A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
Status and phase
Completed
Phase 3
Conditions
Pneumococcal Infections
Treatments
Biological: Pentacel™
Biological: M-M-R™ II
Biological: HIBERIX™
Biological: Prevnar 13™
Biological: VARIVAX™
Biological: RotaTeq™
Biological: RECOMBIVAX HB™
Biological: V114
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
900 patients
Sex
All
Ages
42 to 90 days old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
900 participants in 5 patient groups
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
Active Comparator group
Description:
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.
Treatment:
Biological: RECOMBIVAX HB™
Biological: RotaTeq™
Biological: Prevnar 13™
Biological: VARIVAX™
Biological: M-M-R™ II
Biological: HIBERIX™
Biological: Pentacel™
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
Experimental group
Description:
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.
Treatment:
Biological: RECOMBIVAX HB™
Biological: V114
Biological: RotaTeq™
Biological: Prevnar 13™
Biological: VARIVAX™
Biological: M-M-R™ II
Biological: HIBERIX™
Biological: Pentacel™
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
Experimental group
Description:
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.
Treatment:
Biological: RECOMBIVAX HB™
Biological: V114
Biological: RotaTeq™
Biological: Prevnar 13™
Biological: VARIVAX™
Biological: M-M-R™ II
Biological: HIBERIX™
Biological: Pentacel™
Group 4: Prevnar 13™-V114-V114-V114
Experimental group
Description:
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.
Treatment:
Biological: RECOMBIVAX HB™
Biological: V114
Biological: RotaTeq™
Biological: Prevnar 13™
Biological: VARIVAX™
Biological: M-M-R™ II
Biological: HIBERIX™
Biological: Pentacel™
Group 5: V114-V114-V114-V114
Experimental group
Description:
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.
Treatment:
Biological: RECOMBIVAX HB™
Biological: V114
Biological: RotaTeq™
Biological: VARIVAX™
Biological: M-M-R™ II
Biological: HIBERIX™
Biological: Pentacel™
Trial contacts and locations
31
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Data sourced from clinicaltrials.gov
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