An Open-Label, Randomized Study of a 9-Valent Human Papillomavirus Vaccine Given Concomitantly with Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccines to Healthy Adolescents 11–15 Years of Age

Kosalaraksa, Pope; Mehlsen, Jesper; Vesikari, Timo; Forstén, Aino; Helm, K. von der; Damme, Pierre Van; Joura, Elmar A.; Ciprero, Karen L.; Maansson, Roger; Luxembourg, Alain; Meulen, Ajoke Sobanjo-ter

doi:10.1097/inf.0000000000000694

Cited by 32 publications

(33 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The 9vHPV has been coadministered with Neisseria meningitidis serotypes A/C/Y/W-135 or diphtheria/tetanus/acellular pertussis (Tdap) vaccines in a population of boys and girls aged 9–14 years21 and with diphtheria/tetanus/acellular pertussis/inactivated poliomyelitis vaccine (Tdap-IPV) in a population of boys and girls aged 11–14 years 22. In both studies, the immune response to all component of administered vaccines was noninferior when compared with nonconcomitant administration.…”

Section: Efficacy and Immunogenicity Of The 9vhpvmentioning

confidence: 99%

Spotlight on the 9-valent HPV vaccine

Lopalco¹

2016

DDDT

View full text Add to dashboard Cite

Starting in 2006, vaccination against human papillomavirus (HPV) has been progressively implemented in most developed countries. Two vaccines have been successfully used, a bivalent vaccine targeting HPV-related cancers (bHPV) and a quadrivalent vaccine (qHPV) targeting both HPV-related cancers and genital warts. Between December 2014 and June 2015, a new nonavalent HPV vaccine (9vHPV) was granted marketing authorization in the USA and Europe. The 9vHPV was developed from the qHPV and includes five additional HPV types that should increase the level of protection toward HPV-related cancers. Efficacy and/or immunogenicity of 9vHPV has been assessed in eight clinical studies. The 9vHPV vaccine induced a very robust immune response against all vaccine types, with seroconversion rates close to 100%. The safety profile of 9vHPV is comparable to that of qHPV. Local reactions, especially swelling, have been more frequently reported after 9vHPV than qHPV, and this slightly increases when the 9vHPV is coadministered with other vaccines. The additional coverage offered by the 9vHPV may prevent a significant proportion of HPV-related cancers (variable between 8% and 18%) depending on the local distribution of high-risk HPV types in the population. It is impossible, at present, to anticipate the actual impact of the wide use of the 9vHPV in comparison with the bHPV or the qHPV, since it depends on many variables including duration of protection, potential cross-protection toward nonvaccine types, and herd immunity effect.

show abstract

Section: Efficacy and Immunogenicity Of The 9vhpvmentioning

confidence: 99%

Spotlight on the 9-valent HPV vaccine

Lopalco¹

2016

DDDT

View full text Add to dashboard Cite

show abstract

“…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%

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

et al. 2016

Self Cite

View full text Add to dashboard Cite

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.

show abstract

“…In another study that investigated concomitant administration of 9vHPV vaccine with a diphtheria/tetanus/ pertussis/polio vaccine, more subjects also reported swelling at the 9vHPV vaccine injection site in the concomitant vaccination group. 19 This suggests that the increase in injection-site swelling may be due to the concomitant administration of diphtheria/tetanus/ pertussis antigens (rather than meningococcal antigens) with 9vHPV vaccine.…”

Section: Resultsmentioning

confidence: 99%

“…9 Epidemiologic studies have demonstrated the acquisition of HPV soon after sexual initiation. 10 The median age of sexual debut is in the late teens (15)(16)(17)(18)(19) years) in most countries. 11 Thus, preadolescent boys and girls #15 years of age represent the ideal HPV vaccination population.…”

Section: What This Study Addsmentioning

confidence: 99%

Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines

Schilling

Parra

Gutierrez³

et al. 2015

Pediatrics

Self Cite

View full text Add to dashboard Cite

An Open-Label, Randomized Study of a 9-Valent Human Papillomavirus Vaccine Given Concomitantly with Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccines to Healthy Adolescents 11–15 Years of Age

Abstract: Overall, concomitant administration of 9vHPV vaccine and REPEVAX was generally well tolerated and did not interfere with the immune response to either vaccine. This strategy would minimize the number of visits required to deliver each vaccine individually.

Cited by 32 publications

References 31 publications

Spotlight on the 9-valent HPV vaccine

Spotlight on the 9-valent HPV vaccine

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

Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines

Contact Info

Product

Resources

About