Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)
Condition: Bacterial Infections; Virus Diseases
MeSH terms: Infections; Bacterial Infections; Virus Diseases
Intervention: V419; DAPTACEL™; PedvaxHIB™; Prevnar 13™; RotaTeq™; PENTACEL™; Recombivax HB vaccine; ActHIB™
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, 4, and 6 months of age; DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age; PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age; Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age; ActHIB™ 0.5 mL intramuscular injection at 15 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: None (Open Label)
Enrollment: 1473.0
Sex: All
Minimum age: 46 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Whooping Cough (pertussis); Poliomyelitis; Hepatitis B infection; Haemophilus influenzae type b infection

Summary:

      This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when
      administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of
      DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether
      subjects who receive V419 have a similar immune response to the vaccine compared to subjects
      who receive licensed component vaccine controls.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Participant is a healthy infant

          -  Participant has received one dose of monovalent hepatitis B vaccine prior to or at 1
             month of age

        Exclusion Criteria :

          -  Participant has received more than one dose of monovalent hepatitis B vaccine or
             hepatitis B based combination vaccine prior to study entry

          -  Participant has been vaccinated with any acellular pertussis or whole cell pertussis
             based combination vaccines, haemophilus influenzae type b conjugate, poliovirus,
             pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, or any combination
             of the above

          -  Participant has had a fever ≥38.0°C (≥110.4°F) within 24 hours of study enrollment

          -  Participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated,
             live virus vaccine) within 30 days prior to study enrollment, except for inactivated
             influenza vaccine which will be permitted 15 days or more prior to enrollment

          -  Participant has hepatitis B surface antigen (HBsAg) seropositivity (by medical
             history)

          -  Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria,
             tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection