Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine
NCT ID: NCT00127855
Last Updated: 2018-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
409 participants
INTERVENTIONAL
2003-03-01
2004-02-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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MenHibrix Formulation 1 Group
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Hib-MenCY-TT vaccine (MenHibrix)
Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
MenHibrix Formulation 2 Group
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Hib-MenCY-TT vaccine (MenHibrix)
Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
MenHibrix Formulation 3 Group
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Hib-MenCY-TT vaccine (MenHibrix)
Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Menjugate Group
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Meningitec®
Three doses were administered IM in right lower thigh at Months 0,2 and 4.
ActHIB®
Three doses were administered IM in left thigh at Months 0,2 and 4.
Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
ActHIB Group
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
ActHIB®
Three doses were administered IM in left thigh at Months 0,2 and 4.
Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Interventions
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Hib-MenCY-TT vaccine (MenHibrix)
Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Meningitec®
Three doses were administered IM in right lower thigh at Months 0,2 and 4.
ActHIB®
Three doses were administered IM in left thigh at Months 0,2 and 4.
Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Vaccinated against hepatitis B at birth.
* Born after a gestation period of 36 - 42 weeks.
Exclusion Criteria
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth
* Any chronic drug therapy to be continued during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine(s).
* Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
* History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
6 Weeks
12 Weeks
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
North Adelaide, South Australia, Australia
GSK Investigational Site
Carlton, Victoria, Australia
GSK Investigational Site
Subiaco, Western Australia, Australia
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.
Nolan T, Lambert S, Roberton D, Marshall H, Richmond P, Streeton C, Poolman J, Boutriau D. A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007 Dec 12;25(51):8487-99. doi: 10.1016/j.vaccine.2007.10.013. Epub 2007 Oct 25.
T Nolan et al. A novel Haemophilus influenzae type b - meningococcal serogroups C and Y conjugate (Hib-MenCY-TT) vaccine induces persistent immune responses and immune memory. Abstract presented at Pediatric Academic Societies' (PAS) Annual meeting. San Francisco, California, US, 29 April to 2 May 2006.
Study Documents
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Document Type: Study Protocol
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: Clinical Study Report
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
View DocumentDocument Type: Informed Consent Form
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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792014/002
Identifier Type: OTHER
Identifier Source: secondary_id
792014/001
Identifier Type: -
Identifier Source: org_study_id
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