Clinical trial NCT01953510: Trial of Pneumococcal Vaccine Schedules in Ho Chi Minh City, Vietnam
Official title: Evaluation of Different Infant Vaccination Schedules Incorporating Pneumococcal Vaccination
Conditions: Pneumococcal Vaccines
Summary: Pneumococcus is a group of bacteria that can cause pneumonia, meningitis and other diseases. These bacteria normally live in the nose of humans and are spread from person to person by touching or sneezing. There are vaccines available to protect against infection with these bacteria, and pneumococcus is currently the leading vaccine-preventable cause of death in young children. In countries where pneumococcal vaccine (PCV) has been introduced, there has been a big impact on the amount of disease caused by these bacteria. However, many countries, especially developing countries, are yet to introduce PCV as part of their routine immunizations. Currently a total of four doses of PCV is recommended, and the main barrier to vaccine introduction is cost. This study aims to identify a vaccination schedule to make PCV more effective and affordable for Vietnam and other developing countries.
This study has two distinct purposes: 1) to compare different dosage schedules of PCV and 2) to compare different PCV vaccines.
1. Schedules of Synflorix (PCV10) involving a three, two or one dose PCV primary series and two booster options will be compared. Comparisons will be made firstly in terms of measures of immunity to the vaccine, and secondly in terms of the effect of vaccination on the carriage of bacteria in the nose.
2. The responses to PCV10 and Prevenar-13 (PCV13) will be compared, in the schedule most likely to be considered for global use. Again, comparisons will be made in terms of measures of immunity and effect on carriage in the nose.
Infants aged two months will be randomly assigned to one of six study groups and will provide up to four blood samples for analysis of the measures of immunity and five nose swabs for analysis of carriage of bacteria. Infants will be followed up 8-9 times until the age of 24 months. An additional control group will be recruited at 18 months of age and also followed up until 24 months of age.
The results of this study will be used to facilitate decision making, at global and national levels, regarding introduction of PCV.
Interventions:
description: PCV10 includes serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and protein D is the main carrier protein
name: PCV10
other_name: 10-valent pneumococcal conjugate vaccine
Synflorix
type: Biological
description: PCV13 includes serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually linked to non-toxic diphtheria CRM197 carrier protein
name: PCV13
other_name: 13-valent pneumococcal conjugate vaccine
Prevenar-13
Prevnar-13
type: Biological
Study arms:
design_group_description: PCV10 administered at 2, 3, 4 and 9 months of age
design_group_title: A: 3+1 PCV10
design_group_type: Active Comparator
design_group_description: PCV10 administered at 2, 3 and 4 months of age
design_group_title: B: 3+0 PCV10
design_group_type: Experimental
design_group_description: PCV10 administered at 2, 4 and 9 months of age
design_group_title: C: 2+1 PCV10
design_group_type: Experimental
design_group_description: PCV10 administered at 2 and 6 months of age
design_group_title: D: 1+1 PCV10
design_group_type: Experimental
design_group_description: PCV13 administered at 2, 4 and 9 months of age
design_group_title: E: 2+1 PCV13
design_group_type: Experimental
design_group_description: No infant PCV vaccination. PCV10 administered at 18 and 24 months of age
design_group_title: F: control
design_group_type: No Intervention
design_group_description: Recruited at 18 months of age (non-randomised). PCV10 administered at 24 months of age
design_group_title: G: control
design_group_type: No Intervention
Sponsor: Murdoch Childrens Research Institute
Collaborators: Gates Foundation (United States)
Menzies School of Health Research
GSK Plc
National Health & Medical Research Council
Institut Pasteur
Drug name mappings:
name: Pneumococcal Polysaccharide Conjugate Vaccine(Glaxosmithkline Plc)
lang: EN
name: 13价肺炎球菌多糖结合疫苗 (辉瑞制药)
lang: CN
name: Pneumococcal polysaccharide conjugate vaccine
lang: EN
name: 沈降１３価肺炎球菌結合型ワクチン
lang: JP