Clinical trial NCT00614614: Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
Official title: Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Meningococcal Vaccine 134612 Given at 12-15 Months of Age or at 15-18 Months of Age (Co-administered With Infanrix®) in Primed Healthy Toddlers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: Meningococcal disease
Toddlers
Neisseria meningitidis
Meningococcal vaccines
Immunogenicity
Human serum bactericidal assay
Safety
Vaccines, conjugate
Booster vaccination
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 1558
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.

Detailed description: The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.

Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study.

The protocol posting has been updated following a protocol amendment.

Eligibility criteria: Inclusion Criteria:

* Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
* A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after 36 weeks gestation.
* For inclusion in the booster phase, subjects must have received all three doses in the primary phase.

Exclusion Criteria:

Exclusion criteria for enrolment (primary phase)

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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 since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
* Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
* History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Concurrent 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 (pharmaceutical product or device).

Exclusion criteria for enrolment (booster phase)

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)
* Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
* Previous administration of a booster dose of Hib prior to entry to the booster phase.
* Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
* Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
* Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
* History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products within the past 3 months or planned administration during the study period.
* Concurrent 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 (pharmaceutical product or device).

Primary outcomes:
measure: Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group
timeFrame: One month post vaccination at 12-15 months of age (Month 11)
measure: Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group
timeFrame: One month post vaccination at 15-18 months of age (Month 14)
measure: Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group
timeFrame: One month post vaccination at 12-15 months of age (Month 11)
measure: Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
timeFrame: One month post vaccination at 15-18 months of age (Month 14)
measure: Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group
timeFrame: One month post vaccination at 15-18 months of age (Month 14)
measure: Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group
timeFrame: One month post vaccination at 12-15 months of age (Month 11)
measure: Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group
timeFrame: One month post vaccination at 12-15 months of age (Month 11)
measure: Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group
timeFrame: One month after vaccination at 15-18 months of age (Month 14)
Secondary outcomes:
measure: Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group
timeFrame: One month after vaccination at 12-15 months of age (Month 11)
measure: Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group
timeFrame: One month after vaccination at 12-15 months of age (Month 11)
measure: Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group
timeFrame: One month after vaccination at 12-15 months of age (Month 11)
measure: Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
timeFrame: Prior to vaccination at 15-18 months of age (Month 13)
measure: Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
timeFrame: Prior to vaccination at 15-18 months of age (Month 13)
measure: Anti-D and Anti-T Geometric Mean Antibody Concentrations
timeFrame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
measure: Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
timeFrame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
measure: Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
timeFrame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
measure: Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group
timeFrame: One month after vaccination at 15-18 months of age (Month 14)
measure: Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group
timeFrame: One month after vaccination at 15-18 months of age (Month 14)
measure: Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
timeFrame: One month after vaccination at 15-18 months of age (Month 14)
measure: Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group
timeFrame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine
timeFrame: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
timeFrame: During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination
measure: Number of Subjects Reporting Any Rash
timeFrame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine
timeFrame: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase
measure: Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
timeFrame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
measure: Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
timeFrame: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13)
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination
timeFrame: During a 31-day follow-up period (Day 0-30)
measure: Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination
timeFrame: During the 31-day follow-up period (Day 0-30)
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13).
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Dothan
country: United States
facility: GSK Investigational Site
state: Alabama
city: Benton
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: West Covina
country: United States
facility: GSK Investigational Site
state: California
city: Plantation
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Woodstock
country: United States
facility: GSK Investigational Site
state: Georgia
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Des Moines
country: United States
facility: GSK Investigational Site
state: Iowa
city: West Des Moines
country: United States
facility: GSK Investigational Site
state: Iowa
city: Arkansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Bossier City
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Niles
country: United States
facility: GSK Investigational Site
state: Michigan
city: Portage
country: United States
facility: GSK Investigational Site
state: Michigan
city: Richland
country: United States
facility: GSK Investigational Site
state: Michigan
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Paul
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Henderson
country: United States
facility: GSK Investigational Site
state: Nevada
city: Clyde
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Huber Heights
country: United States
facility: GSK Investigational Site
state: Ohio
city: Gresham
country: United States
facility: GSK Investigational Site
state: Oregon
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: GSK Investigational Site
state: Texas
city: Galveston
country: United States
facility: GSK Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: GSK Investigational Site
state: Texas
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Ogden
country: United States
facility: GSK Investigational Site
state: Utah
city: Orem
country: United States
facility: GSK Investigational Site
state: Utah
city: Provo
country: United States
facility: GSK Investigational Site
state: Utah
city: Roy
country: United States
facility: GSK Investigational Site
state: Utah
city: Saint George
country: United States
facility: GSK Investigational Site
state: Utah
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Syracuse
country: United States
facility: GSK Investigational Site
state: Utah
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Baccarini C, Miller JM. Immunogenicity and reactogenicity of Infanrix when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix and Pediarix. Vaccine. 2015 Feb 11;33(7):924-32. doi: 10.1016/j.vaccine.2014.09.064. Epub 2014 Oct 8.
citation: Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Miller JM. Quadrivalent meningococcal (MenACWY-TT) conjugate vaccine or a fourth dose of H. influenzae-N. meningitidis C/Y conjugate vaccine (HibMenCY-TT) is immunogenic in toddlers who previously received three doses of HibMenCY-TT in infancy. Vaccine. 2015 Feb 11;33(7):933-41. doi: 10.1016/j.vaccine.2014.08.027. Epub 2014 Aug 21.