Evaluation of different infant vaccination schedules incorporating pneumococcal vaccination (The Vietnam Pneumococcal Project): protocol of a randomised controlled trial

Ellinor Temple, Nguyen Trong Toan, Doan Y Uyen, Anne Balloch, Kathryn Bright, Yin Bun Cheung, Paul Licciardi, Cattram Duong Nguyen, Nguyen Thi Minh Phuong, Catherine Satzke, Heidi Smith-Vaughan, Thi Que Huong Vu, Tran Ngoc Huu, Edward Kim Mulholland

    Research output: Contribution to journalComment/debate

    8 Downloads (Pure)

    Abstract

    Introduction: WHO recommends the use of pneumococcal conjugate vaccine (PCV) as a priority. However, there are many countries yet to introduce PCV, especially in Asia. This trial aims to evaluate different PCV schedules and to provide a head-to-head comparison of PCV10 and PCV13 in order to generate evidence to assist with decisions regarding PCV introduction. Schedules will be compared in relation to their immunogenicity and impact on nasopharyngeal carriage of Streptococcus pneumoniae and Haemophilus influenzae.

    Methods and analysis:
    This randomised, single-blind controlled trial involves 1200 infants recruited at 2 months of age to one of six infant PCV schedules: PCV10 in a 3+1, 3+0, 2+1 or two-dose schedule; PCV13 in a 2+1 schedule; and controls that receive two doses of PCV10 and 18 and 24 months. An additional control group of 200 children is recruited at 18 months that receive one dose of PCV10 at 24 months. All participants are followed up until 24 months of age. The primary outcome is the post-primary series immunogenicity, expressed as the proportions of participants with serotype-specific antibody levels ≥0.35 µg/mL for each serotype in PCV10.

    Ethics and dissemination:
    Ethical approval has been obtained from the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (EC00153) and the Vietnam Ministry of Health Ethics Committee. The results, interpretation and conclusions will be presented to parents and guardians, at national and international conferences, and published in peer-reviewed open access journals.
    Original languageEnglish
    Article numbere019795
    Pages (from-to)1-11
    Number of pages11
    JournalBMJ Open
    Volume8
    Issue number6
    DOIs
    Publication statusPublished - 8 Jun 2018

    Fingerprint Dive into the research topics of 'Evaluation of different infant vaccination schedules incorporating pneumococcal vaccination (The Vietnam Pneumococcal Project): protocol of a randomised controlled trial'. Together they form a unique fingerprint.

  • Cite this

    Temple, E., Toan, N. T., Uyen, D. Y., Balloch, A., Bright, K., Cheung, Y. B., Licciardi, P., Nguyen, C. D., Phuong, N. T. M., Satzke, C., Smith-Vaughan, H., Vu, T. Q. H., Huu, T. N., & Mulholland, E. K. (2018). Evaluation of different infant vaccination schedules incorporating pneumococcal vaccination (The Vietnam Pneumococcal Project): protocol of a randomised controlled trial. BMJ Open, 8(6), 1-11. [e019795]. https://doi.org/10.1136/bmjopen-2017-019795