Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years
Condition: Tetanus; Acellular Pertussis; Diphtheria
MeSH terms: Diphtheria
Intervention: GSK Biologicals'Kinrix®; Merck and Company's MMRII; Merck and Company's Varivax
Intervention description: One dose as intramuscular injection at visit 1; One dose as subcutaneous injection at visit 1; One dose as subcutaneous injection at visit 1 or at visit 2
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 478.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Co-administration; Immunization; Preschool; Booster

Summary:

      The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when
      co-administered with varicella (Varivax® [varicella virus vaccine live], Merck and Company)
      and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine
      alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age,
      and there is great potential for the vaccines to be given concurrently. The aim of this trial
      is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity
      or reactogenicity of Kinrix.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects for whom the investigator believes that their parents/ guardians can and will
             comply with the requirements of the protocol.

          -  A male or female child between 4 and 6 years of age, inclusive.

          -  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.

          -  Having received 4 doses of (Diphtheria, Tetanus Acellular Pertussis) DTaP vaccine
             using Pediarix and/or Infanrix, and 3 doses of poliovirus vaccine using Pediarix
             and/or (inactivated poliovirus vaccine, Aventis Pasteur) IPOL in the first 2 years of
             life.

          -  Previously received 1 dose of M-M-RII and Varivax (separate or combined) in the second
             year of life.

        Exclusion Criteria:

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccines within 30 days preceding the administration of study vaccines, or planned use
             during the study period.

          -  Concurrently participating 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
             non-investigational product or device.

          -  History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles,
             mumps, rubella or varicella disease, or of vaccination against these diseases given
             after the second year of life.

          -  Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination.

          -  Poliovirus vaccination with one or more doses of (oral polio virus) OPV vaccine.

          -  Administration or planned administration of a vaccine not foreseen by the study
             protocol within 30 days of study vaccination and ending at Day 30.

          -  Chronic administration or planned administration of immunosuppressants or other immune
             modifying drugs within six months prior to study vaccination or planned administration
             during the study period ending at Day 30.

          -  Administration of immunoglobulins and/or any blood products at any time prior to study
             vaccination or planned administration during the study period ending at Day 30.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  History of seizures or progressive neurological disorder, including infantile spasms,
             uncontrolled epilepsy or progressive encephalopathy.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at the time of enrolment.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine(s).

          -  History of anaphylactic reaction to egg proteins or previous doses of the vaccine(s).

          -  Encephalopathy within 7 days of administration of previous dose of Infanrix or
             Pediarix.

          -  Fever >=40.5°C or 104.9°F (rectal temperature) (39.5°C or 103.1°F, oral/axillary)
             within 48 hours of previous dose of Infanrix or Pediarix not due to another
             identifiable cause.

          -  Collapse or shock-like state within 48 hours of previous dose of DTaP or
             DTaP-containing vaccine.

          -  Persistent, severe, inconsolable screaming or crying lasting ³3 hours occurring within
             48 hours of administration of previous dose of DTaP or DTaP-containing vaccine.

          -  Thrombocytopenia following a previous dose of M-M-RII or its component vaccines

          -  Inability to contact a parent/guardian of the subject by telephone.

          -  Blood dyscrasias, leukemia, lymphomas or other malignant neoplasms affecting the bone
             marrow or lymphatic systems.

          -  Family history of congenital or hereditary immunodeficiency, unless the immune
             competence of the subject has been demonstrated.

          -  Residence in the same household as the following persons:

          -  New-born infants (0-4 weeks of age).

          -  Pregnant mother/women without documented positive history of chickenpox disease or
             laboratory evidence of prior varicella vaccination.

          -  Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination
             status or varicella disease history.

          -  Persons with known immunodeficiency.

          -  Active untreated tuberculosis.