Pneumococcal DiseasePhase 3NCT01734239

A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)

A Phase 3 study testing Pneumovax™ 23 in people with Pneumococcal Disease, 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

The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in participants from the Russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease Read more about this study

Who is it for?: Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Disease
What is being tested?: Pneumovax™ 23
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: No sites listed yet
Study dates: 3 Jun 2013to 22 Oct 2013
Phase: Phase 3
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 2 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

For participants 50 years of age or older: any underlying chronic illness must be in stable condition
For participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell anemia, living in a special environment or social setting such as crowded, closed communities
Male, or female not of reproductive potential, or female of reproductive potential who agrees to remain abstinent or to use 2 acceptable methods of contraception through 6 weeks after study vaccination

Who cannot join

Received prior vaccination with pneumococcal vaccine
Has known or suspected immune dysfunction or conditions associated with immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids
Has history of autoimmune disease
Received a licensed live virus vaccine within 3 months before or is scheduled within 3 months after study vaccination
Received a licensed inactivated vaccine within 28 days before or is scheduled within 28 days after study vaccination
Received an investigational drug or other investigational vaccine within 2 months before or is scheduled within 28 days after study vaccination (3 months if a live virus vaccine)

Show all 13Show fewer

Received any blood product or immunoglobulin preparation within 6 months before or 28 days after study vaccination
Hospitalized for acute illness within 3 months before study vaccination
Is a pregnant woman or nursing mother
History of invasive pneumococcal disease or of other culture-positive pneumococcal disease
History of fever illness within 3 days before study vaccination
Received antibiotic therapy for any acute illness within 7 days before study vaccination
Hypersensitivity to any components of the vaccine, including phenol

About this study

Official title: A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal Disease, From the Russian Population

Conditions: Pneumococcal Disease
Being tested: Pneumovax™ 23
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pneumovax™ 23Biological
Also called V110
Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F

Study groups in NCT01734239
Study group	Role	What they receive
Pneumovax™ 23: Participants Between 2 and 49 Years	Experimental	Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1 Receives: Biological: Pneumovax™ 23
Pneumovax™ 23: Participants >=50 Years	Experimental	Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1 Receives: Biological: Pneumovax™ 23

What is being measured

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

Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays
Measured: Prevaccination and Day 28 after vaccination
Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.
Measured: Day 28 postvaccination
Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)
Measured: Up to 5 days postvaccination
Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint.
Measured: Up to Day 14 postvaccination
Number of Participants Reporting Serious Adverse Experiences
A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention
Measured: Up to Day 28 postvaccination

Timeline

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

3 Jun 201322 Oct 2013

First posted27 Nov 2012 (estimated)
Study start3 Jun 2013
Primary completion22 Oct 2013
Study completion22 Oct 2013

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 DiseaseStudies 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 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01734239
Sponsor's protocol ID: V110-018
Status last verified: Oct 2018
First submitted: 21 Nov 2012
Last updated: 30 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Ciprero K, Zykov KA, Briko NI, Shekar T, Sterling TM, Bitieva E, Stek JE, Musey L. Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects. Hum Vaccin Immunother. 2016 Aug 2;12(8):2142-2147. doi: 10.1080/21645515.2016.1165373. Epub 2016 May 5.
PubMed 27149114

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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All Pneumococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal Disease, From the Russian Population
ClinicalTrials.gov ID: NCT01734239
Acronym / sponsor ID: V110-018
Conditions: Pneumococcal Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 3 Jun 2013 (actual)
Primary completion: 22 Oct 2013 (actual)
Study completion: 22 Oct 2013 (actual)
First posted: 27 Nov 2012 (estimated)
Results: Posted 5 Sep 2014

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pneumovax™ 23: Participants Between 2 and 49 Years	Experimental	Biological: Pneumovax™ 23Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1
Pneumovax™ 23: Participants >=50 Years	Experimental	Biological: Pneumovax™ 23Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

For participants 50 years of age or older: any underlying chronic illness must be in stable condition
For participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell anemia, living in a special environment or social setting such as crowded, closed communities
Male, or female not of reproductive potential, or female of reproductive potential who agrees to remain abstinent or to use 2 acceptable methods of contraception through 6 weeks after study vaccination

Key exclusion criteria (13 listed)

Received prior vaccination with pneumococcal vaccine
Has known or suspected immune dysfunction or conditions associated with immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids
Has history of autoimmune disease
Received a licensed live virus vaccine within 3 months before or is scheduled within 3 months after study vaccination
Received a licensed inactivated vaccine within 28 days before or is scheduled within 28 days after 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
Pneumovax™ 23Also: V110Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F	Biological	Pneumovax™ 23: Participants >=50 Years, Pneumovax™ 23: Participants Between 2 and 49 Years

Primary outcome

Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine
Time frame: Prevaccination and Day 28 after vaccination
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays
Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine
Time frame: Day 28 postvaccination
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.
Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)
Time frame: Up to 5 days postvaccination
Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants
Time frame: Up to Day 14 postvaccination
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint.
Number of Participants Reporting Serious Adverse Experiences
Time frame: Up to Day 28 postvaccination
A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention

Results and safety

Results posted to the registry on 5 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pneumovax™ 23: Participants Between 2 and 49 Years	52	52
Pneumovax™ 23: Participants >=50 Years	50	50

Primary outcome: Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine

Time frame: Prevaccination and Day 28 after vaccination. Mean (95% Confidence Interval). Unit: ug/mL

Measure	Pneumovax™ 23: Participants Between 2 and 49 Years n = 52	Pneumovax™ 23: Participants >=50 Years n = 48
Serotype 1 prevaccination	0.2 (0.2 to 0.3)	0.2 (0.2 to 0.3)
Serotype 1 Day 28 postvaccination	4.1 (3.0 to 5.4)	2.5 (1.7 to 3.8)
Serotype 6B prevaccination	0.5 (0.4 to 0.8)	0.6 (0.5 to 0.8)
Serotype 6B Day 28 postvaccination	2.7 (1.8 to 3.9)	5.3 (3.4 to 8.5)
Serotype 14 prevaccination	1.3 (0.8 to 2.0)	3.6 (2.5 to 5.1)
Serotype 14 Day 28 postvaccination	13.2 (8.7 to 20.1)	32.7 (22.7 to 47.3)
Serotype 19F prevaccination	1.5 (1.1 to 2.2)	1.5 (1.1 to 2.1)
Serotype 19F Day 28 postvaccination	12.6 (9.0 to 17.8)	9.9 (7.0 to 14.1)

Population analysed: The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range

Primary outcome: Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine

Time frame: Day 28 postvaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Pneumovax™ 23: Participants Between 2 and 49 Years n = 52	Pneumovax™ 23: Participants >=50 Years n = 48
Serotype 1	96.2 (86.8 to 99.5)	87.5 (74.8 to 95.3)
Serotype 6B	76.9 (63.2 to 87.5)	89.6 (77.3 to 96.5)
Serotype 14	88.5 (76.6 to 95.6)	89.6 (77.3 to 96.5)
Serotype 19F	82.7 (69.7 to 91.8)	79.2 (65.0 to 89.5)
Serotype 23F	80.8 (67.5 to 90.4)	87.5 (74.8 to 95.3)

Population analysed: The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range

Primary outcome: Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)

Time frame: Up to 5 days postvaccination. Number. Unit: Number of participants

Measure	Pneumovax™ 23: Participants Between 2 and 49 Years n = 52	Pneumovax™ 23: Participants >=50 Years n = 50
Value	1	0

Population analysed: The All Subjects as Treated population included all enrolled participants

Primary outcome: Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants

Time frame: Up to Day 14 postvaccination. Number. Unit: Number of participants

Measure	Pneumovax™ 23: Participants Between 2 and 49 Years n = 52	Pneumovax™ 23: Participants >=50 Years n = 50
Value	16	5

Population analysed: The All Subjects as Treated population included all enrolled participants

Adverse events

Time frame: All adverse experiences were collected through Day 14 postvaccination; serious adverse experiences were collected through Day 28 postvaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pneumovax™ 23	0 of 102 (0%)	14 of 102 (13.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27149114Ciprero K, Zykov KA, Briko NI, Shekar T, Sterling TM, Bitieva E, Stek JE, Musey L. Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects. Hum Vaccin Immunother. 2016 Aug 2;12(8):2142-2147. doi: 10.1080/21645515.2016.1165373. Epub 2016 May 5.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Pneumococcal Disease

Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
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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 3 study testing Pneumovax™ 23 in people with Pneumococcal Disease, 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 13 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 30 Oct 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Sep 2014). 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?

Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine (time frame: Prevaccination and Day 28 after vaccination). The study lists 5 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 NCT01734239, 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 30 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.