Dose Confirmation Efficacy Study (V260-007)

Rotavirus Infections Clinical Trial

Official title:

Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092443
• Other study ID #: V260-007
• Secondary ID: 2004_077
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2004
• Last updated: September 11, 2015
• Start date: September 2002
• Est. completion date: June 2004

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

Description:

The duration of treatment is 10 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1312
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

• Healthy infants

Exclusion Criteria:

• History of abdominal disorders from a birth defect, intussusception, or abdominal surgery

• Known or suspected problems with immune system

• Fever at time of immunization

• Prior administration of a rotavirus vaccine

• History of known prior rotavirus disease

• Chronic diarrhea, or failure to thrive

Study Design

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

Related Conditions & MeSH terms

• Rotavirus Infections

Intervention

Biological:
• RotaTeq™, rotavirus vaccine, live, oral, pentavalent
Three doses of RotaTeq™ administered 28 to 70 days apart.
• Comparator: Placebo matching RotaTeq™
Placebo matching RotaTeq™ administered 28 to 70 days apart.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Block SL, Vesikari T, Goveia MG, Rivers SB, Adeyi BA, Dallas MJ, Bauder J, Boslego JW, Heaton PM; Pentavalent Rotavirus Vaccine Dose Confirmation Efficacy Study Group. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics. 2007 Jan;119(1):11-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.	G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition	At least 14 days following the 3rd vaccination	No
Secondary	Number of Subjects With =3 Fold Rise in Antibody Titer	Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with =3 fold rise in antibody titer)	14 days following the 3rd vaccination	No