Clinical trial NCT00425737: Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants
Official title: A Study to Assess the Efficacy, Immunogenicity and Safety of Two Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in Healthy Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Rotavirus
Keywords: Oral live attenuated human rotavirus vaccine
Gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-23
Enrollment: 405
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus


Eligibility criteria: Inclusion Criteria:

* Healthy infants 6 and 12 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parents or guardians of the subject.
* Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
* Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
* Any clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
* Household contact with an immunosuppressed individual or pregnant woman.
* Abnormal stool pattern.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
* Previous confirmed occurrence of rotavirus gastroenteritis.

Primary outcomes:
measure: Occurrence of RV GE
Secondary outcomes:
measure: Occurrence of severe RV GE, solicited symptoms (Day 0-14), unsolicited Adverse Events (Day 0-42), Serious Adverse Events (full study), presence of rotavirus antigen in stool samples, immunogenicity
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: De Vos B, Vesikari T, Linhares AC, Salinas B, Perez-Schael I, Ruiz-Palacios GM, Guerrero Mde L, Phua KB, Delem A, Hardt K. A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J. 2004 Oct;23(10 Suppl):S179-82. doi: 10.1097/01.inf.0000142370.16514.4a.
citation: De Vos B, Han HH, Bouckenooghe A, Debrus S, Gillard P, Ward R, Cheuvart B. Live attenuated human rotavirus vaccine, RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes: integrated analysis of randomized controlled trials. Pediatr Infect Dis J. 2009 Apr;28(4):261-6. doi: 10.1097/INF.0b013e3181907177.
citation: Soriano-Gabarró M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1):28-32.
citation: Vesikari T et al. (2003) Efficacy of oral human rotavirus vaccine in infants against acute rotavirus gastroenteritis in the community determined with rotavirus antigen detection by EIA and rotavirus RT-PCR as end points. J Clin Virol. 27(1):8 (Abstract n° 24).
citation: Vesikari T, Karvonen A, Puustinen L, Zeng SQ, Szakal ED, Delem A, De Vos B. Efficacy of RIX4414 live attenuated human rotavirus vaccine in Finnish infants. Pediatr Infect Dis J. 2004 Oct;23(10):937-43. doi: 10.1097/01.inf.0000141722.10130.50.
citation: Vesikari T, Karvonen A, Puustinen L, Szakal ED, Zeng SQ, Delem A, De Vos B. A short report on highlights of world-wide development of RIX4414: an European experience. Vaccine. 2006 May 1;24(18):3779. doi: 10.1016/j.vaccine.2005.07.028. Epub 2005 Aug 1. No abstract available.