Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
NCT ID: NCT00129129
Last Updated: 2018-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
756 participants
INTERVENTIONAL
2004-08-01
2006-03-29
Brief Summary
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The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
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Detailed Description
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All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized.
MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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MenHibrix Group
Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccinationDuring Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of Menhibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of Menhibrix™ during the Primary Phase received one dose of Menhibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, Menhibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, Menhibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine
Primary phase: 3 IM doses Booster phase: 1 IM dose
Pediarix
Primary phase: 3 IM doses
Prevnar
Primary phase: 3 IM doses Booster phase: 1 IM dose
ActHIB Group
During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either Menhibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
ActHIB
Primary phase: 3 IM doses Booster phase: 1 IM dose
Pediarix
Primary phase: 3 IM doses
Prevnar
Primary phase: 3 IM doses Booster phase: 1 IM dose
Menomune Group
Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
Pediarix
Primary phase: 3 IM doses
Prevnar
Primary phase: 3 IM doses Booster phase: 1 IM dose
Menomune
Primary phase: 1 SC dose
ActHIB/Menhibrix Group
Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of Menhibrix™ and a concomitant fourth dose of Prevnar™. Menhibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine
Primary phase: 3 IM doses Booster phase: 1 IM dose
ActHIB
Primary phase: 3 IM doses Booster phase: 1 IM dose
Pediarix
Primary phase: 3 IM doses
Prevnar
Primary phase: 3 IM doses Booster phase: 1 IM dose
ActHIB/ActHIB Group
Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
ActHIB
Primary phase: 3 IM doses Booster phase: 1 IM dose
Pediarix
Primary phase: 3 IM doses
Prevnar
Primary phase: 3 IM doses Booster phase: 1 IM dose
Interventions
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GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine
Primary phase: 3 IM doses Booster phase: 1 IM dose
ActHIB
Primary phase: 3 IM doses Booster phase: 1 IM dose
Pediarix
Primary phase: 3 IM doses
Prevnar
Primary phase: 3 IM doses Booster phase: 1 IM dose
Menomune
Primary phase: 1 SC dose
Eligibility Criteria
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Inclusion Criteria
* Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
* Healthy 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.
* Free of obvious health problems as established by medical history and clinical examination before entering the study.
* Born after a gestation period between 36 and 42 weeks.
* 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.
* For Group C
* Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
* Healthy male or female between, and including, 3 and 5 years 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 the study.
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 within six months prior to the first vaccine dose.
* 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, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine.
* History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae disease.
* 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 vaccine(s), 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.
For Group C
* 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 30 days of the dose of study vaccine.
* Previous vaccination against Neisseria meningitidis.
* History of Neisseria meningitidis disease.
* 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 vaccine, including dry natural latex rubber
* Major congenital defects or serious chronic illness.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.
6 Weeks
15 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Fountain Valley, California, United States
GSK Investigational Site
Centennial, Colorado, United States
GSK Investigational Site
Norwich, Connecticut, United States
GSK Investigational Site
Marietta, Georgia, United States
GSK Investigational Site
Des Moines, Iowa, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Bossier City, Louisiana, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
New Bedford, Massachusetts, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Boardman, Ohio, United States
GSK Investigational Site
University Heights, Ohio, United States
GSK Investigational Site
Beaver Falls, Pennsylvania, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Greenville, Pennsylvania, United States
GSK Investigational Site
Norristown, Pennsylvania, 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
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Rydal, Pennsylvania, United States
GSK Investigational Site
Warwick, Rhode Island, United States
Countries
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References
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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.
Marchant CD, Miller JM, Marshall GS, Blatter M, Aris E, Friedland LR, Boutriau D; HibMenCY-TT 005 Study Group. Randomized trial to assess immunogenicity and safety of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in infants. Pediatr Infect Dis J. 2010 Jan;29(1):48-52. doi: 10.1097/INF.0b013e3181c3ce88.
Marshall GS, Marchant CD, Blatter M, Aris E, Boutriau D, Poolman JT, Friedland LR, Miller JM. Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010 May;29(5):469-71. doi: 10.1097/INF.0b013e3181cdd379.
Marshall GS, Marchant CD, Blatter M, Friedland LR, Aris E, Miller JM. Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States. Hum Vaccin. 2011 Feb;7(2):258-64. doi: 10.4161/hv.7.2.14170. Epub 2011 Feb 1.
Study Documents
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Document Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 101858 are summarised with study 102015 on the GSK Clinical Study Register.
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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102015
Identifier Type: OTHER
Identifier Source: secondary_id
101858
Identifier Type: -
Identifier Source: org_study_id
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