- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00130832
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
March 12, 2015 updated by: Merck Sharp & Dohme LLC
Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants
The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
735
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infants in good health
Exclusion Criteria:
- Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine
- Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study
- Any condition resulting in depressed immunity
- Any allergy to any vaccine component as stated in the package circulars
- Allergies to polymyxin B, neomycin or any other antibiotics
- Receipt of intramuscular, oral, or intravenous corticosteroid treatment
- History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness
- History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
- Prior receipt of a blood transfusion or blood products, including immunoglobulin
- Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization
- Infants residing in a household with an immunocompromised person
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
RotaTeq and OPV concomitantly
|
Three doses of rotavirus vaccine, live, oral, pentavalent.
Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
Three doses OPV.
Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
|
EXPERIMENTAL: 2
RotaTeq and OPV on staggered schedule
|
Three doses of rotavirus vaccine, live, oral, pentavalent.
Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
Three doses OPV.
Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3
Time Frame: Approximately 42 days Postdose 3
|
GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
|
Approximately 42 days Postdose 3
|
GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)
Time Frame: Approximately 42 days Postdose 3
|
GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered
|
Approximately 42 days Postdose 3
|
Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered
Time Frame: Approximately 42 days Postdose 3
|
Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
|
Approximately 42 days Postdose 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (ACTUAL)
July 1, 2006
Study Completion (ACTUAL)
July 1, 2006
Study Registration Dates
First Submitted
August 12, 2005
First Submitted That Met QC Criteria
August 12, 2005
First Posted (ESTIMATE)
August 16, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
April 1, 2015
Last Update Submitted That Met QC Criteria
March 12, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V260-014
- 2005_030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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