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

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ClinicalTrials.gov Identifier: NCT00496054
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : March 11, 2010
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Gastroenteritis Rotavirus Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India
Study Start Date : May 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA [ Time Frame: Baseline and Approximately 6 Months ]
  9. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 [ Time Frame: Baseline and Approximately 6 Months ]
  10. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 [ Time Frame: Baseline and Approximately 6 Months ]
  11. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 [ Time Frame: Baseline and Approximately 6 Months ]
  12. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 [ Time Frame: Baseline and Approximately 6 Months ]
  13. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 [ Time Frame: Baseline and Approximately 6 Months ]

Eligibility Criteria
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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496054


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

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
First Posted: July 4, 2007    Key Record Dates
Results First Posted: March 11, 2010
Last Update Posted: April 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Vaccines
Immunologic Factors
Physiological Effects of Drugs