Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)

A Study Evaluating the Safety and Immunogenicity of Revaccination With 23-Valent Pneumococcal Polysaccharide Vaccine in Older Japanese Adults

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02260882

Enrollment

243

Registered

2014-10-09

Start date

2014-10-31

Completion date

2015-04-09

Last updated

2018-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infection

Brief summary

The purpose of this study is to determine if revaccination with pneumococcal vaccine (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese adults. The primary hypothesis being tested is that the geometric mean concentration of antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after revaccination will be superior to that before revaccination in Japanese adults who received a primary vaccination at least 5 years before revaccination.

Interventions

BIOLOGICALPNEUMOVAX™ 23

PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to 89 Years

Healthy volunteers

Yes

Inclusion criteria

* Japanese participant * Good health or any underlying chronic illness is documented to be in stable condition * Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5 years before enrollment in the study * Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination

Exclusion criteria

* Known allergy or sensitivity to any of the components of the study vaccine * History of pneumococcal conjugate vaccination * Known or suspected immune dysfunction, immunosuppression, or autoimmune disease. Participants with a history of cancer who are not actively treated and not immunosuppressed will be eligible * Functional or anatomic asplenia * Received immunoglobulin within 6 months before study vaccine or is planned during the study * Received any investigational drugs or vaccines within 2 months before study vaccination * History of pneumococcal disease (positive culture from blood or other normally sterile site) * Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection * History of convulsion * Previously diagnosed with immunodeficiency or has a close relative with congenital immune deficiency * Participating in any other clinical trial

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination	Baseline and 4 weeks after revaccination	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.

Secondary

Measure	Time frame	Description
Percentage of Participants With an Adverse Event of Injection-site Erythema	Up to 5 days after vaccination	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.
Percentage of Participants With an Adverse Event of Injection-site Swelling	Up to 5 days after vaccination	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.
Percentage of Participants With an Adverse Event of Injection-site Pain	Up to 5 days after vaccination	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.
Percentage of Participants With an Adverse Event of Pyrexia	Up to 5 days after vaccination	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.
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination	Baseline and 4 weeks after primary vaccination	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.
Percentage of Participants With an Adverse Event of Arthralgia	Up to 14 days after vaccination	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.
Percentage of Participants With an Adverse Event of Headache	Up to 14 days after vaccination	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.
Percentage of Participants With an Adverse Event of Fatigue	Up to 14 days after vaccination	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.
Percentage of Participants With an Adverse Event of Myalgia	Up to 14 days after vaccination	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.

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	161
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.	81
Total	242

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol Violation	0	1

Baseline characteristics

Characteristic	Revaccination Group	Primary Vaccination Group	Total
Age, Continuous	78.8 Years STANDARD_DEVIATION 4.8	78.2 Years STANDARD_DEVIATION 5	78.6 Years STANDARD_DEVIATION 4.8
Sex: Female, Male Female	94 Participants	46 Participants	140 Participants
Sex: Female, Male Male	67 Participants	35 Participants	102 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	113 / 161	41 / 81
serious Total, serious adverse events	4 / 161	0 / 81

Outcome results

Primary

Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination

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.

Time frame: Baseline and 4 weeks after revaccination

Population: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Revaccination Group	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
Revaccination Group	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
Revaccination Group	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

Comparison: Serotype 3. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.p-value: <0.001t-test, 1 sided

Comparison: Serotype 6B. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.p-value: <0.001t-test, 1 sided

Comparison: Serotype 23F. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.p-value: <0.001t-test, 1 sided

Secondary

Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination

Time frame: Baseline and 4 weeks after primary vaccination

Population: 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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Revaccination Group	Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination	Serotype 3	4.01 Geometric Mean Fold Rise
Revaccination Group	Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination	Serotype 6B	5.83 Geometric Mean Fold Rise
Revaccination Group	Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination	Serotype 23F	6.11 Geometric Mean Fold Rise

Secondary

Percentage of Participants With an Adverse Event of Arthralgia

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.

Time frame: Up to 14 days after vaccination