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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01734239
• Collaborator: (none)
• Enrollment: 102
• Arms: 2
• Actual Duration (Months): 4.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Disease	Biological: Pneumovax™ 23	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jun 3, 2013
• Actual Primary Completion Date: Oct 22, 2013
• Actual Study Completion Date: Oct 22, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pneumovax™ 23: Participants Between 2 and 49 Years Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1	Biological: Pneumovax™ 23; 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; Other Names: V110
Experimental: Pneumovax™ 23: Participants >=50 Years Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1	Biological: Pneumovax™ 23; 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; Other Names: V110

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine [Prevaccination and Day 28 after vaccination]

   Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays

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

3. Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent) [Up to 5 days postvaccination]

4. Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants [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.

5. Number of Participants Reporting Serious Adverse Experiences [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT01734239
• Other Study ID Numbers: V110-018
• First Posted: Nov 27, 2012
• Last Update Posted: Oct 30, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Pneumococcal Infections; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Arm/Group Title	Pneumovax™ 23: Participants Between 2 and 49 Years	Pneumovax™ 23: Participants >=50 Years
Arm/Group Description	Participants received a single 0.5 mL intramuscular injection on Day 1	Participants received a single 0.5 mL intramuscular injection on Day 1
Period Title: Overall Study
STARTED	52	50
COMPLETED	52	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Pneumovax™ 23: Participants Between 2 and 49 Years	Pneumovax™ 23: Participants >=50 Years	Total
Arm/Group Description	Participants received a single 0.5 mL intramuscular injection on Day 1	Participants received a single 0.5 mL intramuscular injection on Day 1	Total of all reporting groups
Overall Participants	52	50	102
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	21.2 (15.3)	60.4 (7.7)	40.4 (23.1)
Sex: Female, Male (Count of Participants)
Female	16 30.8%	21 42%	37 36.3%
Male	36 69.2%	29 58%	65 63.7%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine
Description	Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays
Time Frame	Prevaccination and Day 28 after vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Pneumovax™ 23: Participants Between 2 and 49 Years	Pneumovax™ 23: Participants >=50 Years
Arm/Group Description	Participants received a single 0.5 mL intramuscular injection on Day 1	Participants received a single 0.5 mL intramuscular injection on Day 1
Measure Participants	52	48
Serotype 1 prevaccination	0.2	0.2
Serotype 1 Day 28 postvaccination	4.1	2.5
Serotype 6B prevaccination	0.5	0.6
Serotype 6B Day 28 postvaccination	2.7	5.3
Serotype 14 prevaccination	1.3	3.6
Serotype 14 Day 28 postvaccination	13.2	32.7
Serotype 19F prevaccination	1.5	1.5
Serotype 19F Day 28 postvaccination	12.6	9.9
Serotype 23F prevaccination	0.6	1.1
Serotype 23F Day 28 postvaccination	5.3	8.1

2. Primary Outcome

Title	Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine
Description	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.
Time Frame	Day 28 postvaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Pneumovax™ 23: Participants Between 2 and 49 Years	Pneumovax™ 23: Participants >=50 Years
Arm/Group Description	Participants received a single 0.5 mL intramuscular injection on Day 1	Participants received a single 0.5 mL intramuscular injection on Day 1
Measure Participants	52	48
Serotype 1	96.2 185%	87.5 175%
Serotype 6B	76.9 147.9%	89.6 179.2%
Serotype 14	88.5 170.2%	89.6 179.2%
Serotype 19F	82.7 159%	79.2 158.4%
Serotype 23F	80.8 155.4%	87.5 175%

3. Primary Outcome

Title	Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)
Time Frame	Up to 5 days postvaccination

Outcome Measure Data

Analysis Population Description

The All Subjects as Treated population included all enrolled participants

Arm/Group Title	Pneumovax™ 23: Participants Between 2 and 49 Years	Pneumovax™ 23: Participants >=50 Years
Arm/Group Description	Participants received a single 0.5 mL intramuscular injection on Day 1	Participants received a single 0.5 mL intramuscular injection on Day 1
Measure Participants	52	50
Number [Number of participants]	1 1.9%	0 0%

4. Primary Outcome

Title	Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants
Description	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.
Time Frame	Up to Day 14 postvaccination

Outcome Measure Data

Analysis Population Description

The All Subjects as Treated population included all enrolled participants

Arm/Group Title	Pneumovax™ 23: Participants Between 2 and 49 Years	Pneumovax™ 23: Participants >=50 Years
Arm/Group Description	Participants received a single 0.5 mL intramuscular injection on Day 1	Participants received a single 0.5 mL intramuscular injection on Day 1
Measure Participants	52	50
Number [Number of participants]	16 30.8%	5 10%

5. Primary Outcome

Title	Number of Participants Reporting Serious Adverse Experiences
Description	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
Time Frame	Up to Day 28 postvaccination

Outcome Measure Data

Analysis Population Description

The All Subjects as Treated population included all enrolled participants

Arm/Group Title	Pneumovax™ 23: Participants Between 2 and 49 Years	Pneumovax™ 23: Participants >=50 Years
Arm/Group Description	Participants received a single 0.5 mL intramuscular injection on Day 1	Participants received a single 0.5 mL intramuscular injection on Day 1
Measure Participants	52	50
Number [Number of participants]	0 0%	0 0%

Adverse Events

Time Frame	All adverse experiences were collected through Day 14 postvaccination; serious adverse experiences were collected through Day 28 postvaccination
Arm/Group Title	Pneumovax™ 23
Arm/Group Description	Participants received a single 0.5 mL intramuscular injection on Day 1
All Cause Mortality
	Pneumovax™ 23
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pneumovax™ 23
	Affected / at Risk (%)	# Events
Total	0/102 (0%)
Other (Not Including Serious) Adverse Events
	Pneumovax™ 23
	Affected / at Risk (%)	# Events
Total	14/102 (13.7%)
General disorders
Injection site pain	14/102 (13.7%)	14

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.