Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
MeSH terms: Influenza, Human; Haemophilus Infections
Intervention: Hib-MenCY-TT vaccine (MenHibrix); Meningitec®; ActHIB®; Infanrix® Penta; Prevenar®; Mencevax® ACWY; PRP (Polyribosyl Ribitol Phosphate)
Intervention description: Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively; Three doses were administered IM in right lower thigh at Months 0,2 and 4.; Three doses were administered IM in left thigh at Months 0,2 and 4.; Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.; Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.; One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.; One dose was administered IM in deltoid region of left arm at Month 10 as booster.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 409.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Invasive bacterial disease caused by Hib; Neisseria meningitidis serogroups C & Y

Summary:

      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.
    

Eligibility criteria:

        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.