Measles VaccinationPhase 4RE-CAMPNCT03460002
Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children
A Phase 4 study testing Measles vaccine and Oral polio vaccine in people with Measles Vaccination and Oral Polio Vaccine, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
The world is set on eradicating measles and polio infections in the coming decade. Once both infections are under control, campaigns with measles and oral polio vaccines will be phased out. This might do more harm than good for child survival in low-income countries. Read more about this study
- Who is it for?
- Ages 0 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Measles Vaccination, Oral Polio Vaccine, Non-specific/Heterologous Effects of Vaccines
- What is being tested?
- Measles vaccine and Oral polio vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28,612 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Nov 2016to Aug 2022
- 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 0 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- the child has temperature > 39.0◦C or a severe acute illness as defined by the examining nurse
- OR
- the child has as a mid upper arm circumference < 110 mm and is older than 6 months (most feasible local indicator of AIDS and chronic immunosuppressive disease)
- OR
- the child has experienced a severe allergic reaction after previous vaccination, drug or food.
- OR
Show all 9Show fewer
- the child is enrolled in an ongoing study of Bacillus Calmette Guerin vaccine and is < 2 months old
- OR
- For the RECAMP-MV trial: the child is enrolled in RECAMP-OPV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Controlled Trial on the Campaign Effect of Measles Vaccine and Oral Polio Vaccine on General Hospital Admissions and Mortality Among Children
The world is set on eradicating measles and polio infections in the coming decade. Once both infections are under control, campaigns with measles and oral polio vaccines will be phased out. This might do more harm than good for child survival in low-income countries. Studies from the Bandim Health Project in Guinea-Bissau, and elsewhere, have revealed, that the live measles and oral polio vaccines have beneficial non-specific effects, i.e. effects on child morbidity and mortality unrelated to prevention of the targeted diseases.
The campaigns are presumed to be most beneficial for children not reached by routine vaccination programs, as they are not already protected. However, studies show that prior routine or campaign vaccination may boost resistance against unrelated infections. If we phase out measles and oral polio campaigns after eradicating their target infections without considering the impact on child survival, the drastic decline in child mortality since 1990 could change direction. We will conduct the first cluster randomized controlled trial to evaluate the effect of measles and oral polio campaigns on general child morbidity and mortality via the Bandim Health Project. Bandim Health Project runs a Health and Demographic Surveillance System in Guinea-Bissau since 1978 and assesses child health interventions' real-life effects, via continuous registration of all interventions given to all children, and follow-up of individuals. We will conduct the trials in rural Guinea-Bissau monitoring all nine health regions.
Read more
The hypotheses are:
RECAMP-MV: Measles vaccination campaign in Guinea-Bissau reduce morbidity and mortality among children between 9 and 59 months of age by 80% during the subsequent 18 months in a context of limited measles infection.
RECAMP-OPV: Oral polio vaccination campaigns in Guinea-Bissau reduce morbidity and mortality among children between 0 and 8 months of age by 25% during the subsequent 12 months in a context with no polio infection.
Originally, the trials were meant to be implemented in 182 clusters, enrolling 21000 children. Following revised sample size calculations and discussions with the Data Safety and Monitoring Board, the number of clusters were increased to 222 and the planned number of enrolments increased from 21,000 to 28,000 (RECAMP-MV: 18000, RECAMP-OPV: 10000).
To explore the hypothesis that at least part of the beneficial non-specific effects of OPV is driven by changes in the gut and/or respiratory microbiome, we will collect microbiome samples in a sub-group:
A nasal swab and a rectal swab will be collected from 50 infants allocated to the intervention group, and 50 infants allocated to the control group. Two sample will be collected for each infant one when recruited for RECAMP-OPV and a second two months later.
- Conditions
- Measles Vaccination, Oral Polio Vaccine, Non-specific/Heterologous Effects of Vaccines, Mortality, Morbidity, Children
- Being tested
- Measles vaccine, Oral polio vaccine
- Keywords
- Measles vaccine, Oral polio vaccine, Campaign, Child mortality, Child morbidity, Non-specific effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measles vaccineBiological
A measles vaccine prequalified from the World Health Organization will be administered in one dose by deep subcutaneous injection into the left subscapular region by a local nurse.
Oral polio vaccineBiological
A bivalent oral polio vaccine prequalified by the World Health Organization will be administered in one or two doses directly into the mouth of the vaccinee with two drops per dose by a local nurse.
| Study group | Role | What they receive |
|---|---|---|
| Measles vaccine | Experimental | In intervention villages children will be weighed and receive standard measles vaccine in one dose if they are between 9-59 months old. Receives: Biological: Measles vaccine |
| Oral polio vaccine | Experimental | In intervention villages children will be weighed and receive standard oral polio vaccine in one or two doses if they are between 0-8 months old. Receives: Biological: Oral polio vaccine |
| Weighing-MV | No intervention | In control villages children aged 9-59 months acting as controls to the MV-intervention arm will be weighed only. |
| Weighing-OPV | No intervention | In control villages children aged 0-8 months acting as controls to the OPV-intervention arm will be weighed only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome: mortality and hospital admission (measured as a rate)
Death (registered through follow-up visits, verified by verbal autopsies) or first admission (overnight stay at hospital registered by interview at follow up visits)
Correction: Non-accidental death (registered through follow-up visits, verified by verbal autopsies) or first admission not caused by accident (overnight stay at hospital registered by interview at follow up visits) The outcomes were correctly specified in the protocol paper and analysis plan (doi: 10.1186/s12889-019-7813-y)
Measured: Enrolment to end of study (longest follow-up 2 years)
Secondary outcomes (3)
Nutritional status
Mid-upper-arm-circumference registered with measurement tape as per UNICEF recommendations
Measured: Enrolment to end of study (longest follow-up 2 years)
Mortality
Death (registered through follow-up visits, verified by verbal autopsies)
Corrections: Non-accidental death (registered through follow-up visits, verified by verbal autopsies) The outcome was correctly specified in the protocol paper and analysis plan (doi: 10.1186/s12889-019-7813-y)
Measured: Enrolment to end of study (longest follow-up 2 years)
Hospital admission
admission (overnight stay at hospital registered by interview at follow up visits)
Correction: admission not caused by accident (overnight stay at hospital registered by interview at follow up visits) The outcome was correctly specified in the protocol paper and analysis plan (doi: 10.1186/s12889-019-7813-y)
Measured: Enrolment to end of study (longest follow-up 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study startNov 2016
- Primary completionOct 2021
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Measles VaccinationStudies 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
- Model description
- The RECAMP trials test two separate hypotheses relating to the potential beneficial non-specific effects of providing live vaccines in general vaccination campaigns. The RECAMP-MV trial tests the effect of a Measles Vaccination campaign among children aged 9-59 months The RECAMP-OPV trial tests the effect of an Oral Polio Vaccination campaign in children aged 0-8 months
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 28,612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut, Research Center for Vitamins and Vaccines
- Responsible party
- Sponsor
- Investigators
- Ane Fisker, MD, PhD, Principal investigator, Bandim Health Project, Guinea-Bissau and Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health ProjectPeter Aaby, DMSc,Professor, Principal investigator, Bandim Health Project, Guinea-Bissau and Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health ProjectAksel Jensen, PhD, Principal investigator, Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health ProjectAnshu Varma, MSc, Principal investigator, Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health ProjectAmabelia Rodrigues, Ph, Principal investigator, Bandim Health Project, Guinea-Bissau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460002
- Sponsor's protocol ID
- RE-CAMP
- Acronym
- RE-CAMP
- Status last verified
- Aug 2024
- First submitted
- 21 Nov 2016
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
World Health Organization. Global measles and rubella strategic plan: 2012-2020. 2012.
World Health Organization. Polio eradication and endgame strategic plan: 2013-2018. 2013.
Meeting of the Strategic Advisory Group of Experts on immunization, October 2015 - conclusions and recommendations. Wkly Epidemiol Rec. 2015 Dec 11;90(50):681-99. No abstract available. English, French.
PubMed 26685390Kristensen I, Aaby P, Jensen H. Routine vaccinations and child survival: follow up study in Guinea-Bissau, West Africa. BMJ. 2000 Dec 9;321(7274):1435-8. doi: 10.1136/bmj.321.7274.1435.
PubMed 11110734Aaby P, Samb B, Simondon F, Seck AM, Knudsen K, Whittle H. Non-specific beneficial effect of measles immunisation: analysis of mortality studies from developing countries. BMJ. 1995 Aug 19;311(7003):481-5. doi: 10.1136/bmj.311.7003.481.
PubMed 7647643Aaby P, Garly ML, Bale C, Martins C, Jensen H, Lisse I, Whittle H. Survival of previously measles-vaccinated and measles-unvaccinated children in an emergency situation: an unplanned study. Pediatr Infect Dis J. 2003 Sep;22(9):798-805. doi: 10.1097/01.inf.0000083821.33187.b5.
PubMed 14506371Aaby P, Martins CL, Garly ML, Bale C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.
PubMed 21118875Lund N, Andersen A, Hansen AS, Jepsen FS, Barbosa A, Biering-Sorensen S, Rodrigues A, Ravn H, Aaby P, Benn CS. The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial. Clin Infect Dis. 2015 Nov 15;61(10):1504-11. doi: 10.1093/cid/civ617. Epub 2015 Jul 28.
PubMed 26219694Lund N, Biering-Sorensen S, Andersen A, Monteiro I, Camala L, Jorgensen MJ, Aaby P, Benn CS. Neonatal vitamin A supplementation associated with a cluster of deaths and poor early growth in a randomised trial among low-birth-weight boys of vitamin A versus oral polio vaccine at birth. BMC Pediatr. 2014 Aug 28;14:214. doi: 10.1186/1471-2431-14-214.
PubMed 25163399Martins CL, Benn CS, Andersen A, Bale C, Schaltz-Buchholzer F, Do VA, Rodrigues A, Aaby P, Ravn H, Whittle H, Garly ML. A randomized trial of a standard dose of Edmonston-Zagreb measles vaccine given at 4.5 months of age: effect on total hospital admissions. J Infect Dis. 2014 Jun 1;209(11):1731-8. doi: 10.1093/infdis/jit804. Epub 2014 Jan 16.
PubMed 24436454Sorup S, Benn CS, Poulsen A, Krause TG, Aaby P, Ravn H. Live vaccine against measles, mumps, and rubella and the risk of hospital admissions for nontargeted infections. JAMA. 2014 Feb 26;311(8):826-35. doi: 10.1001/jama.2014.470.
PubMed 24570246Sorup S, Stensballe LG, Krause TG, Aaby P, Benn CS, Ravn H. Oral Polio Vaccination and Hospital Admissions With Non-Polio Infections in Denmark: Nationwide Retrospective Cohort Study. Open Forum Infect Dis. 2015 Dec 17;3(1):ofv204. doi: 10.1093/ofid/ofv204. eCollection 2016 Jan.
PubMed 26885538Aaby P, Hedegaard K, Sodemann M, Nhante E, Veirum JE, Jakobsen M, Lisse I, Jensen H, Sandstrom A. Childhood mortality after oral polio immunisation campaign in Guinea-Bissau. Vaccine. 2005 Feb 25;23(14):1746-51. doi: 10.1016/j.vaccine.2004.02.054.
PubMed 15705481Andersen A, Fisker AB, Rodrigues A, et al. National immunization campaigns with oral polio vaccine (OPV) reduce the general all-cause mortality rate: An analysis of the effect of campaign-OPV on child mortality within seven randomised trials (submitted). 2016.
Fisker AB, Rodrigues A, Martins C, Ravn H, Byberg S, Thysen S, Storgaard L, Pedersen M, Fernandes M, Benn CS, Aaby P. Reduced All-cause Child Mortality After General Measles Vaccination Campaign in Rural Guinea-Bissau. Pediatr Infect Dis J. 2015 Dec;34(12):1369-76. doi: 10.1097/INF.0000000000000896.
PubMed 26379164
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial on the Campaign Effect of Measles Vaccine and Oral Polio Vaccine on General Hospital Admissions and Mortality Among Children
- ClinicalTrials.gov ID
- NCT03460002
- Acronym / sponsor ID
- RE-CAMP / RE-CAMP
- Conditions
- Measles Vaccination, Oral Polio Vaccine, Non-specific/Heterologous Effects of Vaccines, Mortality, Morbidity, Children
- Keywords
- Measles vaccine, Oral polio vaccine, Campaign, Child mortality, Child morbidity, Non-specific effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28,612 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- Statens Serum Institut, Research Center for Vitamins and Vaccines
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 9 Mar 2018 (actual)
- 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.
The world is set on eradicating measles and polio infections in the coming decade. Once both infections are under control, campaigns with measles and oral polio vaccines will be phased out. This might do more harm than good for child survival in low-income countries. Studies from the Bandim Health Project in Guinea-Bissau, and elsewhere, have revealed, that the live measles and oral polio vaccines have beneficial non-specific effects, i.e. effects on child morbidity and mortality unrelated to prevention of the targeted diseases.
The campaigns are presumed to be most beneficial for children not reached by routine vaccination programs, as they are not already protected. However, studies show that prior routine or campaign vaccination may boost resistance against unrelated infections. If we phase out measles and oral polio campaigns after eradicating their target infections without considering the impact on child survival, the drastic decline in child mortality since 1990 could change direction. We will conduct the first cluster randomized controlled trial to evaluate the effect of measles and oral polio campaigns on general child morbidity and mortality via the Bandim Health Project. Bandim Health Project runs a Health and Demographic Surveillance System in Guinea-Bissau since 1978 and assesses child health interventions' real-life effects, via continuous registration of all interventions given to all children, and follow-up of individuals. We will conduct the trials in rural Guinea-Bissau monitoring all nine health regions.
The hypotheses are:
RECAMP-MV: Measles vaccination campaign in Guinea-Bissau reduce morbidity and mortality among children between 9 and 59 months of age by 80% during the subsequent 18 months in a context of limited measles infection.
RECAMP-OPV: Oral polio vaccination campaigns in Guinea-Bissau reduce morbidity and mortality among children between 0 and 8 months of age by 25% during the subsequent 12 months in a context with no polio infection.
Originally, the trials were meant to be implemented in 182 clusters, enrolling 21000 children. Following revised sample size calculations and discussions with the Data Safety and Monitoring Board, the number of clusters were increased to 222 and the planned number of enrolments increased from 21,000 to 28,000 (RECAMP-MV: 18000, RECAMP-OPV: 10000).
To explore the hypothesis that at least part of the beneficial non-specific effects of OPV is driven by changes in the gut and/or respiratory microbiome, we will collect microbiome samples in a sub-group:
A nasal swab and a rectal swab will be collected from 50 infants allocated to the intervention group, and 50 infants allocated to the control group. Two sample will be collected for each infant one when recruited for RECAMP-OPV and a second two months later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- The RECAMP trials test two separate hypotheses relating to the potential beneficial non-specific effects of providing live vaccines in general vaccination campaigns. The RECAMP-MV trial tests the effect of a Measles Vaccination campaign among children aged 9-59 months The RECAMP-OPV trial tests the effect of an Oral Polio Vaccination campaign in children aged 0-8 months
| Arm | Type | Receives |
|---|---|---|
| Measles vaccine | Experimental | Biological: Measles vaccineIn intervention villages children will be weighed and receive standard measles vaccine in one dose if they are between 9-59 months old. |
| Oral polio vaccine | Experimental | Biological: Oral polio vaccineIn intervention villages children will be weighed and receive standard oral polio vaccine in one or two doses if they are between 0-8 months old. |
| Weighing-MV | No intervention | –In control villages children aged 9-59 months acting as controls to the MV-intervention arm will be weighed only. |
| Weighing-OPV | No intervention | –In control villages children aged 0-8 months acting as controls to the OPV-intervention arm will be weighed only. |
Who may qualify
- Ages
- 0 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- the child has temperature > 39.0◦C or a severe acute illness as defined by the examining nurse
- OR
- the child has as a mid upper arm circumference < 110 mm and is older than 6 months (most feasible local indicator of AIDS and chronic immunosuppressive disease)
- OR
- the child has experienced a severe allergic reaction after previous vaccination, drug or food.
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 |
|---|---|---|
| Measles vaccineA measles vaccine prequalified from the World Health Organization will be administered in one dose by deep subcutaneous injection into the left subscapular region by a local nurse. | Biological | Measles vaccine |
| Oral polio vaccineA bivalent oral polio vaccine prequalified by the World Health Organization will be administered in one or two doses directly into the mouth of the vaccinee with two drops per dose by a local nurse. | Biological | Oral polio vaccine |
Primary outcome
Composite outcome: mortality and hospital admission (measured as a rate)
Time frame: Enrolment to end of study (longest follow-up 2 years)
Death (registered through follow-up visits, verified by verbal autopsies) or first admission (overnight stay at hospital registered by interview at follow up visits) Correction: Non-accidental death (registered through follow-up visits, verified by verbal autopsies) or first admission not caused by accident (overnight stay at hospital registered by interview at follow up visits) The outcomes were correctly specified in the protocol paper and analysis plan (doi: 10.1186/s12889-019-7813-y)
3 secondary outcomes
Nutritional status
Time frame: Enrolment to end of study (longest follow-up 2 years)
Mortality
Time frame: Enrolment to end of study (longest follow-up 2 years)
Hospital admission
Time frame: Enrolment to end of study (longest follow-up 2 years)
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 3 Sep 2024.
- BackgroundWorld Health Organization. Global measles and rubella strategic plan: 2012-2020. 2012.
- BackgroundWorld Health Organization. Polio eradication and endgame strategic plan: 2013-2018. 2013.
- Background: PubMed 26685390Meeting of the Strategic Advisory Group of Experts on immunization, October 2015 - conclusions and recommendations. Wkly Epidemiol Rec. 2015 Dec 11;90(50):681-99. No abstract available. English, French.
- Background: PubMed 11110734Kristensen I, Aaby P, Jensen H. Routine vaccinations and child survival: follow up study in Guinea-Bissau, West Africa. BMJ. 2000 Dec 9;321(7274):1435-8. doi: 10.1136/bmj.321.7274.1435.
- Background: PubMed 7647643Aaby P, Samb B, Simondon F, Seck AM, Knudsen K, Whittle H. Non-specific beneficial effect of measles immunisation: analysis of mortality studies from developing countries. BMJ. 1995 Aug 19;311(7003):481-5. doi: 10.1136/bmj.311.7003.481.
- Background: PubMed 14506371Aaby P, Garly ML, Bale C, Martins C, Jensen H, Lisse I, Whittle H. Survival of previously measles-vaccinated and measles-unvaccinated children in an emergency situation: an unplanned study. Pediatr Infect Dis J. 2003 Sep;22(9):798-805. doi: 10.1097/01.inf.0000083821.33187.b5.
- Background: PubMed 21118875Aaby P, Martins CL, Garly ML, Bale C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.
- Background: PubMed 26219694Lund N, Andersen A, Hansen AS, Jepsen FS, Barbosa A, Biering-Sorensen S, Rodrigues A, Ravn H, Aaby P, Benn CS. The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial. Clin Infect Dis. 2015 Nov 15;61(10):1504-11. doi: 10.1093/cid/civ617. Epub 2015 Jul 28.
- Background: PubMed 25163399Lund N, Biering-Sorensen S, Andersen A, Monteiro I, Camala L, Jorgensen MJ, Aaby P, Benn CS. Neonatal vitamin A supplementation associated with a cluster of deaths and poor early growth in a randomised trial among low-birth-weight boys of vitamin A versus oral polio vaccine at birth. BMC Pediatr. 2014 Aug 28;14:214. doi: 10.1186/1471-2431-14-214.
- Background: PubMed 24436454Martins CL, Benn CS, Andersen A, Bale C, Schaltz-Buchholzer F, Do VA, Rodrigues A, Aaby P, Ravn H, Whittle H, Garly ML. A randomized trial of a standard dose of Edmonston-Zagreb measles vaccine given at 4.5 months of age: effect on total hospital admissions. J Infect Dis. 2014 Jun 1;209(11):1731-8. doi: 10.1093/infdis/jit804. Epub 2014 Jan 16.
- Background: PubMed 24570246Sorup S, Benn CS, Poulsen A, Krause TG, Aaby P, Ravn H. Live vaccine against measles, mumps, and rubella and the risk of hospital admissions for nontargeted infections. JAMA. 2014 Feb 26;311(8):826-35. doi: 10.1001/jama.2014.470.
- Background: PubMed 26885538Sorup S, Stensballe LG, Krause TG, Aaby P, Benn CS, Ravn H. Oral Polio Vaccination and Hospital Admissions With Non-Polio Infections in Denmark: Nationwide Retrospective Cohort Study. Open Forum Infect Dis. 2015 Dec 17;3(1):ofv204. doi: 10.1093/ofid/ofv204. eCollection 2016 Jan.
- Individual participant dataSharing planned: No
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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.
Ane Fisker, MD, PhD principal investigator
Bandim Health Project, Guinea-Bissau and Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
Peter Aaby, DMSc,Professor principal investigator
Bandim Health Project, Guinea-Bissau and Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
Aksel Jensen, PhD principal investigator
Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
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 Measles vaccine and Oral polio vaccine in people with Measles Vaccination and Oral Polio Vaccine, run by Bandim Health Project at 1 site in Guinea-Bissau.
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 0 inclusion and 9 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 3 Sep 2024. 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 Guinea-Bissau. 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?
Composite outcome: mortality and hospital admission (measured as a rate) (time frame: Enrolment to end of study (longest follow-up 2 years)). 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 NCT03460002, which also lists 42 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 3 Sep 2024.