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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: November 3, 2014
Last verified: November 2014

July 3, 2007
November 3, 2014
May 2008
October 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • The proportion of subjects who exhibit a 3 fold rise or greater from baseline to postdose 3 in rotavirus specific serum in iga will be summarized.
  • The 3 fold rise responses to g1, g2, g3, g4 & p1 serum neutralizing antibodies(sna) will also be summarized. gmt at predose 1 & postdose 3 will also be summarized for all assays
Complete list of historical versions of study NCT00496054 on ClinicalTrials.gov Archive Site
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Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Gastroenteritis
  • Rotavirus
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
Experimental: RotaTeq™ Vaccine (V260)
Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.
Intervention: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Lokeshwar MR, Bhave S, Gupta A, Goyal VK, Walia A. Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants. Hum Vaccin Immunother. 2013 Jan;9(1):172-6. doi: 10.4161/hv.22341.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00496054
V260-021, 2007_020
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP