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Purpose

This study is designed to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the Pneumococcal Conjugate Vaccine (PCV) immunization schedule.

Condition

Eligibility

Eligible Ages
Between 42 Days and 90 Days
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy, based on clinical judgment of the investigator
  • Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria

  • History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
  • Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine
  • Any contraindication to the concomitant study vaccines being administered in the study
  • Known or suspected impairment of immunological function
  • History of congenital or acquired immunodeficiency
  • Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
  • Has or his/her mother has a documented hepatitis B surface antigen - positive test
  • Known or history of functional or anatomic asplenia
  • Failure to thrive based on the clinical judgment of the investigator
  • Known coagulation disorder contraindicating intramuscular vaccination
  • History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
  • Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
  • Received a dose of any pneumococcal vaccine prior to study entry
  • Received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
  • Received a dose of rotavirus vaccine prior to study entry
  • Received a blood transfusion or blood products, including immunoglobulins
  • Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study
  • Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
  • Has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group 1: Prevnar 13™ 		Participants will receive a single 0.5 mL intramuscular (IM) injection of double-blind Prevnar 13™ at approximately 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13).
  • Biological: Prevnar 13™
    Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
  • Biological: RotaTeq™
    RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Pentacel™
    Pentacel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Recombivax HB™
    RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Hiberix™
    HIBERIX™ [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: M-M-R™ II
    M-M-R™ II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Varivax™
    VARIVAX™ Varicella Virus Vaccine Live for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Experimental
Group 2: Prevnar 13™ Switch to V114 at Dose 4 		Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4) and double-blind V114 at approximately 12-15 months of age (Study Month 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13).
  • Biological: Prevnar 13™
    Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
  • Biological: V114
    V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
  • Biological: RotaTeq™
    RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Pentacel™
    Pentacel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Recombivax HB™
    RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Hiberix™
    HIBERIX™ [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: M-M-R™ II
    M-M-R™ II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Varivax™
    VARIVAX™ Varicella Virus Vaccine Live for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Experimental
Group 3: Prevnar 13™ Switch to V114 at Dose 3 		Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2 and 4 months of age (Study Day 1 and Month 2) and double-blind V114 at approximately 6 and 12-15 months of age (Study Month 4 and 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13).
  • Biological: Prevnar 13™
    Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
  • Biological: V114
    V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
  • Biological: RotaTeq™
    RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Pentacel™
    Pentacel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Recombivax HB™
    RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Hiberix™
    HIBERIX™ [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: M-M-R™ II
    M-M-R™ II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Varivax™
    VARIVAX™ Varicella Virus Vaccine Live for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Experimental
Group 4: Prevnar 13™ Switch to V114 at Dose 2 		Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2 months of age (Study Day 1) and double-blind V114 at approximately 4, 6 and 12-15 months of age (Study Month 2, 4 and 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13).
  • Biological: Prevnar 13™
    Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
  • Biological: V114
    V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
  • Biological: RotaTeq™
    RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Pentacel™
    Pentacel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Recombivax HB™
    RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Hiberix™
    HIBERIX™ [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: M-M-R™ II
    M-M-R™ II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Varivax™
    VARIVAX™ Varicella Virus Vaccine Live for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Experimental
Group 5: V114 		Participants will receive a single 0.5 mL IM injection of double-blind V114 at approximately 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13).
  • Biological: V114
    V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
  • Biological: RotaTeq™
    RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Pentacel™
    Pentacel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Recombivax HB™
    RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Hiberix™
    HIBERIX™ [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: M-M-R™ II
    M-M-R™ II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: Varivax™
    VARIVAX™ Varicella Virus Vaccine Live for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

More Details

NCT ID
NCT03620162
Status
Active, not recruiting
Sponsor
Merck Sharp & Dohme Corp.

Study Contact

Notice

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