Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of proquad (measles, mumps, rubella, and varicella virus vaccine live)

Pediatrics

Volumn 119, Issue 6, 2007, Pages

  Bernstein, Henry H ^a,i   Eves, Karen ^b   Campbell, Kristy ^b   Black, Steven B ^c   Twiggs, Jerry D ^d   Reisinger, Keith S ^e   Conti, Ralph M ^f   Flodmark, Carl Erik ^g   Rombo, Lars ^h   Klopfer, Stephanie ^b   Schödel, Florian ^b   Hartzel, Jonathan ^b   Kuter, Barbara J ^b   Andrews, Wilson P ^h   Bernstein, Jerry C ^h   Bertino, Joseph ^h   Block, Stanley L ^h   Brine, Louis ^h   Browngoehl, Kevin ^h   Cox, Matthew ^h   Dracker, Robert ^h   Gerber, Michael ^h   Gray, Gregory C ^h   Hedgepeth, J Randy ^h   Keyserling, Harry ^h   Lei, Paul ^h   Levin, Michael ^h   Lindgren, Carl ^h   Luber, Stephen ^h   Malacaman, Edgardo ^h   Marchant, Colin ^h   Ogle, Michelle ^h   Senders, Shelly D ^h   Shepard, Julie ^h   Short, Douglas ^h   Sperling, Malcolm ^h   Stacks, Robert ^h   Troutman, James ^h   more..

^a CHILDREN S HOSPITAL AT DARTMOUTH   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c KAISER PERMANENTE   (United States)

^d Dixie Pediatrics   (United States)

^e Primary Physicians Research   (United States)

^f Foothills Pediatrics   (United States)

^g LUND UNIVERSITY HOSPITAL   (Sweden)

^h Malarsjukhuset ^*

ⁱ DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

Author keywords

Immunization; M M RII; Measles; Mumps; ProQuad; Rubella; Vaccine; Varicella; Varivax

Indexed keywords

CHICKENPOX MEASLES MUMPS RUBELLA VACCINE; GLYCOPROTEIN;

ANTIBODY TITER; ARTICLE; BODY TEMPERATURE; CHICKENPOX; CONTROLLED STUDY; COUGHING; DEHYDRATION; DERMATITIS; DIARRHEA; DRUG DOSAGE FORM COMPARISON; DRUG ERUPTION; DRUG FORMULATION; DRUG RESPONSE; DRUG SAFETY; DRUG STORAGE; DRUG TOLERABILITY; EAR INFECTION; ENZYME LINKED IMMUNOSORBENT ASSAY; FOLLOW UP; GASTROENTERITIS; HERPES ZOSTER; HUMAN; IMMUNOGENICITY; INJECTION SITE BLEEDING; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE RASH; INJECTION SITE SWELLING; MEASLES; MEASLES LIKE RASH; MUMPS; NORMAL HUMAN; OTITIS MEDIA; PHARYNGITIS; PNEUMONIA; PRESCHOOL CHILD; PRIORITY JOURNAL; RHINOPHARYNGITIS; RHINORRHEA; SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VACCINATION; VIRAL RESPIRATORY TRACT INFECTION; VOMITING;

ANTIBODIES, VIRAL; CHICKENPOX VACCINE; DOUBLE-BLIND METHOD; DRUG STABILITY; DRUG STORAGE; FEVER; FREEZING; HUMANS; INFANT; MEASLES-MUMPS-RUBELLA VACCINE; REFRIGERATION; VACCINES, COMBINED;

EID: 34249911705     PISSN: 00314005     EISSN: 02105721     Source Type: Journal    
DOI: 10.1542/peds.2006-2283     Document Type: Article

References (26)

1. Böttiger M, Christenson B, Romanus V, Taranger J, Strandell A. Swedish experience of two dose vaccination programme aiming at eliminating measles, mumps, and rubella. Br Med J (Clin Res Ed). 1987;295:1264-1267
2. Centers for Disease Control and Prevention. Summary of notifiable diseases: United States, 1998. MMWR Morb Mortal Wkly Rep. 1999;47:ii-92
3. Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. 9th ed. Atlanta, GA: Centers for Disease Control and Prevention; 2006:125-170
4. Peltola H, Davidkin I, Paunio M, Valle M, Leinikki P, Heinonen OP. Mumps and rubella eliminated from Finland. JAMA. 2000;284:2643-2647
5. World Health Organization Vaccines and Biologicals. WHO Vaccine-Preventable Diseases: Monitoring System - 2003 Global Summary. Geneva, Switzerland: World Health Organization; 2003
6. Centers for Disease Control and Prevention. National, state, and urban area vaccination coverage among children aged 19-35 months: United States, 2004. MMWR Morb Mortal Wkly Rep. 2005;54:717-721
7. Seward JF, Watson BM, Peterson CL, et al. Varicella disease after introduction of varicella vaccine in the United States, 1995-2000. JAMA. 2002;287:606-611
8. Centers for Disease Control and Prevention. Decline in annual incidence of varicella: selected states, 1990-2001. MMWR Morb Mortal Wkly Rep. 2003;52:884-885
9. Centers for Disease Control and Prevention. Combination vaccines for childhood immunization. MMWR Recomm Rep. 1999;48(RR-5):1-14
10. Shinefield H, Black S, Digilio L, et al. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005;24:665-669
11. Shinefield H, Williams W, Marchant C, et al. Dose-response of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005;24:670-675
12. Mendez R, Henderson F, Reisinger K, et al. Immunogenicity and safety of process upgrade varicella vaccine (PUVV) with new stabilizer as compared to PUVV with current stabilizer when administered concomitantly with M-M-RII in healthy children. Presented at the 22nd annual meeting of the European Society for Paediatric Infectious Diseases; May 26-28, 2004; Tampere, Finland
13. Bell KN, Hogue CJ, Manning C, Kendal A. Risk factors for improper vaccine storage and handling in private provider offices. Pediatrics. 2001;107(6). Available at: www. pediatrics.org/cgi/content/full/107/6/e100
14. Keller PM, Lonergan K, Neff BJ, Morton DA, Ellis RW. Purification of individual varicella-zoster virus (VZV) glycoproteins gpI, gpII, and gpIII and their use in ELISA for detection of VZV glycoprotein-specific antibodies. J Virol Methods. 1986;14:177-188
15. Wasmuth EH, Miller WJ. Sensitive enzyme-linked immunosorbent assay for antibody to varicella-zoster virus using purified VZV glycoprotein antigen. J Med Virol. 1990;32:189-193
16. Provost PJ, Krah DL, Kuter BJ, et al. Antibody assays suitable for assessing immune responses to live varicella vaccine. Vaccine. 1991;9:111-116
17. White CJ, Kuter BJ, Ngai A, et al. Modified cases of chickenpox after varicella vaccination: correlation of protection with antibody response. Pediatr Infect Dis J. 1992;11:19-23
18. Li S, Chan I, Matthews H, et al. Inverse relationship between six week postvaccination varicella antibody response to vaccine and likelihood of long term breakthrough infection. Pediatr Infect Dis J. 2002;21:337-342
19. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4:213-226
20. World Health Organization. Immunization Focus of Western Pacific Regional Office: Assessing New Vaccines for National Immunization Programmes - A Framework to Assist Decision Makers. Geneva, Switzerland: World Health Organization; 2000
21. Centers for Disease Control and Prevention. Notice to readers: guidelines for maintaining and managing the vaccine cold chain. MMWR Morb Mortal Wkly Rep. 2003;52:1023-1025
22. World Health Organization. Global Programme for Vaccines and Immunization (GPV). The WHO position paper on Haemophilus influenzae type b conjugate vaccines. Wkly Epidemiol Rec. 1998;10:64-71
23. Heymann DL, Smith EL, Nakano JH, Jato JG, Martin GE, Maben GK. Further field testing of the more heat-stable measles vaccine in Cameroon. Br Med J (Clin Res Ed). 1982;285:531-533
24. Galazka A, Milstien J, Zaffran M. Thermostability of Vaccines: Global Programme for Vaccines and Immunization (GPV). Geneva, Switzerland: World Health Organization; 1998
25. World Health Organization. Global Programme for Vaccines and Immunization (GPV): Safe Vaccine Handling, Cold Chain and Immunizations - A Manual for the Newly Independent States. Geneva, Switzerland: World Health Organization; 1998
26. World Health Organization, Department of Vaccines and Biologicals. Guidelines for Establishing or Improving Primary and Intermediate Vaccine Stores. Geneva, Switzerland: World Health Organization; 2002