The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two groups of participants (55 through 74 years of age). First group vaccine naïve participants will be open-label to receive a single injection of 0.5 mL PCV13. Second group of participant previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) will be randomized 1:1 to receive two injections of 0.5 mL PCV13, one dose in each arm (Group IIA or Group IIB). Blood samples will be obtained at baseline, at one month and six months post-vaccination. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study
This is a phase IIb open-label immunogenicity and safety study to evaluate dosages of 0.5 mL and 1.0 mL (given as two 0.5 mL injections in separate arms) of PCV13 in adults 55 through 74 years of age previously vaccinated with PPSV23. The study will enroll two groups of participants. Group I participants will all receive an open-label dose of 0.5 mL PCV13 and will include 294 adults 55-74 years of age who have not previously received 23-valent pneumococcal polysaccharide vaccine (PPSV23). Group II will be randomized 1:1 to receive 0.5 mL PCV13 (Group IIA) or 0.5 mL PCV13 in the right arm and 0.5 mL PCV 13 in the left arm (Group IIB). Group II will include 588 adults 55 through 74 years of age who previously received a single dose of PPSV23 \> /=3 years and \< /=7 years prior to enrollment. Enrollment in both groups will be stratified by age group (55 through 64 years and 65 through 74 years).The study duration is approximately 18 months. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study vaccination, and is non-inferior to 12 vaccine serotypes; and determine if two 0.5 mL doses of PCV13 administered to participants previously vaccinated with PPSV23 are non-inferior to a single dose of 0.5 mL of PCV13 administered to vaccine-naïve adults 55 through 74 years of age for the 12 vaccine serotypes, as measured by serotype-specific OPA titers 28 days after study vaccination. The secondary objectives of this study are to: determine if two x 0.5mL doses of PCV13 is statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 180 days after study vaccination, and is non-inferior to 12 vaccine serotypes; to determine if two x 0.5mL doses of PCV13 administered to participants previously vaccinated with PPSV23 is non-inferior to a single dose of 0.5 mL of PCV13 administered to vaccine-naïve adults 55 through 74 years of age for 12 vaccine serotypes, as measured by serotype-specific OPA titers 180 days after study vaccination. Parent protocol to sub-study 12-0031.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Enrollment
884
Prevnar 13 (PCV13) 13-valent pneumococcal conjugate vaccine. All doses given on Day 0. Group IA and IB (open-label): 0.5 mL intramuscular (IM) injection; Group IIA (open-label, randomized): 0.5 mL IM injection; Group IIB (open-label, randomized): 0.5 mL IM injection in the right arm and 0.5 mL IM in the left arm.
Emory Vaccine Center - The Hope Clinic
Decatur, Georgia, United States
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, United States
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, United States
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, United States
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, United States
Group Health Research Institute - Seattle - Vaccines and Infectious Diseases
Seattle, Washington, United States
Number of Participants Reporting Solicited Local and Systemic Adverse Events
Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is \>0mm.
Time frame: Days 0 to Day 7 post vaccination
Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.
Association with PCV13 was determined by the investigator and defined as "Related", meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified.
Time frame: Up to Day 28 post vaccination
Number of Participants Reporting Vaccine-related Serious Adverse Events.
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with PCV13 was determined by the investigator and defined as "Related", meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified.
Time frame: Up to Day 180 post vaccination
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Blood was collected from all participants at Day 0 and Day 28 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).
Time frame: Day 0 and Day 28 post vaccination
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Blood was collected from all participants at Days 0 and 180 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).
Time frame: Day 0 and Day 180 post vaccination
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