Measles VaccinePhase 4NCT04220671
Measles Vaccination at Health System Contacts
A Phase 4 study testing measles vaccine and Saline in people with Measles Vaccine and Hospital Admission, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
In addition to protecting against measles infection, measles vaccine (MV) strengthens the individual's ability to combat infections in general - MV has beneficial non-specific effects (NSE) lowering the risk of death and admissions by around 30%. Read more about this study
- Who is it for?
- Ages 9 to 59 months
- Conditions the study is for
- Measles Vaccine, Hospital Admission, Mortality
- What is being tested?
- measles vaccine and Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,400 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- 8 Jan 2020to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 9 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Measles-unvaccinated children
- 9-59 months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital Simao Mendes.
- Measles-under-vaccinated children (received first but not second dose of MV)
- 15-59 months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital Simao Mendes.
Who cannot join
- Axil temperature >38.0
- Mid upper arm circumference <110 mm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Health Effects of Utilising Curative Health System Contacts to Provide Measles Vaccination - a Randomised Controlled Trial
In addition to protecting against measles infection, measles vaccine (MV) strengthens the individual's ability to combat infections in general - MV has beneficial non-specific effects (NSE) lowering the risk of death and admissions by around 30%.
In Guinea-Bissau 30% of children do not receive a routine MV scheduled at 9 months of age, putting both the individual child's health and measles eradication at risk. The coverage of a second dose of MV, which was added to the Bissau-Guinean vaccination programme in 2022, is even lower. WHO recommends vaccination at health system contacts, including those for curative services. At the paediatric ward of the national hospital in Guinea-Bissau, there are more than 2600 yearly contacts with measles-un or under-vaccinated children aged 9-59 months, but no vaccines are given. In a randomised controlled trial, we will assess the effect of providing MV vs placebo to 5400 children at hospital contacts (at discharge or after an out-patient consultation) to test the hypothesis that MV reduces the risk of admission or death (composite outcome) by 25% over the subsequent 6 months.
- Conditions
- Measles Vaccine, Hospital Admission, Mortality, Non-specific (Heterologous) Effects of Vaccines
- Being tested
- measles vaccine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measles vaccineBiological
Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection
SalineOther
0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Standard dose measles vaccine, 0.5 ml Receives: Biological: measles vaccine |
| Control | Placebo comparator | Saline injection, 0.5 ml Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-accident mortality or admission (Composite outcome)
Composite outcome of non-accidental death (recorded through telephone interviews and passive case detection) or an identified non-accidental hospital admission at the national hospital Simao Mendes
Measured: 6 months
Secondary outcomes (3)
Non-accidental mortality
Non-accidental mortality. For the secondary outcomes, censoring will be applied for children whom we do not succeed to contact by telephone
Measured: 6 and 12 months
Non-accidental hospital admission with an overnight stay in any health facility
Since we rely on passive case detection at the national hospital, we will not censor analysis time of children with no information by telephone interviews in the primary analysis. For the secondary outcomes, censoring will be applied for children whom we do not succeed to contact by telephone
Measured: 6 months
Cause specific hospital admissions at the national hospital.
classifying admissions in the main categories: Respiratory infections, Gastro-intestinal infections, Sepsis, Malaria and other
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start8 Jan 2020
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
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 Measles VaccineStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ane Fisker, MD, PhD, Principal investigator, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220671
- Sponsor's protocol ID
- 053/CNES/INASA/2019
- Status last verified
- Jul 2025
- First submitted
- 5 Jan 2020
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Provided request, data can be made available
Publications
Fisker AB, Martins JSD, Jensen AM, Martins C, Aaby P, Thysen SM. Health effects of utilising hospital contacts to provide measles vaccination to children 9-59 months-a randomised controlled trial in Guinea-Bissau. Trials. 2022 Apr 23;23(1):349. doi: 10.1186/s13063-022-06291-z.
PubMed 35461287
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Utilising Curative Health System Contacts to Provide Measles Vaccination - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04220671
- Acronym / sponsor ID
- 053/CNES/INASA/2019
- Conditions
- Measles Vaccine, Hospital Admission, Mortality, Non-specific (Heterologous) Effects of Vaccines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Jan 2020 (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.
In addition to protecting against measles infection, measles vaccine (MV) strengthens the individual's ability to combat infections in general - MV has beneficial non-specific effects (NSE) lowering the risk of death and admissions by around 30%.
In Guinea-Bissau 30% of children do not receive a routine MV scheduled at 9 months of age, putting both the individual child's health and measles eradication at risk. The coverage of a second dose of MV, which was added to the Bissau-Guinean vaccination programme in 2022, is even lower. WHO recommends vaccination at health system contacts, including those for curative services. At the paediatric ward of the national hospital in Guinea-Bissau, there are more than 2600 yearly contacts with measles-un or under-vaccinated children aged 9-59 months, but no vaccines are given. In a randomised controlled trial, we will assess the effect of providing MV vs placebo to 5400 children at hospital contacts (at discharge or after an out-patient consultation) to test the hypothesis that MV reduces the risk of admission or death (composite outcome) by 25% over the subsequent 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: measles vaccineStandard dose measles vaccine, 0.5 ml |
| Control | Placebo comparator | Other: SalineSaline injection, 0.5 ml |
Who may qualify
- Ages
- 9 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Measles-unvaccinated children
- 9-59 months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital Simao Mendes.
- Measles-under-vaccinated children (received first but not second dose of MV)
- 15-59 months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital Simao Mendes.
Key exclusion criteria (2 listed)
- Axil temperature >38.0
- Mid upper arm circumference <110 mm
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 vaccineMeasles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection | Biological | Intervention |
| Saline0.9% NaCl | Other | Control |
Primary outcome
Non-accident mortality or admission (Composite outcome)
Time frame: 6 months
Composite outcome of non-accidental death (recorded through telephone interviews and passive case detection) or an identified non-accidental hospital admission at the national hospital Simao Mendes
3 secondary outcomes
Non-accidental mortality
Time frame: 6 and 12 months
Non-accidental hospital admission with an overnight stay in any health facility
Time frame: 6 months
Cause specific hospital admissions at the national hospital.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 35461287Fisker AB, Martins JSD, Jensen AM, Martins C, Aaby P, Thysen SM. Health effects of utilising hospital contacts to provide measles vaccination to children 9-59 months-a randomised controlled trial in Guinea-Bissau. Trials. 2022 Apr 23;23(1):349. doi: 10.1186/s13063-022-06291-z.
- Individual participant dataSharing planned: No. Provided request, data can be made available
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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.
Ane Fisker, MD, PhD principal investigator
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 Saline in people with Measles Vaccine and Hospital Admission, 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 29 Jul 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 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Non-accident mortality or admission (Composite outcome) (time frame: 6 months). 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 NCT04220671, 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 29 Jul 2025.