Rotavirus GastroenteritisPhase 4NCT01199874
Immunogenicity of Rotavirus Vaccine
A Phase 4 study testing Rotavirus vaccine in people with Rotavirus Gastroenteritis, run by PATH at 1 site in Pakistan.
Trial summary
Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented… Read more about this study
- Who is it for?
- Ages 6 to 18 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Gastroenteritis
- What is being tested?
- Rotavirus vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,140 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2011to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 to 18 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 weeks 0 days to 6 weeks 6 days age at the time of enrollment.
- Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
- Written informed consent obtained from the parents or guardians.
Who cannot join
- Hypersensitivity to any of the vaccine components.
- Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
- Use of any immunosuppressive drugs.
- Previous intussusception or abdominal surgery.
- Enrolment in any other trial (Simplified Antibiotic Therapy for Neonatal Sepsis Trial, Management of Omphalitis Trial).
- Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
- Immunoglobulin and/or blood products use since birth or during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding Around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine
Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives:
- To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life.
- To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Rotavirus vaccine
- Keywords
- Rotavirus, Rotavirus vaccine, Dosing schedule, Immunogenicity, Breast feeding, Pakistan
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotavirus vaccineBiological
Also called Rotarix
live attenuated oral rotavirus vaccine; lyophilized; 1 ml
| Study group | Role | What they receive |
|---|---|---|
| Primary 1: Rotavirus vaccine 6 and 10 weeks | Active comparator | EPI vaccines + rotavirus vaccine at 6 and 10 weeks Receives: Biological: Rotavirus vaccine |
| Primary 1: Rotavirus vaccine 6, 10 and 14 weeks | Experimental | EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks Receives: Biological: Rotavirus vaccine |
| Primary 1: Rotavirus vaccine 10 and 14 weeks | Experimental | EPI vaccines + rotavirus vaccine at 10 and 14 weeks Receives: Biological: Rotavirus vaccine |
| Primary 2: Rotavirus vaccine withholding breast feeding | Experimental | EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks withholding breastfeeding Receives: Biological: Rotavirus vaccine |
| Primary 2: Rotavirus vaccine with immediate breast feeding | Experimental | EPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks with immediate breastfeeding Receives: Biological: Rotavirus vaccine |
| Baseline seroconversion for rotavirus | No intervention | EPI vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml
Measured: 6, 10, 14 and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startApr 2011
- Primary completionSep 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus GastroenteritisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,140 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- S. Asad Ali, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199874
- Sponsor's protocol ID
- PATH HS534
- Status last verified
- Aug 2013
- First submitted
- 9 Sep 2010
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ali A, Kazi AM, Cortese MM, Fleming JA, Moon S, Parashar UD, Jiang B, McNeal MM, Steele D, Bhutta Z, Zaidi AK. Impact of withholding breastfeeding at the time of vaccination on the immunogenicity of oral rotavirus vaccine--a randomized trial. PLoS One. 2015 Jun 2;10(6):e0127622. doi: 10.1371/journal.pone.0127622. eCollection 2015.
PubMed 26035743
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding Around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine
- ClinicalTrials.gov ID
- NCT01199874
- Acronym / sponsor ID
- PATH HS534
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- Rotavirus, Rotavirus vaccine, Dosing schedule, Immunogenicity, Breast feeding, Pakistan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,140 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives:
- To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life.
- To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Primary 1: Rotavirus vaccine 6 and 10 weeks | Active comparator | Biological: Rotavirus vaccineEPI vaccines + rotavirus vaccine at 6 and 10 weeks |
| Primary 1: Rotavirus vaccine 6, 10 and 14 weeks | Experimental | Biological: Rotavirus vaccineEPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks |
| Primary 1: Rotavirus vaccine 10 and 14 weeks | Experimental | Biological: Rotavirus vaccineEPI vaccines + rotavirus vaccine at 10 and 14 weeks |
| Primary 2: Rotavirus vaccine withholding breast feeding | Experimental | Biological: Rotavirus vaccineEPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks withholding breastfeeding |
| Primary 2: Rotavirus vaccine with immediate breast feeding | Experimental | Biological: Rotavirus vaccineEPI vaccines + rotavirus vaccine at 6, 10 and 14 weeks with immediate breastfeeding |
| Baseline seroconversion for rotavirus | No intervention | –EPI vaccines |
Who may qualify
- Ages
- 6 to 18 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6 weeks 0 days to 6 weeks 6 days age at the time of enrollment.
- Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
- Written informed consent obtained from the parents or guardians.
Key exclusion criteria (7 listed)
- Hypersensitivity to any of the vaccine components.
- Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
- Use of any immunosuppressive drugs.
- Previous intussusception or abdominal surgery.
- Enrolment in any other trial (Simplified Antibiotic Therapy for Neonatal Sepsis Trial, Management of Omphalitis Trial).
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 |
|---|---|---|
| Rotavirus vaccineAlso: Rotarixlive attenuated oral rotavirus vaccine; lyophilized; 1 ml | Biological | Primary 1: Rotavirus vaccine 10 and 14 weeks, Primary 1: Rotavirus vaccine 6 and 10 weeks, Primary 1: Rotavirus vaccine 6, 10 and 14 weeks, Primary 2: Rotavirus vaccine with immediate breast feeding, Primary 2: Rotavirus vaccine withholding breast feeding |
Primary outcome
Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml
Time frame: 6, 10, 14 and 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
- Derived from this study: PubMed 26035743Ali A, Kazi AM, Cortese MM, Fleming JA, Moon S, Parashar UD, Jiang B, McNeal MM, Steele D, Bhutta Z, Zaidi AK. Impact of withholding breastfeeding at the time of vaccination on the immunogenicity of oral rotavirus vaccine--a randomized trial. PLoS One. 2015 Jun 2;10(6):e0127622. doi: 10.1371/journal.pone.0127622. eCollection 2015.
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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.
S. Asad Ali, MBBS principal investigator
Aga Khan University
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 Rotavirus vaccine in people with Rotavirus Gastroenteritis, run by PATH at 1 site in Pakistan.
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 3 inclusion and 7 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 30 Aug 2013. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (time frame: 6, 10, 14 and 18 weeks). 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 NCT01199874, which also lists 1 linked publication.
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 30 Aug 2013.