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

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.

Conditions

• Pneumococcal Vaccines

Interventions

BIOLOGICAL

PCV10

PCV10 includes serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and protein D is the main carrier protein

BIOLOGICAL

PCV13

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

Sponsors & Collaborators

• Institut Pasteur

  collaborator INDUSTRY

• Menzies School of Health Research

  collaborator OTHER

• National Health and Medical Research Council, Australia

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• GlaxoSmithKline

  collaborator INDUSTRY

• Murdoch Childrens Research Institute

  lead OTHER

Principal Investigators

• Edward K Mulholland, MBBS, FRACP · Murdoch Childrens Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Days

Max Age

74 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2016-01-27

Completion

2021-11-08

Countries

• Vietnam

Study Locations