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A prospective, single-arm, open-label, non-randomized, phase IIa trial of a nonavalent prophylactic HPV vaccine to assess immunogenicity of a prime and deferred-booster dosing schedule among 9–11 year-old girls and boys – clinical protocol

Crossref DOI link: https://doi.org/10.1186/s12885-019-5444-4

Published Online: 2019-04-01

Published Print: 2019-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Zeng, Yi

Moscicki, Anna-Barbara

Sahasrabuddhe, Vikrant V.

Garcia, Francisco

Woo, Heide

Hsu, Chiu-Hsieh

Szabo, Eva

Dimond, Eileen

Vanzzini, Susan

Mondragon, Angelica

Butler, Valerie

DeRose, Hillary

Chow, H.-H. Sherry http://orcid.org/0000-0002-9638-711X
Funding

Funding for this research was provided by:

Division of Cancer Prevention, National Cancer Institute (HHSN26100009)
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Article History

Received: 2 February 2019

Accepted: 7 March 2019

First Online: 1 April 2019

Ethics approval and consent to participate

: The protocol and all recruiting materials have been approved by the Central Institutional Review Board for the National Cancer Institute (protocol #UAZ 2015-05-01) and institutional IRBs. Written informed consent to participate in the study was obtained from the legal representatives (most often parents and legal guardians) of all study participants. Written assent form to participate in the study was obtained from all study participant. Participants and their legal representatives also signed the amended consent, when changes were made to the consent.

: Not applicable

: The authors declare that they have no competing interests.

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