Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
Condition: Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Intervention: PR5I; Rotavirus vaccine; Prevenar 13™; INFANRIX™ hexa
Intervention description: DTaP-HB-IPV-Hib (Diphtheria, tetanus, pertussis [acellular, component], hepatitis B [recombinant DNA], polio virus [inactivated], and Haemophilus influenza type b conjugate vaccine [adsorbed]) Vaccine 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. PR5I is a liquid suspension hexavalent vaccine.; Rotarix™ 1.5 mL oral dose at 2 and 4 months of age (subset 1, Italy and Sweden) or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age (subset 2, Finland); Prevenar 13™ 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine.; Combined Diphtheria-Tetanus-acellular Pertussis [DTaP], Hepatitis B [HepB], Poliovirus [IPV] and Haemophilus influenzae type b [Hib] Vaccine 0.5 mL intramuscular injection at 2, 4 and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. INFANRIX™ hexa is provided as 2 components (lyophilized Hib and liquid DTaP, IPV, and HepB). Prior to administration, the vaccine must be reconstituted by adding the liquid DTaP-HepB-IPV component to the vial containing the Hib pellet.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1315.0
Sex: All
Minimum age: 46 Days
Maximum age: 89 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 V419 (PR5I) at 2, 4, and 11 to 12
      months of age have an acceptable response to the vaccine. This study will also determine
      whether the immune response to V419 is similar to that of participants who received a
      licensed vaccine control. The primary hypothesis is that participants who receive PR5I at 2,
      4, and 11 to 12 months have an acceptable response rate to all PR5I-contained antigens at one
      month after the Toddler dose of PR5I.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infant able to attend all study visits

          -  Parent(s)/legal representative are 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 study entry

          -  Vaccinated with any acellular pertussis or whole cell pertussis based combination
             vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate
             or pneumococcal polysaccharide, rotavirus vaccine, or 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 enrolment

          -  Has a coagulation disorder

          -  Has developmental delay or neurological disorder

          -  Participant or his/her mother has a medical history of hepatitis B surface antigens
             (HBsAg) seropositivity

          -  History of Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis,
             poliomyelitis, rotavirus gastroenteritis, or invasive pneumococcal infection