Pneumococcal InfectionsPhase 2NCT02573181

Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)

A Phase 2 study testing V114 and Prevnar 13™ in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: V114 and Prevnar 13™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 253 participants
Where: No sites listed yet
Study dates: 30 Oct 2015to 28 Jan 2016
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Is in good health (any underlying chronic illness must be documented to be in stable condition)
Has documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine ≥1 year prior to study entry
Is a male or postmenopausal female

Who cannot join

Has received prior administration of any pneumococcal vaccine other than 23-valent pneumococcal polysaccharide vaccine
Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
Is known or suspected impairment of immune function
Has received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination
Has a coagulation disorder contraindicating intramuscular vaccination

Show all 10Show fewer

Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease
Has received a blood transfusion or blood products, including immunoglobulins 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
Has participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical 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.

About this study

Official title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

Conditions: Pneumococcal Infections
Being tested: V114, 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.

V114Biological
V114 contains 2 µg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 μg of serotype 6B; and 30 µg of CRM₁₉₇ and 125 µg of Aluminum Phosphate Adjuvant (APA) per 0.5 mL dose.
Prevnar 13™Biological
Prevnar 13™ contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4.4 μg of serotype 6B; and 34 μg of CRM₁₉₇ and 125 μg of aluminum per 0.5mL dose.

Study groups in NCT02573181
Study group	Role	What they receive
V114	Experimental	Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of V114 on Day 1. Receives: Biological: V114
Prevnar 13™	Active comparator	Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1. Receives: Biological: Prevnar 13™

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to Day 44 after vaccination
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.
Measured: Up to Day 5 after vaccination
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.
Measured: Up to Day 14 after vaccination
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence.
Measured: Baseline (Day 1) and Day 30 after vaccination
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
The GMFR (Day 30 geometric mean concentration [GMC] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
Measured: Baseline (Day 1) and Day 30 after vaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
Measured: Baseline (Day 1) and Day 30 after vaccination

Secondary outcomes (3)

Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
The OPA GMTs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Titer levels were determined with multiplexed OPA (MOPA-4).
Measured: Baseline (Day 1) and Day 30 after vaccination
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
The GMFR (Day 30 GMT / Day 1 GMT) from baseline (Day 1) to Day 30 of each OPA serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).
Measured: Baseline (Day 1) and Day 30 after vaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).
Measured: Baseline (Day 1) and Day 30 after vaccination

Timeline

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

30 Oct 201528 Jan 2016

First posted9 Oct 2015 (estimated)
Study start30 Oct 2015
Primary completion28 Jan 2016
Study completion28 Jan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 253 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02573181
Sponsor's protocol ID: V114-007
Other IDs: V114-007
Status last verified: Jul 2019
First submitted: 8 Oct 2015
Last updated: 14 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Peterson JT, Stacey HL, MacNair JE, Li J, Hartzel JS, Sterling TM, Benner P, Tamms GM, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults >/=65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Hum Vaccin Immunother. 2019;15(3):540-548. doi: 10.1080/21645515.2018.1532250. Epub 2018 Nov 14.
PubMed 30427749

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2
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A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
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Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
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All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
ClinicalTrials.gov ID: NCT02573181
Acronym / sponsor ID: V114-007
Conditions: Pneumococcal Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 253 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 30 Oct 2015 (actual)
Primary completion: 28 Jan 2016 (actual)
Study completion: 28 Jan 2016 (actual)
First posted: 9 Oct 2015 (estimated)
Results: Posted 14 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
V114	Experimental	Biological: V114Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of V114 on Day 1.
Prevnar 13™	Active comparator	Biological: Prevnar 13™Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Is in good health (any underlying chronic illness must be documented to be in stable condition)
Has documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine ≥1 year prior to study entry
Is a male or postmenopausal female

Key exclusion criteria (10 listed)

Has received prior administration of any pneumococcal vaccine other than 23-valent pneumococcal polysaccharide vaccine
Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
Is known or suspected impairment of immune function
Has received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
V114V114 contains 2 µg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 μg of serotype 6B; and 30 µg of CRM₁₉₇ and 125 µg of Aluminum Phosphate Adjuvant (APA) per 0.5 mL dose.	Biological	V114
Prevnar 13™Prevnar 13™ contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4.4 μg of serotype 6B; and 34 μg of CRM₁₉₇ and 125 μg of aluminum per 0.5mL dose.	Biological	Prevnar 13™

Primary outcome

Percentage of Participants With an Adverse Event (AE)
Time frame: Up to Day 44 after vaccination
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Time frame: Up to Day 5 after vaccination
Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Time frame: Up to Day 14 after vaccination
Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Time frame: Baseline (Day 1) and Day 30 after vaccination
The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence.
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Time frame: Baseline (Day 1) and Day 30 after vaccination
The GMFR (Day 30 geometric mean concentration [GMC] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Time frame: Baseline (Day 1) and Day 30 after vaccination
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.

3 secondary outcomes

Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Time frame: Baseline (Day 1) and Day 30 after vaccination
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Time frame: Baseline (Day 1) and Day 30 after vaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Time frame: Baseline (Day 1) and Day 30 after vaccination

Results and safety

Results posted to the registry on 14 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V114	127	127
Prevnar 13™	126	126

Primary outcome: Percentage of Participants With an Adverse Event (AE)

Time frame: Up to Day 44 after vaccination. Number. Unit: Percentage of Participants

Measure	V114 n = 127	Prevnar 13™ n = 126
Value	68.5	64.3

V114 vs Prevnar 13™: Difference: 4.2 (95% CI -7.4 to 15.8)

Population analysed: All participants who received study vaccination are included.

Primary outcome: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

Time frame: Up to Day 5 after vaccination. Number. Unit: Percentage of Participants

Measure	V114 n = 127	Prevnar 13™ n = 126
Erythema/Redness	7.9	7.1
Swelling	14.2	6.3
Tenderness/Pain	55.1	44.4

Population analysed: All participants who received study vaccination are included.

Primary outcome: Percentage of Participants With a Solicited Systemic Adverse Event (AE)

Time frame: Up to Day 14 after vaccination. Number. Unit: Percentage of Participants

Measure	V114 n = 127	Prevnar 13™ n = 126
Fatigue	18.1	19.0
Arthralgia	5.5	8.7
Myalgia	15.7	11.1
Headache	13.4	15.9

V114 vs Prevnar 13™: Fatigue difference: -0.9 (95% CI -10.7 to 8.8)
V114 vs Prevnar 13™: Arthralgia difference: -3.2 (95% CI -10.2 to 3.4)
V114 vs Prevnar 13™: Myalgia difference: 4.6 (95% CI -3.9 to 13.3)

Population analysed: All participants who received study vaccination are included.

Primary outcome: Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)

Time frame: Baseline (Day 1) and Day 30 after vaccination. Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	V114 n = 127	Prevnar 13™ n = 126
Serotype 1 Day 1	1.11 (0.85 to 1.45)	1.27 (.98 to 1.64)
Serotype 1 Day 30	3.31 (2.60 to 4.23)	3.42 (2.61 to 4.47)
Serotype 3 Day 1	0.19 (0.15 to 0.23)	0.19 (0.15 to 0.24)
Serotype 3 Day 30	0.72 (0.57 to 0.91)	0.46 (0.36 to 0.58)
Serotype 4 Day 1	0.32 (0.25 to 0.41)	0.33 (0.26 to 0.43)
Serotype 4 Day 30	1.13 (0.88 to 1.45)	1.15 (0.88 to 1.51)
Serotype 5 Day 1	1.31 (1.01 to 1.70)	1.48 (1.14 to 1.91)
Serotype 5 Day 30	2.69 (2.05 to 3.53)	3.67 (2.75 to 4.90)

Population analysed: Randomized and vaccinated participants with no protocol violations are included.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V114	0 of 127 (0%)	86 of 127 (67.7%)	0 of 127
Prevnar 13®	2 of 126 (1.6%)	74 of 126 (58.7%)	0 of 126

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30427749Peterson JT, Stacey HL, MacNair JE, Li J, Hartzel JS, Sterling TM, Benner P, Tamms GM, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults >/=65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Hum Vaccin Immunother. 2019;15(3):540-548. doi: 10.1080/21645515.2018.1532250. Epub 2018 Nov 14.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Pneumococcal Infections

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing V114 and Prevnar 13™ in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC.

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 3 inclusion and 10 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

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 14 Aug 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 With an Adverse Event (AE) (time frame: Up to Day 44 after vaccination). 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 NCT02573181, 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 14 Aug 2019.