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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014