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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00425737
Other study ID # 444563/004
Secondary ID
Status Completed
Phase Phase 2
First received January 22, 2007
Last updated September 15, 2016
Start date August 2000
Est. completion date July 2001

Study information

Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 405
Est. completion date July 2001
Est. primary completion date July 2001
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks to 12 Weeks
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Rotarix


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

References & Publications (6)

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. — View Citation

De Vos B, Vesikari T, Linhares AC, Salinas B, Pérez-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. — View Citation

Soriano-Gabarró M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1):28-32.

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).

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. Epub 2005 Aug 1. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of RV GE
Secondary 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
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