Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)

NCT ID: NCT03950622

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2020-03-30

Brief Summary

The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.

Conditions

Pneumococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

V114

Single intramuscular (IM) dose at 0.5 mL of V114 pneumococcal conjugate vaccine at Visit 1 (Day 1)

Group Type: EXPERIMENTAL

V114

Intervention Type: BIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.

Prevnar 13™

Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)

Group Type: ACTIVE_COMPARATOR

Prevnar 13®

Intervention Type: BIOLOGICAL

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in each 0.5 mL dose.

Interventions

V114

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.

Intervention Type: BIOLOGICAL

Prevnar 13®

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in each 0.5 mL dose.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Participant has good health in the opinion of the investigator. Any underlying chronic condition must be documented to be in stable condition according to the investigator's judgment.
• Male or female ≥50 years of age at the time of signing the informed consent. (For Japan only: Is male or female ≥65 years of age at the time of signing the informed consent)
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Female participant is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use agreed upon contraception during the treatment period and for at least 6 weeks after the last dose of study intervention.
• Provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.

Exclusion Criteria

• History of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1).
• Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine.
• Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
• Coagulation disorder contraindicating intramuscular (IM) vaccinations.
• Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine.
• History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
• A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1).
• Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol.
• Has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.
• Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue [e.g., bursa, tendon steroid injections], and inhaled/nebulized steroids are permitted.)
• Is receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.
• Has received any non-live vaccine within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.)
• Has received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine.
• Has received a blood transfusion or blood products, including immunoglobulin, within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
• Currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.
• In the opinion of the investigator, has a history of clinically relevant drug or alcohol use that would interfere with participation in protocol-specified activities.
• History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study.
• An immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Synexus ( Site 1001)

Mesa, Arizona, United States

Artemis Institute for Clinical Research ( Site 1012)

San Diego, California, United States

Indago Research & Health Center, Inc ( Site 1002)

Hialeah, Florida, United States

Research Centers of America, LLC ( Site 1014)

Hollywood, Florida, United States

Advanced Medical Research Institute ( Site 0117)

Miami, Florida, United States

Lakes Research LLC ( Site 1005)

Miami Lakes, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 1008)

Newton, Kansas, United States

Wake Research Clinical Research Center of Nevada, LLC ( Site 1010)

Las Vegas, Nevada, United States

Rapid Medical Research, Inc. ( Site 1011)

Cleveland, Ohio, United States

Diagnostics Research Group ( Site 1000)

San Antonio, Texas, United States

Synexus ( Site 1009)

San Antonio, Texas, United States

J Lewis Research Inc / Foothill Family Clinic ( Site 1013)

Salt Lake City, Utah, United States

Charlottesville Medical Research Center, LLC ( Site 1003)

Charlottesville, Virginia, United States

Health Research of Hampton Roads, Inc. ( Site 1007)

Newport News, Virginia, United States

Colchester Research Group ( Site 2002)

Truro, Nova Scotia, Canada

Milestone Research ( Site 2003)

London, Ontario, Canada

Bluewater Clinical Research Group Inc ( Site 2004)

Sarnia, Ontario, Canada

Manna Research Inc.. ( Site 2007)

Toronto, Ontario, Canada

Dynamik Research ( Site 2000)

Pointe-Claire, Quebec, Canada

Q & T Research Sherbrooke Inc. ( Site 2001)

Sherbrooke, Quebec, Canada

P-One Clinic, Keikokai Medical Corp. ( Site 0400)

Hachiōji, Tokyo, Japan

Souseikai PS Clinic ( Site 0402)

Fukuoka, , Japan

Souseikai Nishikumamoto Hospital ( Site 0404)

Kumamoto, , Japan

Medical Corporation Heishinkai OPHAC Hospital ( Site 0401)

Osaka, , Japan

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 0403)

Tokyo, , Japan

Hospital Universitario Quiron Madrid ( Site 0304)

Pozuelo de Alarcón, Madrid, Spain

Instituto de Ciencias Medicas - ICM ( Site 0300)

Alicante, , Spain

CAP Centelles ( Site 0301)

Centelles, , Spain

National Cheng Kung University Hospital ( Site 0501)

Dawan, , Taiwan

National Taiwan University Hospital ( Site 0500)

Taipei, , Taiwan

Countries

United States; Canada; Japan; Spain; Taiwan

References

Platt HL, Cardona JF, Haranaka M, Schwartz HI, Narejos Perez S, Dowell A, Chang CJ, Dagan R, Tamms GM, Sterling T, Morgan L, Shi Y, Pedley A, Musey LK, Buchwald UK. A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE). Vaccine. 2022 Jan 3;40(1):162-172. doi: 10.1016/j.vaccine.2021.08.049. Epub 2021 Sep 8.

Reference Type: DERIVED

PMID: 34507861 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-004316-22

Identifier Type: OTHER

Identifier Source: secondary_id

V114-019

Identifier Type: OTHER

Identifier Source: secondary_id

194845

Identifier Type: REGISTRY

Identifier Source: secondary_id

V114-019

Identifier Type: -

Identifier Source: org_study_id