Pneumococcal Infection Clinical Trial
Official title:
A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants
Verified date | September 2018 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.
Status | Completed |
Enrollment | 72 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 42 Days to 55 Years |
Eligibility |
Inclusion Criteria: 1. Age at the time of enrollment is: - 18 through 55 years (before the fifty sixth birthday) for Group 1. - 3 through 5 years (before the sixth birthday) for Group 2. - 42 to 98 days for Group 3. 2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. Exclusion Criteria: - Previous vaccination with licensed or investigational pneumococcal vaccine. - Previous anaphylactic reaction to any vaccine or vaccine-related component. - Contraindication to vaccination with pneumococcal vaccine. |
Country | Name | City | State |
---|---|---|---|
China | Pfizer Investigational Site | Huaian | Jiangsu |
China | Pfizer Investigational Site | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants reporting Adverse Events | Baseline to Month 1 |
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 |
NCT01654263 -
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
|
Phase 2 | |
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 |