Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months

Infections, Rotavirus Clinical Trial

Official title:

To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385320
• Other study ID #: 444563/006
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2001
• Est. completion date: April 30, 2003

Study information

• Verified date: December 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2640
• Est. completion date: April 30, 2003
• Est. primary completion date: April 30, 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

• Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of >2000g.

• Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

• Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection

• History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.

• Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.

• History of allergic disease

• 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.

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

• Previous confirmed occurrence of RV GE.

• Household contact with an immunosuppressed individual or pregnant women.

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

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• HRV vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (11)

Araujo EC, Clemens SA, Oliveira CS, Justino MC, Rubio P, Gabbay YB, da Silva VB, Mascarenhas JD, Noronha VL, Clemens R, Gusmão RH, Sanchez N, Monteiro TA, Linhares AC. Safety, immunogenicity, and protective efficacy of two doses of RIX4414 live attenuated human rotavirus vaccine in healthy infants. J Pediatr (Rio J). 2007 May-Jun;83(3):217-24. doi: 10.2223/JPED.1600. Epub 2007 Mar 20. — View Citation

Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix™ in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8. — View Citation

Cheuvart B, Neuzil KM, Steele AD, Cunliffe N, Madhi SA, Karkada N, Han HH, Vinals C. Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis: analysis of clinical trials of human rotavirus vaccine. Hum Vaccin Immunother. 2014;10(2):505-11. doi: 10.4161/hv.27097. Epub 2013 Nov 13. — View Citation

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

Linhares AC, Ruiz-Palacios GM, Guerrero ML, Salinas B, Perez-Schael I, Clemens SA, Innis B, Yarzabal JP, Vespa G, Cervantes Y, Hardt K, De Vos B. A short report on highlights of world-wide development of RIX4414: a Latin American experience. Vaccine. 2006 May 1;24(18):3784-5. Epub 2005 Jul 26. — View Citation

Linhares AC, Verstraeten T, Wolleswinkel-van den Bosch J, Clemens R, Breuer T. Rotavirus serotype G9 is associated with more-severe disease in Latin America. Clin Infect Dis. 2006 Aug 1;43(3):312-4. Epub 2006 Jun 23. — View Citation

Perez-Schael I, Salinas B, Tomat M, Linhares AC, Guerrero ML, Ruiz-Palacios GM, Bouckenooghe A, Yarzabal JP. Efficacy of the human rotavirus vaccine RIX4414 in malnourished children. J Infect Dis. 2007 Aug 15;196(4):537-40. Epub 2007 Jun 29. — View Citation

Ruiz-Palacios GM, Guerrero ML, Bautista-Márquez A, Ortega-Gallegos H, Tuz-Dzib F, Reyes-González L, Rosales-Pedraza G, Martínez-López J, Castañón-Acosta E, Cervantes Y, Costa-Clemens S, DeVos B. Dose response and efficacy of a live, attenuated human rotavirus vaccine in Mexican infants. Pediatrics. 2007 Aug;120(2):e253-61. Epub 2007 Jul 2. — View Citation

Salinas B, Pérez Schael I, Linhares AC, Ruiz Palacios GM, Guerrero ML, Yarzábal JP, Cervantes Y, Costa Clemens S, Damaso S, Hardt K, De Vos B. Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RIX4414: A randomized, placebo-controlled trial in Latin American infants. Pediatr Infect Dis J. 2005 Sep;24(9):807-16. — View Citation

Soriano-Gabarró M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1) Supplement: S28-S32.

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of RV GE
Secondary	Serum RV IgA antibody titre, Viral shedding, Seroprotection/seropositivity status for DTPwHBVHib antigens, Solicited, unsolicited & SAE

External 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.