Reduced Dose Pneumococcal Conjugate Vaccine Schedules: Closing the Knowledge Gap and Informing Immunization Policies in Thailand

Phase 4

• Conditions: Healthy Thai infants aged 2 months.; Healthy, Infant

• Registration Number: TCTR20230929001
• Lead Sponsor: The National Vaccine Institute (NVI), Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-29
• Last Update Posted: 19 August 2024
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

1)Female or male infants aged 2 months (plus/minus 7 days).
2)Participants with normal birthweight.
3)Participants born to HIV-uninfected mothers.
4)Participants that have parent or legal caregiver capable of comprehending Thai (speaking, reading, writing) and abiding by protocol instructions.
5)Participants that have parent or legal caregiver that are available throughout the trial period.
6)Participants that have parent or legal caregiver willing to provide written inform consent to have their children participate in the clinical trial.

Exclusion Criteria

1)Participants with severe illnesses, unmanageable symptoms, or underlying unstable disease.
2)Participants with a history of pneumococcal disease (microbiologically confirmed).
3)Participants with a history of severe drug or vaccine allergies (anaphylaxis), especially PCV or vaccines that contain diphtheria toxoid.
4)Participants with Streptococcus pneumoniae vaccination history.
5)Participants that received any vaccines within 14 days of screening and enrollment.
6)Participants that received plasma, immunoglobulins, antivirals, antibodies, or blood transfusions, products, or components within 90 days prior to screening and enrollment.
7)Participants with a fever (greater than 37.2 degree celsius under the arm) at screening or baseline.
8)Participants with a history of immunodeficiencies or immunocompromise since, or soon after, birth.
9)Participants with severe cardiovascular, digestive, pulmonary, endocrine, or central nerve system illness since, or soon after, birth.
10)Participants with other clinically significant reason, as determined by the investigator, that may affect immune responses to PCV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pneumococcal serotype-specific carriage Month 7, 18 Nasopharyngeal swab

Secondary Outcome Measures

Name	Time	Method
Immunogenicity Month 7, 10, 18 IgG