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

NCT00429481 | Completed Phase 2

• 1 other identifier: 444563/007
• Study Type: interventional
• Target: 2,464
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis B

Keywords

Oral live attenuated human rotavirus vaccine; Gastroenteritis; Vomiting

Outcome Measures

Primary Outcomes (1)

• Occurrence of any RV GE

Secondary Outcomes (1)

• Occurrence of severe RV GE, rotavirus IgA antibody titres, solicited symptoms (Day 0-15), unsolicited Adverse Events (D0-42), Serious Adverse Events (full study),

Interventions

Rotarix BIOLOGICAL

Eligibility Criteria

• Age: 11 Weeks - 17 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (6)

• 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.

  PMID: 15502699 BACKGROUND

• 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.

  PMID: 19289978 BACKGROUND

• 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. doi: 10.1086/431511.

  PMID: 16088807 BACKGROUND

• 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 Singap. 2006 Jan;35(1):38-44.

  PMID: 16470273 BACKGROUND

• 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. doi: 10.1016/j.vaccine.2006.03.040. Epub 2006 Mar 23.

  PMID: 16600443 BACKGROUND

• 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 Singap. 2008 Jul;37(7):546-53.

  PMID: 18695765 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hepatitis B; Gastroenteritis; Vomiting

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Gastrointestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: January 31, 2007
• Study Start: January 1, 2001
• Primary Completion: April 1, 2003
• Study Completion: April 1, 2003
• Last Updated: September 16, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share