Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)

Gastroenteritis Clinical Trial

Official title:

Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496054
• Other study ID #: V260-021
• Secondary ID: 2007_020
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2007
• Last updated: January 5, 2015
• Start date: May 2008
• Est. completion date: October 2008

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

• Age 6 weeks through exactly 12 weeks

• Healthy infants

Exclusion Criteria:

• Clinical evidence of active gastrointestinal illness

• Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization

• History of congenital abdominal disorders, intussusception, or abdominal surgery

• History of known prior rotavirus disease

• Known or suspected impairment of immunological function

• Prior administration of any rotavirus vaccine

• Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus

Intervention

Biological:
• Rotavirus Vaccine, Live, Oral, Pentavalent
Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA		Baseline and Approximately 6 Months	No
Primary	The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)		Baseline and Approximately 6 Months	No
Primary	The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)		Baseline and Approximately 6 Months	No
Primary	The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)		Baseline and Approximately 6 Months	No
Primary	The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)		Baseline and Approximately 6 Months	No
Primary	The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)		Baseline and Approximately 6 Months	No
Primary	The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)		Baseline and Approximately 6 Months	No
Primary	The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA		Baseline and Approximately 6 Months	No
Primary	The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1		Baseline and Approximately 6 Months	No
Primary	The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2		Baseline and Approximately 6 Months	No
Primary	The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3		Baseline and Approximately 6 Months	No
Primary	The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4		Baseline and Approximately 6 Months	No
Primary	The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1		Baseline and Approximately 6 Months	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site