Phase 4
N=101
Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
Intussusception · Rotavirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT02542462 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy — 2; 1; 0; 1 Participants — p=0.2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rotarix®, (Drug); Rotarix®, with other routine vaccines (Drug); RotaTeq®, (Drug); RotaTeq®, with other routine vaccines (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy |
2; 1; 0; 1; 11; 9 | 0.2 |
| PRIMARY The Feasibility of Conducting a Larger Scale Study as Determined by Study Recruitment Rates (Number of Participants Eligible/Participants Who Enrolled) |
144 | — |
| PRIMARY The Feasibility of Conducting a Larger Scale Study as Determined by the Percentage of Participants Who Completed All Study Visits |
100 | — |
Summary
This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with other recommended vaccines. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study.
Eligibility Criteria
Inclusion Criteria
- healthy infant 6 to 13 weeks (12 weeks and 6 days) of age at day of rotavirus vaccine administration
- free of obvious health problems as established by medical history and confirmed with infant's primary physician prior to Visit 1
- parent/legal guardian willing to have infant feed from a bottle for contrast
- parent/legal guardian willing and capable of signing informed consent
- parent/legal guardian and infant expected to be available for entire study
- parent/legal guardian can be reached by telephone
- parent/legal guardian expresses willingness to complete study procedures and receive 2 month immunizations, according to recommended schedule
Exclusion Criteria
- gestational age of <37 weeks
- infant unable to fast for 4 hours prior to MRI procedure
- receipt of any vaccine except initial HBV (must have at least 28 days between HBV and Visit 1 to be included)
- history of severe allergic reaction to HBV vaccine
- contraindications for any of the routine vaccines
- Severe Combined Immune Deficiency
- history of intussusception
- precautions for either RV1 or RV5 (may interfere with study outcomes)
a. altered immunocompetence i. infants with primary and acquired immunodeficiency states, cellular immunodeficiency, hypogammaglobulinemic and dysgammaglobulinemic states ii. infants with blood dyscrasias, leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic system iii. infants on immunosuppressive therapy (including high-dose systemic corticosteroids) iv. infants who are HIV-exposed or infected b. acute gastroenteritis c. moderate or severe acute illness with or without fever d. pre-existing chronic gastrointestinal diseases (e.g., congenital malabsorption syndromes, Hirschsprung's disease, or short-gut syndrome) e. infants with spina bifida or bladder exstrophy (latex rubber is contained in the RV1 oral applicator)
- sensitivity to latex (latex rubber is contained in the RV1 oral applicator)
- febrile illness within previous 14 days (axillary temperature of 100.4◦ F or higher)
- history of vomiting (forceful expulsion of partially digested milk/food) and/or diarrhea (3 watery stools) within 14 days of Visit 1
- receipt of any steroids, immunoglobulins, other blood products/transfusion
- receipt of non-steroidal anti-inflammatory drugs in previous 72 hours (may affect cytokine response)
- receipt of an antipyretic medication (acetaminophen or ibuprofen) within 72 hours prior to the first dose of rotavirus vaccine or is already planning to administer a prophylactic antipyretic medication on the day of and the day following vaccination (this exclusion does not apply if the caretaker indicates he/she might administer antipyretics after vaccination to reduce a fever)
- is enrolled or plans to enroll in another clinical trial with an investigational product while participating in this study (observational studies are allowed)
- any condition which, in the opinion of the investigators, may post a health risk to the subject or interfere with the MRI or vaccine evaluation
- currently receiving medication for gastroesophageal reflux (GERD) or any other gastrointestinal condition including colic
- infant who is a relative of any research study personnel
- allergy to barium
- failed newborn hearing screening
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Data sourced from ClinicalTrials.gov (NCT02542462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.