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Purpose

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

Condition

Eligibility

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

Inclusion Criteria

  • Is 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

  • Has a 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 - Has a 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 - Has any contraindication to the concomitant study vaccines being administered in the study - Has a known or suspected impairment of immunological function - Has a 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 - Has known or history of functional or anatomic asplenia - Has failure to thrive based on the clinical judgment of the investigator - Has a known coagulation disorder contraindicating intramuscular vaccination - Has a 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) - Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders - Has received a dose of any pneumococcal vaccine prior to study entry - Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry - Has received a dose of rotavirus vaccine prior to study entry - Has received a blood transfusion or blood products, including immunoglobulins - Has 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™-Prevnar 13™-Prevnar 13™-Prevnar 13™ 		Participants will receive a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
  • Biological: Prevnar 13™
    Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
  • Biological: RotaTeq™
    RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
    Other names:
    • V260; 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, given as background treatment via 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), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V232, HEPTAVAX™-II, HBVAXPRO; 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), given as background treatment via 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), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: VARIVAX™
    VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Experimental
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 		Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
  • Biological: Prevnar 13™
    Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
  • Biological: V114
    V114 contains the 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 given via IM injection.
    Other names:
    • VAXNEUVANCE™
  • Biological: RotaTeq™
    RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
    Other names:
    • V260; 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, given as background treatment via 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), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V232, HEPTAVAX™-II, HBVAXPRO; 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), given as background treatment via 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), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: VARIVAX™
    VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Experimental
Group 3: Prevnar 13™-Prevnar 13™-V114-V114 		Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
  • Biological: Prevnar 13™
    Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
  • Biological: V114
    V114 contains the 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 given via IM injection.
    Other names:
    • VAXNEUVANCE™
  • Biological: RotaTeq™
    RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
    Other names:
    • V260; 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, given as background treatment via 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), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V232, HEPTAVAX™-II, HBVAXPRO; 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), given as background treatment via 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), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: VARIVAX™
    VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Experimental
Group 4: Prevnar 13™-V114-V114-V114 		Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
  • Biological: Prevnar 13™
    Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
  • Biological: V114
    V114 contains the 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 given via IM injection.
    Other names:
    • VAXNEUVANCE™
  • Biological: RotaTeq™
    RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
    Other names:
    • V260; 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, given as background treatment via 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), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V232, HEPTAVAX™-II, HBVAXPRO; 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), given as background treatment via 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), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: VARIVAX™
    VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Experimental
Group 5: V114-V114-V114-V114 		Participants will receive a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
  • Biological: V114
    V114 contains the 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 given via IM injection.
    Other names:
    • VAXNEUVANCE™
  • Biological: RotaTeq™
    RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
    Other names:
    • V260; 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, given as background treatment via 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), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V232, HEPTAVAX™-II, HBVAXPRO; 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), given as background treatment via 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), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
  • Biological: VARIVAX™
    VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
    Other names:
    • V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

More Details

Status
Completed
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.