Aims:
  • This project aims to guide the identification of a new schedule for routine infant immunisation in developing countries to support the most efficient use of pneumococcal conjugate vaccines (PCVs).
Objectives:

This study is specifically designed to address two independent questions:

  • What is the optimal schedule for provision of EPI vaccines with the incorporation of Synflorixb. How do the responses to the two currently available PCV vaccines (Synflorix and Prevenar-13) compare?
Summary:

This trial involves 1200 infants from two districts in Ho Chi Minh City, Vietnam.

Participants are randomised to one of six vaccination schedules: four schedules involving Synflorix (a 3+1 schedule at 2, 3, 4 and 9 months of age; a 3+0 schedule at 2, 3 and 4 months of age; a 2+1 schedule at 2, 4 and 9 months of age; and a 1+1 schedule at 2 and 6 months of age); one schedule involving Prevenar-13 (a 2+1 schedule at 2, 4 and 9 months of age); and one control schedule without infant PCV doses. All participants receive the standard number of doses of routine EPI vaccines and at least two doses of PCV.

Participants are enrolled at two months of age and are followed up until at least 18 months of age. Participants provide a series of blood samples for analysis of vaccine responses, and nasopharyngeal swabs for analysis of pneumococcal carriage.

Implications for policy and practice:

This study aims to generate data that can be used to provide advice regarding pneumococcal vaccination schedules, in Vietnam and elsewhere. These data will be useful both in the immediate future, as developing countries begin to introduce pneumococcal vaccines, and in the longer term, as the basic EPI schedule is likely to be revised. Thus, this study is designed to facilitate decision making, at global and country levels, with regard to the introduction of pneumococcal conjugate vaccines into developing countries.

Chief Investigator:
  • Kim Mulholland 
Project Manager:
  • Beth Temple
Contact information:
Project dates:

September 2013 - July 2016.

Funders:
  • National Health and Medical Research Council (NHMRC)
Collaborators:
  • Pasteur Institute of Ho Chi Minh City, Vietnam
  • Murdoch Childrens Research Institute, Melbourne
  • GlaxoSmithKline Biologicals, Belgium
  • National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
     
  1. Balloch, A., Licciardi, P. V., Tang, M. L. (2013) Serotype-Specific Anti-Pneumococcal IgG and Immune Competence: Critical Differences in Interpretation Criteria When Different Methods are Used. J Clin Immunol, 33(2), 335-41.
  2. Binks, M. J., Temple, B., Kirkham, L. A., Wiertsema, S. P., Dunne, E. M., Richmond, P.C., et al. (2012). Molecular surveillance of true nontypeable Haemophilus influenza: an evaluation of PCR screening assays. PLoS One, 7(3), e34083.
  3. Mulholland, K., & Satzke, C. (2012) Serotype replacement after pneumococcal vaccination. Lancet, 379(9824), 1387.
  4. Dunne, E. M., Manning, J., Russell, F. M., Robins-Browne, R. M., Mulholland, E.K., & Satzke, C. (2012) Effect of pneumococcal vaccination on nasopharyngeal carriage of Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus in Fijian children. J Clin Microbiol, 50(3), 1034-8.
  5. Dunne, E. M., Ong, E. K., Moser, R. J., Siba, P. M., Phuanukoonnon. S., Greenhill, A. R., et al. (2011) Multilocus Sequence Typing of Streptococcus pneumoniae using Mass Spectrometry. J Clin Microbiol, 49(11), 3756-60.