Pneumococcal InfectionsPhase 3PNEU-PEDNCT03893448
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
A Phase 3 study testing V114, Prevnar 13™ and RotaTeq™ in people with Pneumococcal Infections and Pneumococcal Vaccines, run by Merck Sharp & Dohme LLC at 81 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior… Read more about this study
- Who is it for?
- Ages 42 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections, Pneumococcal Vaccines
- What is being tested?
- V114, Prevnar 13™ and RotaTeq™
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,720 participants
- Where
- 81 sitesin 4 countries
- Study dates
- 19 Jun 2019to 24 May 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Is healthy (based on a review of medical history and physical examination) in the clinical judgement 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.
Who cannot join
- Has a history of invasive pneumococcal disease (IPD; 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.
- Had a recent febrile illness (rectal temperature ≥38.1°C [=100.5°F] or axillary temperature ≥37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine.
Trial locations and contacts
81 sites in 4 countries.
81 sites in 4 countries
United States66 sites
Advanced Clinical Research - Rancho Paseo ( Site 0163)
Banning, California, 92220
Kentucky Pediatric/Adult Research Inc ( Site 0136)
Bardstown, Kentucky, 40004
Altissima Clinical Research LLC ( Site 0213)
Bellflower, California, 90706
Southland Clinical Research Center ( Site 0187)
Bellflower, California, 90706
Alabama Clinical Therapeutics ( Site 0159)
Birmingham, Alabama, 35205
Tufts Medical Center-Floating Hospital for Children ( Site 0129)
Boston, Massachusetts, 02111
Palmetto Pediatrics, PA ( Site 0164)
Charleston, South Carolina, 29406-9170
MultiCare Rockwood Cheney Clinic ( Site 0195)
Cheney, Washington, 99004
Cheraw Pediatrics ( Site 0280)
Cheraw, South Carolina, 29520
Senders Pediatrics ( Site 0190)
Cleveland, Ohio, 44121
Haywood Pediatric and Adolescent Medicine Group ( Site 0248)
Clyde, North Carolina, 28721
Davita Medical Group ( Site 0141)
Colorado Springs, Colorado, 80922
DFW Clinical Research ( Site 0111)
Dallas, Texas, 75234
Dayton Clinical Research ( Site 0188)
Dayton, Ohio, 45406
Southeastern Pediatric Associates, P.A. ( Site 0107)
Dothan, Alabama, 36305
Premier Health Research Center, LLC ( Site 0121)
Downey, California, 90240
Pediatric Medical Associates ( Site 0239)
East Norriton, Pennsylvania, 19401
Child Health Care Associates ( Site 0242)
East Syracuse, New York, 13057
Allegheny Health & Wellness Pavilion West ( Site 0210)
Erie, Pennsylvania, 16506
Pediatric Associates of Fall River ( Site 0183)
Fall River, Massachusetts, 02721
Northwest Arkansas Pediatric Clinic ( Site 0172)
Fayetteville, Arkansas, 72703
Lockman & Lubell Pediatrics ( Site 0166)
Fort Washington, Pennsylvania, 19034
University of Texas Medical Branch ( Site 0185)
Galveston, Texas, 77555
Parkside Pediatric ( Site 0125)
Greenville, South Carolina, 29607
Cyn3rgy Research ( Site 0246)
Gresham, Oregon, 97030
ACC Pediatric Research ( Site 0147)
Haughton, Louisiana, 71037
CCP- Kid's Way ( Site 0130)
Hermitage, Pennsylvania, 16148
Ventavia Research Group LLC ( Site 0142)
Houston, Texas, 77008
Pediatric Associates ( Site 0209)
Houston, Texas, 77087
Houston Clinical Research Network ( Site 0266)
Houston, Texas, 77090
Children's Clinic of Jonesboro, PA ( Site 0184)
Jonesboro, Arkansas, 72401
Children's Mercy Clinics on Broadway ( Site 0171)
Kansas City, Missouri, 64111
Ventavia Research Group LLC ( Site 0139)
Keller, Texas, 76248
Holston Medical Group ( Site 0165)
Kingsport, Tennessee, 37660
FMC Science ( Site 0115)
Lampasas, Texas, 76550
Wee Care Pediatrics ( Site 0154)
Layton, Utah, 84041
University of Texas Medical Branch ( Site 0170)
League City, Texas, 77573
Midwest Children's Health Research Institute, LLC ( Site 0109)
Lincoln, Nebraska, 68505
Midwest Children's Health Research Institute, LLC ( Site 0106)
Lincoln, Nebraska, 68522
Child Health Care Associates ( Site 0267)
Liverpool, New York, 13090
DCOL Center for Clinical Research ( Site 0247)
Longview, Texas, 75605
Medpharmics, LLC ( Site 0157)
Metairie, Louisiana, 70006
Suncoast Research Associates, LLC ( Site 0250)
Miami, Florida, 33184
Cottonwood Pediatrics ( Site 0153)
Murray, Utah, 84107
Saltzer Medical Group ( Site 0215)
Nampa, Idaho, 83686
Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276)
Nicholasville, Kentucky, 40356
Suncoast Research Associates, LLC ( Site 0249)
North Miami Beach, Florida, 33160
Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282)
Oakland, California, 94612
Children's Physicians, UNMC ( Site 0252)
Omaha, Nebraska, 68198
South Alabama Pediatrics ( Site 0263)
Opp, Alabama, 36467
MediSync Clinical Research Hattiesburg Clinic ( Site 0259)
Petal, Mississippi, 39465
Pediatric Care ( Site 0138)
Provo, Utah, 84604
Capitol Pediatrics & Adolescent Center ( Site 0223)
Raleigh, North Carolina, 27609
Wee Care Pediatrics-Roy ( Site 0174)
Roy, Utah, 84067
Kaiser Permanente - Sacramento ( Site 0257)
Sacramento, California, 95815
Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256)
Sacramento, California, 95823
University of Utah ( Site 0214)
Salt Lake City, Utah, 84113
Kaiser Permanente - San Jose ( Site 0258)
San Jose, California, 95119
Kaiser Permanente - Santa Clara ( Site 0244)
Santa Clara, California, 95051
Southwest CARE Center ( Site 0161)
Santa Fe, New Mexico, 87501
Virgo-Carter Pediatrics ( Site 0275)
Silver Spring, Maryland, 20910
Multicare / Rockwood Clinic ( Site 0167)
Spokane, Washington, 99202
Dixie Pediatrics ( Site 0260)
St. George, Utah, 84790
Wee Care Pediatrics ( Site 0193)
Syracuse, Utah, 84075
Children's Health Center ( Site 0272)
Tampa, Florida, 33617
Advantage Clinical Trials ( Site 0274)
The Bronx, New York, 10468
Puerto Rico6 sites
Cooperativa de Facultad Medica Sanacoop ( Site 0077)
Bayamón, 00961
Clinical Research of Puerto Rico ( Site 0075)
Guayama, 00784
CAIMED Center - Ponce School of Medicine ( Site 0076)
Ponce, 00716
San Juan Hospital ( Site 0079)
San Juan, 00935
University of Puerto Rico - Medical Science Campus ( Site 0078)
San Juan, 00935
Elba Antoniette Perez Vargas MD-Private Practice ( Site 0081)
Trujillo Alto, 00976
Turkey (Türkiye)5 sites
Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0060)
Adana, 01330
Ankara Universitesi Tip Fakultesi ( Site 0053)
Ankara, 06590
Ege University Medical Faculty Hospital ( Site 0050)
Izmir, 35040
Dokuz Eylul University Faculty of Medicine ( Site 0054)
Izmir, 35340
Erciyes Universitesi Tip Fakultesi ( Site 0057)
Kayseri, 38039
Thailand4 sites
Phramongkutklao Hospital ( Site 0033)
Bangkok, 10400
Siriraj Hospital ( Site 0032)
Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital ( Site 0030)
Chiang Mai, 50200
Khon Kaen University ( Site 0031)
Muang, Changwat Khon Kaen, 40002
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.
- Conditions
- Pneumococcal Infections, Pneumococcal Vaccines
- Being tested
- V114, Prevnar 13™, RotaTeq™, Pentacel™, RECOMBIVAX HB™
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V114Biological
Also called VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
V114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.
Prevnar 13™Biological
Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
RotaTeq™Biological
A total of 3 RotaTeq™ 2 mL oral dosings at ~2, ~4, and ~6 months of age.
Pentacel™Biological
A total of 3 Pentacel™ 0.5 mL IM dosings at ~2, ~4, and ~6 months of age.
RECOMBIVAX HB™Biological
A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at ~2, ~4, and ~6 months of age.
VAQTA™Biological
One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.
MMR II™Biological
One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.
VARIVAX™Biological
One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.
HIBERIX™Biological
One HIBERIX™ 0.5 mL IM dosing at Visit 5.
| Study group | Role | What they receive |
|---|---|---|
| V114 | Experimental | Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at ~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. Receives: Biological: V114; Biological: RotaTeq™; Biological: Pentacel™; Biological: RECOMBIVAX HB™; Biological: VAQTA™; Biological: MMR II™; Biological: VARIVAX™; Biological: HIBERIX™ |
| Prevnar 13™ | Active comparator | Participants receive 4 total 0.5 mL IM vaccinations at ~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. Receives: Biological: Prevnar 13™; Biological: RotaTeq™; Biological: Pentacel™; Biological: RECOMBIVAX HB™; Biological: VAQTA™; Biological: MMR II™; Biological: VARIVAX™; Biological: HIBERIX™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
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. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump.
Measured: Up to 14 days after each vaccination with either V114 or Prevnar 13™
Percentage of Participants With Solicited Systemic AEs
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. Solicited systemic AEs consisted of irritability, drowsiness, appetite lost, and hives or welts.
Measured: Up to 14 days after each vaccination with either V114 or Prevnar 13™
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination are summarized.
Measured: From Day 1 up to 6 months after Vaccination 4 (up to 21 months)
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Measured: One month after Vaccination 3 (Month 7)
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
Measured: One month after Vaccination 3 (Month 7)
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
Measured: One month after Vaccination 4 (Month 13 to Month 16)
Secondary outcomes (14)
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens were measured using Luminex Assay. The percentage of participants meeting specific criteria are summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % neutralizing antibody (NAb) ≥1:8 dilution; poliovirus 2: % NAb ≥1:8 dilution, poliovirus 3: % NAb ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL.
Measured: One month after Vaccination 3 (Month 7)
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Pertussis antibody GMCs were measured using Luminex Assay.
Measured: One month after Vaccination 3 (Month 7)
Hepatitis A Antibody Response Rate One Month After Vaccination 4
Antibody response rates to hepatitis A were measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL are reported.
Measured: One month after Vaccination 4 (Month 13 to Month 16)
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4
Antibody responses to measles were measured with the bulk measles IgG enzyme immunoassay (EIA). Antibody responses to mumps were measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella were measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, are reported.
Measured: One month after Vaccination 4 (Month 13 to Month 16)
Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4
Antibody responses to varicella-zoster virus were measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL are reported.
Measured: One month after Vaccination 4 (Month 13 to Month 16)
Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4
Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) were measured with ELISA. The percentage of participants with anti-HiB PRP antigen ≥0.15 ug/mL are reported.
Measured: One month after Vaccination 4 (Month 13 to Month 16)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported.
Measured: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Serotype-specific anti-PnP IgG response rates for the 2 unique V114 serotypes were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Measured: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes
Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported.
Measured: One month after Vaccination 4 (Month 13 to Month 16)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized.
Measured: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype-specific anti-PnP OPA GMTs were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype.
Measured: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3
Serotype 3-specific anti-PnP IgG response rates were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for Serotype 3.
Measured: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Serotype 3-specific anti-PnP GMC was measured with PnECL.
Measured: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4
Serotype 3-specific anti-PnP GMC were measured with PnECL.
Measured: One month after Vaccination 4 (Month 13 to Month 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start19 Jun 2019
- Primary completion24 May 2021
- Study completion24 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893448
- Sponsor's protocol ID
- V114-029
- Other IDs
- V114-029, 2018-004109-21, 2018
- Acronym
- PNEU-PED
- Status last verified
- Jul 2023
- First submitted
- 26 Mar 2019
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Lupinacci R, Rupp R, Wittawatmongkol O, Jones J, Quinones J, Ulukol B, Dagan R, Richmond P, Stek JE, Romero L, Koseoglu S, Tamms G, McFetridge R, Li J, Cheon K, Musey L, Banniettis N, Bickham K; V114-029 PNEU-PED study group. A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023 Jan 27;41(5):1142-1152. doi: 10.1016/j.vaccine.2022.12.054. Epub 2023 Jan 6.
PubMed 36621410Mt-Isa S, Chumbley JR, Crawford EL, Banniettis N, Buchwald UK, Weaver J, Weiss T. An indirect treatment comparison (ITC) and matching-adjusted indirect comparison (MAIC) between a 15-valent (V114) and a 20-valent (PCV20) pneumococcal conjugate vaccine among healthy infants. Expert Rev Vaccines. 2023 Jan-Dec;22(1):906-917. doi: 10.1080/14760584.2023.2270039. Epub 2023 Oct 19.
PubMed 37846456
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
- ClinicalTrials.gov ID
- NCT03893448
- Acronym / sponsor ID
- PNEU-PED / V114-029
- Conditions
- Pneumococcal Infections, Pneumococcal Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,720 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Posted 25 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V114 | Experimental | Biological: V114, Biological: RotaTeq™, Biological: Pentacel™, Biological: RECOMBIVAX HB™, Biological: VAQTA™, Biological: MMR II™, Biological: VARIVAX™, Biological: HIBERIX™Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at ~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. |
| Prevnar 13™ | Active comparator | Biological: Prevnar 13™, Biological: RotaTeq™, Biological: Pentacel™, Biological: RECOMBIVAX HB™, Biological: VAQTA™, Biological: MMR II™, Biological: VARIVAX™, Biological: HIBERIX™Participants receive 4 total 0.5 mL IM vaccinations at ~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule. |
Who may qualify
- Ages
- 42 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Is healthy (based on a review of medical history and physical examination) in the clinical judgement 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.
Key exclusion criteria (4 listed)
- Has a history of invasive pneumococcal disease (IPD; 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.
- Had a recent febrile illness (rectal temperature ≥38.1°C [=100.5°F] or axillary temperature ≥37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V114Also: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate VaccineV114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration. | Biological | V114 |
| Prevnar 13™Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration. | Biological | Prevnar 13™ |
| RotaTeq™A total of 3 RotaTeq™ 2 mL oral dosings at ~2, ~4, and ~6 months of age. | Biological | Prevnar 13™, V114 |
| Pentacel™A total of 3 Pentacel™ 0.5 mL IM dosings at ~2, ~4, and ~6 months of age. | Biological | Prevnar 13™, V114 |
| RECOMBIVAX HB™A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at ~2, ~4, and ~6 months of age. | Biological | Prevnar 13™, V114 |
| VAQTA™One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age. | Biological | Prevnar 13™, V114 |
| MMR II™One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age. | Biological | Prevnar 13™, V114 |
| VARIVAX™One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age. | Biological | Prevnar 13™, V114 |
| HIBERIX™One HIBERIX™ 0.5 mL IM dosing at Visit 5. | Biological | Prevnar 13™, V114 |
Primary outcome
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
Time frame: Up to 14 days after each vaccination with either V114 or Prevnar 13™
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. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump.
Percentage of Participants With Solicited Systemic AEs
Time frame: Up to 14 days after each vaccination with either V114 or Prevnar 13™
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. Solicited systemic AEs consisted of irritability, drowsiness, appetite lost, and hives or welts.
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
Time frame: From Day 1 up to 6 months after Vaccination 4 (up to 21 months)
An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination are summarized.
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Time frame: One month after Vaccination 3 (Month 7)
Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Time frame: One month after Vaccination 3 (Month 7)
The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
14 secondary outcomes
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Time frame: One month after Vaccination 3 (Month 7)
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Time frame: One month after Vaccination 3 (Month 7)
Hepatitis A Antibody Response Rate One Month After Vaccination 4
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Time frame: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Time frame: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Time frame: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Time frame: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3
Time frame: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Time frame: One month after Vaccination 3 (Month 7)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36621410Lupinacci R, Rupp R, Wittawatmongkol O, Jones J, Quinones J, Ulukol B, Dagan R, Richmond P, Stek JE, Romero L, Koseoglu S, Tamms G, McFetridge R, Li J, Cheon K, Musey L, Banniettis N, Bickham K; V114-029 PNEU-PED study group. A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023 Jan 27;41(5):1142-1152. doi: 10.1016/j.vaccine.2022.12.054. Epub 2023 Jan 6.
- Derived from this study: PubMed 37846456Mt-Isa S, Chumbley JR, Crawford EL, Banniettis N, Buchwald UK, Weaver J, Weiss T. An indirect treatment comparison (ITC) and matching-adjusted indirect comparison (MAIC) between a 15-valent (V114) and a 20-valent (PCV20) pneumococcal conjugate vaccine among healthy infants. Expert Rev Vaccines. 2023 Jan-Dec;22(1):906-917. doi: 10.1080/14760584.2023.2270039. Epub 2023 Oct 19.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
81 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V114, Prevnar 13™ and RotaTeq™ in people with Pneumococcal Infections and Pneumococcal Vaccines, run by Merck Sharp & Dohme LLC at 81 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, Puerto Rico, Turkey (Türkiye), Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ (time frame: Up to 14 days after each vaccination with either V114 or Prevnar 13™). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03893448, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.