Trial of Pneumococcal Vaccine Schedules in Ho Chi Minh City, Vietnam

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Sep 25, 2013

Keywords

ClinConnect Summary

Introduction

The overall purpose of this study is to investigate simplified childhood vaccination schedules that are more appropriate for developing country use. This study is specifically designed to address two independent questions within a single study:

1. What is the optimal schedule for provision of EPI vaccines with the incorporation of PCV10? Schedules involving a three, two or one dose PCV10 primary series will be evaluated, timed around options for simplification of the Expanded Programme of Immunization (EPI) schedule for developing countries. A simplified schedule with the pne...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged between 2 months and 2 months plus 2 weeks (Arms A-F) or aged between 18 months and 18 months plus 2 weeks (Arm G)
• • No significant maternal or perinatal history
• • Born at or after 36 weeks gestation
• • Written and signed informed consent from parent/legal guardian
• • Lives within approximately 30 minutes of the commune health centre
• • Family anticipates living in the study area for the next 22 months (Arms A-F) or 6 months (Arm G)
• • Has received three doses of either Infanrix-hexa or Quinvaxem in infancy (Arm G)
• Exclusion Criteria:
• • Known allergy to any component of the vaccine
• • Allergic reaction or anaphylactic reaction to any previous vaccine
• • Known immunodeficiency disorder
• • Known HIV-infected mother
• • Known thrombocytopenia or coagulation disorder
• • On immunosuppressive medication
• • Administration or planned administration of any immunoglobulin or blood product since birth
• • Severe birth defect requiring ongoing medical care
• • Chronic or progressive disease
• • Seizure disorder
• • History of invasive pneumococcal, meningococcal or Haemophilus influenzae type b diseases, or tetanus, measles, pertussis or diphtheria infections
• • Receipt of any 2 month vaccines through the EPI program (Arms A-F) or receipt of PCV (Arm G)
• • Family plans on giving the infant Quinvaxem or oral polio vaccine (Arms A-F)