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Pneumococcal InfectionsPhase 3NCT03692871

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

A Phase 3 study testing V114 and Prevnar 13™ in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 76 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). 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
What is being tested?
V114 and Prevnar 13™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,409 participants
Where
76 sitesin 10 countries
Study dates
14 Dec 2018to 26 Mar 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

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

76 sites in 10 countries.

76 sites in 10 countries

United States22 sites

  • Medical Research South, LLC ( Site 0013)

    Charleston, South Carolina, 29407

  • Primedical Clinical Research ( Site 0035)

    Dayton, Ohio, 45419

  • Premier Health Research Center, LLC ( Site 0005)

    Downey, California, 90240

  • Child Health Care Associates ( Site 0024)

    East Syracuse, New York, 13057

  • Allegheny Health & Wellness Pavilion West ( Site 0034)

    Erie, Pennsylvania, 16506

  • CCP- Kid's Way ( Site 0008)

    Hermitage, Pennsylvania, 16148

  • Pediatric Associates [Houston, TX] ( Site 0039)

    Houston, Texas, 77087

  • Beach Pediatrics ( Site 0040)

    Huntington Beach, California, 92647

  • Children's Research, LLC ( Site 0025)

    Lake Mary, Florida, 32746

  • Tanner Clinic ( Site 0009)

    Layton, Utah, 84041

  • Wee Care Pediatrics ( Site 0031)

    Layton, Utah, 84041

  • University of Texas Medical Branch ( Site 0018)

    League City, Texas, 77573

  • Novak Center for Childrens Health ( Site 0033)

    Louisville, Kentucky, 40202

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

    Madison, Wisconsin, 53792

  • Medpharmics, LLC ( Site 0037)

    Metairie, Louisiana, 70006

  • Advanced Research For Health Improvement LLC ( Site 0030)

    Naples, Florida, 34102

  • Pediatric Partners, P.A. ( Site 0010)

    Overland Park, Kansas, 66213

  • Thomas Jefferson University ( Site 0029)

    Philadelphia, Pennsylvania, 19107

  • Wee Care Pediatrics ( Site 0020)

    Roy, Utah, 84067

  • Khruz Biotechnology Research Institute ( Site 0006)

    San Diego, California, 92102

  • Kaiser Permanente - San Jose ( Site 0036)

    San Jose, California, 95119

  • Kaiser Permanente - Santa Clara ( Site 0027)

    Santa Clara, California, 95051

Other trials in United States

Finland10 sites

  • Espoon rokotetutkimuskeskus ( Site 0066)

    Espoo, 02230

  • Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0064)

    Helsinki, 00100

  • Ita-Helsingin Rokotetutkimuskeskus ( Site 0065)

    Helsinki, 00930

  • Jarvenpaan rokotetutkimuskeskus ( Site 0067)

    Jarvenpaa, 04400

  • Kokkolan rokotetutkimusklinikka ( Site 0071)

    Kokkola, 67100

  • Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0072)

    Oulu, 90220

  • Porin Rokotetutkimusklinikka ( Site 0069)

    Pori, 28100

  • Seinajoki Vaccine Research Center ( Site 0070)

    Seinäjoki, 60100

  • Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0063)

    Tampere, 33100

  • Turun rokotetutkimuskeskus ( Site 0068)

    Turku, 20520

Other trials in Finland

Germany9 sites

  • Kinderarztpraxis ( Site 0124)

    Aschaffenburg, 63739

  • Kinderarztpraxis ( Site 0123)

    Bramsche, 49565

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

    Hamburg, 22415

  • Kinderarztpraxis ( Site 0081)

    Hürth, 50354

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

    Lauffen am Neckar, 74348

  • Kinderarztpraxis ( Site 0080)

    Mönchengladbach, 41236

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

    Munchengladbach, 41236

  • Kinderarztpraxis ( Site 0084)

    Schönau, 83471

  • Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0083)

    Wolfsburg, 38448

Other trials in Germany

Canada8 sites

  • Alberta Children s Hospital ( Site 0048)

    Calgary, Alberta, T3B 6A8

  • Medicor Research Inc. ( Site 0041)

    Greater Sudbury, Ontario, P3A 1Y8

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

    Halifax, Nova Scotia, B3K 6R8

  • Hamilton Medical Research Group ( Site 0049)

    Hamilton, Ontario, L8M 1K7

  • CHU Sainte Justine ( Site 0047)

    Montreal, Quebec, H3T 1C5

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

    Pierrefonds, Quebec, H9H 4Y6

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

    Québec, Quebec, G1E 7G9

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

    Vancouver, British Columbia, V5Z 4H4

Other trials in Canada

Israel7 sites

  • Soroka University Medical Center ( Site 0077)

    Beersheba, 8410101

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

    Beersheba, 8471844

  • Rambam Medical Center ( Site 0076)

    Haifa, 3109601

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

    Haifa, 3515427

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

    Haifa, 3542129

  • Soroka Medical Center_ Hura Family health center ( Site 0137)

    Hura, 8573000

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

    Rahat, 8535700

Other trials in Israel

Malaysia5 sites

  • Klinik Kesihatan Greentown ( Site 0132)

    Ipoh, Perak, 30450

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

    Kuala Lumpur, 59100

  • Sarawak General Hospital ( Site 0107)

    Kuching, Sarawak, 93586

  • Klinik Kesihatan Pandamaran ( Site 0110)

    Port Klang, 42000

  • Hospital Sibu ( Site 0111)

    Sibu, Sarawak, 96000

Other trials in Malaysia

Thailand5 sites

  • Chulalongkorn University ( Site 0102)

    Bangkok, 10330

  • Siriraj Hospital ( Site 0101)

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital ( Site 0103)

    Chiang Mai, 50200

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

    Hat Yai, 90110

  • Srinagarind Hospital. Khon Kaen University ( Site 0104)

    Khon Kaen, 40002

Other trials in Thailand

Taiwan4 sites

  • Taichung Veterans General Hospital ( Site 0100)

    Taichung, 407

  • National Taiwan University Hospital ( Site 0097)

    Taipei, 10002

  • Mackay Memorial Hospital ( Site 0099)

    Taipei, 10491

  • Chang Gung Medical Foundation. Linkou ( Site 0098)

    Taoyuan, 333

Other trials in Taiwan

Australia3 sites

  • Monash Children s Hospital ( Site 0093)

    Clayton, Victoria, 3168

  • Perth Children s Hospital ( Site 0092)

    Nedlands, 6009

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

    North Adelaide, 5087

Other trials in Australia

Peru3 sites

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

    Lima, 15001

  • Instituto de Investigacion Nutricional ( Site 0058)

    Lima, 15416

  • Clinica Peruano Americana S.A. ( Site 0061)

    Trujillo, 13011

Other trials in Peru

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)

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™.

Being tested
V114, Prevnar 13™
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 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

  • 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

Study groups in NCT03692871
Study groupRoleWhat they receive
V114ExperimentalParticipants 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).
Receives: Biological: V114
Prevnar 13™Active comparatorParticipants 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).
Receives: Biological: Prevnar 13™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Day 14 after each study vaccination

  2. 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).

    Measured: Up to Day 14 after each study vaccination

  3. 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.

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

Secondary outcomes (4)

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

    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

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

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

    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

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

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

    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

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

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

    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2018
  2. Study start14 Dec 2018
  3. Primary completion26 Mar 2021
  4. Study completion26 Mar 2021

Resources

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
2,409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03692871
Sponsor's protocol ID
V114-031
Other IDs
V114-031, 2018-003308-38, 2018
Status last verified
Jul 2023
First submitted
28 Sep 2018
Last updated
28 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 37309607

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V114 and Prevnar 13™ in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 76 sites in 10 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 3 inclusion and 15 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 76 sites in United States, Finland, Germany, Canada, Israel and 5 more countries. 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 10 May 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 a Solicited Injection-site Adverse Event (time frame: Up to Day 14 after each study vaccination). The study lists 3 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 NCT03692871, which also lists 1 linked publication.

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.

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