. Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value [ Time Frame: One month after the first dose (at Month 1) ]
    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.

  2. Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value [ Time Frame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4 ]
    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

  3. hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers [ Time Frame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4 ]
    Antibody titers were presented as geometric mean titers (GMTs).

  4. Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value [ Time Frame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4 ]
    The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.

  5. Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value [ Time Frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4 ]
    The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.

  6. rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers [ Time Frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4 ]
    Antibody titers were presented as geometric mean titers (GMTs).

  7. Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value [ Time Frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4 ]
    The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).

  8. Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value [ Time Frame: At Month 1 (GSK 134612 s doses Group only) and Month 4 ]
    The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).

  9. Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations [ Time Frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4 ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

  10. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

  11. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination ]
    Assessed solicited general symptoms were drowsiness, fever [defined as axillary, oral, tympanic or rectal temperature equal to or above (≥) 38 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  12. Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Up to 1 month post-vaccination ]
    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.

  13. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: Up to study end (Month 9) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  14. Number of Subjects With New Onset Chronic Ilnesses (NOCI) [ Time Frame: Up to study end (Month 9) ]
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

  15. Number of Subjects Reporting Rash [ Time Frame: Up to study end (Month 9) ]
    Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.

  16. Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits [ Time Frame: Up to study end (Month 9) ]
    Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
  • A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment.
  • Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site.
  • Written informed consent obtained from parents/guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.
  • Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination).
  • Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y.
  • History of meningococcal diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
  • A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • History of reactions or allergic disease 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 enrollment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471081


Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35205
United States, Arkansas
GSK Investigational Site
Benton, Arkansas, United States, 72015
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Antioch, California, United States, 94509
GSK Investigational Site
Fremont, California, United States, 94538
GSK Investigational Site
Hayward, California, United States, 94545
GSK Investigational Site
Madera, California, United States, 93637
GSK Investigational Site
Santa Rosa, California, United States, 95403
GSK Investigational Site
Vacaville, California, United States, 95688
United States, Colorado
GSK Investigational Site
Lakewood, Colorado, United States, 80226
GSK Investigational Site
Littleton, Colorado, United States, 80122
GSK Investigational Site
Littleton, Colorado, United States, 80234
GSK Investigational Site
Westminster, Colorado, United States, 80234
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Georgia
GSK Investigational Site
Birmingham, Georgia, United States, 35244
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16501
GSK Investigational Site
Greenville, Pennsylvania, United States, 16125
United States, Texas
GSK Investigational Site
Amarillo, Texas, United States, 79124
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 109375
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 109375
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 109375
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 109375
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 109375
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 109375
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 109375
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Klein N et al. Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Toddlers: 1-year Persistence. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00471081     History of Changes
Other Study ID Numbers: 109375
First Posted: May 9, 2007    Key Record Dates
Results First Posted: September 14, 2018
Last Update Posted: September 14, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Neisseria meningitidis;
Humans;
Meningococcal vaccines;
Safety
Vaccines, conjugate;
Toddlers;
Immunogenicity;

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs