A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
Study Details
Study Description
Brief Summary
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The purpose of this study is to describe the safety of the study vaccine (called 13vPnC) in people who are 18-49 years of age in India.
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This study is seeking participants who are generally healthy adults ≥18 and <50 years of age, with no prior history of pneumococcal vaccination.
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Participants will take part in the study for approximately one month which includes two visits to the study clinic.
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Participants will receive a single dose of study vaccine (13vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine (13vPnC) |
Biological: 13-valent pneumococcal conjugate vaccine
One dose of 13vPnC (0.5mL) will be administered intramuscularly.
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants reporting prompted local reactions within 7 days after vaccination [7 days]
Prompted local reactions (redness, swelling, and pain at the injection site) after vaccination
- Percentage of participants reporting prompted systemic events within 7 days after vaccination [7 days]
Prompted systemic events (fever, fatigue, headache, muscle pain and joint pain) after vaccination
- Percentage of participants reporting adverse events (AEs) within 1 month after vaccination [1 month]
Adverse events (AEs) occurring within 1 month after vaccination
- Percentage of participants reporting serious adverse events (SAEs) within 1 month after vaccination [1 month]
Serious adverse events (SAEs) occurring within 1 month after vaccination
Eligibility Criteria
Criteria
Inclusion Criteria:
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Generally healthy participants between the ages of ≥18 and <50 years at the time of consent.
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Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion Criteria:
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History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, or to any other diphtheria toxoid-containing vaccine.
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Congenital, functional, or surgical asplenia.
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Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
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Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nirmal Hospital Pvt Ltd. | Surat | Gujarat | India | 395002 |
| 2 | BGS Global Institute of Medical Sciences (BGSGIMS) | Bangalore | Karnataka | India | 560060 |
| 3 | Jawahar Lal Nehru Medical College | Ajmer | Rajasthan | India | 305001 |
| 4 | Calcutta School of Tropical Medicine | Kolkata | WEST Bengal | India | 700073 |
| 5 | Aakash Healthcare Private Limited | Delhi | India | 110075 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B1851214