Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03950856




Registration number
NCT03950856
Ethics application status
Date submitted
13/05/2019
Date registered
15/05/2019
Date last updated
12/04/2021

Titles & IDs
Public title
Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-TRUE)
Secondary ID [1] 0 0
V114-020
Secondary ID [2] 0 0
V114-020
Universal Trial Number (UTN)
Trial acronym
PNEU-TRUE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Infections 0 0
Pneumonia, Pneumococcal 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - V114
Treatment: Drugs - Prevnar 13™

Experimental: V114 Lot 1 - Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)

Experimental: V114 Lot 2 - Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)

Experimental: V114 Lot 3 - Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)

Active comparator: Prevnar 13™ - Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)


Treatment: Drugs: V114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.

Treatment: Drugs: Prevnar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in each 0.5. mL dose.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots
Timepoint [1] 0 0
Up to Day 5
Primary outcome [2] 0 0
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Timepoint [2] 0 0
Up to Day 5
Primary outcome [3] 0 0
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots
Timepoint [3] 0 0
Up to Day 14
Primary outcome [4] 0 0
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Timepoint [4] 0 0
Up to Day 14
Primary outcome [5] 0 0
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots
Timepoint [5] 0 0
Up to Month 6
Primary outcome [6] 0 0
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Timepoint [6] 0 0
Up to Month 6
Primary outcome [7] 0 0
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Timepoint [7] 0 0
Day 30
Secondary outcome [1] 0 0
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Timepoint [1] 0 0
Day 30
Secondary outcome [2] 0 0
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Timepoint [2] 0 0
Day 30
Secondary outcome [3] 0 0
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Timepoint [3] 0 0
Day 1 (Baseline) and Day 30
Secondary outcome [4] 0 0
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Timepoint [4] 0 0
Day 1 (Baseline) and Day 30
Secondary outcome [5] 0 0
Percentage of Participants With =4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Timepoint [5] 0 0
Day 1 (Baseline) and Day 30
Secondary outcome [6] 0 0
Percentage of Participants With =4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Timepoint [6] 0 0
Day 1 (Baseline) and Day 30

Eligibility
Key inclusion criteria
* Participant has good health in the opinion of the investigator. Any underlying chronic condition must be documented to be in stable condition according to the investigator's judgment.
* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Female participant is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use agreed upon contraception during the treatment period and for at least 6 weeks after the last dose of study intervention.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 of Visit 1 (Day 1).
* Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine.
* Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
* Coagulation disorder contraindicating intramuscular vaccinations.
* Recent febrile illness (defined as oral or tympanic temperature =100.4°F [=38.0°C] or axillary or temporal temperature =99.4°F [=37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine.
* 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).
* Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol.
* Has received systemic corticosteroids (prednisone equivalent of =20 mg/day) for =14 consecutive days and has not completed intervention at least 30 days before study entry.
* Has 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).
* Is 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.
* Has received any non-live vaccine within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.)
* Has received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine. If this exclusion criterion is met, then Day 1 Visit may be rescheduled for a time when criterion is not met.
* Has 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.
* 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.
* In the opinion of the investigator, has a history of clinically relevant drug or alcohol use that would interfere with participation in protocol-specified activities.
* History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study.
* 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/04/2020
Sample size
Target
Accrual to date
Final
2340
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 6006) - Blacktown
Recruitment hospital [2] 0 0
Australian Clinical Research Network ( Site 6000) - Maroubra
Recruitment hospital [3] 0 0
Box Hill Hospital ( Site 6001) - Box Hill
Recruitment hospital [4] 0 0
Trialswest ( Site 6004) - Murdoch
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Chile
State/province [16] 0 0
Región Metropolitana
Country [17] 0 0
Chile
State/province [17] 0 0
RM
Country [18] 0 0
Chile
State/province [18] 0 0
Santiago
Country [19] 0 0
Chile
State/province [19] 0 0
Temuco
Country [20] 0 0
Denmark
State/province [20] 0 0
Aalborg
Country [21] 0 0
Denmark
State/province [21] 0 0
Aarhus N
Country [22] 0 0
Denmark
State/province [22] 0 0
Ballerup
Country [23] 0 0
Denmark
State/province [23] 0 0
Copenhagen
Country [24] 0 0
Denmark
State/province [24] 0 0
Hvidovre
Country [25] 0 0
Denmark
State/province [25] 0 0
Odense
Country [26] 0 0
Finland
State/province [26] 0 0
Helsinki
Country [27] 0 0
Finland
State/province [27] 0 0
Jarvenpaa
Country [28] 0 0
Finland
State/province [28] 0 0
Kokkola
Country [29] 0 0
Finland
State/province [29] 0 0
Oulu
Country [30] 0 0
Finland
State/province [30] 0 0
Pori
Country [31] 0 0
Finland
State/province [31] 0 0
Tampere
Country [32] 0 0
Finland
State/province [32] 0 0
Turku
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Northamptonshire
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Harrow
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.
Trial website
https://clinicaltrials.gov/study/NCT03950856
Trial related presentations / publications
Simon JK, Staerke NB, Hemming-Harlo M, Layle S, Dagan R, Shekar T, Pedley A, Jumes P, Tamms G, Sterling T, Musey L, Buchwald UK; V114-020 PNEU-TRUE study group. Lot-to-lot consistency, safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in healthy adults aged >/=50 years: A randomized phase 3 trial (PNEU-TRUE). Vaccine. 2022 Feb 23;40(9):1342-1351. doi: 10.1016/j.vaccine.2021.12.067. Epub 2022 Jan 14.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03950856