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

NCT ID: NCT00496054

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-10-31

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.

Conditions

Gastroenteritis; Rotavirus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

RotaTeq™ Vaccine (V260)

Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.

Group Type: EXPERIMENTAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

RotaTeq™ Vaccine; V260

Eligibility 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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 23442588 (View on PubMed)

Other Identifiers

2007_020

Identifier Type: -

Identifier Source: secondary_id

V260-021

Identifier Type: -

Identifier Source: org_study_id