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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00496054

First received: July 3, 2007

Last updated: April 20, 2010

Last verified: April 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 3, 2007

Last Updated Date

April 20, 2010

Start Date ^ICMJE

May 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00496054 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Gastroenteritis
Rotavirus

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

110

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

6 Weeks to 12 Weeks

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00496054

Other Study ID Numbers ^ICMJE

2007_020, V260-021

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2010

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

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