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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00614614
Other study ID # 110870
Secondary ID 110871
Status Completed
Phase Phase 3
First received
Last updated
Start date February 13, 2008
Est. completion date September 17, 2009

Study information

Verified date October 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1558
Est. completion date September 17, 2009
Est. primary completion date July 31, 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Weeks to 12 Weeks
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)
One dose in the booster phase as intramuscular injection
GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)
Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection
Infanrix®
One dose as intramuscular injection
ActHIB®
Three doses in the priming phase as intramuscular injection
Pediarix®
Three doses in the priming phase as intramuscular injection

Locations

Country Name City State
United States GSK Investigational Site Amarillo Texas
United States GSK Investigational Site Arkansas City Kansas
United States GSK Investigational Site Bardstown Kentucky
United States GSK Investigational Site Benton Arkansas
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Bossier City Louisiana
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Clyde North Carolina
United States GSK Investigational Site Des Moines Iowa
United States GSK Investigational Site Dothan Alabama
United States GSK Investigational Site Erie Pennsylvania
United States GSK Investigational Site Fall River Massachusetts
United States GSK Investigational Site Fayetteville Arkansas
United States GSK Investigational Site Fountain Valley California
United States GSK Investigational Site Fresno California
United States GSK Investigational Site Galveston Texas
United States GSK Investigational Site Greenville Pennsylvania
United States GSK Investigational Site Gresham Oregon
United States GSK Investigational Site Henderson Nevada
United States GSK Investigational Site Huber Heights Ohio
United States GSK Investigational Site Huntington Beach California
United States GSK Investigational Site Jonesboro Arkansas
United States GSK Investigational Site Kalamazoo Michigan
United States GSK Investigational Site Kingsport Tennessee
United States GSK Investigational Site Layton Utah
United States GSK Investigational Site Lexington Kentucky
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Marietta Georgia
United States GSK Investigational Site Marshfield Wisconsin
United States GSK Investigational Site Nampa Idaho
United States GSK Investigational Site Niles Michigan
United States GSK Investigational Site Ogden Utah
United States GSK Investigational Site Orem Utah
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Plantation Florida
United States GSK Investigational Site Portage Michigan
United States GSK Investigational Site Provo Utah
United States GSK Investigational Site Raleigh North Carolina
United States GSK Investigational Site Richland Michigan
United States GSK Investigational Site Roy Utah
United States GSK Investigational Site Saint George Utah
United States GSK Investigational Site Saint Paul Minnesota
United States GSK Investigational Site South Jordan Utah
United States GSK Investigational Site Stevensville Michigan
United States GSK Investigational Site Sugar Land Texas
United States GSK Investigational Site Syracuse Utah
United States GSK Investigational Site Uniontown Pennsylvania
United States GSK Investigational Site West Covina California
United States GSK Investigational Site West Des Moines Iowa
United States GSK Investigational Site West Palm Beach Florida
United States GSK Investigational Site Woodstock Georgia

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (=) 1:8 One month post vaccination at 12-15 months of age (Month 11)
Primary 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 The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (=) 1:8 One month post vaccination at 15-18 months of age (Month 14)
Primary Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group Antibody titers were expressed as Geometric mean titers (GMTs) One month post vaccination at 12-15 months of age (Month 11)
Primary Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group Antibody titers were expressed as Geometric mean titers (GMTs) One month post vaccination at 15-18 months of age (Month 14)
Primary 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 The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (=) 1.0 International Units per milliliter (IU/mL). One month post vaccination at 15-18 months of age (Month 14)
Primary Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group Antibody titers were expressed as Geometric mean titers (GMTs) One month post vaccination at 12-15 months of age (Month 11)
Primary 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 The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (=) 1:8 One month post vaccination at 12-15 months of age (Month 11)
Primary 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 Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) One month after vaccination at 15-18 months of age (Month 14)
Secondary 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 The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (=) 1:4 One month after vaccination at 12-15 months of age (Month 11)
Secondary 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 The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (=) 1:4 One month after vaccination at 12-15 months of age (Month 11)
Secondary Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group Antibody titers were expressed as Geometric mean titers (GMTs) One month after vaccination at 12-15 months of age (Month 11)
Secondary Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group Antibody titers were expressed as Geometric mean titers (GMTs) Prior to vaccination at 15-18 months of age (Month 13)
Secondary 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 The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (=) 1:4 and = 1:8 Prior to vaccination at 15-18 months of age (Month 13)
Secondary Anti-D and Anti-T Geometric Mean Antibody Concentrations Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL). One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Secondary Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (=) 0.1 International Units per milliliter (IU/mL). One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Secondary Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value The cut-off values assessed were greater than or equal to (=) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Secondary Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) One month after vaccination at 15-18 months of age (Month 14)
Secondary 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 The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (=) 1.0 International Units per milliliter (IU/mL). One month after vaccination at 15-18 months of age (Month 14)
Secondary 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 The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (=) 1:4 One month after vaccination at 15-18 months of age (Month 14)
Secondary Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group Antibody titers were expressed as Geometric mean titers (GMTs) One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Secondary Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase
Secondary Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e =38.0°C, grade 3 fever was axillary temperature > 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination. During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination
Secondary Number of Subjects Reporting Any Rash Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae. From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Secondary Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase
Secondary Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Secondary Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13)
Secondary Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. During a 31-day follow-up period (Day 0-30)
Secondary Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. During the 31-day follow-up period (Day 0-30)
Secondary Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13).
Secondary Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
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