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Human Vaccines & Immunotherapeutics Volume 15, 2019 - Issue 7-8: HPV vaccination: from seroprevalence to public health policy and everything in between
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Research Paper

A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years

Tino F. Schwarza Institute of Laboratory Medicine and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Würzburg, GermanyCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0003-1505-1823View further author information
ORCID Icon,
Li-Min Huangb Department of Pediatrics, National Taiwan University Hospital, Taipei, TaiwanView further author information
,
Alejandra Valenciac Department of Pediatrics, Fundación de Santa Fe de Bogotá, Bogota, ColombiaView further author information
,
Falko Panzerd Practice for Pediatric and Adolescent Medicine, Mannheim, GermanyORCID Iconhttps://orcid.org/0000-0002-3254-3881View further author information
ORCID Icon,
Cheng-Hsun Chiue Department of Pediatrics, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, TaiwanView further author information
,
Annabelle Decreuxf GSK, Wavre/Rixensart, BelgiumView further author information
,
Sylviane Ponceletf GSK, Wavre/Rixensart, BelgiumORCID Iconhttps://orcid.org/0000-0002-2279-5444View further author information
ORCID Icon,
Naveen Karkadaf GSK, Wavre/Rixensart, BelgiumORCID Iconhttps://orcid.org/0000-0002-7543-1345View further author information
ORCID Icon,
Nicolas Folschweillerf GSK, Wavre/Rixensart, BelgiumORCID Iconhttps://orcid.org/0000-0003-0299-7783View further author information
ORCID Icon,
Lan Linf GSK, Wavre/Rixensart, BelgiumORCID Iconhttps://orcid.org/0000-0001-6604-918XView further author information
ORCID Icon,
Gary Dubing GSK, King of Prussia, PA, USA;h Takeda Pharmaceuticals, Glattpark-Opfikon, Zurich, SwitzerlandView further author information
&
Frank Struyff GSK, Wavre/Rixensart, BelgiumORCID Iconhttps://orcid.org/0000-0001-9988-0260View further author information
ORCID Icon show all
Pages 1970-1979 | Received 11 Jan 2019, Accepted 19 May 2019, Published online: 17 Jul 2019

Figures & data

Figure 1. Study design flow chart with the disposition of subjects from the primary study to follow-up studies. ATP, according-to-protocol; HPV: Human Papillomavirus; n: number of seropositive subjects; N: number of tested subjects; TVC, total vaccinated cohort.

Figure 1. Study design flow chart with the disposition of subjects from the primary study to follow-up studies. ATP, according-to-protocol; HPV: Human Papillomavirus; n: number of seropositive subjects; N: number of tested subjects; TVC, total vaccinated cohort.

Figure 2. GMTs for anti-HPV-16 and anti-HPV-18 antibodies in initially seronegative subjects (Month 120 ATP immunogenicity cohort). CI: 95% Confidence interval; ELISA: Enzyme-linked immunosorbent assay; EU: ELISA units; GMT: Geometric Mean Titer; HPV: Human papillomavirus; M: Month.

Figure 2. GMTs for anti-HPV-16 and anti-HPV-18 antibodies in initially seronegative subjects (Month 120 ATP immunogenicity cohort). CI: 95% Confidence interval; ELISA: Enzyme-linked immunosorbent assay; EU: ELISA units; GMT: Geometric Mean Titer; HPV: Human papillomavirus; M: Month.

Figure 3. GMTs for anti-HPV-31 and anti-HPV-45 antibodies in initially seronegative subjects (Month 120 ATP immunogenicity cohort). CI: 95% Confidence interval; ELISA: Enzyme-linked immunosorbent assay; EU: ELISA units; GMT: Geometric Mean Titer; HPV: Human papillomavirus; n: number of seropositive subjects; N: number of tested subjects.

Figure 3. GMTs for anti-HPV-31 and anti-HPV-45 antibodies in initially seronegative subjects (Month 120 ATP immunogenicity cohort). CI: 95% Confidence interval; ELISA: Enzyme-linked immunosorbent assay; EU: ELISA units; GMT: Geometric Mean Titer; HPV: Human papillomavirus; n: number of seropositive subjects; N: number of tested subjects.

Table 1. Predicted duration ensuring 95% of women have HPV-16 and -18 antibody titers above antibody titers after natural infection. ELISA: enzyme-linked immunosorbent assay; EU: ELISA unit; GMT: geometric mean titer; HPV: human papillomavirus.

Figure 4. Predicted antibody responses against HPV-16 and HPV-18 over 50 years using Piecewise model and modified power-law model. ELISA: Enzyme-linked immunosorbent assay; EU: ELISA unit; FU: Follow-up; HPV: Human Papillomavirus; Y: Year.

Figure 4. Predicted antibody responses against HPV-16 and HPV-18 over 50 years using Piecewise model and modified power-law model. ELISA: Enzyme-linked immunosorbent assay; EU: ELISA unit; FU: Follow-up; HPV: Human Papillomavirus; Y: Year.

Figure 5. Focus on the patient.

Figure 5. Focus on the patient.

Table

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