Rotavirus DiarrheaPhase 3PROVIDENCT01375647
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
A Phase 3 study testing IPV (inactivated polio vaccine) and Rotarix in people with Rotavirus Diarrhea and Vaccine Virus Shedding, run by University of Vermont at 1 site in Bangladesh.
Trial summary
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Diarrhea, Vaccine Virus Shedding, Tropical Enteropathy
- What is being tested?
- IPV (inactivated polio vaccine) and Rotarix
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteBangladesh
- Study dates
- May 2011to Nov 2014
- Phase
- Phase 3
- 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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother willing to sign informed consent form.
- Healthy infant aged 0 to 7 days old.
- No obvious congenital abnormalities or birth defects.
- No abnormal (frequency and consistency) stools since birth.
- Stable household with no plans to leave the area for the next one year.
Who cannot join
- Parents are not willing to have child vaccinated at the field clinic.
- Parents are not willing to have child's blood drawn.
- Parents are planning to enroll child into another clinical study during the time period of this trial.
- Mother not willing to have blood drawn and breast milk extracted.
- Parents not willing to have field research assistant in home two times per week.
- History of seizures or other apparent neurologic disorders.
- Infant received any vaccines before start of study, except Bacillus Calmette-Guerin (BCG).
- Infant has any sibling currently or previously enrolled in this study, including a twin.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and genetic susceptibility.
Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh.
Read more
Secondary Objectives: 1) to determine the impact of an IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix oral rotavirus vaccine to prevent rotavirus diarrhea
The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.
- Being tested
- IPV (inactivated polio vaccine), Rotarix
- Keywords
- Oral Vaccines, Vaccine Responsiveness, Tropical Enteropathy
- Medical subject headings
- Sprue, Tropical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPV (inactivated polio vaccine)Biological
Administered per protocol
RotarixBiological
Administered per protocol
| Study group | Role | What they receive |
|---|---|---|
| Rotarix + No IPV (inactivated polio vaccine) | Experimental | Oral Rotarix vaccine at 10 and 17 weeks of age and oral polio vaccine series Receives: Biological: Rotarix |
| Rotarix + IPV (inactivated polio vaccine) | Experimental | Oral Rotarix vaccine at 10 and 17 weeks of age plus IPV (inactivated polio vaccine) boost in place of oral polio vaccine dose at 39 weeks Receives: Biological: IPV (inactivated polio vaccine); Biological: Rotarix |
| No Rotarix + No IPV (inactivated polio vaccine) | No intervention | No Rotarix and oral polio vaccine series only |
| No Rotarix + IPV (inactivated polio vaccine) | Experimental | No Rotarix vaccine and IPV (inactivated polio vaccine) boost in place of oral polio vaccine dose at 39 weeks Receives: Biological: IPV (inactivated polio vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial)
Any Sabin type poliovirus in any fecal samples at days 0, 4, 11, 18 or 25 following week 52 dose
Measured: 25 days following week 52 visit
Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial)
Diarrheal episode defined as presence of 3 or more abnormally loose stools in 24h period with >=72 hours separating episodes. Rotavirus antigen detected by ELISA in diarrheal stool.
Measured: Birth to one year
Secondary outcomes (6)
Duration of Fecal Shedding of Polio Vaccine Virus, Each Sabin Type (Polio Trial)
Shedding index, calculated as duration days multiplied by mean log (shedding amount) for Sabin types 1, 2, and 3.
Outcome is conditioned on infants with at least one detection by quantitative PCR (qPCR) at day 4,11,18, or 25. If shedding data point was missing it was assumed that the infant was not shedding at that time.
Lower shedding index is better outcome
Measured: from day 4 to day 25 following the week 52 visit
Community Fecal Shedding of Polio Vaccine Virus Just Prior to Oral Polio Vaccine Dose at 52 Weeks (Polio Trial)
Only 8 infants were shedding at baseline so results are not presented for this outcome due to insufficient data
Measured: post 52 weeks
Presence of Fecal Polio Virus Shedding Within the Three Sabin Strains (Polio Trial)
Frequency (%) of infants excreting poliovirus at any of the 5 time points (day 0, 4,11,18, 25) post week 52 oral polio vaccine dose.
Presence of poliovirus is determined by polymerase chain reaction (PCR)
Measured: 25 days following week 52 visit
Serum Neutralizing Antibody Response (Polio Trial)
Seropositive defined as antibodies present at ≥1:8 dilution, antibody titers <1:8 were seronegative.
Non-seroconversions are those who did not seroconvert between week 18 (post oral polio vaccine dose 2) and week 40, adjusted for residual maternal antibody
Measured: 18-40 weeks
Total Number of Diarrheal Episodes (Rotavirus Trial)
A diarrheal episode is defined as the presence of 3 or more abnormally loose stools in a 24 hour period with at least 72 diarrhea-free hours separating distinct episodes
Measured: Birth to one year
Total Duration of Rotavirus-associated Diarrheal Episodes (Rotavirus Trial)
A diarrheal episode is defined as the presence of 3 or more abnormally loose stools in a 24 hour period with at least 72 diarrhea-free hours separating distinct episodes.
Rotavirus positive specimens were determined by ELISA Those with no rotavirus diarrheal episodes are counted as duration 0
Measured: Birth to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2014
- Study completionNov 2014
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.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Rotavirus DiarrheaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Virginia, International Centre for Diarrhoeal Disease Research, Bangladesh, Washington University School of Medicine, Stanford University, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Beth Kirkpatrick, University of Vermont
- Investigators
- Beth Kirkpatrick, M.D., Principal investigator, University of VermontWilliam Petri, M.D., Ph.D., Principal investigator, University of Virginia School of MedicineRashidul Haque, M.D., Ph.D., Principal investigator, International Center for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375647
- Sponsor's protocol ID
- PROVIDE
- Acronym
- PROVIDE
- Status last verified
- Apr 2025
- First submitted
- 3 Jun 2011
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kirkpatrick BD, Colgate ER, Mychaleckyj JC, Haque R, Dickson DM, Carmolli MP, Nayak U, Taniuchi M, Naylor C, Qadri F, Ma JZ, Alam M, Walsh MC, Diehl SA; PROVIDE Study Teams; Petri WA Jr. The "Performance of Rotavirus and Oral Polio Vaccines in Developing Countries" (PROVIDE) study: description of methods of an interventional study designed to explore complex biologic problems. Am J Trop Med Hyg. 2015 Apr;92(4):744-51. doi: 10.4269/ajtmh.14-0518. Epub 2015 Feb 23.
PubMed 25711607Colgate ER, Haque R, Dickson DM, Carmolli MP, Mychaleckyj JC, Nayak U, Qadri F, Alam M, Walsh MC, Diehl SA, Zaman K, Petri WA, Kirkpatrick BD. Delayed Dosing of Oral Rotavirus Vaccine Demonstrates Decreased Risk of Rotavirus Gastroenteritis Associated With Serum Zinc: A Randomized Controlled Trial. Clin Infect Dis. 2016 Sep 1;63(5):634-41. doi: 10.1093/cid/ciw346. Epub 2016 May 23.
PubMed 27217217Mychaleckyj JC, Haque R, Carmolli M, Zhang D, Colgate ER, Nayak U, Taniuchi M, Dickson D, Weldon WC, Oberste MS, Zaman K, Houpt ER, Alam M, Kirkpatrick BD, Petri WA Jr. Effect of substituting IPV for tOPV on immunity to poliovirus in Bangladeshi infants: An open-label randomized controlled trial. Vaccine. 2016 Jan 12;34(3):358-66. doi: 10.1016/j.vaccine.2015.11.046. Epub 2015 Nov 28.
PubMed 26643930Naylor C, Lu M, Haque R, Mondal D, Buonomo E, Nayak U, Mychaleckyj JC, Kirkpatrick B, Colgate R, Carmolli M, Dickson D, van der Klis F, Weldon W, Steven Oberste M; PROVIDE study teams; Ma JZ, Petri WA Jr. Environmental Enteropathy, Oral Vaccine Failure and Growth Faltering in Infants in Bangladesh. EBioMedicine. 2015 Sep 25;2(11):1759-66. doi: 10.1016/j.ebiom.2015.09.036. eCollection 2015 Nov.
PubMed 26870801Ciszewski J, Taniuchi M, Lee B, Colgate ER, Platts-Mills JA, Haque R, Zaman K, Lopman B, Petri WA Jr, Kirkpatrick BD, Rogawski McQuade ET. Differences in Rotavirus Shedding and Duration by Infant Oral Rotavirus Vaccination Status in Dhaka, Bangladesh, 2011-2014. J Infect Dis. 2024 Jul 25;230(1):e75-e79. doi: 10.1093/infdis/jiad502.
PubMed 39052701Kupkova K, Shetty SJ, Haque R, Petri WA Jr, Auble DT. Histone H3 lysine 27 acetylation profile undergoes two global shifts in undernourished children and suggests altered one-carbon metabolism. Clin Epigenetics. 2021 Sep 26;13(1):182. doi: 10.1186/s13148-021-01173-8.
PubMed 34565452Lin Y, Zhou J, Kumar S, Xie W, G Jensen SK, Haque R, Nelson CA, Petri WA Jr, Ma JZ. Group penalized generalized estimating equation for correlated event-related potentials and biomarker selection. BMC Med Res Methodol. 2020 Aug 31;20(1):221. doi: 10.1186/s12874-020-01103-x.
PubMed 32867719Williams FB, Kader A, Colgate ER, Dickson DM, Carmolli M, Uddin MI, Sharmin S, Islam S, Bhuiyan TR, Alam M, Nayak U, Mychaleckyj JC, Petri WA, Haque R, Qadri F, Kirkpatrick BD, Lee B. Maternal Secretor Status Affects Oral Rotavirus Vaccine Response in Breastfed Infants in Bangladesh. J Infect Dis. 2021 Oct 13;224(7):1147-1151. doi: 10.1093/infdis/jiaa101.
PubMed 32157282Rogawski ET, Platts-Mills JA, Colgate ER, Haque R, Zaman K, Petri WA, Kirkpatrick BD. Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study. J Infect Dis. 2018 Mar 5;217(6):861-868. doi: 10.1093/infdis/jix668.
PubMed 29514306Lee B, Carmolli M, Dickson DM, Colgate ER, Diehl SA, Uddin MI, Islam S, Hossain M, Rafique TA, Bhuiyan TR, Alam M, Nayak U, Mychaleckyj JC, McNeal MM, Petri WA, Qadri F, Haque R, Kirkpatrick BD. Rotavirus-Specific Immunoglobulin A Responses Are Impaired and Serve as a Suboptimal Correlate of Protection Among Infants in Bangladesh. Clin Infect Dis. 2018 Jul 2;67(2):186-192. doi: 10.1093/cid/ciy076.
PubMed 29394355Lee B, Dickson DM, deCamp AC, Ross Colgate E, Diehl SA, Uddin MI, Sharmin S, Islam S, Bhuiyan TR, Alam M, Nayak U, Mychaleckyj JC, Taniuchi M, Petri WA Jr, Haque R, Qadri F, Kirkpatrick BD. Histo-Blood Group Antigen Phenotype Determines Susceptibility to Genotype-Specific Rotavirus Infections and Impacts Measures of Rotavirus Vaccine Efficacy. J Infect Dis. 2018 Apr 11;217(9):1399-1407. doi: 10.1093/infdis/jiy054.
PubMed 29390150Upfill-Brown A, Taniuchi M, Platts-Mills JA, Kirkpatrick B, Burgess SL, Oberste MS, Weldon W, Houpt E, Haque R, Zaman K, Petri WA Jr. Nonspecific Effects of Oral Polio Vaccine on Diarrheal Burden and Etiology Among Bangladeshi Infants. Clin Infect Dis. 2017 Aug 1;65(3):414-419. doi: 10.1093/cid/cix354.
PubMed 28444240Lu M, Zhou J, Naylor C, Kirkpatrick BD, Haque R, Petri WA Jr, Ma JZ. Application of penalized linear regression methods to the selection of environmental enteropathy biomarkers. Biomark Res. 2017 Mar 9;5:9. doi: 10.1186/s40364-017-0089-4. eCollection 2017.
PubMed 28293424Taniuchi M, Platts-Mills JA, Begum S, Uddin MJ, Sobuz SU, Liu J, Kirkpatrick BD, Colgate ER, Carmolli MP, Dickson DM, Nayak U, Haque R, Petri WA Jr, Houpt ER. Impact of enterovirus and other enteric pathogens on oral polio and rotavirus vaccine performance in Bangladeshi infants. Vaccine. 2016 Jun 8;34(27):3068-3075. doi: 10.1016/j.vaccine.2016.04.080. Epub 2016 May 3.
PubMed 27154394
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
- ClinicalTrials.gov ID
- NCT01375647
- Acronym / sponsor ID
- PROVIDE / PROVIDE
- Keywords
- Oral Vaccines, Vaccine Responsiveness, Tropical Enteropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Virginia, International Centre for Diarrhoeal Disease Research, Bangladesh, Washington University School of Medicine, Stanford University, Centers for Disease Control and Prevention
- Study start
- May 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and genetic susceptibility.
Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh.
Secondary Objectives: 1) to determine the impact of an IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix oral rotavirus vaccine to prevent rotavirus diarrhea
The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rotarix + No IPV (inactivated polio vaccine) | Experimental | Biological: RotarixOral Rotarix vaccine at 10 and 17 weeks of age and oral polio vaccine series |
| Rotarix + IPV (inactivated polio vaccine) | Experimental | Biological: IPV (inactivated polio vaccine), Biological: RotarixOral Rotarix vaccine at 10 and 17 weeks of age plus IPV (inactivated polio vaccine) boost in place of oral polio vaccine dose at 39 weeks |
| No Rotarix + No IPV (inactivated polio vaccine) | No intervention | –No Rotarix and oral polio vaccine series only |
| No Rotarix + IPV (inactivated polio vaccine) | Experimental | Biological: IPV (inactivated polio vaccine)No Rotarix vaccine and IPV (inactivated polio vaccine) boost in place of oral polio vaccine dose at 39 weeks |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Mother willing to sign informed consent form.
- Healthy infant aged 0 to 7 days old.
- No obvious congenital abnormalities or birth defects.
- No abnormal (frequency and consistency) stools since birth.
- Stable household with no plans to leave the area for the next one year.
Key exclusion criteria (8 listed)
- Parents are not willing to have child vaccinated at the field clinic.
- Parents are not willing to have child's blood drawn.
- Parents are planning to enroll child into another clinical study during the time period of this trial.
- Mother not willing to have blood drawn and breast milk extracted.
- Parents not willing to have field research assistant in home two times per week.
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 |
|---|---|---|
| IPV (inactivated polio vaccine)Administered per protocol | Biological | No Rotarix + IPV (inactivated polio vaccine), Rotarix + IPV (inactivated polio vaccine) |
| RotarixAdministered per protocol | Biological | Rotarix + IPV (inactivated polio vaccine), Rotarix + No IPV (inactivated polio vaccine) |
Primary outcome
Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial)
Time frame: 25 days following week 52 visit
Any Sabin type poliovirus in any fecal samples at days 0, 4, 11, 18 or 25 following week 52 dose
Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial)
Time frame: Birth to one year
Diarrheal episode defined as presence of 3 or more abnormally loose stools in 24h period with >=72 hours separating episodes. Rotavirus antigen detected by ELISA in diarrheal stool.
6 secondary outcomes
Duration of Fecal Shedding of Polio Vaccine Virus, Each Sabin Type (Polio Trial)
Time frame: from day 4 to day 25 following the week 52 visit
Community Fecal Shedding of Polio Vaccine Virus Just Prior to Oral Polio Vaccine Dose at 52 Weeks (Polio Trial)
Time frame: post 52 weeks
Presence of Fecal Polio Virus Shedding Within the Three Sabin Strains (Polio Trial)
Time frame: 25 days following week 52 visit
Serum Neutralizing Antibody Response (Polio Trial)
Time frame: 18-40 weeks
Total Number of Diarrheal Episodes (Rotavirus Trial)
Time frame: Birth to one year
Total Duration of Rotavirus-associated Diarrheal Episodes (Rotavirus Trial)
Time frame: Birth to one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25711607Kirkpatrick BD, Colgate ER, Mychaleckyj JC, Haque R, Dickson DM, Carmolli MP, Nayak U, Taniuchi M, Naylor C, Qadri F, Ma JZ, Alam M, Walsh MC, Diehl SA; PROVIDE Study Teams; Petri WA Jr. The "Performance of Rotavirus and Oral Polio Vaccines in Developing Countries" (PROVIDE) study: description of methods of an interventional study designed to explore complex biologic problems. Am J Trop Med Hyg. 2015 Apr;92(4):744-51. doi: 10.4269/ajtmh.14-0518. Epub 2015 Feb 23.
- Results publication: PubMed 27217217Colgate ER, Haque R, Dickson DM, Carmolli MP, Mychaleckyj JC, Nayak U, Qadri F, Alam M, Walsh MC, Diehl SA, Zaman K, Petri WA, Kirkpatrick BD. Delayed Dosing of Oral Rotavirus Vaccine Demonstrates Decreased Risk of Rotavirus Gastroenteritis Associated With Serum Zinc: A Randomized Controlled Trial. Clin Infect Dis. 2016 Sep 1;63(5):634-41. doi: 10.1093/cid/ciw346. Epub 2016 May 23.
- Results publication: PubMed 26643930Mychaleckyj JC, Haque R, Carmolli M, Zhang D, Colgate ER, Nayak U, Taniuchi M, Dickson D, Weldon WC, Oberste MS, Zaman K, Houpt ER, Alam M, Kirkpatrick BD, Petri WA Jr. Effect of substituting IPV for tOPV on immunity to poliovirus in Bangladeshi infants: An open-label randomized controlled trial. Vaccine. 2016 Jan 12;34(3):358-66. doi: 10.1016/j.vaccine.2015.11.046. Epub 2015 Nov 28.
- Results publication: PubMed 26870801Naylor C, Lu M, Haque R, Mondal D, Buonomo E, Nayak U, Mychaleckyj JC, Kirkpatrick B, Colgate R, Carmolli M, Dickson D, van der Klis F, Weldon W, Steven Oberste M; PROVIDE study teams; Ma JZ, Petri WA Jr. Environmental Enteropathy, Oral Vaccine Failure and Growth Faltering in Infants in Bangladesh. EBioMedicine. 2015 Sep 25;2(11):1759-66. doi: 10.1016/j.ebiom.2015.09.036. eCollection 2015 Nov.
- Derived from this study: PubMed 39052701Ciszewski J, Taniuchi M, Lee B, Colgate ER, Platts-Mills JA, Haque R, Zaman K, Lopman B, Petri WA Jr, Kirkpatrick BD, Rogawski McQuade ET. Differences in Rotavirus Shedding and Duration by Infant Oral Rotavirus Vaccination Status in Dhaka, Bangladesh, 2011-2014. J Infect Dis. 2024 Jul 25;230(1):e75-e79. doi: 10.1093/infdis/jiad502.
- Derived from this study: PubMed 34565452Kupkova K, Shetty SJ, Haque R, Petri WA Jr, Auble DT. Histone H3 lysine 27 acetylation profile undergoes two global shifts in undernourished children and suggests altered one-carbon metabolism. Clin Epigenetics. 2021 Sep 26;13(1):182. doi: 10.1186/s13148-021-01173-8.
- Derived from this study: PubMed 32867719Lin Y, Zhou J, Kumar S, Xie W, G Jensen SK, Haque R, Nelson CA, Petri WA Jr, Ma JZ. Group penalized generalized estimating equation for correlated event-related potentials and biomarker selection. BMC Med Res Methodol. 2020 Aug 31;20(1):221. doi: 10.1186/s12874-020-01103-x.
- Derived from this study: PubMed 32157282Williams FB, Kader A, Colgate ER, Dickson DM, Carmolli M, Uddin MI, Sharmin S, Islam S, Bhuiyan TR, Alam M, Nayak U, Mychaleckyj JC, Petri WA, Haque R, Qadri F, Kirkpatrick BD, Lee B. Maternal Secretor Status Affects Oral Rotavirus Vaccine Response in Breastfed Infants in Bangladesh. J Infect Dis. 2021 Oct 13;224(7):1147-1151. doi: 10.1093/infdis/jiaa101.
- Derived from this study: PubMed 29514306Rogawski ET, Platts-Mills JA, Colgate ER, Haque R, Zaman K, Petri WA, Kirkpatrick BD. Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study. J Infect Dis. 2018 Mar 5;217(6):861-868. doi: 10.1093/infdis/jix668.
- Derived from this study: PubMed 29394355Lee B, Carmolli M, Dickson DM, Colgate ER, Diehl SA, Uddin MI, Islam S, Hossain M, Rafique TA, Bhuiyan TR, Alam M, Nayak U, Mychaleckyj JC, McNeal MM, Petri WA, Qadri F, Haque R, Kirkpatrick BD. Rotavirus-Specific Immunoglobulin A Responses Are Impaired and Serve as a Suboptimal Correlate of Protection Among Infants in Bangladesh. Clin Infect Dis. 2018 Jul 2;67(2):186-192. doi: 10.1093/cid/ciy076.
- Derived from this study: PubMed 29390150Lee B, Dickson DM, deCamp AC, Ross Colgate E, Diehl SA, Uddin MI, Sharmin S, Islam S, Bhuiyan TR, Alam M, Nayak U, Mychaleckyj JC, Taniuchi M, Petri WA Jr, Haque R, Qadri F, Kirkpatrick BD. Histo-Blood Group Antigen Phenotype Determines Susceptibility to Genotype-Specific Rotavirus Infections and Impacts Measures of Rotavirus Vaccine Efficacy. J Infect Dis. 2018 Apr 11;217(9):1399-1407. doi: 10.1093/infdis/jiy054.
- Derived from this study: PubMed 28444240Upfill-Brown A, Taniuchi M, Platts-Mills JA, Kirkpatrick B, Burgess SL, Oberste MS, Weldon W, Houpt E, Haque R, Zaman K, Petri WA Jr. Nonspecific Effects of Oral Polio Vaccine on Diarrheal Burden and Etiology Among Bangladeshi Infants. Clin Infect Dis. 2017 Aug 1;65(3):414-419. doi: 10.1093/cid/cix354.
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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.
Beth Kirkpatrick, M.D. principal investigator
University of Vermont
William Petri, M.D., Ph.D. principal investigator
University of Virginia School of Medicine
Rashidul Haque, M.D., Ph.D. principal investigator
International Center for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IPV (inactivated polio vaccine) and Rotarix in people with Rotavirus Diarrhea and Vaccine Virus Shedding, run by University of Vermont at 1 site in Bangladesh.
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 5 inclusion and 8 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 29 Apr 2025. 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 Bangladesh. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 29 Apr 2025). 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?
Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (time frame: 25 days following week 52 visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01375647, which also lists 14 linked publications.
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 29 Apr 2025.