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

Phase 2

Completed

• Conditions: Infections, Meningococcal
• Interventions: Biological: Meningococcal vaccine GSK134612

• Registration Number: NCT00471081
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2007-05-08
• Study First Submitted QC: 2007-05-08
• Study First Posted: 2007-05-09
• Study Start: 2007-07-05
• Primary Completion: 2008-10-23
• Study Completion: 2008-11-26
• Disposition First Submitted: 2009-09-03
• Disposition First Submitted QC: 2009-09-03
• Disposition First Posted: 2009-09-04
• Results First Submitted: 2017-03-09
• Results First Submitted QC: 2018-08-16
• Results First Posted: 2018-09-14
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Meningococcal vaccine GSK134612	Single dose GSK134612.
Group B	Meningococcal vaccine GSK134612	Two doses of GSK134612.

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers	At Month 1 (for GSK 134612 2 doses Group only) and Month 4	Antibody titers were presented as geometric mean titers (GMTs).
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	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.
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	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.
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	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.
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers	At Month 1 (GSK 134612 2 doses Group only) and Month 4	Antibody titers were presented as geometric mean titers (GMTs).
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	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).
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	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).
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations	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).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	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.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	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.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	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.
Number of Subjects With Serious Adverse Events (SAEs)	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.
Number of Subjects With New Onset Chronic Ilnesses (NOCI)	Up to study end (Month 9)	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects Reporting Rash	Up to study end (Month 9)	Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits	Up to study end (Month 9)	Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Amarillo, Texas, United States