Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496093
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2007-07-03
Brief Title:
Safety Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India V110-011
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Safety Tolerability and Immunogenicity of Pneumovax 23 V110 in Healthy Adults in India
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To describe the safety tolerability and immunogenicity of pneumovax 23 V110 in healthy adults in India
Detailed Description:
This was an open-label non-randomized study to assess the safety and immunogenicity of PNEUMOVAXTM 23 in healthy adults in India The participants enrolled in this study were healthy Indian adults 50 years of age or older with no prior history of having received a pneumococcal vaccination 14-valent or 23-valent and no prior history of Pneumococcal disease All participants enrolled in the study received one 05 mL dose of PNEUMOVAXTM 23 by intramuscular deltoid injection on Day 1 Serum samples were obtained prior to vaccination on Day 1 and on Day 28 -7 days postvaccination The duration of participation for each participant was approximately one month with the study completion at the Day 28 postvaccination bleed and return of the Vaccination Report Card VRC Enrollment was completed within approximately 2 months The last postvaccination blood sample was collected within 3 months of study initiation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007_018 | None | None | None |