Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
Query!
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)
Query!
Secondary ID [1]
0
0
V114-020
Query!
Secondary ID [2]
0
0
V114-020
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PNEU-TRUE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Infections
0
0
Query!
Pneumonia, Pneumococcal
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots
Query!
Assessment method [1]
0
0
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. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited injection-site AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Query!
Timepoint [1]
0
0
Up to Day 5
Query!
Primary outcome [2]
0
0
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Query!
Assessment method [2]
0
0
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. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. Per the statistical analysis plan, within-group CIs were not calculated.
Query!
Timepoint [2]
0
0
Up to Day 5
Query!
Primary outcome [3]
0
0
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots
Query!
Assessment method [3]
0
0
An 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. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited systemic AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Query!
Timepoint [3]
0
0
Up to Day 14
Query!
Primary outcome [4]
0
0
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Query!
Assessment method [4]
0
0
An 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. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Per the statistical analysis plan, within-group CIs were not calculated.
Query!
Timepoint [4]
0
0
Up to Day 14
Query!
Primary outcome [5]
0
0
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots
Query!
Assessment method [5]
0
0
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with SAEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Query!
Timepoint [5]
0
0
Up to Month 6
Query!
Primary outcome [6]
0
0
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
Query!
Assessment method [6]
0
0
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. Per the statistical analysis plan, within-group CIs were not calculated.
Query!
Timepoint [6]
0
0
Up to Month 6
Query!
Primary outcome [7]
0
0
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Query!
Assessment method [7]
0
0
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). Per the statistical analysis plan, within-group CIs were not calculated. 95% CIs were calculated for the GMT ratios between pairs of V114 lots by a constrained longitudinal data analysis (cLDA) model; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Query!
Timepoint [7]
0
0
Day 30
Query!
Secondary outcome [1]
0
0
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
Query!
Assessment method [1]
0
0
The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay. Per the statistical analysis plan, within-group CIs were not calculated; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Query!
Timepoint [1]
0
0
Day 30
Query!
Secondary outcome [2]
0
0
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
Query!
Assessment method [2]
0
0
The GMC of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Per the statistical analysis plan, within-group CIs were not calculated,
Query!
Timepoint [2]
0
0
Day 30
Query!
Secondary outcome [3]
0
0
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Query!
Assessment method [3]
0
0
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA which reads the reciprocal of the highest dilution that gives =50% bacterial killing. The Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratio Day 30/Day 1 OPA responses. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Query!
Timepoint [3]
0
0
Day 1 (Baseline) and Day 30
Query!
Secondary outcome [4]
0
0
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Query!
Assessment method [4]
0
0
The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The GMFR is the geometric mean of the ratio Day 30/Day 1 IgG concentration. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Query!
Timepoint [4]
0
0
Day 1 (Baseline) and Day 30
Query!
Secondary outcome [5]
0
0
Percentage of Participants With =4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Query!
Assessment method [5]
0
0
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, with the MOPA which reads the reciprocal of the highest dilution (1/dil) that gives =50% bacterial killing. Percentage of participants with a = 4-fold change from Day 1 (baseline) to Day 30 (Day 30/Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Query!
Timepoint [5]
0
0
Day 1 (Baseline) and Day 30
Query!
Secondary outcome [6]
0
0
Percentage of Participants With =4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
Query!
Assessment method [6]
0
0
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Percentage of participants with a = 4-fold change from Day 1 (baseline) to Day 30 (Day 30/ Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Query!
Timepoint [6]
0
0
Day 1 (Baseline) and Day 30
Query!
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.
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/06/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
3/04/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2340
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 6006) - Blacktown
Query!
Recruitment hospital [2]
0
0
Australian Clinical Research Network ( Site 6000) - Maroubra
Query!
Recruitment hospital [3]
0
0
Box Hill Hospital ( Site 6001) - Box Hill
Query!
Recruitment hospital [4]
0
0
Trialswest ( Site 6004) - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
2148 - Blacktown
Query!
Recruitment postcode(s) [2]
0
0
2035 - Maroubra
Query!
Recruitment postcode(s) [3]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [4]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Louisiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Maryland
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Nevada
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New Mexico
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Oklahoma
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
South Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Utah
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Wisconsin
Query!
Country [16]
0
0
Chile
Query!
State/province [16]
0
0
Región Metropolitana
Query!
Country [17]
0
0
Chile
Query!
State/province [17]
0
0
RM
Query!
Country [18]
0
0
Chile
Query!
State/province [18]
0
0
Santiago
Query!
Country [19]
0
0
Chile
Query!
State/province [19]
0
0
Temuco
Query!
Country [20]
0
0
Denmark
Query!
State/province [20]
0
0
Aalborg
Query!
Country [21]
0
0
Denmark
Query!
State/province [21]
0
0
Aarhus N
Query!
Country [22]
0
0
Denmark
Query!
State/province [22]
0
0
Ballerup
Query!
Country [23]
0
0
Denmark
Query!
State/province [23]
0
0
Copenhagen
Query!
Country [24]
0
0
Denmark
Query!
State/province [24]
0
0
Hvidovre
Query!
Country [25]
0
0
Denmark
Query!
State/province [25]
0
0
Odense
Query!
Country [26]
0
0
Finland
Query!
State/province [26]
0
0
Helsinki
Query!
Country [27]
0
0
Finland
Query!
State/province [27]
0
0
Jarvenpaa
Query!
Country [28]
0
0
Finland
Query!
State/province [28]
0
0
Kokkola
Query!
Country [29]
0
0
Finland
Query!
State/province [29]
0
0
Oulu
Query!
Country [30]
0
0
Finland
Query!
State/province [30]
0
0
Pori
Query!
Country [31]
0
0
Finland
Query!
State/province [31]
0
0
Tampere
Query!
Country [32]
0
0
Finland
Query!
State/province [32]
0
0
Turku
Query!
Country [33]
0
0
United Kingdom
Query!
State/province [33]
0
0
Northamptonshire
Query!
Country [34]
0
0
United Kingdom
Query!
State/province [34]
0
0
Harrow
Query!
Country [35]
0
0
United Kingdom
Query!
State/province [35]
0
0
Liverpool
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Merck Sharp & Dohme LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03950856
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Merck Sharp & Dohme LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03950856
Download to PDF