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

Hepatitis B Clinical Trial

Official title:

Study to Assess Efficacy, Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at Different Viral Concentrations in Healthy Infants Previously Uninfected With Human Rotavirus and Approximately 3 Months of Age.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429481
• Other study ID #: 444563/007
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2007
• Last updated: September 15, 2016
• Start date: January 2001
• Est. completion date: April 2003

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2464
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Weeks to 17 Weeks

Eligibility

Inclusion Criteria:

• Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks).

• Written informed consent obtained from the parents or guardians of the subject.

Exclusion Criteria:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or Hib.

• 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 including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.

• History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.

• GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).

• Household contact with an immunosuppressed individual or pregnant woman.

• Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.

• Previous confirmed occurrence of RV GE.

Study Design

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

Related Conditions & MeSH terms

• Hepatitis B

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

Phua KB, Emmanuel SC, Goh P, Quak SH, Lee BW, Han HH, Ward RL, Bernstein DI, De Vos B, Bock HL. A rotavirus vaccine for infants: the Asian experience. Ann Acad Med Singapore. 2006 Jan;35(1):38-44. Review. — View Citation

Phua KB, Quak SH, Emmanuel S, Goh PS, Han HH, Hardt K, Bock HL, De Vos B. A short report on highlights of worldwide development of RIX4414: a Singaporean experience. Vaccine. 2006 May 1;24(18):3782-3. Epub 2006 Mar 23. — View Citation

Phua KB, Quak SH, Lee BW, Emmanuel SC, Goh P, Han HH, De Vos B, Bock HL. Evaluation of RIX4414, a live, attenuated rotavirus vaccine, in a randomized, double-blind, placebo-controlled phase 2 trial involving 2464 Singaporean infants. J Infect Dis. 2005 Sep 1;192 Suppl 1:S6-S16. — View Citation

Phua KB, Quak SH, Lim FS, Goh P, Teoh YL, Datta SK, Han HH, Bock HL. Immunogenicity, reactogenicity and safety of a diphtheria-tetanus-acellular pertussis-inactivated polio and Haemophilus influenzae type b vaccine in a placebo-controlled rotavirus vaccine study. Ann Acad Med Singapore. 2008 Jul;37(7):546-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of any RV GE
Secondary	Occurrence of severe RV GE, rotavirus IgA antibody titres, solicited symptoms (Day 0-15), unsolicited Adverse Events (D0-42), Serious Adverse Events (full study),

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