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Pneumococcal InfectionsPhase 3NCT03615482

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU)

A Phase 3 study testing V114 and QIV in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 45 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This study was designed to evaluate the safety and tolerability of a single dose of V114 when administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza vaccine. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Pneumococcal Infections
What is being tested?
V114 and QIV
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,200 participants
Where
45 sitesUnited States
Study dates
14 Sep 2018to 24 Jun 2019
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • In good health. Any underlying chronic illness must be documented to be in stable condition.
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) not a woman of childbearing potential (WOCBP) OR b) a WOCBP who agrees to use 1 of the contraceptive methods as defined in the protocol during the treatment period and for at least 6 weeks after the last dose of study intervention.

Who cannot join

  • 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 before Visit 1 (Day 1)
  • Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine
  • Known hypersensitivity to any component of influenza vaccines, including egg protein, or following a previous dose of any influenza vaccine.
  • Known or suspected impairment of immunological function
  • Experienced Guillain-Barré syndrome within 6 weeks of receiving a previous influenza vaccination
  • Coagulation disorder contraindicating intramuscular vaccinations.
Show all 18Show fewer
  • 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)
  • Prior administration of any PCV (e.g., Prevnar 13®) or is expected to receive any pneumococcal vaccine during the study outside of the protocol.
  • Prior administration of PNEUMOVAX®23 ≤12 months before Visit 1 (Note: individuals who received PNEUMOVAX®23 >12 months prior to Visit 1 are eligible for this study.)
  • Previous receipt of influenza vaccine during the 2018/2019 flu season or expected to receive any influenza vaccine during the study outside of the protocol
  • Received systemic corticosteroids (≥20 mg/day prednisone equivalent) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.
  • 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).
  • 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
  • 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.
  • Is 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.
  • Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator.
  • Is or has 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.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 sites

  • Wellness Clinical Research Associates ( Site 0048)

    Allen, Texas, 75013

  • Heartland Research Associates, LLC ( Site 0031)

    Augusta, Kansas, 67010

  • Kentucky Pediatric/Adult Research Inc ( Site 0011)

    Bardstown, Kentucky, 40004

  • Achieve Clinical Research, LLC ( Site 0046)

    Birmingham, Alabama, 35216

  • Holston Medical Group ( Site 0003)

    Bristol, Tennessee, 37620

  • PMG Research Of Cary LLC ( Site 0035)

    Cary, North Carolina, 27518

  • Synexus Clinical Research US, Inc. ( Site 0039)

    Chandler, Arizona, 85224

  • Charlottesville Medical Research Center, LLC ( Site 0008)

    Charlottesville, Virginia, 22911

  • Synexus Clinical Research US, Inc./Colorado Springs Family Practice ( Site 0021)

    Colorado Springs, Colorado, 80909

  • Regional Clinical Research, Inc. ( Site 0029)

    Endwell, New York, 13760

  • Evanston Premier Healthcare & Research, LLC. ( Site 0012)

    Evanston, Illinois, 60201

  • Healthcare Research Network LLC ( Site 0006)

    Flossmoor, Illinois, 60422

  • Benchmark Research ( Site 0037)

    Fort Worth, Texas, 76135

  • Southland Clinical Research Center ( Site 0033)

    Fountain Valley, California, 92708

  • San Gabriel Clinical Research ( Site 0047)

    Georgetown, Texas, 78626

  • Healthcare Research Network LLC ( Site 0032)

    Hazelwood, Missouri, 63042

  • Indago Research & Health Center, Inc ( Site 0007)

    Hialeah, Florida, 33012

  • Research Centers of America, LLC ( Site 0036)

    Hollywood, Florida, 33024

  • Holston Medical Group ( Site 0028)

    Kingsport, Tennessee, 37660

  • Clinical Research Center of Neveda, LLC. ( Site 0022)

    Las Vegas, Nevada, 89104

  • Unity Clinical Research ( Site 0044)

    Lindsay, Oklahoma, 73052

  • Community Clinical Research Network (Marlboro, MA) ( Site 0030)

    Marlborough, Massachusetts, 01752

  • Synexus Clinical Research, US,Inc/Central Arizona Medical Associates, PC ( Site 0004)

    Mesa, Arizona, 85206

  • Suncoast Research Group, LLC ( Site 0020)

    Miami, Florida, 33135

  • L&C Professional Medical Research Institute ( Site 0015)

    Miami, Florida, 33144

  • Alpha Science Research ( Site 0018)

    Miami, Florida, 33186

  • Lakes Research LLC ( Site 0034)

    Miami Lakes, Florida, 33014

  • PMG Research Inc ( Site 0027)

    Mt. Pleasant, South Carolina, 29464

  • Clinical Research Associates Inc. ( Site 0040)

    Nashville, Tennessee, 37203

  • Mid Hudson Medical Research ( Site 0024)

    New Windsor, New York, 12553

  • Heartland Research Associates, LLC ( Site 0016)

    Newton, Kansas, 67114

  • Valley Clinical Trials Inc. ( Site 0001)

    Northridge, California, 91325

  • Center for Clinical Trials, LLC ( Site 0025)

    Paramount, California, 90723

  • Clinical Research Partners, LLC. ( Site 0005)

    Richmond, Virginia, 23220

  • Rochester Clinical Research, Inc. ( Site 0009)

    Rochester, New York, 14609

  • Synexus Clinical Research US, Inc. ( Site 0019)

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research ( Site 0026)

    San Diego, California, 92103

  • California Research Foundation ( Site 0002)

    San Diego, California, 92123

  • Southwest CARE Center ( Site 0013)

    Santa Fe, New Mexico, 87505

  • Synexus Clinical Research US, Inc. ( Site 0042)

    Scottsdale, Arizona, 85251

  • Springfield Clinic ( Site 0045)

    Springfield, Illinois, 62703

  • Bayview Research Group, LLC ( Site 0010)

    Valley Village, California, 91607

  • Omega Medical Research ( Site 0049)

    Warwick, Rhode Island, 02886

  • Allegiance Research Specialists ( Site 0017)

    Wauwatosa, Wisconsin, 53226

  • Clinical Research Center Of Reading LLP ( Site 0014)

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (PNEU-FLU)

This study was designed to evaluate the safety and tolerability of a single dose of V114 when administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza vaccine. It also evaluated whether V114 can be administered concomitantly with influenza vaccine without impairing the antibody response to the 15 serotypes contained in V114 and to the 4 influenza viruses contained in the seasonal inactivated quadrivalent influenza vaccine (QIV). The primary hypotheses state that immune responses to V114 and to QIV are non-inferior when administered concomitantly as compared with non-concomitant administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination. This study will also contribute to the overall safety database and immunogenicity data for V114 to support initial licensure in adults.

Being tested
V114, QIV, Matching Placebo for V114
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

    Single 0.5 mL injection

  • QIVBiological

    Also called Quadrivalent influenza vaccine (seasonal inactivated), Fluarix Quadrivalent (Influenza Vaccine)

    Single 0.5 mL injection

  • Matching Placebo for V114Biological

    Single 0.5 mL injection

Study groups in NCT03615482
Study groupRoleWhat they receive
Concomitant VaccinationExperimentalParticipants will receive a single 0.5 mL intramuscular (IM) injection of V114 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30
Receives: Biological: V114; Biological: QIV; Biological: Matching Placebo for V114
Non-concomitant VaccinationExperimentalParticipants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V114 on Day 30
Receives: Biological: V114; Biological: QIV; Biological: Matching Placebo for V114

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 intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited injection-site AEs included injection-site erythema /redness, pain /tenderness, swelling.

    Measured: Up to Day 5 after vaccination

  2. Percentage of Participants With a Solicited Systemic Adverse Event

    An adverse event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited systemic AEs included myalgia/muscle pain, arthralgia/joint pain, headache, and fatigue/tiredness.

    Measured: Up to Day 14 after any vaccination

  3. Percentage of Participants With a Vaccine-Related Serious Adverse Event

    A serious adverse event (SAE) is an AE that results in death, 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. Relatedness of an SAE to the study vaccine was determined by the investigator.

    Measured: Up to 7 months

  4. Geometric Mean Titer (GMT) Ratio of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)

    Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) method utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated.

    Measured: 30 days after V114 vaccination (Day 30 for concomitant vaccination group and Day 60 for non-concomitant vaccination group)

  5. GMT of Influenza Strain-Specific Hemagglutination Inhibition

    Activity for the 4 strains contained in QIV vaccine was determined using an hemagglutination inhibition (HAI) assay. Serotype-specific HAI GMTs (estimated) and GMT ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) method utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated.

    Measured: Day 30

Secondary outcomes (8)

  1. Geometric Mean Concentration (GMC) of Pneumococcal Serotype-specific Immunoglobulin G (IgG)

    Serotype-specific IgG GMC ratios (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) method utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated.

    Measured: 30 days after V114 vaccination (Day 30 for concomitant vaccination group and Day 60 for non-concomitant vaccination group)

  2. Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-Specific OPA

    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.

    Measured: Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)

  3. GMFR in Pneumococcal Serotype-Specific IgG

    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.

    Measured: Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)

  4. Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific OPA

    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The percentage of participants who had ≥ 4-fold rise in GMFR were calculated from baseline to postvaccination.

    Measured: Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)

  5. Percentage of Participants With GMFR ≥4 in Pneumococcal Serotype-specific IgG

    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The percentage of participants who had ≥ 4-fold rise in GMFR are calculated from baseline to postvaccination.

    Measured: Baseline and 30 days after V114 vaccination (Day 1 and Day 30 for concomitant vaccination group, and Day 30 and Day 60 for non-concomitant vaccination group, respectively)

  6. GMFR of Influenza Strain-Specific HAI

    Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.

    Measured: Baseline (Day 1) and Day 30

  7. Percentage of Participants With Influenza Strain-specific HAI Titer ≥1:40

    Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. Seroconversion is defined as achieving a 4-fold rise from baseline to postvaccination among participants who are seropositive at baseline (HAI titer ≥ 1:10) or a titer of ≥ 1:40 at postvaccination among participants who are seronegative at baseline (HAI titer < 1:10).

    Measured: Day 30

  8. Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI

    Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. Seroconversion for HAI responses is defined as achieving either 1) a 4-fold rise in influenza strain-specific HAI titer from Baseline to Day 30 among participants who are seropositive at Baseline (HAI titer ≥1:10) or 2) a influenza strain-specific HAI titer of ≥1:40 at Day 30 among participants who are seronegative at Baseline (HAI titer <1:10).

    Measured: Baseline (Day 1) and Day 30

Timeline

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

  1. First posted3 Aug 2018
  2. Study start14 Sep 2018
  3. Primary completion24 Jun 2019
  4. Study completion24 Jun 2019

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
Double blind
Who is masked
Participant, Investigator
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615482
Sponsor's protocol ID
V114-021
Other IDs
V114-021
Status last verified
May 2024
First submitted
31 Jul 2018
Last updated
22 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Severance R, Schwartz H, Dagan R, Connor L, Li J, Pedley A, Hartzel J, Sterling TM, Nolan KM, Tamms GM, Musey LK, Buchwald UK. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, administered concomitantly with influenza vaccine in healthy adults aged >/=50 years: a randomized phase 3 trial (PNEU-FLU). Hum Vaccin Immunother. 2022 Dec 31;18(1):1-14. doi: 10.1080/21645515.2021.1976581. Epub 2021 Nov 2.

    PubMed 34726574

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V114 and QIV in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 45 sites in United States.

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 18 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. 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 29 Jun 2020). 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 5 after vaccination). The study lists 5 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 NCT03615482, 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 22 May 2024.

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