An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) vaccine given concomitantly with diphtheria, tetanus, pertussis, and poliomyelitis vaccine in healthy adolescents 11 to 17 years of age

Pediatric Infectious Disease Journal

Volumn 29, Issue 4, 2010, Pages 314-318

  Vesikari, Timo ^a   Van Damme, Pierre ^b   Lindblad, Niklas ^c   Pfletschinger, Ulrich ^d   Radley, David ^e   Ryan, Desmond ^e   Vuocolo, Scott ^e   Haupt, Richard M ^e   Guris, Dalya ^e  

^a UNIVERSITY OF TAMPERE MEDICAL SCHOOL   (Finland)

^b UNIVERSITY OF ANTWERP   (Belgium)

^c TURKU UNIVERSITY HOSPITAL   (Finland)

^d Pediatric Offices   (Germany)

^e MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Concomitant; GARDASIL; HPV vaccine; REPEVAX

Indexed keywords

DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS VACCINE; SILGARD; UNCLASSIFIED DRUG; WART VIRUS VACCINE;

ADOLESCENT; ARTICLE; BODY TEMPERATURE; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DIPHTHERIA; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEADACHE; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 11; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 6; IMMUNE RESPONSE; IMMUNOGENICITY; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PERTUSSIS; POLIOMYELITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SEROCONVERSION; SIDE EFFECT; TETANUS; VACCINATION; VERRUCA VULGARIS;

EID: 77950214394     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e3181c177fb     Document Type: Article

References (11)

1. Garland SM, Hernandez-Avila M, Wheeler CM, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007;356:1928-1943.
2. The FUTURE II Study Group. Quadrivalent vaccine against human papillo-mavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356:1915-1927.
3. The FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virologic evidence of HPV infection. J Infect Dis. 2007;196:1438-1446.
4. Lowe RS, Brown DR, Bryan JT, et al. Human papillomavirus type 11 (HPV-11) neutralizing antibodies in the serum and genital mucosal secretions of African green monkeys immunized with HPV-11 virus-like particles expressed in yeast. J Infect Dis. 1997;176:1141-1145.
5. Koutsky LA, Ault KA, Wheeler CM, et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med. 2002;347:1645-1651.
6. Ault K, Giuliano AR, Edwards R, et al. A phase I study to evaluate a human papillomavirus (HPV) type 18 L1 VLP vaccine. Vaccine. 2004;22:3004-3007.
7. Opalka D, Lachman CE, MacMullen SA, et al. Simultaneous quantitation of antibodies to neutralizing epitopes on virus-like particles for human papil-lomavirus types 6, 11, 16 and 18 by a multiplexed luminex assay. Clin Diagn Lab Immunol. 2003;10:108-115.
8. Reisinger KS, Block SL, Lazcano-Ponce E, et al. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Ped Infect Dis J. 2007;26:201-209.
9. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4:213-226.
10. Block SL, Nolan T, Sattler C, et al. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006;118:2135-2145.
11. Joura EA, Kjaer SK, Wheeler CM, et al. HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine. Vaccine. 2008;26:6844-6851.