Following changes were made: The word 'minutes' was added as per EC's comment; Added statement: "The parents or their child may withdraw their consent to the storage of samples at any time during the study. If at the age of 18, the child decides to withdraw his/her consent for the storage of his/her samples, he/she will have to contact the site who will inform the sponsor of the study to destroy his/her samples."; throughout the study the age of subject was changed from 8 through 12 years to 9 through 13 years; To align to Art 46 of Regulation (EC) No 1901/2006 for pediatric studies and also to the public disclosure of the study results modalities, the study results should be submitted no later than 6 months after the last visit of last subject (LVLS). As the cell-mediated immunity (CMI) results would be available later than 6 months after the LVLS, it was decided to release a first CSR with available data 6 months after the LVLS and the final clinical study report (CSR) when the CMI results are available; Text was updated to reflect that there was no coordinating investigator but there was a principal investigator; Planned study timelines were updated; Updated the exclusion criteria text to reflect: If the subject has a primary physician who is not the Investigator, the site must obtain the subject’s / subject’s parent or legal guardian’s consent prior to contacting this physician and informing him/her of the subject’s participation in the study; Updated text to reflect: All statistical analyses will be performed under the responsibility of the Sponsor’s Biostatistics Platform using the SAS® software, Version 9.4 or newer (SAS Institute, Cary, North Carolina, USA); Updated table of study procedures.

Following changes were made: The cover page was updated with details of the new regional trial manager; Number of subjects was corrected throughout; Corrected and clarified the synopsis and immunogenicity endpoints; Updated identity of study product; Updated visit procedures; Updated planned study calender; Updated randomisation and allocation procedures to provide clarification of subject number; Updated blood samples for CMI; Clarified sample storage and shipment to Global Clinical Immunology (GCI); Corrected sample storage and shipment to research-Eu Marcy l'Etoile, France; Corrected future use of stored serum samples for research; Updated immunogenicity assessment method. Updated the cover page to replace the age of subjects by the years of birth, updated details of the new medical study leader and global safety office; Updated synopsis, study design, schedule of study procedures and methodology; Updated inclusion and exclusion criteria; Updated background section, recruitment procedures, identity of study product; timelines in the planned study calendar section were updated.

Following changes were made: Updated title page to reflect changes within the company; Replaced 'subject' with 'participant', 'trial' with 'study' and Research-EU Human Immunology Platform was replaced by Vaccine R&D, Clinical Exploratory Research Platform throughout the document; Clarified regarding the number of subjects concerned by blood sampling for the humoral immune response; Updated the study calender; Clarified on the HIV treatment medications; Updated the immunogenicity endpoints due to the development of a more sensitive assay; The exploratory assay for the quantification of the memory B cells by Fluorospot was suppressed because of the difficult interpretation of the results for IgM and IgA secreting cells. The dual color Fluorospot was replaced by a more sensitive triple Fluorospot to measure interferon (IFN)-γ, Interleukin (IL)-17, and IL-4 to interrogate the Th profile. The Luminex assay on culture supernatant was also suppressed as this assay is redundant and less sensitive than the Fluorospot assay.