Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
Condition: Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Intervention: V419; INFANRIX™ hexa; RotaTeq; Prevenar 13; ProQuad™
Intervention description: V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.; INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.; RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age; Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age; ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1250.0
Sex: All
Minimum age: 46 Days
Maximum age: 74 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: combination vaccine; diphtheria; pertussis; tetanus; hepatitis B; Hep B; Haemophilus influenzae b; Hib; polio; poliovirus

Summary:

      This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and
      12 months of age have an acceptable immune response to the vaccine. The study will also
      determine whether the immune response to V419 is similar to that of participants who receive
      a licensed vaccine control.
    

Eligibility criteria:

        Inclusion Criteria

          -  Healthy infants able to attend all study visits

          -  Parent(s)/legal representative able to read, understand, and complete study
             questionnaires

        Exclusion Criteria

          -  History of congenital or acquired immunodeficiency

          -  Received or is expected to receive immunosuppressive agents or systemic
             immunomodulatory steroids

          -  History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder

          -  Hypersensitivity to any of the vaccine components or history of a life-threatening
             reaction to a vaccine containing the same substances as the study vaccines or
             concomitant study vaccines

          -  Has any chronic illness that could interfere with study conduct or completion

          -  Received any immune globulin, blood, or blood-derived products since birth

          -  Received a dose of hepatitis B vaccine prior to the study

          -  Vaccinated with any acellular pertussis or whole cell pertussis based combination
             vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate
             or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella
             vaccines, or any combination thereof

          -  Fever within 24 hours prior to enrollment

          -  Received any non-study vaccine within 30 days prior to enrollment, except for
             inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment

          -  Has a coagulation disorder

          -  Has developmental delay or neurological disorder

          -  Participant or his/her mother has a medical history of hepatitis B surface antigen
             (HBsAg) seropositivity

          -  History of measles, mumps, rubella, varicella, Haemophilus influenzae type B,
             hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or
             poliomyelitis infection