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

NCT ID: NCT00429481

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 2464 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2003-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Rotarix

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 11 Weeks
• Maximum Eligible Age: 17 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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.

Reference Type: BACKGROUND

PMID: 15502699 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19289978 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16088807 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16470273 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16600443 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18695765 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

444563/007

Identifier Type: -

Identifier Source: org_study_id