Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Treatments: Biological: Mencevax® ACWY; Biological: Prevenar®; Biological: Hib-MenCY-TT vaccine (MenHibrix); Biological: PRP (Polyribosyl Ribitol Phosphate); Biological: ActHIB®; Biological: Infanrix® Penta; Biological: Meningitec®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00127855

792014/001

792014/002 (Other Identifier)

Details and patient eligibility

About

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.

Enrollment: 409 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female between, and including, 6 and 12 weeks (42-90 days) 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 into the study.
• Vaccinated against hepatitis B at birth.
• Born after a gestation period of 36 - 42 weeks.

Exclusion criteria

• Use of any investigational or non-registered 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 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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409 participants in 5 patient groups

MenHibrix Formulation 1 Group

Experimental group

Description:

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.

Treatment:

Biological: Infanrix® Penta

Biological: Mencevax® ACWY

Biological: Prevenar®

Biological: Hib-MenCY-TT vaccine (MenHibrix)

Biological: PRP (Polyribosyl Ribitol Phosphate)

MenHibrix Formulation 2 Group

Experimental group

Description:

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.

Treatment:

Biological: Infanrix® Penta

Biological: Mencevax® ACWY

Biological: Prevenar®

Biological: Hib-MenCY-TT vaccine (MenHibrix)

Biological: PRP (Polyribosyl Ribitol Phosphate)

MenHibrix Formulation 3 Group

Experimental group

Description:

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.

Treatment:

Biological: Infanrix® Penta

Biological: Mencevax® ACWY

Biological: Prevenar®

Biological: Hib-MenCY-TT vaccine (MenHibrix)

Biological: PRP (Polyribosyl Ribitol Phosphate)

Menjugate Group

Active Comparator group

Description:

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.

Treatment:

Biological: Infanrix® Penta

Biological: Meningitec®

Biological: Mencevax® ACWY

Biological: ActHIB®

Biological: PRP (Polyribosyl Ribitol Phosphate)

ActHIB Group

Active Comparator group

Description:

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.

Treatment:

Biological: Infanrix® Penta

Biological: Mencevax® ACWY

Biological: Prevenar®

Biological: ActHIB®

Biological: PRP (Polyribosyl Ribitol Phosphate)