A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)
2 other identifiers
interventional
900
4 countries
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2018
CompletedStudy Start
First participant enrolled
October 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2020
CompletedResults Posted
Study results publicly available
August 23, 2021
CompletedJanuary 17, 2023
January 1, 2023
2.2 years
August 3, 2018
July 28, 2021
January 12, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited injection-site AEs was assessed for up to \~14 days after each vaccination. The solicited injection-site AEs assessed were erythema/redness, induration/hard lump, tenderness/pain and swelling.
Up to ~14 days after each vaccination
Percentage of Participants With a Solicited Systemic AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited systemic AEs was assessed for up to \~14 days after each vaccination. The solicited systemic AEs assessed were appetite lost/decreased appetite, irritability, drowsiness/somnolence and hives or welts/urticaria.
Up to ~14 days after each vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgement. Relatedness of an SAE to the study vaccine was determined by the investigator. Per protocol, the percentage of participants with vaccine-related SAEs was assessed through 6 months following Vaccination 4.
Up to ~6 months after Vaccination 4 (up to ~19 months)
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a pneumococcal electrochemiluminescence (PnECL) assay. Per protocol, 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified primary outcome analysis; 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified secondary outcome analysis and reported later in the record.
30 Days after Vaccination 4 (Months 11-14)
Secondary Outcomes (5)
Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3
30 Days after Vaccination 3 (Month 5)
Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3
30 Days after Vaccination 3 (Month 5)
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
30 Days after Vaccination 3 (Month 5)
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
30 Days after Vaccination 3 (Month 5)
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
30 Days after Vaccination 4 (Months 11-14)
Study Arms (5)
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
ACTIVE COMPARATORParticipants 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.
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
EXPERIMENTALParticipants 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.
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
EXPERIMENTALParticipants 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.
Group 4: Prevnar 13™-V114-V114-V114
EXPERIMENTALParticipants 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.
Group 5: V114-V114-V114-V114
EXPERIMENTALParticipants 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.
Interventions
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.
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.
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
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.
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
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.
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.
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Alabama Clinical Therapeutics ( Site 0015)
Birmingham, Alabama, 35205, United States
Southeastern Pediatric Associates, P.A. ( Site 0002)
Dothan, Alabama, 36305, United States
Children's Clinic of Jonesboro, PA ( Site 0022)
Jonesboro, Arkansas, 72401, United States
Davita Medical Group ( Site 0012)
Colorado Springs, Colorado, 80922, United States
Suncoast Research Associates, LLC ( Site 0035)
Miami, Florida, 33184, United States
Kentucky Pediatric/Adult Research Inc ( Site 0011)
Bardstown, Kentucky, 40004, United States
Pediatric Associates of Fall River ( Site 0021)
Fall River, Massachusetts, 02721, United States
Midwest Children's Health Research Institute, LLC ( Site 0024)
Lincoln, Nebraska, 68504, United States
Midwest Children's Health Research Institute, LLC ( Site 0003)
Lincoln, Nebraska, 68505, United States
Midwest Children's Health Research Institute, LLC ( Site 0004)
Lincoln, Nebraska, 68516, United States
Midwest Children's Health Research Institute, LLC ( Site 0001)
Lincoln, Nebraska, 68522, United States
Summerwood Pediatrics ( Site 0009)
Liverpool, New York, 13088, United States
University of Rochester Medical Center ( Site 0029)
Rochester, New York, 14642, United States
SUNY Upstate Medical University ( Site 0008)
Syracuse, New York, 13202, United States
Piedmont Healthcare, PA ( Site 0025)
Statesville, North Carolina, 28625, United States
Coastal Pediatric Research ( Site 0006)
Charleston, South Carolina, 29414, United States
Parkside Pediatric ( Site 0007)
Greenville, South Carolina, 29607, United States
Holston Medical Group ( Site 0018)
Kingsport, Tennessee, 37660, United States
Ventavia Research Group LLC ( Site 0017)
Fort Worth, Texas, 76104, United States
University of Texas Medical Branch ( Site 0023)
Galveston, Texas, 77555, United States
Wasatch Pediatrics-Cottonwood Office ( Site 0014)
Murray, Utah, 84107, United States
Multicare ( Site 0019)
Spokane, Washington, 99202, United States
Cooperativa de Facultad Medica Sanacoop ( Site 0057)
Bayamón, 00961, Puerto Rico
Clinical Research of Puerto Rico ( Site 0050)
Guayama, 00784, Puerto Rico
CAIMED Center - Ponce School of Medicine ( Site 0053)
Ponce, 00716, Puerto Rico
San Juan Hospital ( Site 0056)
San Juan, 00935, Puerto Rico
University of Puerto Rico ( Site 0051)
San Juan, 00935, Puerto Rico
Srinagarind Hospital. Khon Kaen University ( Site 0093)
Muang, Changwat Khon Kaen, 40002, Thailand
Chulalongkorn University ( Site 0092)
Bangkok, 10330, Thailand
Siriaj Hospital ( Site 0091)
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 0090)
Chiang Mai, 50200, Thailand
Hacettepe University Faculty of Medicine ( Site 0070)
Ankara, 06230, Turkey (Türkiye)
Eskisehir Osmangazi University Faculty of Medicine ( Site 0071)
Eskişehir, 26480, Turkey (Türkiye)
Ege University Medical Faculty Hospital ( Site 0072)
Izmir, 35040, Turkey (Türkiye)
Related Publications (1)
Bili A, Dobson S, Quinones J, Phongsamart W, Oberdorfer P, Kosalaraksa P, Dagan R, Richmond P, Wilck M, Vallejos W, Nunn C, McFetridge R, Tamms G, Fu R, Lupinacci R, Musey L, Banniettis N, Bickham K; V114-027 PNEU-DIRECTION study group. A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION). Vaccine. 2023 Jan 16;41(3):657-665. doi: 10.1016/j.vaccine.2022.10.072. Epub 2022 Dec 13.
PMID: 36522265RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2018
First Posted
August 8, 2018
Study Start
October 18, 2018
Primary Completion
December 14, 2020
Study Completion
December 14, 2020
Last Updated
January 17, 2023
Results First Posted
August 23, 2021
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf