Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination

Phase 3

Completed

Conditions: Pneumococcal Disease

Registration Number: NCT03835975

Lead Sponsor: Pfizer

Brief Summary: This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 875

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination	Within 6 months after vaccination	An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination	Within 7 days after vaccination	Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination	Within 1 month after vaccination	An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination	Within 6 months after vaccination	An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.
Percentage of Participants With Local Reactions Within 10 Days After Vaccination	Within 10 days after vaccination	Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination	1 month after vaccination	OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.

Secondary Outcome Measures

Name	Time	Method
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination	From before vaccination to 1 month after vaccination	OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination	From before vaccination to 1 month after vaccination	Percentage of participants with a \>=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination	1 month after vaccination	The percentage of participants with OPA titers \>=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

Trial Locations

Locations (37): Coastal Clinical Research, Inc.
🇺🇸
Mobile, Alabama, United States
East Valley Gastroenterology and Hepatology Associates
🇺🇸
Chandler, Arizona, United States
The Pain Center of Arizona
🇺🇸
Phoenix, Arizona, United States
HOPE Research Institute
🇺🇸
Phoenix, Arizona, United States
Anaheim Clinical Trials, LLC
🇺🇸
Anaheim, California, United States
Diablo Clinical Research, Inc.
🇺🇸
Walnut Creek, California, United States
Clinical Research Consulting, LLC
🇺🇸
Milford, Connecticut, United States
Optimal Research, LLC
🇺🇸
Melbourne, Florida, United States
Synexus Clinical Research US, Inc
🇺🇸
The Villages, Florida, United States
Meridian Clinical Research, LLC
🇺🇸
Norfolk, Nebraska, United States
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Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States