NCT03098628

Trial of Simplified Pneumococcal Vaccination in Vietnam II

Trial of Simplified Pneumococcal Vaccination in Vietnam II: The Herd Immunity Approach

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,501 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 8 Weeks – 10 Weeks
• Healthy volunteers: Accepted

Summary

This is a single-blind, open-label, randomised controlled trial with five groups. There are four different Pneumococcal Conjugate Vaccine (PCV) schedules to be evaluated.

Detailed description

This is a single-blind, open-label, randomised controlled trial with five groups. There are four different PCV schedules to be evaluated: a 0+1 schedule of PCV10 at 12 months of age (Group V), a 0+1 schedule of PCV13 at 12 months of age (Group W), a 1+1 schedule of PCV10 at 2 and 12 months of age (Group X), and a 1+1 schedule of PCV13 at 2 and 12 months of age (Group Y); along with a control group that receives a dose of PCV10 at 24 months of age (Group Z). Additionally, all participants will receive four doses of Infanrix-hexa at 2, 3, 4 and 18 months of age.

Conditions

• Pneumococcal Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	PCV Vaccine	PCV vaccination

Timeline

• Start date: 2017-03-08
• Primary completion: 2020-06-11
• Completion: 2020-06-11
• First posted: 2017-04-04
• Last updated: 2024-11-27

Locations

1 site across 1 country: Vietnam