Child MortalityNCT02943681
A Second Dose of Measles Vaccine (MV) in the Second Year of Life
A study testing Measles vaccine in people with Child Mortality and Child Morbidity, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
This study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. Half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the… Read more about this study
- Who is it for?
- Ages 18 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Mortality, Child Morbidity
- What is being tested?
- Measles vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,812 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Oct 2016to May 2021
- Phase
- Interventional
- 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 18 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination.
Who cannot join
- Having severe malformations that impairs their health
- Having received a second dose of measles vaccine
- Severely ill (requiring hospitalization) upon clinical examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Boosting the Beneficial Non-specific Effects of Live Attenuated Vaccines: A Randomized Controlled Trial (RCT) of a Second Dose of Measles Vaccine (MV) in the Second Year of Life
This study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. Half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the end of the study.
- Conditions
- Child Mortality, Child Morbidity
- Being tested
- Measles vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measles vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Measles vaccine | Experimental | Measles vaccine, 1 dose of 0.5 ml Receives: Biological: Measles vaccine |
| Control | No intervention | Nothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality registered monthly by Health and Demographic Surveillance System fieldworkers. Mortality will be combined with hospital admissions in the analysis to form the outcome severe morbidity. This will be examined overall and by sex
Measured: 30 months
Hospital admissions
Hospital admissions registered daily at the national hospital. Hospital admissions will be combined with mortality in the analysis to form the outcome severe morbidity. This will be examined overall and by sex
Measured: 30 months
Secondary outcomes (2)
Hospital admission by cause
Causes of hospital admissions registered daily at the national hospital. These will be examined overall and by sex
Measured: 30 months
Consultations
Consultations registered daily at the local health centers and the national hospital. These will be examined overall and by sex
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2020
- Study completionMay 2021
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 Child MortalityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943681
- Sponsor's protocol ID
- MV18Months
- Status last verified
- Jan 2024
- First submitted
- 13 Oct 2016
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Berendsen MLT, Silva I, Bale C, Nielsen S, Hvidt S, Martins CL, Benn CS, Aaby P. The Effect of a Second Dose of Measles Vaccine at 18 Months of Age on Nonaccidental Deaths and Hospital Admissions in Guinea-Bissau: Interim Analysis of a Randomized Controlled Trial. Clin Infect Dis. 2022 Oct 12;75(8):1370-1378. doi: 10.1093/cid/ciac155.
PubMed 35218356
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting the Beneficial Non-specific Effects of Live Attenuated Vaccines: A Randomized Controlled Trial (RCT) of a Second Dose of Measles Vaccine (MV) in the Second Year of Life
- ClinicalTrials.gov ID
- NCT02943681
- Acronym / sponsor ID
- MV18Months
- Conditions
- Child Mortality, Child Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,812 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2020 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 25 Oct 2016 (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.
This study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. Half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measles vaccine | Experimental | Biological: Measles vaccineMeasles vaccine, 1 dose of 0.5 ml |
| Control | No intervention | –Nothing |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination.
Key exclusion criteria (3 listed)
- Having severe malformations that impairs their health
- Having received a second dose of measles vaccine
- Severely ill (requiring hospitalization) upon clinical examination
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 vaccine | Biological | Measles vaccine |
Primary outcome
Mortality
Time frame: 30 months
Mortality registered monthly by Health and Demographic Surveillance System fieldworkers. Mortality will be combined with hospital admissions in the analysis to form the outcome severe morbidity. This will be examined overall and by sex
Hospital admissions
Time frame: 30 months
Hospital admissions registered daily at the national hospital. Hospital admissions will be combined with mortality in the analysis to form the outcome severe morbidity. This will be examined overall and by sex
2 secondary outcomes
Hospital admission by cause
Time frame: 30 months
Consultations
Time frame: 30 months
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 19 Jan 2024.
- Background: PubMed 35218356Berendsen MLT, Silva I, Bale C, Nielsen S, Hvidt S, Martins CL, Benn CS, Aaby P. The Effect of a Second Dose of Measles Vaccine at 18 Months of Age on Nonaccidental Deaths and Hospital Admissions in Guinea-Bissau: Interim Analysis of a Randomized Controlled Trial. Clin Infect Dis. 2022 Oct 12;75(8):1370-1378. doi: 10.1093/cid/ciac155.
- Individual participant dataSharing planned: No
Related trials for Child Mortality
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Not yet recruitingObservational study
Frequency of Metabolic Acidosis in the Pediatric Intensive Care Unit
Metabolic Acidosis, Acid-Base Imbalance
RecruitingPhase 4
Azithromycin for Child Survival in Niger II
Mortality, Antimicrobial Resistance
Active, not recruiting
Enhancing Intergenerational Health in Nigeria: Peripartum as Critical Life Stage for Cardiovascular Health
Hypertension in Pregnancy, Hypertension
Not yet recruiting
Perinatal Mortality Outcomes Through Household Infection Pathways
Stillbirth and Neonatal Mortality, Perinatal Mortality
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 study testing Measles vaccine in people with Child Mortality and Child Morbidity, 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 1 inclusion and 3 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 19 Jan 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.
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: 30 months). 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 NCT02943681, 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 19 Jan 2024.