Pneumococcal InfectionsPhase 2NCT02547649

Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)

A Phase 2 study testing V114-A, V114-B 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.

Official record

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Trial summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants ≥50 years of age in good health. 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-A, V114-B and Prevnar 13®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 690 participants
Where: No sites listed yet
Study dates: 8 Oct 2015to 20 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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Good health; any underlying chronic illness must be documented to be in stable condition
Highly unlikely to conceive through 6 weeks after administration of the study vaccine

Who cannot join

Prior administration of any pneumococcal vaccine
History of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease
Known hypersensitivity to any vaccine component
Known or suspected impairment of immune function
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
Coagulation disorder contraindicating intramuscular vaccination

Show all 11Show 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
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.
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
Breast feeding
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 Pneumococcal Vaccine-Naïve Adults 50 Years of Age or Older

≥50 years of age in good health.

Conditions: Pneumococcal Infections
Being tested: V114-A, V114-B, 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.

V114-ABiological
Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
V114-BBiological
Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
Prevnar 13®Biological
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 mcg) in each 0.5 mL dose.

Study groups in NCT02547649
Study group	Role	What they receive
V114 Formulation A	Experimental	Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1 Receives: Biological: V114-A
V114 Formulation B	Experimental	Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1 Receives: Biological: V114-B
Prevnar 13®	Active comparator	Participants 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)
The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 14 days after vaccination
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.
Measured: Up to 14 days after vaccination
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.
Measured: Up to 14 days after vaccination
Percentage of Participants With a Serious Adverse Event (SAE)
The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.
Measured: Up to 30 days after vaccination
Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE)
The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.
Measured: Up to 30 days after vaccination
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA).
Measured: Day 30 (one month after vaccination)

Secondary outcomes (3)

Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
The IgG GMCs of each common pneumococcal serotype (CS) and V114-specific pneumococcal serotype (VS) were determined for each arm. Concentrations were determined with pneumococcal electrochemiluminescence (PnECL).
Measured: Day 30 (one month after vaccination)
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
The percentage of participants with ≥4-fold rise from baseline in OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.
Measured: Baseline and Day 30 (one month after vaccination)
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
The percentage of participants with ≥4-fold rise from baseline in IgG GMCs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.
Measured: Baseline and Day 30 (one month after vaccination)

Timeline

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

8 Oct 201520 Jan 2016

First posted11 Sep 2015 (estimated)
Study start8 Oct 2015
Primary completion20 Jan 2016
Study completion20 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: 690 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02547649
Sponsor's protocol ID: V114-006
Other IDs: V114-006
Status last verified: Apr 2019
First submitted: 10 Sep 2015
Last updated: 16 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Stacey HL, Rosen J, Peterson JT, Williams-Diaz A, Gakhar V, Sterling TM, Acosta CJ, Nolan KM, Li J, Pedley A, Benner P, Abeygunawardana C, Kosinski M, Smith WJ, Pujar H, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults. Hum Vaccin Immunother. 2019;15(3):530-539. doi: 10.1080/21645515.2018.1532249. Epub 2019 Jan 16.
PubMed 30648919

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

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 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 Pneumococcal Vaccine-Naïve Adults 50 Years of Age or Older
ClinicalTrials.gov ID: NCT02547649
Acronym / sponsor ID: V114-006
Conditions: Pneumococcal Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 690 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 8 Oct 2015 (actual)
Primary completion: 20 Jan 2016 (actual)
Study completion: 20 Jan 2016 (actual)
First posted: 11 Sep 2015 (estimated)
Results: Posted 2 Apr 2019

Clinical summary

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

≥50 years of age in good health.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
V114 Formulation A	Experimental	Biological: V114-AParticipants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1
V114 Formulation B	Experimental	Biological: V114-BParticipants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1
Prevnar 13®	Active comparator	Biological: Prevnar 13®Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Good health; any underlying chronic illness must be documented to be in stable condition
Highly unlikely to conceive through 6 weeks after administration of the study vaccine

Key exclusion criteria (11 listed)

Prior administration of any pneumococcal vaccine
History of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease
Known hypersensitivity to any vaccine component
Known or suspected impairment of immune function
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
V114-AFormulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).	Biological	V114 Formulation A
V114-BFormulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).	Biological	V114 Formulation B
Prevnar 13®Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 mcg) in each 0.5 mL dose.	Biological	Prevnar 13®

Primary outcome

Percentage of Participants With an Adverse Event (AE)
Time frame: Up to 14 days after vaccination
The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 14 days after vaccination
The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Time frame: Up to 14 days after vaccination
The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.
Percentage of Participants With a Serious Adverse Event (SAE)
Time frame: Up to 30 days after vaccination
The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.
Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE)
Time frame: Up to 30 days after vaccination
The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
Time frame: Day 30 (one month after vaccination)
The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA).

3 secondary outcomes

Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
Time frame: Day 30 (one month after vaccination)
Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
Time frame: Baseline and Day 30 (one month after vaccination)
Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
Time frame: Baseline and Day 30 (one month after vaccination)

Results and safety

Results posted to the registry on 2 Apr 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-A	231	228
V114-B	231	226
Prevnar 13®	228	224

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

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

Measure	V114-A n = 231	V114-B n = 231	Prevnar 13® n = 227
Value	74.9	72.3	67.4

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 14 days after vaccination. Number. Unit: Percentage of Participants

Measure	V114-A n = 231	V114-B n = 231	Prevnar 13® n = 227
Erythema	8.7	11.3	10.1
Pain	62.3	60.2	52.4
Swelling	11.7	16.5	12.3

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 14 days after vaccination. Number. Unit: Percentage of Participants

Measure	V114-A n = 231	V114-B n = 231	Prevnar 13® n = 227
Arthralgia	9.5	7.4	6.2
Myalgia	22.9	18.6	14.1
Headache	12.1	12.6	16.7
Fatigue	24.2	17.7	22.5

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

Primary outcome: Percentage of Participants With a Serious Adverse Event (SAE)

Time frame: Up to 30 days after vaccination. Number. Unit: Percentage of Participants

Measure	V114-A n = 231	V114-B n = 231	Prevnar 13® n = 227
Value	0.4	0.9	0.0

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 days after vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V114-A	1 of 231 (0.4%)	169 of 231 (73.2%)	0 of 231
V114-B	2 of 231 (0.9%)	163 of 231 (70.6%)	0 of 231
Prevnar 13®	0 of 227 (0%)	148 of 227 (65.2%)	0 of 227

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30648919Stacey HL, Rosen J, Peterson JT, Williams-Diaz A, Gakhar V, Sterling TM, Acosta CJ, Nolan KM, Li J, Pedley A, Benner P, Abeygunawardana C, Kosinski M, Smith WJ, Pujar H, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults. Hum Vaccin Immunother. 2019;15(3):530-539. doi: 10.1080/21645515.2018.1532249. Epub 2019 Jan 16.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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-A, V114-B 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 2 inclusion and 11 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 16 Apr 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 2 Apr 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 14 days 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 NCT02547649, 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 16 Apr 2019.