A Phase 4 interventional study of Rotarix®, and Rotarix®, with other routine vaccines in Intussusception and Rotavirus Infections, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 42 Days to 90 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-12.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 4, Interventional, and Other
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.
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.
31 studies on the registry are indexed under Intussusception; 6 are open to participants now.
This study's enrollment of 144 is above the median of 78 across 16 interventional studies indexed under Intussusception.
Browse Intussusception studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
for any of the routine vaccines
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 therapy (including high-dose systemic ) iv. infants who are -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)
failed newborn hearing screening
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
monovalent rotavirus vaccine (Rotarix®, RV1)
Drug: Rotarix®,
monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations
Drug: Rotarix®, with other routine vaccines
pentavalent rotavirus vaccine (RotaTeq®, RV5)
Drug: RotaTeq®,
pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations
Drug: RotaTeq®, with other routine vaccines
Single oral dose of licensed rotavirus vaccine given alone
Also known as: Rotavirus vaccine
Single oral dose of licensed rotavirus vaccine given with other routine vaccines
Also known as: Rotavirus vaccine
Single oral dose of licensed rotavirus vaccine given alone
Also known as: Rotavirus vaccine
Single oral dose of licensed rotavirus vaccine given with other routine vaccines
Also known as: Rotavirus vaccine
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)
Time frame: 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
Time frame: 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
Time frame: 15 months
During the study period, there were 252 children screened and of these, 238 were eligible for enrollment. These subjects were identified through screening at a primary care clinic and through advertisement
| Milestone | Rotarix® Alone | Rotarix®,With Other Routine Vaccines | RotaTeq®, Alone | RotaTeq®,With Other Routine Vaccines |
|---|---|---|---|---|
| Started | 25 | 25 | 25 | 26 |
| Completed | 25 | 25 | 25 | 25 |
| Not completed | 0 | 0 | 0 | 1 |
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)
| Participants | Rotarix® Alone | Rotarix®,With Other Routine Vaccines | RotaTeq®, Alone | RotaTeq®,With Other Routine Vaccines |
|---|---|---|---|---|
| Terminal Ileum increase | 2 | 1 | 0 | 1 |
| Lymph node increase | 11 | 9 | 5 | 10 |
Study will be determined to be feasible on a larger scale if 10% or more of eligible subjects enroll in the study
| Participants | All Study Participants |
|---|---|
| The Feasibility of Conducting a Larger Scale Study as Determined by Study Recruitment Rates (Number of Participants Eligible/Participants Who Enrolled) | 144 |
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
| Participants | All Study Participants |
|---|---|
| The Feasibility of Conducting a Larger Scale Study as Determined by the Percentage of Participants Who Completed All Study Visits | 100 |
Collected over 15 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotarix® Alone | 0/25 (0%) | 0/25 (0%) | 25/25 (100%) |
| Rotarix®,With Other Routine Vaccines | 0/25 (0%) | 0/25 (0%) | 25/25 (100%) |
| RotaTeq®, Alone | 0/25 (0%) | 0/25 (0%) | 25/25 (100%) |
| RotaTeq®,With Other Routine Vaccines | 0/26 (0%) | 0/26 (0%) | 25/26 (96.2%) |
| Event | Rotarix® Alone | Rotarix®,With Other Routine Vaccines | RotaTeq®, Alone | RotaTeq®,With Other Routine Vaccines |
|---|---|---|---|---|
| IrritabilityNervous system disorders | 17/25 | 15/25 | 13/25 | 16/26 |
| VomitingGastrointestinal disorders | 8/25 | 7/25 | 5/25 | 8/26 |
| FeverInfections and infestations | 4/25 | 1/25 | 6/25 | 1/26 |
| DiarrheaGastrointestinal disorders | 3/25 | 3/25 | 3/25 | 2/26 |
| Age, Continuous(weeks) | Rotarix® Alone | Rotarix®,With Other Routine Vaccines | RotaTeq®, Alone | RotaTeq®,With Other Routine Vaccines | Total |
|---|---|---|---|---|---|
| Mean | 8.5 (6 to 10.6) | 8 (6 to 10.7) | 8.2 (6.1 to 10.1) | 8.4 (6.1 to 10.4) | 8.2 (6 to 10.7) |
| Sex: Female, Male(Participants) | Rotarix® Alone | Rotarix®,With Other Routine Vaccines | RotaTeq®, Alone | RotaTeq®,With Other Routine Vaccines | Total |
|---|---|---|---|---|---|
| Female | 12 | 8 | 13 | 12 | 45 |
| Male | 13 | 17 | 12 | 14 | 56 |
| Ethnicity (NIH/OMB)(Participants) | Rotarix® Alone | Rotarix®,With Other Routine Vaccines | RotaTeq®, Alone | RotaTeq®,With Other Routine Vaccines | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 1 | 0 | 3 |
| Not Hispanic or Latino | 23 | 25 | 24 | 26 | 98 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Rotarix® Alone | Rotarix®,With Other Routine Vaccines | RotaTeq®, Alone | RotaTeq®,With Other Routine Vaccines | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 21 | 23 | 21 | 23 | 88 |
| White | 1 | 0 | 3 | 3 | 7 |
| More than one race | 3 | 2 | 1 | 0 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Rotarix® Alone | Rotarix®,With Other Routine Vaccines | RotaTeq®, Alone | RotaTeq®,With Other Routine Vaccines | Total |
|---|---|---|---|---|---|
| United States | 25 | 25 | 25 | 26 | 101 |
| Gestational age at birth (weeks)(weeks) | Rotarix® Alone | Rotarix®,With Other Routine Vaccines | RotaTeq®, Alone | RotaTeq®,With Other Routine Vaccines | Total |
|---|---|---|---|---|---|
| Mean | 38.6 (37 to 41) | 38.8 (37 to 41) | 38.9 (37 to 42) | 38.8 (37 to 41) | 38.8 (37 to 42) |
| Birthweight(kilograms) | Rotarix® Alone | Rotarix®,With Other Routine Vaccines | RotaTeq®, Alone | RotaTeq®,With Other Routine Vaccines | Total |
|---|---|---|---|---|---|
| Mean | 3 (1.8 to 3.7) | 3 (1.9 to 3.7) | 3 (1.8 to 4.1) | 3 (2.3 to 3.7) | 3 (1.8 to 4.1) |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: RIX4414 vaccine · RotaTeq
Children's Hospital Medical Center, Cincinnati →