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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00496054
First received: July 3, 2007
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Gastroenteritis
Rotavirus
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA) [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA) [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA) [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA) [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA) [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA) [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]
  • The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 [ Time Frame: Baseline and Approximately 6 Months ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RotaTeq™ Vaccine (V260)
Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.
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.
Other Names:
  • RotaTeq™ Vaccine
  • V260

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496054

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00496054     History of Changes
Other Study ID Numbers: V260-021, 2007_020
Study First Received: July 3, 2007
Results First Received: November 12, 2009
Last Updated: January 31, 2014
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014