A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

NCT03692871 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: V114-0312018-003308-38
• Study Type: interventional
• Target: 2,409
• Locations: 10 countries
• Sites: 76

Brief Summary

This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With a Solicited Injection-site Adverse Event

  An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.

  Up to Day 14 after each study vaccination

• Percentage of Participants With a Solicited Systemic Adverse Event

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).

  Up to Day 14 after each study vaccination

• Percentage of Participants With a Vaccine-related Serious Adverse Event

  A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.

  Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)

Secondary Outcomes (4)

• Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)

  30 days after Vaccination 3 (approximately 5 months after Vaccination 1)

• GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)

  Before Vaccination 4 (10-13 months after Vaccination 1)

• GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)

  30 days after Vaccination 4 (11-14 months after Vaccination 1)

• Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only)

  30 days after Vaccination 3 (approximately 5 months after Vaccination 1)

Study Arms (2)

V114

EXPERIMENTAL

Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Biological: V114

Prevnar 13™

ACTIVE COMPARATOR

Participants will receive a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Biological: Prevnar 13™

Interventions

V114 BIOLOGICAL

V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose

Also known as: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine

V114

Prevnar 13™ BIOLOGICAL

Prevnar 13™ 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

Prevnar 13™

Eligibility Criteria

• Age: 42 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator
• Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
• Have 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:

• 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
• Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine
• Known or suspected impairment of immunological function
• History of congenital or acquired immunodeficiency
• Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
• Known or history of functional or anatomic asplenia
• Failure to thrive based on the clinical judgment of the investigator
• Known coagulation disorder contraindicating intramuscular vaccination
• 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)
• Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
• Received a dose of any pneumococcal vaccine prior to study entry
• Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
• Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included.
• 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 who is investigational site or Sponsor staff directly involved with this study.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (76)

Premier Health Research Center, LLC ( Site 0005)

Downey, California, 90240, United States

Location

Beach Pediatrics ( Site 0040)

Huntington Beach, California, 92647, United States

Location

Khruz Biotechnology Research Institute ( Site 0006)

San Diego, California, 92102, United States

Location

Kaiser Permanente - San Jose ( Site 0036)

San Jose, California, 95119, United States

Location

Kaiser Permanente - Santa Clara ( Site 0027)

Santa Clara, California, 95051, United States

Location

Children's Research, LLC ( Site 0025)

Lake Mary, Florida, 32746, United States

Location

Advanced Research For Health Improvement LLC ( Site 0030)

Naples, Florida, 34102, United States

Location

Pediatric Partners, P.A. ( Site 0010)

Overland Park, Kansas, 66213, United States

Location

Novak Center for Childrens Health ( Site 0033)

Louisville, Kentucky, 40202, United States

Location

Medpharmics, LLC ( Site 0037)

Metairie, Louisiana, 70006, United States

Location

Child Health Care Associates ( Site 0024)

East Syracuse, New York, 13057, United States

Location

Primedical Clinical Research ( Site 0035)

Dayton, Ohio, 45419, United States

Location

Allegheny Health & Wellness Pavilion West ( Site 0034)

Erie, Pennsylvania, 16506, United States

Location

CCP- Kid's Way ( Site 0008)

Hermitage, Pennsylvania, 16148, United States

Location

Thomas Jefferson University ( Site 0029)

Philadelphia, Pennsylvania, 19107, United States

Location

Medical Research South, LLC ( Site 0013)

Charleston, South Carolina, 29407, United States

Location

Pediatric Associates [Houston, TX] ( Site 0039)

Houston, Texas, 77087, United States

Location

University of Texas Medical Branch ( Site 0018)

League City, Texas, 77573, United States

Location

Tanner Clinic ( Site 0009)

Layton, Utah, 84041, United States

Location

Wee Care Pediatrics ( Site 0031)

Layton, Utah, 84041, United States

Location

Wee Care Pediatrics ( Site 0020)

Roy, Utah, 84067, United States

Location

University of Wisconsin American Family Children's Hospital ( Site 0023)

Madison, Wisconsin, 53792, United States

Location

Monash Children s Hospital ( Site 0093)

Clayton, Victoria, 3168, Australia

Location

Perth Children s Hospital ( Site 0092)

Nedlands, 6009, Australia

Location

Children, Youth and Woman's Health Service ( Site 0094)

North Adelaide, 5087, Australia

Location

Alberta Children s Hospital ( Site 0048)

Calgary, Alberta, T3B 6A8, Canada

Location

Vaccine Evaluation Center BC Children s Hospital Research Institute ( Site 0046)

Vancouver, British Columbia, V5Z 4H4, Canada

Location

IWK Health Centre [Halifax, Canada] ( Site 0043)

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Medicor Research Inc. ( Site 0041)

Greater Sudbury, Ontario, P3A 1Y8, Canada

Location

Hamilton Medical Research Group ( Site 0049)

Hamilton, Ontario, L8M 1K7, Canada

Location

CHU Sainte Justine ( Site 0047)

Montreal, Quebec, H3T 1C5, Canada

Location

McGill University Health Centre - Vaccine Study Centre ( Site 0045)

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

CHUQ - Unite de Recherche en Sante Publique ( Site 0042)

Québec, Quebec, G1E 7G9, Canada

Location

Espoon rokotetutkimuskeskus ( Site 0066)

Espoo, 02230, Finland

Location

Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0064)

Helsinki, 00100, Finland

Location

Ita-Helsingin Rokotetutkimuskeskus ( Site 0065)

Helsinki, 00930, Finland

Location

Jarvenpaan rokotetutkimuskeskus ( Site 0067)

Jarvenpaa, 04400, Finland

Location

Kokkolan rokotetutkimusklinikka ( Site 0071)

Kokkola, 67100, Finland

Location

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0072)

Oulu, 90220, Finland

Location

Porin Rokotetutkimusklinikka ( Site 0069)

Pori, 28100, Finland

Location

Seinajoki Vaccine Research Center ( Site 0070)

Seinäjoki, 60100, Finland

Location

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0063)

Tampere, 33100, Finland

Location

Turun rokotetutkimuskeskus ( Site 0068)

Turku, 20520, Finland

Location

Kinderarztpraxis ( Site 0124)

Aschaffenburg, 63739, Germany

Location

Kinderarztpraxis ( Site 0123)

Bramsche, 49565, Germany

Location

Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0085)

Hamburg, 22415, Germany

Location

Kinderarztpraxis ( Site 0081)

Hürth, 50354, Germany

Location

Kinderarztpraxis Dr. Muehlschlegel - Dr. Goetz ( Site 0122)

Lauffen am Neckar, 74348, Germany

Location

Kinderarztpraxis ( Site 0080)

Mönchengladbach, 41236, Germany

Location

Kinderarztpraxis Matthias Donner Dr. M. Luechtrath ( Site 0091)

Munchengladbach, 41236, Germany

Location

Kinderarztpraxis ( Site 0084)

Schönau, 83471, Germany

Location

Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0083)

Wolfsburg, 38448, Germany

Location

Soroka University Medical Center ( Site 0077)

Beersheba, 8410101, Israel

Location

Soroka University Medical Center - Ramot Family health center ( Site 0078)

Beersheba, 8471844, Israel

Location

Rambam Medical Center ( Site 0076)

Haifa, 3109601, Israel

Location

Rambam Medical Center- Keriat Eliezer Family Health Center ( Site 0138)

Haifa, 3515427, Israel

Location

Rambam Medical Center- Neve David Family Health Center ( Site 0139)

Haifa, 3542129, Israel

Location

Soroka Medical Center_ Hura Family health center ( Site 0137)

Hura, 8573000, Israel

Location

Soroka University Medical Center - Rahat Family health center ( Site 0079)

Rahat, 8535700, Israel

Location

Klinik Kesihatan Greentown ( Site 0132)

Ipoh, Perak, 30450, Malaysia

Location

Sarawak General Hospital ( Site 0107)

Kuching, Sarawak, 93586, Malaysia

Location

Hospital Sibu ( Site 0111)

Sibu, Sarawak, 96000, Malaysia

Location

Universiti Malaya Medical Center-Clinical Investigation Center ( Site 0108)

Kuala Lumpur, 59100, Malaysia

Location

Klinik Kesihatan Pandamaran ( Site 0110)

Port Klang, 42000, Malaysia

Location

Hospital Nacional Docente Madre - Nino San Bartolome ( Site 0057)

Lima, 15001, Peru

Location

Instituto de Investigacion Nutricional ( Site 0058)

Lima, 15416, Peru

Location

Clinica Peruano Americana S.A. ( Site 0061)

Trujillo, 13011, Peru

Location

Taichung Veterans General Hospital ( Site 0100)

Taichung, 407, Taiwan

Location

National Taiwan University Hospital ( Site 0097)

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital ( Site 0099)

Taipei, 10491, Taiwan

Location

Chang Gung Medical Foundation. Linkou ( Site 0098)

Taoyuan District, 333, Taiwan

Location

Chulalongkorn University ( Site 0102)

Bangkok, 10330, Thailand

Location

Siriraj Hospital ( Site 0101)

Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital ( Site 0103)

Chiang Mai, 50200, Thailand

Location

Prince of Songkla University, Faculty of Medicine ( Site 0105)

Hat Yai, 90110, Thailand

Location

Srinagarind Hospital. Khon Kaen University ( Site 0104)

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• Banniettis N, Horn M, Sadarangani M, Patel SM, Greenberg D, Oberdorfer P, Klein NP, Rupp R, Dagan R, Richmond P, Lumley J, Zhou W, Shi Y, Tamms G, Feemster K, Lupinacci R, Musey L, Bickham K; V114-031 (PNEU-LINK) study group. Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. Pediatrics. 2023 Jul 1;152(1):e2022060428. doi: 10.1542/peds.2022-060428.

  PMID: 37309607 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Clinical Trials Disclosure
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

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: September 28, 2018
• First Posted: October 2, 2018
• Study Start: December 14, 2018
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: July 28, 2023
• Results First Posted: May 10, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

FI (10); DE (9); TW (4); AU (3); CA (8); IL (7); TH (5); MY (5); PE (3); US (22)