Immunogenicity and Safety of Pneumococcal 13-valent Conjugate Vaccine between Weuphoria and Prevnar 13 in Thai Older People

Phase 4

• Conditions: Healthy participants with no health conditions or stable chronic diseases.; -

• Registration Number: TCTR20230923001
• Lead Sponsor: ational Vaccine Institute (NVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-23
• Last Update Posted: 19 August 2024
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

1. Male or female participants aged greater than or equal to 50 years old.
2. Healthy participants with no health conditions or stable chronic diseases.
3. Participants capable of comprehending (speaking, reading, and/or writing) Thai.
4. Participants capable of communicating through electronic platforms such as Google Forms or LINE.
5. Participants capable of attending all visits in the study schedule.
6. Participants willing to provide written informed consent before any study procedures.

Exclusion Criteria

1. Participants with a history of pneumococcal vaccination.
2. Participants with a history of severe drug or vaccine allergic reactions (i.e., anaphylaxis).
3. Participants allergic to any of the investigational product components.
4. Participants with a history of diphtheria vaccine allergies (diphtheria toxoid allergies).
5. Immunodeficient participants.
6. Participants with a history of continuous immunosuppressive or steroid treatments (equivalent to 15 mg prednisolone) less than or equal to 14 days prior to enrollment.
7. Participants that received an inactivated vaccine less than or equal to 2 weeks or a live-attenuated vaccine less than or equal to 4 weeks before enrollment or that plan to receive other vaccines less than or equal to 6 weeks of the administered investigational product.
8. Participants with a positive urine pregnancy test.
9. Participants with an acute medical illness less than or equal to 7 days of enrollment.
10. Female participants that are pregnant or lactating.
11. Participants with underlying unstable diseases or medical conditions.
12. Participants with any other conditions that may interfere with the study, as deemed appropriate by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity Day 0, 29 Immunoglobulin G (IgG) geometric mean concentrations (GMCs) against all 13 serotypes.

Secondary Outcome Measures

Name	Time	Method
Reactogenicity and safety Day 0, 7, 14, 29 Patient reported outcome using a questionnaire interview