Safety and immunogenicity of a 9-valent HPV vaccine in females 12–26 years of age who previously received the quadrivalent HPV vaccine

Garland, Suzanne M.; Cheung, Tak‐Hong; McNeill, Shelly; Petersen, Lone Kjeld; Romaguera, Josefina; Vazquez-Narvaez, Jorge; Bautista, Oliver; Shields, Christine; Vuocolo, Scott; Luxembourg, Alain

doi:10.1016/j.vaccine.2015.08.059

Cited by 70 publications

(72 citation statements)

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“…All participants who received ≥1 study vaccination and had follow-up data are included in the analysis of safety with the following exceptions: (1) subjects enrolled in the dose-selection portion of study 001 who received 9vHPV vaccine dose formulations not selected for Phase III evaluation, that is, lowdose and high-dose 9vHPV vaccine (previously reported) 15,16 ; (2) subjects randomized to the saline placebo arm of study 006 (previously reported; n = 306) 12 ; and (3) a small number of subjects (<0.1%) who accidentally received noncompliant dosing regimens (eg, mixed regimens of 9vHPV and qHPV vaccine or mixed regimen of 9vHPV vaccine and placebo). This combined analysis of safety data provides a cross-study summary of AEs and new medical conditions, described as frequencies and percentages across study group and type of event.…”

Section: Discussionmentioning

confidence: 99%

“…In studies 002, 003, 005, and 007, all participants received 9vHPV vaccine. Study 001 (NCT00543543; protocol V503-001) 8 ; Study 002 (NCT00943722; protocol V503-002) 9 ; Study 003 (NCT01651949; protocol V503-003) 10 ; Study 005 (NCT00988884, protocol V503-005) 11 ; Study 006 (NCT01047345; protocol V503-006) 12 ; Study 007 (NCT01073293; protocol V503-007) 13 ; Study 009 (NCT01304498; protocol V503-009/GDS01C). 14 N/n = subjects who received at least 1 vaccination and did not receive a mixed vaccine regimen.…”

Section: Vaccinationmentioning

confidence: 99%

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Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials

et al. 2016

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The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age. METHODS:Vaccination was administered as a 3-dose regimen at day 1, and months 2 and 6. More than 15 000 subjects received ≥1 dose of 9vHPV vaccine. In 2 of the studies, >7000 control subjects received ≥1 dose of quadrivalent HPV (qHPV) vaccine. Serious and nonserious adverse events (AEs) and new medical conditions were recorded throughout the study. Subjects testing positive for pregnancy at day 1 were not vaccinated; those who became pregnant after day 1 were discontinued from further vaccination until resolution of the pregnancy. Pregnancies detected after study start (n = 2950) were followed to outcome. RESULTS:The most common AEs (≥5%) experienced by 9vHPV vaccine recipients were injection-site AEs (pain, swelling, erythema) and vaccine-related systemic AEs (headache, pyrexia). Injection-site AEs were more common in 9vHPV vaccine than qHPV vaccine recipients; most were mild-to-moderate in intensity. Discontinuations and vaccine-related serious AEs were rare (0.1% and <0.1%, respectively). Seven deaths were reported; none were considered vaccine related. The proportions of pregnancies with adverse outcome were within ranges reported in the general population. CONCLUSIONS:The 9vHPV vaccine was generally well tolerated in subjects aged 9 to 26 years with an AE profile similar to that of the qHPV vaccine; injection-site AEs were more common with 9vHPV vaccine. Its additional coverage and safety profile support widespread 9vHPV vaccination. WHAT'S KNOWN ON THIS SUBJECT: 9-valent HPV vaccination prevents infection and disease associated with vaccine HPV types in 16-to 26-year-old women. Effi cacy fi ndings were extended to 9-to 15-yearold girls and boys by demonstrating noninferior immunogenicity compared with women.

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Section: Discussionmentioning

confidence: 99%

Section: Vaccinationmentioning

confidence: 99%

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials

et al. 2016

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“…This is not correct. The only saline placebo trial of approved HPV vaccines is a Gardasil 9 trial (V503-006; NCT01047345) that was published in 2015 4. Its participants had previously been vaccinated with four-valent Gardasil, but according to the Cochrane review protocol,5 this was not an exclusion criterion.…”

Section: The Cochrane Review Missed Nearly Half Of the Eligible Trialsmentioning

confidence: 99%

The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias

Jørgensen

Gøtzsche

Jefferson

2018

BMJ EBM

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“…Serious AE were very infrequent, and were not reported more frequently in the intervention group compared to the control group. Clinical trials investigating the 9vHPV vaccine had lower numbers of participants, but the results were comparable to those obtained with 4vHPV [5][6][7][8]. In nearly 13,500 participants, three non-causallyrelated serious AE were noted: one case of tonsillitis, one case of asthma exacerbation, and one case of severe headache; all cases fully recovered.…”

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confidence: 74%

Overcoming barriers in HPV vaccination and screening programs

Vorsters

Arbyn

Baay³

et al. 2017

Papillomavirus Research

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A B S T R A C TThe Human Papillomavirus Prevention and Control Board brought together experts to discuss optimizing HPV vaccination and screening programs.Board members reviewed the safety profile of licensed HPV vaccines based on clinical and post-marketing data, reaching a consensus that current safety data is reassuring.Successful vaccination programs used well-coordinated communication campaigns, integrating (social) media to spread awareness. Communication of evidence supporting vaccine effectiveness had beneficial effects on the perception of the vaccine. However, anti-vaccination campaigns have threatened existing programs in many countries.Measurement and monitoring of HPV vaccine confidence over time could help understand the nature and scale of waning confidence, define issues and intervene appropriately using context-specific evidence-based strategies. Finally, a broad group of stakeholders, such as teachers, health care providers and the media should also be provided with accurate information and training to help support prevention efforts through enhanced understanding of the risks and benefits of vaccination.Similarly, while cervical cancer screening through population-based programs is highly effective, barriers to screening exist: awareness in countries with population-based screening programs, access for vulnerable populations, and access and affordability in low-and middle-income countries. Integration of primary and secondary prevention has the potential to accelerate the decrease in cervical cancer incidence. IntroductionThe HPV Prevention and Control Board was created in December 2015 [1] with the aim to share relevant information on HPV with a broad array of stakeholders, and to implement preventive strategies to reduce the HPV-related disease burden. Here we report the discussion that took place during the first official meeting, held on June 27 and 28, 2016, in Antwerp, Belgium.1The objectives of the meeting were (a) to summarize the available adverse event profile and any reported safety concerns following HPV vaccination, (b) to summarize cultural, perceptual, infrastructural and financial barriers to the implementation of vaccination, (c) to identify factors that influence adherence to cervical screening programs, (d) to propose strategies to build public confidence in HPV prevention programs and address any vaccination and screening hesitancy, and (e) to discuss new approaches to improve HPV prevention and cervical cancer control. Vaccine safety profileThe safety of new products is critical for licensure and successful implementation/uptake. Critical review of clinical trial data is the first step in this process. However, as clinical trials generally involve limited numbers, and participants may have health conditions different from those in the general population, post-marketing surveillance is essential.While licensure has varied according to country, HPV vaccines have been available since 2006 beginning with the quadrivalent (4vHPV, Gardasil, Merck), followed by the bivalent (2vHP...

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Safety and immunogenicity of a 9-valent HPV vaccine in females 12–26 years of age who previously received the quadrivalent HPV vaccine

Cited by 70 publications

References 28 publications

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials

The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias

Overcoming barriers in HPV vaccination and screening programs

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