Measles VaccinePhase 4NCT01668745
Trial of Additional Measles Vaccine to Reduce Child Mortality. Burkina Faso.
A Phase 4 study testing Early measles vaccine in people with Measles Vaccine, run by Bandim Health Project at 1 site in Burkina Faso.
Trial summary
Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival. Read more about this study
- Who is it for?
- Ages 4 to 6 months
- Conditions the study is for
- Measles Vaccine
- What is being tested?
- Early measles vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,559 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 3 May 2013to 15 Jun 2016
- 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 4 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who
- received the third dose of pentavalent vaccine at least 28 days before enrolment
- are between 4 and 6 months old
- belong to households of the existing HDSS
Who cannot join
- Children
- with serious malformation
- who are severely sick (needing hospitalisation)
- with high fever (>38.5 C axillary temperature)
- who are severely malnourished (mid-upper-arm-circumference (MUAC) < 110 mm and/or bilateral peripheral oedema)
- who have received neonatal vitamin A supplementation
- whose parents/guardians state that they intend to permanently move out of the study area before the child reaches 9 months of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-site Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality in Rural Areas of Burkina Faso and Guinea-Bissau
Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival.
Objective: To evaluate in a multi-center RCT the effect on child survival and other health indicators of a two-dose measles vaccination schedule by providing an additional dose of Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard measles vaccine at 9 months of age. Three trials are planned in Guinea-Bissau, Ghana and Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site separately and a 32% reduction overall. Based on the results from the RCT, the investigators will assess the cost-effectiveness of the intervention.
Read more
Design, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Centre de Recherche en Sante de Nouna. Information on routine and campaign vaccinations will be collected regularly through home visits and health centre registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3), the children will be eligible for enrollment in the trial if they are not severely ill. Eligible children will be invited to take part in the trial. Provided parental informed consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based on consumption of services and average cost per unit. The incremental cost effectiveness ratio will be calculated.
Sample size, follow-up and analyses: To detect a 43% reduction in overall mortality at each site the investigators intend to enroll at least 4050 children in Burkina Faso. The children will be followed for survival and hospitalisations to 3 years of age or to the end of the study after three years. The investigators will analyse the effects by site and combined; by sex and season; possible interactions with other interventions like campaigns with drugs, vaccines or micronutrients will be explored.
Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of maternal antibody levels on subsequent antibody responses to MV. The children will be followed to 24 months of age and samples collected at 4, 9 and 24 months of age.
- Conditions
- Measles Vaccine
- Being tested
- Early measles vaccine
- Keywords
- Child mortality, Measles vaccine, Non-specific effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early measles vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Early measles vaccine | Experimental | The intervention is about to administer an early standard dose of Edmonston-Zagreb (EZ) measles vaccine in addition to the conventional dose. As such children will be randomised to receive either an early measles vaccine at 4 months after DTP3 or not. Thereafter both groups of children will receive the recommended EZ measles vaccine at 9 months of age according to WHO policy. Receives: Biological: Early measles vaccine |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 4 months - 3 years
Secondary outcomes (4)
Mortality
Measured: 4 to 9 months of age and from 9 months to 3 years of age
Morbidity
Measured: 4 months - 3 years of age
Growth
Measured: 4 months to 3 years of age
Antibody titres
Measured: 9 months to 3 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study start3 May 2013
- Primary completion31 Dec 2015
- Study completion15 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 4,559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso, Navrongo Health Research Centre, Ghana, Heidelberg University, National Institute for Public Health and the Environment (RIVM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668745
- Sponsor's protocol ID
- OPTIMUNISE_NOUNA_early MV
- Status last verified
- Feb 2026
- First submitted
- 16 Aug 2012
- Last updated
- 11 Feb 2026
- Results posted
- No
Publications
Aaby 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 21118875Fisker AB, Nebie E, Schoeps A, Martins C, Rodrigues A, Zakane A, Kagone M, Byberg S, Thysen SM, Tiendrebeogo J, Coulibaly B, Sankoh O, Becher H, Whittle HC, van der Klis FRM, Benn CS, Sie A, Muller O, Aaby P. A Two-Center Randomized Trial of an Additional Early Dose of Measles Vaccine: Effects on Mortality and Measles Antibody Levels. Clin Infect Dis. 2018 May 2;66(10):1573-1580. doi: 10.1093/cid/cix1033.
PubMed 29177407Schoeps A, Nebie E, Fisker AB, Sie A, Zakane A, Muller O, Aaby P, Becher H. No effect of an additional early dose of measles vaccine on hospitalization or mortality in children: A randomized controlled trial. Vaccine. 2018 Apr 5;36(15):1965-1971. doi: 10.1016/j.vaccine.2018.02.104. Epub 2018 Mar 6.
PubMed 29523450
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-site Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality in Rural Areas of Burkina Faso and Guinea-Bissau
- ClinicalTrials.gov ID
- NCT01668745
- Acronym / sponsor ID
- OPTIMUNISE_NOUNA_early MV
- Conditions
- Measles Vaccine
- Keywords
- Child mortality, Measles vaccine, Non-specific effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,559 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso, Navrongo Health Research Centre, Ghana, Heidelberg University, National Institute for Public Health and the Environment (RIVM)
- Study start
- 3 May 2013 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 20 Aug 2012 (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.
Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival.
Objective: To evaluate in a multi-center RCT the effect on child survival and other health indicators of a two-dose measles vaccination schedule by providing an additional dose of Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard measles vaccine at 9 months of age. Three trials are planned in Guinea-Bissau, Ghana and Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site separately and a 32% reduction overall. Based on the results from the RCT, the investigators will assess the cost-effectiveness of the intervention.
Design, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Centre de Recherche en Sante de Nouna. Information on routine and campaign vaccinations will be collected regularly through home visits and health centre registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3), the children will be eligible for enrollment in the trial if they are not severely ill. Eligible children will be invited to take part in the trial. Provided parental informed consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based on consumption of services and average cost per unit. The incremental cost effectiveness ratio will be calculated.
Sample size, follow-up and analyses: To detect a 43% reduction in overall mortality at each site the investigators intend to enroll at least 4050 children in Burkina Faso. The children will be followed for survival and hospitalisations to 3 years of age or to the end of the study after three years. The investigators will analyse the effects by site and combined; by sex and season; possible interactions with other interventions like campaigns with drugs, vaccines or micronutrients will be explored.
Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of maternal antibody levels on subsequent antibody responses to MV. The children will be followed to 24 months of age and samples collected at 4, 9 and 24 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early measles vaccine | Experimental | Biological: Early measles vaccineThe intervention is about to administer an early standard dose of Edmonston-Zagreb (EZ) measles vaccine in addition to the conventional dose. As such children will be randomised to receive either an early measles vaccine at 4 months after DTP3 or not. Thereafter both groups of children will receive the recommended EZ measles vaccine at 9 months of age according to WHO policy. |
| Control | No intervention | – |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who
- received the third dose of pentavalent vaccine at least 28 days before enrolment
- are between 4 and 6 months old
- belong to households of the existing HDSS
Key exclusion criteria (7 listed)
- Children
- with serious malformation
- who are severely sick (needing hospitalisation)
- with high fever (>38.5 C axillary temperature)
- who are severely malnourished (mid-upper-arm-circumference (MUAC) < 110 mm and/or bilateral peripheral oedema)
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 |
|---|---|---|
| Early measles vaccine | Biological | Early measles vaccine |
Primary outcome
Mortality
Time frame: 4 months - 3 years
4 secondary outcomes
Mortality
Time frame: 4 to 9 months of age and from 9 months to 3 years of age
Morbidity
Time frame: 4 months - 3 years of age
Growth
Time frame: 4 months to 3 years of age
Antibody titres
Time frame: 9 months to 3 years of age
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 11 Feb 2026.
- 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.
- Results publication: PubMed 29177407Fisker AB, Nebie E, Schoeps A, Martins C, Rodrigues A, Zakane A, Kagone M, Byberg S, Thysen SM, Tiendrebeogo J, Coulibaly B, Sankoh O, Becher H, Whittle HC, van der Klis FRM, Benn CS, Sie A, Muller O, Aaby P. A Two-Center Randomized Trial of an Additional Early Dose of Measles Vaccine: Effects on Mortality and Measles Antibody Levels. Clin Infect Dis. 2018 May 2;66(10):1573-1580. doi: 10.1093/cid/cix1033.
- Results publication: PubMed 29523450Schoeps A, Nebie E, Fisker AB, Sie A, Zakane A, Muller O, Aaby P, Becher H. No effect of an additional early dose of measles vaccine on hospitalization or mortality in children: A randomized controlled trial. Vaccine. 2018 Apr 5;36(15):1965-1971. doi: 10.1016/j.vaccine.2018.02.104. Epub 2018 Mar 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Early measles vaccine in people with Measles Vaccine, run by Bandim Health Project at 1 site in Burkina Faso.
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 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 11 Feb 2026. 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 Burkina Faso. 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?
Mortality (time frame: 4 months - 3 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 NCT01668745, which also lists 3 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 11 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.