Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children

Completed

• Conditions: Pneumonia; Meningitis

• Registration Number: NCT04275284
• Lead Sponsor: University of Witwatersrand, South Africa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-2-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Children between and including the ages of 36 - 38 months of age at the time of<br> first blood sampling;<br><br> 2. Subjects who previously participated in the PCV1+1 study and received the full study<br> vaccination regime as per protocol;<br><br> 3. The parent or legal guardian of the child must be able and willing to provide<br> written informed consent for all 3 visits and comply with all study requirements;<br><br> 4. The parent or legal guardian of the child must indicate the intention to remain in<br> the study area for the duration of the trial - or be willing to bring the child for<br> all visits.<br><br>Exclusion Criteria:<br><br> 1. Receipt of any additional pneumococcal vaccine since the end of participation in the<br> PCV1+1 study;<br><br> 2. Any known or suspected immunodeficiency condition which could affect immune response<br> to vaccination, including living with HIV;<br><br> 3. Receipt of any immunoglobulins and/or blood products less than 6 months prior to<br> blood sampling;<br><br> 4. Parent/legal guardian unable or unwilling to attend scheduled study visits.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serotype specific geometric mean antibody concentrations (GMC)

Secondary Outcome Measures

Name	Time	Method
Modified threshold of protection;Comparison between 6-week and 14-week primary dose;Colonization outcome