Trial Outcomes & Findings for Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902) (NCT NCT02260882)
NCT ID: NCT02260882
Last Updated: 2018-10-30
Results Overview
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.
COMPLETED
PHASE4
243 participants
Baseline and 4 weeks after revaccination
2018-10-30
Participant Flow
Depending on prior history of Pneumovax™ 23 vaccination, 161 participants with a history of prior Pneumovax™ 23 vaccination were enrolled into the Revaccination group and 82 participants without a history of prior Pneumovax™ vaccination were enrolled into the Primary vaccination group.
Participant milestones
| Measure |
Revaccination Group
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
82
|
|
Overall Study
COMPLETED
|
161
|
81
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Revaccination Group
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)
Baseline characteristics by cohort
| Measure |
Revaccination Group
n=161 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.8 Years
STANDARD_DEVIATION 4.8 • n=93 Participants
|
78.2 Years
STANDARD_DEVIATION 5.0 • n=4 Participants
|
78.6 Years
STANDARD_DEVIATION 4.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
140 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks after revaccinationPopulation: Per Protocol Set: all participants in the Revaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window.
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.
Outcome measures
| Measure |
Revaccination Group
n=161 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination
Serotype 3: n=161
|
2.72 Geometric Mean Fold Rise
Interval 2.35 to 3.14
|
—
|
|
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination
Serotype 6B: n=161
|
2.27 Geometric Mean Fold Rise
Interval 2.02 to 2.55
|
—
|
|
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination
Serotype 23F: n=160
|
2.40 Geometric Mean Fold Rise
Interval 2.12 to 2.72
|
—
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after primary vaccinationPopulation: Per Protocol Set: all participants in the Primary Vaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.
Outcome measures
| Measure |
Revaccination Group
n=81 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination
Serotype 3
|
4.01 Geometric Mean Fold Rise
Interval 3.17 to 5.08
|
—
|
|
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination
Serotype 6B
|
5.83 Geometric Mean Fold Rise
Interval 4.41 to 7.69
|
—
|
|
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination
Serotype 23F
|
6.11 Geometric Mean Fold Rise
Interval 4.65 to 8.02
|
—
|
SECONDARY outcome
Timeframe: Up to 5 days after vaccinationPopulation: All Subjects as Treated set: all participants who received study vaccine.
An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.
Outcome measures
| Measure |
Revaccination Group
n=161 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event of Injection-site Erythema
|
35.4 Percentage of participants
|
14.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 days after vaccinationPopulation: All Subjects as Treated set: all participants who received study vaccine.
An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.
Outcome measures
| Measure |
Revaccination Group
n=161 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event of Injection-site Swelling
|
38.5 Percentage of participants
|
17.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 days after vaccinationPopulation: All Subjects as Treated set: all participants who received study vaccine.
An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.
Outcome measures
| Measure |
Revaccination Group
n=161 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event of Injection-site Pain
|
62.7 Percentage of participants
|
46.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 days after vaccinationPopulation: All Subjects as Treated set: all participants who received study vaccine.
Percentage of participants with an adverse event of pyrexia (\>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.
Outcome measures
| Measure |
Revaccination Group
n=161 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event of Pyrexia
|
6.8 Percentage of participants
|
1.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 14 days after vaccinationPopulation: All Subjects as Treated set: all participants who received study vaccine.
An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.
Outcome measures
| Measure |
Revaccination Group
n=161 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event of Myalgia
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 14 days after vaccinationPopulation: All Subjects as Treated set: all participants who received study vaccine.
An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.
Outcome measures
| Measure |
Revaccination Group
n=161 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event of Arthralgia
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 14 days after vaccinationPopulation: All Subjects as Treated set: all participants who received study vaccine.
An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.
Outcome measures
| Measure |
Revaccination Group
n=161 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event of Headache
|
1.9 Percentage of participants
|
1.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 14 days after vaccinationPopulation: All Subjects as Treated set: all participants who received study vaccine.
An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.
Outcome measures
| Measure |
Revaccination Group
n=161 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 Participants
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event of Fatigue
|
1.2 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
Revaccination Group
Primary Vaccination Group
Serious adverse events
| Measure |
Revaccination Group
n=161 participants at risk
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 participants at risk
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
General disorders
Pyrexia
|
0.62%
1/161 • Number of events 1 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
0.00%
0/81 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
|
Infections and infestations
Herpes virus infection
|
0.62%
1/161 • Number of events 1 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
0.00%
0/81 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.62%
1/161 • Number of events 1 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
0.00%
0/81 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.62%
1/161 • Number of events 1 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
0.00%
0/81 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
Other adverse events
| Measure |
Revaccination Group
n=161 participants at risk
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
|
Primary Vaccination Group
n=81 participants at risk
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
|
|---|---|---|
|
General disorders
Injection-site erythema
|
35.4%
57/161 • Number of events 57 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
14.8%
12/81 • Number of events 12 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
|
General disorders
Injection-site pain
|
62.7%
101/161 • Number of events 102 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
46.9%
38/81 • Number of events 38 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
|
General disorders
Injection-site pruritus
|
6.8%
11/161 • Number of events 11 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
2.5%
2/81 • Number of events 2 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
|
General disorders
Injection-site swelling
|
38.5%
62/161 • Number of events 62 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
17.3%
14/81 • Number of events 14 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
|
General disorders
Pyrexia
|
6.8%
11/161 • Number of events 11 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
1.2%
1/81 • Number of events 1 • All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER