Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants

Infections, Rotavirus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425737
• Other study ID #: 444563/004
• 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

• Infections, Rotavirus
• Rotavirus Infections

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

External Links

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