Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Vaccine in Healthy Boys Aged 10–18 Years

Petäjä, Tiina; Keränen, Heli; Karppa, Tiina; Kawa, Anna; Lantela, S.; Siitari-Mattila, Mari; Levänen, Helena; Tocklin, T.; Godeaux, Olivier; Lehtinen, Matti; Dubin, Gary

doi:10.1016/j.jadohealth.2008.10.002

Cited by 125 publications

(59 citation statements)

References 27 publications

(44 reference statements)

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“…In other clinical trials and surveillance studies conducted in different countries such as Japan, the Netherlands and United Kingdom7, 8, 9, 10, 11, 12, 13, 14, 15, 24, 25, 26, 27, 28, 29, transient injection‐site pain lasting for less than 5 days 30 was consistently the most commonly occurring AE. The results of the present study now provide further evidence that the safety profile of the HPV‐16/18 AS04‐adjuvanted vaccine is similar when administered to women in Korea.…”

Section: Discussionmentioning

confidence: 84%

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Kim

Song²,

Chen

et al. 2017

Pharmacoepidemiology and Drug

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PurposeTo evaluate the safety of HPV‐16/18 AS04‐adjuvanted vaccine when administered as per the PI in Korea.MethodsA total of 3084 women aged 10–25 years were enrolled in this post‐marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose. All AEs, ADRs and SAEs were presented with exact 95% confidence intervals (CI) (NCT01101542).ResultsInjection‐site pain was the most frequent AE and ADR reported by 322 subjects (10.4% [95%CI: 9.4–11.6]); the local pain was transient and lasted 4–7 days in most cases. Dysmenorrhoea and vaginitis were the most common unexpected AEs reported by 30 (1.0% [95%CI: 0.7–1.4]) and 16 subjects (0.7% [95%CI: 0.3–0.8]), respectively. Pain (toe pain, leg pain and body pain [one case each]; foot pain [two cases]) was the most common unexpected ADR reported by five subjects (0.2% [95%CI: 0.1–0.4]). Four subjects reported a single SAE (one case each of exostosis, gastroenteritis, abortion and tonsillitis); none were fatal. All SAEs were assessed as unlikely to be related to vaccination; gastroenteritis, exostosis and tonsillitis resolved during the study period.ConclusionsThis is the first post‐marketing surveillance study in Korea that provides 6‐year safety data for HPV‐16/18 AS04‐adjuvanted vaccine. The vaccine showed an acceptable safety profile and favourable benefit/risk ratio when given to women aged 10–25 years in Korea. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

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Section: Discussionmentioning

confidence: 84%

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Kim

Song²,

Chen

et al. 2017

Pharmacoepidemiology and Drug

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“…Our findings confirm the high safety and tolerability of the bivalent Human Papillomavirus vaccine. [21][22][23][24] The safety and tolerability of the HPV-16/18 AS04-adjuvated vaccine in this sample of adult women aged 25 did not differ much from that previously observed in a sample of preadolescents Italian girls: 13 in both cases and in agreement with the data from the international scientific literature regarding both controlled clinical studies and post-licensure surveillance, the most frequently reported adverse reaction related with the administration of Cervarix proved to be pain at the site of injection and no unexpected or serious side effects with a causal relationship with the vaccination occurred following the administration of 616 doses. Fever and local pain were however more frequently registered in our sample of adult women than in the preadolescent girls group examined in the study cited.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of bivalent human papillomavirus (HPV) vaccine safety and tolerability in a sample of 25 year old Tuscan women

Levi

Bonanni

Burroni

et al. 2013

Human Vaccines & Immunotherapeutics

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“…There are two vaccine types; the quadrivalent targeting HPV types 6, 11, 16 and 18 [14] and the bivalent targeting HPV types 16 and 18 [17]. Both can be given to females and males to prevent HPV infection [1], [2], [29]. Research shows that HPV vaccines should reduce the incidence of cervical cancer by 70%, genital warts by 90% and universal protection if administered to people not previously exposed to the implicated HPV types [10].…”

Section: Introductionmentioning

confidence: 99%

Parents' Knowledge, Risk Perception and Willingness to Allow Young Males to Receive Human Papillomavirus (HPV) Vaccines in Uganda

et al. 2014

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The Ministry of Health in Uganda in collaboration with the Program for Appropriate Technology for Health (PATH) supported by Bill and Melinda Gates Foundation in 2008–2009 vaccinated approximately 10,000 girls with the bivalent humanpapilloma virus (HPV) vaccine. We assessed parent's knowledge, risk perception and willingness to allow son(s) to receive HPV vaccines in future through a cross-sectional survey of secondary school boys aged 10–23 years in 4 districts. 377 questionnaires were distributed per district and 870 were used in analysis. Parents that had ever heard about cervical cancer and HPV vaccines; those who would allow daughter(s) to be given the vaccine and those who thought that HPV infection was associated with genital warts were more willing to allow son(s) to receive the HPV vaccine. Unwilling parents considered HPV vaccination of boys unimportant (p = 0.003), believed that only females should receive the vaccine (p = 0.006), thought their son(s) couldn't contract HPV (p = 0.010), didn't know about HPV sexual transmissibility (p = 0.002), knew that males could not acquire HPV (p = 0.000) and never believed that the HPV vaccines could protect against HPV (p = 0.000). Acceptance of HPV vaccination of daughters and likelihood of recommending HPV vaccines to son(s) of friends and relatives predicted parental willingness to allow sons to receive HPV vaccines. Probable HPV vaccination of boys is a viable complement to that of girls. Successfulness of HPV vaccination relies on parental acceptability and sustained sensitization about usefulness of HPV vaccines even for boys is vital.

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Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Vaccine in Healthy Boys Aged 10–18 Years

Cited by 125 publications

References 27 publications

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Evaluation of bivalent human papillomavirus (HPV) vaccine safety and tolerability in a sample of 25 year old Tuscan women

Parents' Knowledge, Risk Perception and Willingness to Allow Young Males to Receive Human Papillomavirus (HPV) Vaccines in Uganda

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