Concomitant administration of live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) and measles, mumps, rubella (MMR) vaccine: Randomized study in toddlers in Taiwan

Vaccine

Volumn 32, Issue 41, 2014, Pages 5363-5369

  Huang, Li Min ^a   Lin, Tzou Yien ^b   Chiu, Cheng Hsun ^b   Chiu, Nan Chang ^c   Chen, Po Yen ^d   Yeh, Shu Jen ^e   Boaz, Mark ^f   Hutagalung, Yanee ^g   Bouckenooghe, Alain ^g   Feroldi, Emmanuel ^f  

^a NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^b CHANG GUNG UNIVERSITY COLLEGE OF MEDICINE   (Taiwan)

^c MACKAY MEMORIAL HOSPITAL   (Taiwan)

^d TAICHUNG VETERANS GENERAL HOSPITAL   (Taiwan)

^e FAR EASTERN MEMORIAL HOSPITAL   (Taiwan)

^f SANOFI PASTEUR   (France)

^g Sanofi Pasteur Research and Development   (Singapore)

Author keywords

Children; Immunogenicity; Japanese encephalitis (JE) vaccine; MMR; Safety

Indexed keywords

JAPANESE ENCEPHALITIS VACCINE; MEASLES MUMPS RUBELLA ANTIBODY; MEASLES MUMPS RUBELLA VACCINE; NEUTRALIZING ANTIBODY; UNCLASSIFIED DRUG; VIRUS ANTIBODY;

ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CHILD; CONTROLLED STUDY; DROWSINESS; DRUG ERUPTION; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEBRILE CONVULSION; FEMALE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE REACTION; INJECTION SITE SWELLING; IRRITABILITY; LOSS OF APPETITE; MALE; MOOD DISORDER; MULTICENTER STUDY; OPEN STUDY; PATHOLOGICAL CRYING; PREVENTION STUDY; PRIORITY JOURNAL; PROTECTION; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SEROLOGY; SEROPROTECTION; TAIWAN; TODDLER; TREATMENT OUTCOME; VACCINATION; VACCINATION REACTION; VOMITING; ANTIBODY PRODUCTION; BLOOD; CLINICAL TRIAL; ENCEPHALITIS, JAPANESE; INFANT; MEASLES; MUMPS; PHASE 3 CLINICAL TRIAL; RUBELLA;

ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; ANTIBODY FORMATION; ENCEPHALITIS, JAPANESE; FEMALE; HUMANS; INFANT; JAPANESE ENCEPHALITIS VACCINES; MALE; MEASLES; MEASLES-MUMPS-RUBELLA VACCINE; MUMPS; RUBELLA; TAIWAN;

EID: 84925884794     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.02.085     Document Type: Article

References (14)

1. WHO Position paper on Japanese encephalitis vaccines. Weekly epidemiological record 2006, 81:325-340. 34.
2. Solomon T., Thao T.T., Lewthwaite P., Ooi M.H., Kneen R., Dung N.M., et al. A cohort study to assess the new WHO Japanese encephalitis surveillance standards. Bull World Health Organ 2008, 86(3):178-186.
3. Halstead S.B., Jacobson J. Japanese encephalitis vaccines. Vaccines 2008, 311-352. Saunders Elsevier, Philadelphia, PA. 5th ed. S.A. Plotkin, W.A. Orenstein, P.A. Offit (Eds.).
4. Beasley D.W.C., Lewthwaite P., Solomon T. Current use and development of vaccines for Japanese encephalitis. Expert Opin Biol Ther 2008, 8(1):95-106.
5. Torresi J., McCarthy K., Feroldi E., Méric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: randomised controlled phase 3 trials. Vaccine 2010, 28(50):7993-8000.
6. Chokephaibulkit K., Sirivichayakul C., Thisyakorn U., Sabchareon A., Pancharoen C., et al. Safety and immunogenicity of a single administration of live-attenuated Japanese encephalitis vaccine in previously primed 2- to 5-year-olds and naive 12- to 24-month-olds: multicenter randomized controlled trial. Pediatr Infect Dis J 2010, 29(12):1111-1117.
7. Feroldi E., Pancharoen C., Kosalaraksa P., Watanaveeradej V., Phirangkul K., Capeding M.R., et al. Single-dose, live-attenuated Japanese encephalitis vaccine in JE-naïve infants aged 12-18 months; a randomized, controlled phase 3 trial of immunogenicity and safety. Hum Vaccin Immunother 2012, 8(7):929-937.
8. Hombach J., Solomon T., Kurane I., Jacobson J., Wood D. Report on a WHO consultation on immunological endpoints for evaluation of new Japanese encephalitis vaccines, WHO, Geneva, 2-3 September, 2004. Vaccine 2005, 23(45):5205-5211.
9. World Health Organization Recommendations to assure the quality, safety and efficacy of Japanese encephalitis vaccine (live, attenuated) for human use. Replacement of WHO TRS no. 910 (Annex 3) 2012, World Health Organization, Available at 〈http://www.who.int/biologicals/vaccines/WHO_BS_2012_JE_LA_DB_4March2012.pdf〉 (accessed 10 September 2013).
10. Newcombe R.G. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 1998, 17:873-890.
11. Farrington C.P., Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med 1990, 9(12):1447-1454.
12. Newcombe R.G. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med 1998, 17:857-872.
13. Eskola J., Olander R.M., Hovi T., Litmanen L., Peltola S., Käyhty H. Randomised trial of the effect of co-administration with acellular pertussis DTP vaccine on immunogenicity of Haemophilus influenzae type b conjugate vaccine. Lancet 1996, 348(9043):1688-1692.
14. Feroldi E., Capeding M.R., Boaz M., Gailhardou S., Meric C., Bouckenooghe A. Memory immune response and safety of a booster dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in JE-CV-primed children. Hum Vaccin Immunother 2013 Feb 26, 9(4):889-897.