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Pneumococcal InfectionsPhase 2NCT02987972

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

A Phase 2 study testing V114 Lot 1, V114 Lot 2 and Prevnar 13™ in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 49 sites in 6 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, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG >=0.35 mcg/mL for each… Read more about this study

Who is it for?
Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for
Pneumococcal Infections
What is being tested?
V114 Lot 1, V114 Lot 2 and Prevnar 13™
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,051 participants
Where
49 sitesin 6 countries
Study dates
21 Mar 2017to 4 Oct 2018
Phase
Phase 2
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 6 to 12 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Infant approximately 2 months of age (42 days to 90 days), inclusive
  • In good health

Who cannot join

  • Prior administration of any pneumococcal vaccine
  • Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
  • Known or suspected impairment of immunological function
  • History of congenital or acquired immunodeficiency (eg, splenomegaly)
  • Mother has documented human immunodeficiency virus (HIV) infection
  • Mother has documented hepatitis B surface antigen-positive test result
Show all 15Show fewer
  • Known or history of functional or anatomic asplenia
  • History of failure to thrive
  • History of a coagulation disorder
  • History of autoimmune disease
  • Known neurologic or cognitive behavioral disorder
  • Expects to require systemic corticosteroids within 30 days after each vaccination during the trial
  • Prior administration of a blood transfusion or blood products, including immunoglobulin
  • Participated in another clinical trial of an investigational product
  • History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease

Trial locations and contacts

49 sites in 6 countries.

49 sites in 6 countries

United States30 sites

  • Kentucky Pediatric/Adult Research Inc ( Site 0037)

    Bardstown, Kentucky, 40004

  • Birmingham Pediatric Research ( Site 0043)

    Birmingham, Alabama, 35205

  • Coastal Pediatric Research ( Site 0070)

    Charleston, South Carolina, 29414

  • Pediatric Research of Charlottesville, LLC ( Site 0066)

    Charlottesville, Virginia, 22902

  • Pediatric Associates of Mt. Carmel, Inc. ( Site 0052)

    Cincinnati, Ohio, 45245

  • Senders Pediatrics ( Site 0058)

    Cleveland, Ohio, 44121

  • Ohio Pediatric Research Association ( Site 0060)

    Dayton, Ohio, 45414

  • Southeastern Pediatric Associates, P.A. ( Site 0079)

    Dothan, Alabama, 36305

  • Premier Health Research Center, LLC ( Site 0035)

    Downey, California, 90241

  • Pediatric Medical Associates ( Site 0059)

    East Norriton, Pennsylvania, 19401

  • Child Health Care Associates ( Site 0064)

    East Syracuse, New York, 13057

  • Family Health Care of Ellensburg ( Site 0077)

    Ellensburg, Washington, 98926

  • University of Texas Medical Branch at Galveston ( Site 0056)

    Galveston, Texas, 77555

  • ACC Pediatric Research ( Site 0039)

    Haughton, Louisiana, 71037

  • Kid's Way Pediatrics ( Site 0036)

    Hermitage, Pennsylvania, 16148

  • Children's Clinic of Jonesboro, PA ( Site 0054)

    Jonesboro, Arkansas, 72401

  • Holston Medical Group [Kingsport, TN] ( Site 0048)

    Kingsport, Tennessee, 37660

  • Wee Care Pediatrics ( Site 0042)

    Layton, Utah, 84041

  • University of Texas Medical Branch at Galveston ( Site 0068)

    League City, Texas, 77573

  • University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)

    Louisville, Kentucky, 40202

  • Huguenot Pediatrics ( Site 0057)

    Midlothian, Virginia, 23113

  • Cottonwood Pediatrics ( Site 0041)

    Murray, Utah, 84107

  • Dundee Clinic ( Site 0063)

    Omaha, Nebraska, 68132

  • Sherif Khamis MD, Inc. ( Site 0044)

    Palmdale, California, 93550

  • Thomas Jefferson University ( Site 0067)

    Philadelphia, Pennsylvania, 19107

  • Kaiser Permanente - Roseville ( Site 0045)

    Roseville, California, 95661

  • Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)

    Sacramento, California, 95815

  • Copperview Medical Center ( Site 0062)

    South Jordan, Utah, 84095

  • State University of New York Upstate Medical University ( Site 0065)

    Syracuse, New York, 13210

  • Woburn Pediatric Associates ( Site 0046)

    Woburn, Massachusetts, 01801

Other trials in United States

Finland8 sites

  • Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)

    Espoo

  • Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005)

    Helsinki

  • Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)

    Helsinki

  • Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)

    Jarvenpaa

  • Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)

    Oulu

  • Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)

    Pori

  • Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)

    Tampere

  • Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)

    Turku

Other trials in Finland

Israel4 sites

  • Soroka University Medical Center ( Site 0019)

    Beersheba

  • Soroka University Medical Center - Rahat Family health center ( Site 0020)

    Beersheba

  • Soroka University Medical Center - Ramot Family health center ( Site 0021)

    Beersheba

  • Soroka University Medical Center - Vav Family health center ( Site 0022)

    Beersheba

Other trials in Israel

Canada3 sites

  • CHU Ste-Justine ( Site 0084)

    Montreal, Quebec, H9H 4M7

  • McGill University Health Centre - Vaccine Study Centre ( Site 0030)

    Pierrefonds, Quebec, H9H 4M7

  • CHU de Quebec Universite de Laval ( Site 0031)

    Québec, Quebec, H9H 4M7

Other trials in Canada

Denmark2 sites

  • Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025)

    Aarhus N

  • OUH Klinisk Forsk center Gyn Obs D. ( Site 0024)

    Odense

Other trials in Denmark

Spain2 sites

  • Hospital Clinico Universitario de Santiago ( Site 0016)

    Santiago de Compostela

  • Unidad de Estudios e Investigacion IHP ( Site 0017)

    Seville

Other trials in Spain

About this study

Official title: A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants

This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13™.

Being tested
V114 Lot 1, V114 Lot 2, 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.

  • V114 Lot 1Biological

    Also called V114-1

    Lot 1: 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

  • V114 Lot 2Biological

    Also called V114-2

    Lot 2: 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

  • Prevnar 13™Biological

    Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

Study groups in NCT02987972
Study groupRoleWhat they receive
V114 Lot 1ExperimentalInfants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Receives: Biological: V114 Lot 1
V114 Lot 2ExperimentalInfants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Receives: Biological: V114 Lot 2
Prevnar 13™Active comparatorInfants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
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 Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3

    Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.

    Measured: 1 month post vaccination 3 (Month 5)

  2. Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3

    Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.

    Measured: 1 month post Vaccination 3 (Month 5)

  3. Percentage of Participants Who Experience at Least 1 Adverse Event

    An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.

    Measured: Up to 1 month post Vaccination 4 (up to 14 months)

  4. Percentage of Participants Who Discontinued From the Study Due to an Adverse Event

    The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.

    Measured: Up to 1 month post Vaccination 4 (up to 14 months)

  5. Percentage of Participants With a Solicited Injection-site Adverse Event

    Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.

    Measured: Up to 14 days post any vaccination

  6. Percentage of Participants With a Solicited Systemic Adverse Event

    Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.

    Measured: Up to 14 days post any vaccination

Secondary outcomes (2)

  1. Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4

    Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.

    Measured: Before Vaccination 4 (Month 10 to 13)

  2. Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4

    Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.

    Measured: 1 month post vaccination 4 (Month 11-14)

Timeline

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

  1. First posted9 Dec 2016 (estimated)
  2. Study start21 Mar 2017
  3. Primary completion4 Oct 2018
  4. Study completion4 Oct 2018

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,051 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02987972
Sponsor's protocol ID
V114-008
Other IDs
2016-001117-25, 2016
Status last verified
Sep 2019
First submitted
6 Dec 2016
Last updated
23 Oct 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Platt HL, Greenberg D, Tapiero B, Clifford RA, Klein NP, Hurley DC, Shekar T, Li J, Hurtado K, Su SC, Nolan KM, Acosta CJ, McFetridge RD, Bickham K, Musey LK; V114-008 Study Group. A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2020 Aug;39(8):763-770. doi: 10.1097/INF.0000000000002765.

    PubMed 32639460

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing V114 Lot 1, V114 Lot 2 and Prevnar 13™ in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 49 sites in 6 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 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Finland, Israel, Canada, Denmark and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Oct 2019). 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 Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 (time frame: 1 month post vaccination 3 (Month 5)). 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 NCT02987972, 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 23 Oct 2019.

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