Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612

Phase 2

Completed

• Conditions: Infections, Meningococcal
• Interventions: Biological: Mencevax™ ACWY; Biological: GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix); Biological: Meningitec™

• Registration Number: NCT00427908
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination.

Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.

Detailed Description

Subjects will be enrolled in 3 age strata. Subjects including and above two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Mencevax™ ACWY, subjects below two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Meningitec™. All subjects will have 7 blood samples taken: prior and one month after vaccination and one, two, three, four and five years after vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Study Timeline

• Study First Submitted: 2007-01-26
• Study First Submitted QC: 2007-01-26
• Study First Posted: 2007-01-29
• Study Start: 2007-02-07
• Primary Completion: 2007-12-03
• Study Completion: 2007-12-03
• Disposition First Submitted: 2012-08-02
• Disposition First Submitted QC: 2012-08-02
• Disposition First Posted: 2012-08-07
• Results First Submitted: 2017-05-04
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-08
• Last Update Submitted: 2018-05-08
• Results First Posted: 2018-06-04
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 613

Inclusion Criteria

• Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol.
• A male or female between, and including, 1 through 10 years of age at the time of vaccination.
• Written informed consent obtained from the parent 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.

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Exclusion Criteria

For the primary phase:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, 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 one month of the dose of vaccine(s).
• Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
• Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
• Previous vaccination with tetanus toxoid containing vaccine within the last 28 days.
• History of meningococcal disease due to serogroup A, C, W, or Y.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• 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 first dose of study vaccine or planned administration during the study period.

For the long term persistence phase:

• History of meningococcal serogroup A, C, W, and/or Y disease.
• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Mencevax™ ACWY	Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.
Group B	Meningitec™	Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.
Group A	GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)	All subjects received GSK Biolgicals' meningococcal vaccine 134612.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value	One month after vaccination [PI(M1)]	The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
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) Antibodies Vaccine Response	One Month after vaccination	Vaccine response was defined as: * for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32; * for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value	One month after vaccination [PI(M1)]	The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values	Prior to (PRE) and one month after vaccination [PI(M1)]	The cut-off value for the rSBA titers were greater than or equal to ≥ 1:8 and ≥ 1:128. These analyses were performed by the GSK Biologicals' laboratory.
Anti-PS Antibody Concentrations	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]	Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).
Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value	Prior to (PRE) and one month after vaccination [PI(M1)]	The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Anti-TT Antibody Concentrations	Prior to (PRE) and one month post vaccination [PI(M1)]	Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value	Prior to (PRE) and one month after vaccination [PI(M1)]	The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]	The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value	Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]	The cut-off value for the hSBA titers was greater or equal to (≥) 1:4.
Number of Subjects With Solicited Local Symptoms	During the 4-day (Day 0-3) follow-up period	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) (1 - \< 2 years of age and 2 - \< 6 years of age groups) and 50 mm (6 - \< 11 years of age groups) of injection site, respectively.
rSBA Antibody Titers	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and at Persistence Year 5 [PI(M60)]	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
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	Prior to (PRE) and one month after vaccination [PI(M1)]	The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]	The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]	The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
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-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value	Prior to (PRE) and one month after vaccination [PI(M1)]	The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)	From administration of the vaccine dose until 6 months later	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects With Anti-TT Antibody Concentrations	Prior to (PRE) and one month after vaccination [PI(M1)]	Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]	The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]	The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Number of Subjects With Solicited General Symptoms	During the 4-day (Day 0-3) follow-up period	Assessed solicited general symptoms were drowsiness, fever \[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\], 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 \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit	From administration of the vaccine dose until 6 months later	Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.
Number of Subjects With Serious Adverse Events (SAEs)	Up to 6 Months after vaccination	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 Rash	From administration of the vaccine dose until 6 months later	Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
hSBA Antibody Titers	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]	Antibody titers are presented as geometric mean titers (GMTs).
rSBA Antibody Titers (HPA Laboratory Assay)	At Persistence Year 4 [PI(M48)]	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
Number of Subjects With Unsolicited AEs	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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With SAE(s)	From 6 Months following vaccination up to Year 5	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Trial Locations

Locations (1)

GSK Investigational Site; 🇫🇮 Vantaa, Finland