The human rotavirus vaccine RIX4414 in infants: A review of safety and tolerability

Pediatric Infectious Disease Journal

Volumn 28, Issue 3, 2009, Pages 225-232

  Cheuvart, Brigitte ^a   Friedland, Leonard R ^b   Abu Elyazeed, Remon ^b   Han, Htay Htay ^b   Guerra, Yolanda ^a   Verstraeten, Thomas ^a  

^a GSK   (Belgium)

^b GLAXOSMITHKLINE   (United States)

Author keywords

Gastrointestinal disease; Intussusception; Rotavirus; Vaccine

Indexed keywords

DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; MENINGOCOCCUS VACCINE; ORAL POLIOMYELITIS VACCINE; PLACEBO; PNEUMOCOCCUS VACCINE; POLIOMYELITIS VACCINE; ROTAVIRUS VACCINE; LIVE VACCINE; RIX4414 VACCINE;

ANOREXIA; ARTICLE; ASTHMA; BRONCHIOLITIS; BRONCHOPNEUMONIA; BRONCHOSPASM; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; COUGHING; DEHYDRATION; DIARRHEA; FEBRILE CONVULSION; FEVER; FOREIGN BODY; GASTROENTERITIS; GASTROINTESTINAL SYMPTOM; HEAD INJURY; HUMAN; HUMAN ROTAVIRUS; ILEUS; INFANT; INFECTION; INTUSSUSCEPTION; IRRITABILITY; LYMPHATIC SYSTEM DISEASE; MEDIASTINUM DISEASE; METABOLIC DISORDER; MORTALITY; NEUROLOGIC DISEASE; NEWBORN; NUTRITIONAL DISORDER; PERTUSSIS; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHINORRHEA; SIDE EFFECT; THORAX DISEASE; TREATMENT RESPONSE; URINARY TRACT INFECTION; VACCINATION; VIRAL GASTROENTERITIS; VOMITING; GASTROINTESTINAL DISEASE; IMMUNOLOGY; REVIEW; ROTAVIRUS; TREATMENT OUTCOME; VIROLOGY; VIRUS INFECTION;

CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; GASTROINTESTINAL DISEASES; HUMANS; INFANT; INFANT, NEWBORN; INTUSSUSCEPTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; ROTAVIRUS; ROTAVIRUS INFECTIONS; TREATMENT OUTCOME; VACCINES, ATTENUATED;

EID: 63449107525     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e31819715fa     Document Type: Article

References (14)

1. Kosek M, Bern C, Guerrant RL. The global burden of diarrhoeal disease, as estimated from studies published between 1992 and 2000. Bull World Health Org. 2003;81:197-204.
2. Kapikian AZ, Hioshino Y, Chanock RM. Rotaviruses. In: Knipe DM, Howley PM, eds. Fields Virology. 4th ed. New York, NY: Lippincott Williams & Wilkins; 2001:1787-1833.
3. Parashar UD, Gibson CJ, Bresse JS, et al. Rotavirus and severe childhood diarrhea. Emerg Infect Dis. 2006;12:304-306.
4. Glass RI, Parashar UD, Bresee JS, et al. Rotavirus vaccines: current prospects and future challenges. Lancet. 2006;368:323-332.
5. Bernstein DI, Ward RL. Rotarix: development of a live attenuated mono-valent human rotavirus vaccine. Pediatr Ann. 2006;35:38-43.
6. Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006;354:11-22.
7. Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007; 370:1757-1763.
8. Linhares AC, Velázquez FR, Pérez-Schael I, et al. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet. 2008;371:1181-1189.
9. Parashar UD, Hummelman EG, Bresee JS, et al. Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis. 2003;9:565-572.
10. Murphy TV, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med. 2001;344:564-572.
11. Bines JE, Kohl KS, Forster J, et al. Acute intussusception in infants and children as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004;22:569 -574.
12. Council for International Organizations of Medical Sciences. Management of Safety Information from Clinical Trials, Report of CIOMS Working Group VI.
13. Chang EJ, Zangwill KM, Lee H, et al. Lack of association between rotavirus infection and intussusception: implications for use of attenuated rotavirus vaccines. Pediatr Infect Dis J. 2002;21:97-102.
14. Rennels MB, Parashar UD, Holman RC, et al. Lack of an apparent association between intussusception and wild or vaccine rotavirus infection. Pediatr Infect Dis J. 1998;17:924-925.