Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine

GlaxoSmithKline793 enrolled

Overview

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Multicentre study with 4 parallel groups. One group will receive GSK134612 co-administered with Infanrix hexa™, two groups will receive sequential administration of GSK134612 and Infanrix hexa™ and the final group will receive Meningitec™. For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination. For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after vaccination.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

793

Conditions

Infections, Meningococcal

Interventions

Meningococcal vaccine GSK134612BIOLOGICAL

Single dose intramuscular injection

Infanrix™ hexaBIOLOGICAL

Single dose intramuscular injection

Meningitec™BIOLOGICAL

Single dose intramuscular injection

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 23 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 12 and 23 months of age at the time of the first 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. * Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination. Exclusion Criteria: * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first 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 first vaccine dose. * Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s). * Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y. * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y. * Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis or Haemophilus influenzae type b. * History of meningococcal disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination. * History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * 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. Additional criteria for subjects receiving Infanrix hexa™ * Hypersensitivity reaction due to previous vaccination with Infanrix hexa™. * Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.

Locations (89)

Outcomes

Primary Outcomes

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

The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.

Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1)

Anti-PT, Anti-FHA and Anti-PRN Concentrations

The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: 1 month after the first vaccination (Month 1)

Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off

The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).

Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1)

Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off

The cut-off for the assay was ≥ 1μg/mL.

Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1)

Secondary Outcomes

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

The cut-off values for the assay were ≥ 1:8 and ≥ 1:128

Time frame: At month 0, month 1 and month 2

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers

The results were tabulated as geometric mean expressed in titers.

Time frame: At month 0, month 1 and month 2

Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off

Data from ClinicalTrials.gov

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GSK Investigational Site

Eferding, Austria

GSK Investigational Site

Neufeld/Leitha, Austria

GSK Investigational Site

Salzburg, Austria

GSK Investigational Site

Villach, Austria

GSK Investigational Site

Wels, Austria

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Bretten, Baden-Wurttemberg, Germany

GSK Investigational Site

Heilbronn, Baden-Wurttemberg, Germany

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

...and 79 more locations

The cut-off for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively.

Time frame: At month 0, month 1 and month 2

Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations

The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).

Time frame: At month 0, month 1 and month 2

Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)

The cut-off for the assay was ≥ 0.1

Time frame: At month 0, month 1 and month 2

Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations

The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).

Time frame: At month 0, month 1 and month 2

Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off

The cut-off for the assay was ≥ 0.1

Time frame: At month 0, month 1 and month 2

Anti-diphtheria (Anti-D) Antibody Concentrations

The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).

Time frame: At month 0, month 1 and month 2

Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off

The cut-off for the assay was ≥ 1:8.

Time frame: At month 0, month 1 and month 2

Anti-polio Type 1, 2 & 3 Titers

The results for the assay were tabulated as geometric mean expressed in titers.

Time frame: At month 0, 1 and 2

Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off

The cut-off for the assay was ≥ 1.0

Time frame: At month 0, month 1 and month 2

Anti-PRP Antibody Concentrations

The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).

Time frame: At month 0, month 1 and month 2

Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs

The cut-offs for the assay were ≥ 10 mIU/mL and ≥ 100 mIU/mL respectively .

Time frame: At month 0, month 1 and month 2

Anti-HBs Antibody Concentrations

The results for the assay were tabulated as geometric mean expressed in milli-international units per milliliter (mIU/mL).

Time frame: At month 0, month 1 and month 2

Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens

Vaccine response to these antigens is defined as appearance of antibodies in subjects who were seronegative (antibody concentration \< 5 EL.U/mL) at pre-vaccination or as at least a 2-fold increase in post-over pre-vaccination antibody concentrations in subjects seropositive at pre-vaccination. The analysis was based only on subjects receiving experimental vaccination.

Time frame: 1 month after vaccination (Month 1)

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

The results were tabulated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: At month 0, month 1 and month 2

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom irrespective of intensity grade. Grade 3 Pain was defined as crying when limb was moved/ spontaneously painful.

Time frame: During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination

The analysis was based only on subjects receiving combined-diphtheria vaccination.

Time frame: During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination

Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose

Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Any was defined as occurrence of any general symptom irrespective of intensity grade and relationship. Subjects in the Nimenrix + Infanrix-hexa Group did not receive a second dose of vaccination.

Time frame: During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)

Number of Subjects Reporting Any Rash

Any was defined as occurrence of at least one symptom experienced.

Time frame: Day 0 - Month 7

Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)

Any was defined as occurrence of at least one symptom experienced.

Time frame: Day 0 - Month 7

Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)

Any was defined as occurrence of at least one symptom experienced.

Time frame: Day 0 - Month 7

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose

An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Time frame: Occurring within Day 0-30 following vaccination

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose

Time frame: Occurring within Day 0-30 following vaccination

Number of Subjects Reporting Any Serious Adverse Events (SAEs)

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.

Time frame: From dose 1 (Month 0) up to study end (Month 7)