Trial Outcomes & Findings for A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018) (NCT NCT01734239)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

102 participants

Primary outcome timeframe

Prevaccination and Day 28 after vaccination

Results posted on

2018-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Pneumovax™ 23: Participants Between 2 and 49 Years Participants received a single 0.5 mL intramuscular injection on Day 1	Pneumovax™ 23: Participants >=50 Years Participants received a single 0.5 mL intramuscular injection on Day 1
Overall Study STARTED	52	50
Overall Study COMPLETED	52	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pneumovax™ 23: Participants Between 2 and 49 Years n=52 Participants Participants received a single 0.5 mL intramuscular injection on Day 1	Pneumovax™ 23: Participants >=50 Years n=50 Participants Participants received a single 0.5 mL intramuscular injection on Day 1	Total n=102 Participants Total of all reporting groups
Age, Continuous	21.2 Years STANDARD_DEVIATION 15.3 • n=5 Participants	60.4 Years STANDARD_DEVIATION 7.7 • n=7 Participants	40.4 Years STANDARD_DEVIATION 23.1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	29 Participants n=7 Participants	65 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prevaccination and Day 28 after vaccination

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

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

Outcome measures

Outcome measures
Measure	Pneumovax™ 23: Participants Between 2 and 49 Years n=52 Participants Participants received a single 0.5 mL intramuscular injection on Day 1	Pneumovax™ 23: Participants >=50 Years n=48 Participants Participants received a single 0.5 mL intramuscular injection on Day 1
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 1 prevaccination	0.2 ug/mL Interval 0.2 to 0.3	0.2 ug/mL Interval 0.2 to 0.3
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 1 Day 28 postvaccination	4.1 ug/mL Interval 3.0 to 5.4	2.5 ug/mL Interval 1.7 to 3.8
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 6B prevaccination	0.5 ug/mL Interval 0.4 to 0.8	0.6 ug/mL Interval 0.5 to 0.8
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 6B Day 28 postvaccination	2.7 ug/mL Interval 1.8 to 3.9	5.3 ug/mL Interval 3.4 to 8.5
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 14 prevaccination	1.3 ug/mL Interval 0.8 to 2.0	3.6 ug/mL Interval 2.5 to 5.1
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 14 Day 28 postvaccination	13.2 ug/mL Interval 8.7 to 20.1	32.7 ug/mL Interval 22.7 to 47.3
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 19F prevaccination	1.5 ug/mL Interval 1.1 to 2.2	1.5 ug/mL Interval 1.1 to 2.1
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 19F Day 28 postvaccination	12.6 ug/mL Interval 9.0 to 17.8	9.9 ug/mL Interval 7.0 to 14.1
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 23F prevaccination	0.6 ug/mL Interval 0.4 to 1.0	1.1 ug/mL Interval 0.7 to 1.5
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 23F Day 28 postvaccination	5.3 ug/mL Interval 3.6 to 7.7	8.1 ug/mL Interval 5.3 to 12.4

PRIMARY outcome

Timeframe: Day 28 postvaccination

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

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.

Outcome measures

Outcome measures
Measure	Pneumovax™ 23: Participants Between 2 and 49 Years n=52 Participants Participants received a single 0.5 mL intramuscular injection on Day 1	Pneumovax™ 23: Participants >=50 Years n=48 Participants Participants received a single 0.5 mL intramuscular injection on Day 1
Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 23F	80.8 Percentage of participants Interval 67.5 to 90.4	87.5 Percentage of participants Interval 74.8 to 95.3
Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 1	96.2 Percentage of participants Interval 86.8 to 99.5	87.5 Percentage of participants Interval 74.8 to 95.3
Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 6B	76.9 Percentage of participants Interval 63.2 to 87.5	89.6 Percentage of participants Interval 77.3 to 96.5
Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 14	88.5 Percentage of participants Interval 76.6 to 95.6	89.6 Percentage of participants Interval 77.3 to 96.5
Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine Serotype 19F	82.7 Percentage of participants Interval 69.7 to 91.8	79.2 Percentage of participants Interval 65.0 to 89.5

PRIMARY outcome

Timeframe: Up to 5 days postvaccination

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

Outcome measures

Outcome measures
Measure	Pneumovax™ 23: Participants Between 2 and 49 Years n=52 Participants Participants received a single 0.5 mL intramuscular injection on Day 1	Pneumovax™ 23: Participants >=50 Years n=50 Participants Participants received a single 0.5 mL intramuscular injection on Day 1
Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)	1 Number of participants	0 Number of participants

PRIMARY outcome

Timeframe: Up to Day 14 postvaccination

Population: The All Subjects as Treated population included all enrolled 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.

Outcome measures

Outcome measures
Measure	Pneumovax™ 23: Participants Between 2 and 49 Years n=52 Participants Participants received a single 0.5 mL intramuscular injection on Day 1	Pneumovax™ 23: Participants >=50 Years n=50 Participants Participants received a single 0.5 mL intramuscular injection on Day 1
Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants	16 Number of participants	5 Number of participants

PRIMARY outcome

Timeframe: Up to Day 28 postvaccination

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

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

Outcome measures

Outcome measures
Measure	Pneumovax™ 23: Participants Between 2 and 49 Years n=52 Participants Participants received a single 0.5 mL intramuscular injection on Day 1	Pneumovax™ 23: Participants >=50 Years n=50 Participants Participants received a single 0.5 mL intramuscular injection on Day 1
Number of Participants Reporting Serious Adverse Experiences	0 Number of participants	0 Number of participants

Adverse Events

Pneumovax™ 23

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pneumovax™ 23 n=102 participants at risk Participants received a single 0.5 mL intramuscular injection on Day 1
General disorders Injection site pain	13.7% 14/102 • Number of events 14 • All adverse experiences were collected through Day 14 postvaccination; serious adverse experiences were collected through Day 28 postvaccination

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER