NCT04275284

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

Evaluation of Persistence of Immunogenicity Following an Open-labelled, Randomized Controlled Trial Evaluating Non-inferiority of 1+1 Compared to 2+1 Dosing Schedules of 10-valent and 13-valent Pneumococcal Conjugate Vaccine in South Africa

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: University of Witwatersrand, South Africa · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: —

Summary

This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 PCV schedule (6, 14 weeks of age and 9 months of age).

Detailed description

Between 2017 and 2019, we conducted an open-labelled, randomized controlled trial to evaluate for non-inferiority in the post-booster serotype-specific geometric mean concentrations (GMC's) in children randomized to receive either PCV10 or PCV13 as a 1+1 schedule (with the first dose occurring either at 6 or 14 weeks of age) compared to infants who received a two dose primary series (6 and 14 weeks of age). All six study groups received a booster dose at 40 weeks of age, and serotype-specific IgG and opsonophagocytic activity was measured one-month post booster. Subjects were planned to be followed-up until 18 months of age as part of the initial study. In the present study, we propose to extent the follow-up of the cohort to include annual visit at 3, 4 and 5 years of age, to evaluate the sustainability of the humoral immune response of the different PCV dosing schedules.

Conditions

• Pneumonia
• Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	PCV10	0.5 ml injection
BIOLOGICAL	PCV13	0.5 ml injection

Timeline

• Start date: 2020-02-14
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-02-19
• Last updated: 2024-08-23

Locations

1 site across 1 country: South Africa