Clinical trial NCT00496054: Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)
Official title: Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroenteritis
Rotavirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
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
timeFrame: Baseline and Approximately 6 Months
measure: The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)
timeFrame: Baseline and Approximately 6 Months
measure: The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)
timeFrame: Baseline and Approximately 6 Months
measure: The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)
timeFrame: Baseline and Approximately 6 Months
measure: The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)
timeFrame: Baseline and Approximately 6 Months
measure: The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)
timeFrame: Baseline and Approximately 6 Months
measure: The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)
timeFrame: Baseline and Approximately 6 Months
measure: The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
timeFrame: Baseline and Approximately 6 Months
measure: The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
timeFrame: Baseline and Approximately 6 Months
measure: The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
timeFrame: Baseline and Approximately 6 Months
measure: The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
timeFrame: Baseline and Approximately 6 Months
measure: The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
timeFrame: Baseline and Approximately 6 Months
measure: The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
timeFrame: Baseline and Approximately 6 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.