IntussusceptionPhase 4NCT02542462
Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
A Phase 4 study testing Rotarix®,, Rotarix®, with other routine vaccines and RotaTeq®, in people with Intussusception and Rotavirus Infections, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Intussusception, Rotavirus Infections
- What is being tested?
- Rotarix®,, Rotarix®, with other routine vaccines and RotaTeq®,
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to May 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- history of intussusception
- precautions for either RV1 or RV5 (may interfere with study outcomes)
- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hosptital Medical Center
Cincinnati, Ohio, 45219
About this study
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.
Read the detailed description
Healthy infants 6-13 weeks of age will be randomized (1:1:1:1) to receive either, RV1 alone, RV1 with Advisory Committee on Immunization Practices (ACIP) routinely recommended immunizations (Diphtheria, Tetanus and Pertussis (DTaP), Haemophilus influenza type b (Hib), pneumococcal conjugate (PCV13), Hepatitis B (HBV) and inactivated polio (IPV)), RV5 alone or RV5 with ACIP routinely recommended immunizations. Imaging study personnel and parents will be blinded to the rotavirus vaccine type; parents will be informed about the rotavirus vaccine type at the completion of the study. Up to 100 infants will be enrolled.
Recruitment and enrollment will occur prior to the first clinic visit. There will be four study visits including the recruitment/enrollment visit and three clinic visits. Infants will be randomized to either RV1, RV1 plus other immunizations, RV5 alone, or RV5 plus other immunizations. Clinic Visit 1 (day 0) will include blood, saliva, stool and breast milk collection . The MRI and ultrasound will be performed prior to vaccination. Children will receive the immunizations to which they are randomized. Imaging personnel and parents will be blinded to rotavirus vaccine type; they will be informed about other vaccines administered. A second MRI and ultrasound will be performed at Clinic Visit 2 (day 5) and blood and stool samples collected. Parents will be unblinded at the completion of Clinic Visit 3 (day 14). Arrangements will be made to get remaining doses of same rotavirus vaccine. Daily stool samples will be collected at home during the 15 day study period (on vaccination day 0 and for next 14 days). A memory aid will be completed to collect reactogenicity data on days 0 and for the next 14 days. Remaining stools and reactogenicity data from parents will be collected at Visit 3.
The investigators will assess blood and stool cytokine responses and intestinal anatomy and motility after rotavirus vaccination by comparing pre-vaccination with post-vaccination responses in the study infants. Cytokines and intestinal anatomy and motility will be assessed at baseline (Visit 1, the day of vaccine receipt) and 5 days after vaccination (Visit 2). For both blood and stool, the following cytokines will be tested: IL-2, IL-6, IL-7, IL-8, IL-15, INF-γ and TNF-α. Additional biomarkers may be studied.
- Conditions
- Intussusception, Rotavirus Infections
- Being tested
- Rotarix®,, Rotarix®, with other routine vaccines, RotaTeq®,, RotaTeq®, with other routine vaccines
- Keywords
- mechanisms for intussusception, rotavirus vaccine
- Medical subject headings
- Intussusception, Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotarix®,Drug
Also called Rotavirus vaccine
Single oral dose of licensed rotavirus vaccine given alone
Rotarix®, with other routine vaccinesDrug
Also called Rotavirus vaccine
Single oral dose of licensed rotavirus vaccine given with other routine vaccines
RotaTeq®,Drug
Also called Rotavirus vaccine
Single oral dose of licensed rotavirus vaccine given alone
RotaTeq®, with other routine vaccinesDrug
Also called Rotavirus vaccine
Single oral dose of licensed rotavirus vaccine given with other routine vaccines
| Study group | Role | What they receive |
|---|---|---|
| Rotarix® alone | Active comparator | monovalent rotavirus vaccine (Rotarix®, RV1) Receives: Drug: Rotarix®, |
| Rotarix®,with other routine vaccines | Active comparator | monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations Receives: Drug: Rotarix®, with other routine vaccines |
| RotaTeq®, alone | Active comparator | pentavalent rotavirus vaccine (RotaTeq®, RV5) Receives: Drug: RotaTeq®, |
| RotaTeq®,with other routine vaccines | Active comparator | pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations Receives: Drug: RotaTeq®, with other routine vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy
Number of subjects with an increase in the number of abdominal lymph nodes, as measured by abdominal ultrasound, or an increase of 1 mm or more of terminal ileum wall thickness, as measured by abdominal MRI, from Day 0 (Visit 1) to Day 4-6 (Visit 2)
Measured: 4- 6 days
The Feasibility of Conducting a Larger Scale Study as Determined by Study Recruitment Rates (Number of Participants Eligible/Participants Who Enrolled)
Study will be determined to be feasible on a larger scale if 10% or more of eligible subjects enroll in the study
Measured: 15 months
The Feasibility of Conducting a Larger Scale Study as Determined by the Percentage of Participants Who Completed All Study Visits
Study will be determined to be feasible on a larger scale if 70% or more of randomized subjects complete all study visits and remain in the study until completion
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IntussusceptionStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Mary A. Staat, MD, MPH, Principal investigator, Children's Hospital Medical Center, CincinnatiKaren Broder, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542462
- Sponsor's protocol ID
- 2015-2754
- Status last verified
- Jul 2018
- First submitted
- 24 Jun 2015
- Last updated
- 12 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
- ClinicalTrials.gov ID
- NCT02542462
- Acronym / sponsor ID
- 2015-2754
- Conditions
- Intussusception, Rotavirus Infections
- Keywords
- mechanisms for intussusception, rotavirus vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 12 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Healthy infants 6-13 weeks of age will be randomized (1:1:1:1) to receive either, RV1 alone, RV1 with Advisory Committee on Immunization Practices (ACIP) routinely recommended immunizations (Diphtheria, Tetanus and Pertussis (DTaP), Haemophilus influenza type b (Hib), pneumococcal conjugate (PCV13), Hepatitis B (HBV) and inactivated polio (IPV)), RV5 alone or RV5 with ACIP routinely recommended immunizations. Imaging study personnel and parents will be blinded to the rotavirus vaccine type; parents will be informed about the rotavirus vaccine type at the completion of the study. Up to 100 infants will be enrolled.
Recruitment and enrollment will occur prior to the first clinic visit. There will be four study visits including the recruitment/enrollment visit and three clinic visits. Infants will be randomized to either RV1, RV1 plus other immunizations, RV5 alone, or RV5 plus other immunizations. Clinic Visit 1 (day 0) will include blood, saliva, stool and breast milk collection . The MRI and ultrasound will be performed prior to vaccination. Children will receive the immunizations to which they are randomized. Imaging personnel and parents will be blinded to rotavirus vaccine type; they will be informed about other vaccines administered. A second MRI and ultrasound will be performed at Clinic Visit 2 (day 5) and blood and stool samples collected. Parents will be unblinded at the completion of Clinic Visit 3 (day 14). Arrangements will be made to get remaining doses of same rotavirus vaccine. Daily stool samples will be collected at home during the 15 day study period (on vaccination day 0 and for next 14 days). A memory aid will be completed to collect reactogenicity data on days 0 and for the next 14 days. Remaining stools and reactogenicity data from parents will be collected at Visit 3.
The investigators will assess blood and stool cytokine responses and intestinal anatomy and motility after rotavirus vaccination by comparing pre-vaccination with post-vaccination responses in the study infants. Cytokines and intestinal anatomy and motility will be assessed at baseline (Visit 1, the day of vaccine receipt) and 5 days after vaccination (Visit 2). For both blood and stool, the following cytokines will be tested: IL-2, IL-6, IL-7, IL-8, IL-15, INF-γ and TNF-α. Additional biomarkers may be studied.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rotarix® alone | Active comparator | Drug: Rotarix®,monovalent rotavirus vaccine (Rotarix®, RV1) |
| Rotarix®,with other routine vaccines | Active comparator | Drug: Rotarix®, with other routine vaccinesmonovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations |
| RotaTeq®, alone | Active comparator | Drug: RotaTeq®,pentavalent rotavirus vaccine (RotaTeq®, RV5) |
| RotaTeq®,with other routine vaccines | Active comparator | Drug: RotaTeq®, with other routine vaccinespentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations |
Who may qualify
- Ages
- 42 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotarix®,Also: Rotavirus vaccineSingle oral dose of licensed rotavirus vaccine given alone | Drug | Rotarix® alone |
| Rotarix®, with other routine vaccinesAlso: Rotavirus vaccineSingle oral dose of licensed rotavirus vaccine given with other routine vaccines | Drug | Rotarix®,with other routine vaccines |
| RotaTeq®,Also: Rotavirus vaccineSingle oral dose of licensed rotavirus vaccine given alone | Drug | RotaTeq®, alone |
| RotaTeq®, with other routine vaccinesAlso: Rotavirus vaccineSingle oral dose of licensed rotavirus vaccine given with other routine vaccines | Drug | RotaTeq®,with other routine vaccines |
Primary outcome
The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy
Time frame: 4- 6 days
Number of subjects with an increase in the number of abdominal lymph nodes, as measured by abdominal ultrasound, or an increase of 1 mm or more of terminal ileum wall thickness, as measured by abdominal MRI, from Day 0 (Visit 1) to Day 4-6 (Visit 2)
The Feasibility of Conducting a Larger Scale Study as Determined by Study Recruitment Rates (Number of Participants Eligible/Participants Who Enrolled)
Time frame: 15 months
Study will be determined to be feasible on a larger scale if 10% or more of eligible subjects enroll in the study
The Feasibility of Conducting a Larger Scale Study as Determined by the Percentage of Participants Who Completed All Study Visits
Time frame: 15 months
Study will be determined to be feasible on a larger scale if 70% or more of randomized subjects complete all study visits and remain in the study until completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary A. Staat, MD, MPH principal investigator
Children's Hospital Medical Center, Cincinnati
Karen Broder, MD principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotarix®,, Rotarix®, with other routine vaccines and RotaTeq®, in people with Intussusception and Rotavirus Infections, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy (time frame: 4- 6 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.