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Completed

NCT Number: NCT02260882

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

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.

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Key information

Conditions

Pneumococcal Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

70 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumovax™ 23

Biological

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. 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

    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.

  2. Percentage of Participants With an Adverse Event of Injection-site Erythema

    Time frame: 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.

  3. Percentage of Participants With an Adverse Event of Injection-site Swelling

    Time frame: 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.

  4. Percentage of Participants With an Adverse Event of Injection-site Pain

    Time frame: 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.

  5. Percentage of Participants With an Adverse Event of Pyrexia

    Time frame: 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.

  6. Percentage of Participants With an Adverse Event of Myalgia

    Time frame: 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.

  7. Percentage of Participants With an Adverse Event of Arthralgia

    Time frame: 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.

  8. Percentage of Participants With an Adverse Event of Headache

    Time frame: 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.

  9. Percentage of Participants With an Adverse Event of Fatigue

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 9, 2014
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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