Pneumococcal Infection Clinical Trial
Official title:
A Phase IIb, Open-Label, Dose-Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02463539 -
Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis
|
N/A | |
Completed |
NCT03095326 -
Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
|
Phase 4 | |
Completed |
NCT02260882 -
Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)
|
Phase 4 | |
Completed |
NCT02572635 -
A Phase I Study to Evaluate the Safety and Immunogenicity of PnuBioVax
|
Phase 1 | |
Completed |
NCT01531322 -
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT00496093 -
Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)
|
Phase 3 | |
Completed |
NCT02062281 -
Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults
|
Phase 4 | |
Completed |
NCT00133549 -
9-valent CRM 197 Pneumococcal
|
Phase 2 | |
Completed |
NCT03467984 -
A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
|
Phase 2 | |
Active, not recruiting |
NCT03489018 -
The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants
|
Phase 4 | |
Recruiting |
NCT02463578 -
Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis
|
N/A | |
Completed |
NCT00535730 -
ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)
|
Phase 3 | |
Completed |
NCT02558751 -
Pneumonia Vaccine in Aging HIV Positive Individuals
|
Phase 0 | |
Completed |
NCT02515240 -
Immune Response to Pneumococcal Vaccination in HIV Infected Individuals
|
Phase 0 | |
Completed |
NCT00560950 -
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
|
Phase 3 | |
Completed |
NCT05425732 -
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
|
Phase 3 | |
Not yet recruiting |
NCT03549208 -
A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults
|
Phase 1 | |
Completed |
NCT03619252 -
Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents
|
Phase 4 | |
Not yet recruiting |
NCT03341195 -
Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan
|
N/A | |
Recruiting |
NCT06177912 -
A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
|
Phase 3 |