Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India

Official Title: “Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India”

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: RotaTeq™ Vaccine (V260)
  • Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.

Primary 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
    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
    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
    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
    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
    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
    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
    Safety Issue?: No
• The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
  • Time Frame: Baseline and Approximately 6 Months
    Safety Issue?: No
• The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
  • Time Frame: Baseline and Approximately 6 Months
    Safety Issue?: No
• The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
  • Time Frame: Baseline and Approximately 6 Months
    Safety Issue?: No
• The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
  • Time Frame: Baseline and Approximately 6 Months
    Safety Issue?: No
• The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
  • Time Frame: Baseline and Approximately 6 Months
    Safety Issue?: No
• The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
  • Time Frame: Baseline and Approximately 6 Months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Weeks

Maximum Age for this Clinical Trial: 12 Weeks

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00496054

Study ID Number: 2007_020

ClinicalTrials.gov Identifier: NCT00496054

Health Authority: India: Ministry of Health

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Merck: Patient & Caregiver U.S. Product Web Site