Publication policy
A manuscript detailing the results of this study will form the primary publication and be published in a peer-reviewed journal. Authorship will be determined as per ICMJE guidelines and all other contributors will be acknowledged. The authors will also acknowledge that this trial was funded by the Bill and Melinda Gates Foundation, with vaccines donated by BiologicalE. The Directorate of Public Health, Government of Tamil Nadu, will review all publications prior to their submission.