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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03615482
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study is 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 will also evaluate whether V114 can be administered concomitantly with influenza vaccine without impairing the antibody responses 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. This study will also contribute to the overall safety database and immunogenicity data for V114 to support initial licensure in adults.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Biological: QIV Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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)
Actual Study Start Date : September 14, 2018
Actual Primary Completion Date : June 24, 2019
Actual Study Completion Date : June 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Concomitant Vaccination
Participants 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
Biological: V114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose

Biological: QIV
QIV protects against the influenza viruses that research indicates will be most common during the upcoming season, and includes antigens from influenza A (H1N1) virus, influenza A (H3N2) virus, influenza B/Victoria virus, and influenza B/Yamagata virus
Other Names:
  • Quadrivalent influenza vaccine (seasonal inactivated)
  • Fluarix Quadrivalent (Influenza Vaccine)

Biological: Placebo
Placebo matching V114 vaccine

Experimental: Non-concomitant Vaccination
Participants 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
Biological: V114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose

Biological: QIV
QIV protects against the influenza viruses that research indicates will be most common during the upcoming season, and includes antigens from influenza A (H1N1) virus, influenza A (H3N2) virus, influenza B/Victoria virus, and influenza B/Yamagata virus
Other Names:
  • Quadrivalent influenza vaccine (seasonal inactivated)
  • Fluarix Quadrivalent (Influenza Vaccine)

Biological: Placebo
Placebo matching V114 vaccine




Primary Outcome Measures :
  1. Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after any vaccination ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be redness/erythema, swelling, and pain/tenderness.

  2. Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after any vaccination ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.

  3. Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to Month 7 ]
    A serious adverse event (SAE) is an AE that 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. Relatedness of an SAE to the study vaccine will be determined by the investigator.

  4. Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) [ Time Frame: 30 days after V114 vaccination (Day 30 for concomitant vaccination group and Day 60 for non-concomitant vaccination group) ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay.

  5. GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) [ Time Frame: Day 30 ]
    Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay


Secondary Outcome Measures :
  1. Geometric Mean Concentration of Pneumococcal Serotype-specific Immunoglobulin G (IgG) [ Time Frame: 30 days after V114 vaccination (Day 30 for concomitant vaccination group and Day 60 for non-concomitant vaccination group) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.

  2. Geometric Mean Fold Rise (GMFR) in Pneumococcal Serotype-specific OPA [ Time Frame: 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) ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.

  3. GMFR in Pneumococcal Serotype-specific IgG [ Time Frame: 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) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC 30 days after vaccination / GMC at Baseline.

  4. Percentage of Participants with GMFR ≥4 in Pneumococcal Serotype-specific OPA [ Time Frame: 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) ]
    Activity for the 15 serotypes contained in V114 vaccine will be determined using a Multiplex Opsonophagocytic Assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.

  5. Percentage of Participants with GMFR ≥4 in Pneumococcal Serotype-specific IgG [ Time Frame: 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) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. GMFR is GMC 30 days after vaccination / GMC at Baseline.

  6. GMFR in Influenza Strain-specific HAI [ Time Frame: Baseline (Day 1) and Day 30 ]
    Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.

  7. Percentage of Participants with Influenza Strain-specific HAI Titer ≥1:40 [ Time Frame: Day 30 ]
    Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.

  8. Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI [ Time Frame: Baseline (Day 1) and Day 30 ]
    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).



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

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 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615482


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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03615482     History of Changes
Other Study ID Numbers: V114-021
V114-021 ( Other Identifier: Merck Protocol Number )
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs