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Sponsors and Collaborators: |
Children's Hospital of Michigan Merck and Company William Beaumont Hospitals |
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Information provided by: | Children's Hospital of Michigan |
ClinicalTrials.gov Identifier: | NCT00767364 |
Rotavirus infection is a common pediatric illness and is the leading cause of severe acute gastroenteritis (vomiting and diarrhea) in infants and young children. Since February of 2006, an oral vaccine to prevent rotavirus has been approved by the Food and Drug Administration (FDA). The company that makes the oral vaccine is Merck and Company. Since the FDA approval, the American Academy of Pediatrics (AAP) and that Advisory Committee on Immunization Practices (ACIP) has recommended the use of this oral vaccine in infants. A previous rotavirus oral vaccine, Rotashield, was removed from the market for concerns that it was causing an increase in a gastrointestinal (GI) disease called intussusception. However, the new rotavirus vaccine was studied by the manufacturer and was not found to cause an increase in the cases of intussusception. Intussusception is a disease in which a portion of the GI tract folds back on itself leading to GI tract obstruction or back-up.
The manufacturer of the vaccine noted on package insert information that the vaccine was not studied, originally, in infants with a history of GI disorders or in infants who have had surgery on their abdomen. Currently, there is no information available in the scientific literature about the use of the oral rotavirus vaccine in infants with GI diseases or those who have had GI surgeries.
The aim of the study is assess the number of infants who have a good immune response (three-fold rise in IgA titer or greater) to the complete rotavirus vaccine series (three oral vaccines in total) by a blood test to check the rotavirus immunoglobulin A (IgA) level in infants with short bowel syndrome compared to normal infants.
Infants, meeting eligibility criteria and whose parents have signed informed consent will have their study information collected including date of birth, estimated gestational age, birth weight, and current weight. Infants in the study group will have their date(s) of surgery and details of their surgical GI tract resection recorded (participant age at time of surgery, type of bowel resected and length of resection).
These infants will then have their initial blood drawn for laboratory analysis for the presence of pre-vaccine anti-rotavirus antibody, IgA levels, mentioned above. After the blood is obtained, participants will receive their first oral rotavirus vaccine dose between the ages of 6 weeks to 14 weeks, 6 days of life per ACIP recommendations. This oral rotavirus vaccine may be administered with other routine pediatric vaccines at the participant primary care provider's office. The date of the rotavirus vaccine and lot number would be recorded on vaccine administration date cards. Most participants will have their vaccines given through the Infectious Disease clinic staff at the Children's Hospital of Michigan. Additionally, parents will be asked to fill out a vaccine safety report card for the first 42 days after each of the three vaccine administration dates.
Subsequent doses of the oral rotavirus vaccine will be given at a minimal interval between vaccines of four weeks. The third, and final vaccine dose must be given by 8 months 0 days per ACIP recommendations. Any adverse reactions to the vaccine will be reported on the National Vaccine Adverse Event Reporting System.
Finally, two weeks after the participants have had all three oral rotavirus vaccine doses, the second and final blood draw will take place for measuring the post-vaccine level of anti-rotavirus antibody, IgA. Participants in the study will be monitored by telephone contacts on days 7, 14, and 42 after each dose of the rotavirus vaccine regarding any serious adverse events. As above, parents of participants will be asked to fill out the vaccine report card and record the child's temperature, and any episodes of vomiting, diarrhea, blood in the stools or fussiness for the first seven days. The parents will also be asked to record any other events from day 8 through 42 after each vaccine is administered such as fever, ear infection, runny nose, etc. Afterward, parents will also have monthly phone call safety follow-ups during the 12 month period following the first vaccination. A Data Safety and Monitoring Board will oversee the study and it's progress and will have the ability to vote to stop the study should any safety concerns arise.
Condition | Intervention | Phase |
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Short Bowel Syndrome |
Biological: Oral, live, pentavalent rotavirus vaccine; RotaTeq(R) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome: A Pilot Study |
Estimated Enrollment: | 40 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Infants with bowel resection: Experimental
Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
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Biological: Oral, live, pentavalent rotavirus vaccine; RotaTeq(R)
Oral vaccine for prevention of rotavirus infection, 3 dose series
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Healthy Infants: Active Comparator
Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
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Biological: Oral, live, pentavalent rotavirus vaccine; RotaTeq(R)
Oral vaccine for prevention of rotavirus infection, 3 dose series
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Ages Eligible for Study: | 6 Weeks to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eric J McGrath, MD | 313-745-5863 | emcgrath@med.wayne.edu |
Contact: Basim I Asmar, MD | 313745-5862 | basmar@wayne.edu |
United States, Michigan | |
Children's Hospital of Michigan | |
Detroit, Michigan, United States, 48201 | |
William Beaumont Hospital | |
Royal Oak, Michigan, United States, 48073 |
Principal Investigator: | Eric J McGrath, MD | Children's Hospital of Michigan |
Responsible Party: | The Children's Hospital of Michigan ( Eric McGrath, MD ) |
Study ID Numbers: | Merck IISP #35817 |
Study First Received: | October 6, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00767364 |
Health Authority: | United States: Food and Drug Administration |
Infant |
Digestive System Diseases Postoperative Complications Gastrointestinal Diseases |
Malabsorption Syndromes Short Bowel Syndrome Intestinal Diseases |
Disease Pathologic Processes Syndrome |