Clinical trial NCT00289783: Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
Official title: A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b
Neisseria Meningitidis
Keywords: Primary and booster vaccination
Neisseria meningitidis
Hib disease
Meningococcal vaccine
Meningococcal disease
Children
Immunogenicity
Safety
Infants
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 4441
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.

Detailed description: The subjects from this study will participate in one of three cohorts:

* US Safety and Immunogenicity (Cohort 1): All immunogenicity analyses in the primary and booster phases will be evaluated in this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases.
* Safety Only (Cohort 2): Only safety objectives will be assessed in the primary and booster phases for this cohort.
* Non-US Safety and Immunogenicity (Cohort 3): Only descriptive immunogenicity results in the primary and booster phases will be reported for this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases.

Treatment allocation:

Primary phase: Subjects will be randomized with balanced allocation (1:1:1:1) to 1 of the 4 treatment groups and with a stratification according to the cohort. Assignment to a cohort will be based on study site.

Booster phase: Subjects who received Hib-MenCY-TT vaccine in the primary phase will receive a booster dose of Hib-MenCY-TT vaccine. Subjects who received ActHIB in the primary phase will receive a booster dose of PedvaxHIB.

During the 3-dose primary vaccination course, co-administration of Prevnar, Synagis, and/or rotavirus vaccine is permitted; co-administration of influenza vaccine is permitted at dose 3.

During the booster vaccination, co-administration of Prevnar, hepatitis A vaccine and influenza vaccine is permitted for all subjects in Cohort 1, 2 and 3; and co-administration of measles, mumps, rubella and varicella vaccine is permitted for all subjects in Cohort 2 and 3.

The study will be conducted in a double-blind fashion with regard to consistency of the 3 manufacturing lots of Hib-MenCY-TT vaccine and single-blind fashion for Hib-MenCY-TT vaccine versus monovalent Hib vaccine. The parents/guardians will be blinded up to collection of all data pertaining to the period up to one month after booster vaccination. Therefore, the extended safety follow-up after the booster dose will be conducted in an unblinded manner. The person administering the vaccines will ensure that the parent/guardian does not see the vaccine vial used in reconstituting the vaccine. Due to the differences in the presentations of the candidate Hib-MenCY-TT vaccine and control vaccines, it is not possible to blind study personnel who administer the vaccines.

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 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.
* Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
* Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

Exclusion Criteria:

* 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). (Synagis® \[palivizumab, MedImmune\], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed.
* 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, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including 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).

Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be administered M-M-R II and Varivax if any of these criteria apply:

* History of measles, mumps, rubella or varicella.
* Previous vaccination against measles, mumps, rubella or varicella.
* Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
* Patients receiving immunosuppressive therapy.
* Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
* Individuals with primary and acquired immunodeficiency states.
* Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
* Individuals with active tuberculosis.
* Acute disease at time of booster vaccination.

Primary outcomes:
measure: Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations
timeFrame: One month after primary vaccination
measure: Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
timeFrame: One month after primary vaccination
measure: Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
timeFrame: One month after primary vaccination
measure: hSBA-MenC Antibody Titers
timeFrame: Prior to the fourth dose vaccination and 42 days after the fourth dose
measure: hSBA-MenY Antibody Titers
timeFrame: Prior to the fourth dose vaccination and 42 days after the fourth dose
measure: Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)
timeFrame: One month after primary vaccination
measure: Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8
timeFrame: 42 days after the fourth dose
measure: Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8
timeFrame: 42 days after the fourth dose
measure: Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)
timeFrame: 42 days after the fourth dose
measure: Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter
timeFrame: 42 days after the fourth dose
measure: Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)
timeFrame: 42 days after the fourth dose
measure: Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)
timeFrame: 42 days after the fourth dose
measure: Number of Subjects With Anti-varicella Titer Equal to or Above 1:5
timeFrame: 42 days after the fourth dose
Secondary outcomes:
measure: Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)
timeFrame: One month after primary vaccination
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: One month after primary vaccination
measure: Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)
timeFrame: One month after primary vaccination
measure: Anti-HBS Antibody Concentrations
timeFrame: One month after primary vaccination
measure: Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)
timeFrame: One month after primary vaccination
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: One month after primary vaccination
measure: Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)
timeFrame: One month after primary vaccination
measure: Anti-poliovirus Types 1, 2 and 3 Titers
timeFrame: One month after primary vaccination
measure: Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values
timeFrame: One month after primary vaccination
measure: Anti-PSC and Anti-PSY Antibody Concentrations
timeFrame: One month after primary vaccination
measure: Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values
timeFrame: One month after the primary vaccination course
measure: Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values
timeFrame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
measure: Anti-PRP Antibody Concentrations
timeFrame: One month after the primary vaccination course
measure: Anti-PRP Antibody Concentrations
timeFrame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
measure: Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values
timeFrame: One month after the primary vaccination course
measure: Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values
timeFrame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
measure: hSBA-MenC and hSBA-MenY Antibody Titers
timeFrame: One month after the primary vaccination course
measure: hSBA-MenC and hSBA-MenY Antibody Titers
timeFrame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
measure: Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
timeFrame: One month after the primary vaccination course
measure: Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
timeFrame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
measure: Anti-PSC and Anti-PSY Antibodies Concentrations
timeFrame: One month after the primary vaccination course
measure: Anti-PSC and Anti-PSY Antibody Concentrations
timeFrame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
measure: Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value
timeFrame: One month after the primary vaccination course
measure: Anti-PRP Antibody Concentrations
timeFrame: One month after the primary vaccination course and prior to the fourth dose vaccination
measure: Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
timeFrame: One month after the primary vaccination course
measure: Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
timeFrame: Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
measure: Anti-PSC and Anti-PSY Antibody Concentrations
timeFrame: Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
measure: Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)
timeFrame: Prior to the fourth dose vaccination and 42 days after fourth vaccination
measure: Anti-PRP Antibody Concentrations
timeFrame: Prior to the fourth vaccination and 42 days after fourth vaccination
measure: Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4
timeFrame: Prior to the fourth dose vaccination and 42 days after fourth vaccination
measure: Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)
timeFrame: 42 days after fourth vaccination
measure: Anti-measles Antibody Concentrations
timeFrame: 42 days after fourth vaccination
measure: Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values
timeFrame: 42 days after fourth vaccination
measure: Anti-mumps Antibody Titers
timeFrame: 42 days after fourth vaccination
measure: Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)
timeFrame: 42 days after fourth vaccination
measure: Anti-rubella Antibody Concentrations
timeFrame: 42 days after fourth vaccination
measure: Number of Subjects With Anti-varicella Titer Equal to or Above 1:40
timeFrame: 42 days after fourth vaccination
measure: Anti-varicella Antibody Titers
timeFrame: 42 days after fourth vaccination
measure: Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40
timeFrame: Prior to the fourth dose vaccination and one month after the fourth dose vaccination
measure: Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit
timeFrame: In the 4-day (Day 0-3) follow-up period after primary vaccination course
measure: Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit
timeFrame: In the 4-day (Day0-3) follow-up period after the fourth dose
measure: Number of Subjects Reporting Solicited Local and General Symptoms
timeFrame: Within the 4 days (Day 0-3) following each dose of the primary vaccination course
measure: Number of Subjects Reporting Solicited Local and General Symptoms
timeFrame: Within the 4 days (Day 0-3) post-vaccination period following the fourth dose
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: Within 31 days (Day 0-30) following the primary vaccination course
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: Within 31 days (Day 0-30) following the fourth dose
measure: Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)
timeFrame: Within 4 days (Day 0 to Day 3) after fourth dose vaccination
measure: Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination
timeFrame: Within 43 days (Day 0 through Day 42) after vaccination
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: From the fourth dose through the end of the 6-month safety follow-up
measure: Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)
timeFrame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
measure: Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)
timeFrame: From the fourth dose through the end of the 6-month safety follow-up
measure: Number of Subjects Reporting Rash
timeFrame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
measure: Number of Subjects Reporting Rash
timeFrame: From the fourth dose through the end of the 6-month safety follow-up
measure: Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
timeFrame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
measure: Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.
timeFrame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
measure: Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
timeFrame: From the fourth dose through the end of the 6-month safety follow-up
measure: Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits
timeFrame: From the fourth dose through the end of the 6-month safety follow-up
measure: Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).
timeFrame: Prior to the fourth dose vaccination
measure: Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.
timeFrame: Prior to the fourth dose vaccination
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: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Bryant
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: East Artesia
country: United States
facility: GSK Investigational Site
state: California
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: La Jolla
country: United States
facility: GSK Investigational Site
state: California
city: Oakland
country: United States
facility: GSK Investigational Site
state: California
city: Paramount
country: United States
facility: GSK Investigational Site
state: California
city: Rolling Hills Estates
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: West Covina
country: United States
facility: GSK Investigational Site
state: California
city: Longmont
country: United States
facility: GSK Investigational Site
state: Colorado
city: Norwich
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Cocoa Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Rockledge
country: United States
facility: GSK Investigational Site
state: Florida
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Des Moines
country: United States
facility: GSK Investigational Site
state: Iowa
city: Des Moines
country: United States
facility: GSK Investigational Site
state: Iowa
city: Arkansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Kansas 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: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Bossier City
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Fall River
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Jamaica Plain
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Portage
country: United States
facility: GSK Investigational Site
state: Michigan
city: Stevensville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Brainerd
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Saint Paul
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: North Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Ithaca
country: United States
facility: GSK Investigational Site
state: New York
city: New Hartford
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Stony Brook
country: United States
facility: GSK Investigational Site
state: New York
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Sylva
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Boardman
country: United States
facility: GSK Investigational Site
state: Ohio
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Huber Heights
country: United States
facility: GSK Investigational Site
state: Ohio
city: South Euclid
country: United States
facility: GSK Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Gresham
country: United States
facility: GSK Investigational Site
state: Oregon
city: Beaver Falls
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
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: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Lexington
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Amarillo
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Galveston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Temple
country: United States
facility: GSK Investigational Site
state: Texas
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Pleasant Grove
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: Mechanicsville
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Vancouver
country: United States
facility: GSK Investigational Site
state: Washington
city: La Crosse
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: GSK Investigational Site
state: Queensland
city: South Brisbane
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Carlton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
citation: Bryant KA, Marshall GS, Marchant CD, Pavia-Ruiz N, Nolan T, Rinderknecht S, Blatter M, Aris E, Lestrate P, Boutriau D, Friedland LR, Miller JM. Immunogenicity and safety of H influenzae type b-N meningitidis C/Y conjugate vaccine in infants. Pediatrics. 2011 Jun;127(6):e1375-85. doi: 10.1542/peds.2009-2992. Epub 2011 May 29.
citation: Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1.
citation: Bryant KA et al. Immune response to measles, mumps, rubella (MMR) and varicella (V) vaccine coadministered with a fourth dose of Haemophilus influenzae type b - Neisseria meningitidis serogroups C and Y - tetanus toxoid conjugate (HibMenCY) vaccine in toddlers. Abstract presented at the Annual meeting of Pediatric Academic Societies (PAS). Vancouver, Canada, 1-4 May 2010.
citation: Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.