MorbidityPhase 4BCGSTRAINNCT02447536
Trial of Two Strains of BCG
A Phase 4 study testing BCG-Denmark 1331 (Statens Serum Institute) and BCG-Russia-I (Serum Institute of India) in people with Morbidity and Bacille Calmette-Guérin, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
The investigators aim to conduct a randomised controlled trial comparing two Bacille Calmette-Guérin (BCG) strains currently used in Guinea-Bissau, the Danish and the Russian, in terms of prevention of neonatal and early life morbidity and mortality, immune responses and adverse events related to BCG vaccination. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Morbidity, Bacille Calmette-Guérin
- What is being tested?
- BCG-Denmark 1331 (Statens Serum Institute) and BCG-Russia-I (Serum Institute of India)
- 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
- 12,006 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- 8 Dec 2014to 1 May 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Newborn infants at the HNSM maternity ward.
Who cannot join
- Infants included in another randomized trial of BCG. Infants with a severe congenital abnormality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of Different BCG Strains on Early Life Hospital Admissions in Guinea-Bissau: A Randomised Trial
The investigators aim to conduct a randomised controlled trial comparing two Bacille Calmette-Guérin (BCG) strains currently used in Guinea-Bissau, the Danish and the Russian, in terms of prevention of neonatal and early life morbidity and mortality, immune responses and adverse events related to BCG vaccination. The primary outcome will be hospital admissions within 6 weeks of age.
Read the detailed description
BACKGROUND At the Bandim Health Project (www.bandim.org) in Guinea-Bissau, we observed that Bacille Calmette-Guérin (BCG) vaccination at birth is associated with survival benefits which cannot be explained by prevention of tuberculosis (TB), which is rare during the first year of life. There is mounting evidence that the beneficial effects of BCG on neonatal mortality stems from non-specific beneficial immune training, also termed heterologous immunity. This way, BCG immunisation possibly confers enhanced protection against a broad range of severe infections such as pneumonia and septicemia.
In addition, observational studies from Guinea-Bissau suggest that BCG-vaccinated children who produced a scar upon immunisation have significantly better survival than BCG-vaccinated children who did not produce a scar. The pattern is the same with regard to PPD (tuberculin) skin test. While correct BCG-vaccination technique is undoubtedly important for scarring, several studies have shown that the strain of BCG might be important as well.
Globally, BCG coverage exceeds 90%, making BCG the most widely used vaccine in the world. According to UNICEF, the annual demand for the BCG vaccine was 130 million doses in 2013. Several different vaccine strains are being used, yet few studies have compared the different strains. However, several animal and human studies have shown that these genetically diverse vaccine strains induce different protective efficacy against TB, risk of adverse events and susceptibility to anti-TB drugs. Recently, a large observational study based in Uganda showed that there were significant differences between BCG strains concerning the response to specific mycobacteria and non-specific immune responses. In particular, BCG-Denmark was associated with a much higher rate of scarring (93%) than BCG-Russia (52%), but also a higher rate of adverse events in terms of ulcers and abscesses (1.8% versus 0.3%).
OBJECTIVE We aim to compare the effect of two strains of BCG (BCG-Denmark, BCG-Russia) provided at birth to children born at the National Hospital Simão Mendes (HNSM) on subsequent hospitalisations. Furthermore, mortality in the first 6 weeks and adverse events at 2 and 6 months of age will be reported for all children, and BCG scar frequency (2 and 6 months) and PPD response (6 months) will be reported for a proportion of the infants.
METHODS The study will be conducted by the Bandim Health Project (BHP). The BHP maintains a health and demographic surveillance system (HDSS) in 6 districts of the capital in Guinea-Bissau covering approximately 102,000 inhabitants. All houses in the HDSS are visited monthly and all pregnancies and births are registered.
Study participants will be enrolled at the National Hospital and followed up through the HDSS and by telephone interviews as well as through hospital records. The study will be individually randomised, with 1:1 randomisation between the two strains (BCG-Denmark, BCG-Russia). During a two year inclusion period, we expect to be able to include at least 12,000 children, i.e. 6,000 in each BCG strain group. Of these, around 25% will reside within the HDSS.
- Conditions
- Morbidity, Bacille Calmette-Guérin
- Being tested
- BCG-Denmark 1331 (Statens Serum Institute), BCG-Russia-I (Serum Institute of India)
- Keywords
- Immunization, Morbidity, Mortality, BCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG-Denmark 1331 (Statens Serum Institute)Biological
See above
BCG-Russia-I (Serum Institute of India)Biological
See above
| Study group | Role | What they receive |
|---|---|---|
| BCG-DENMARK | Active comparator | Infants randomised to receive BCG-DENMARK at dismissal from the Maternity Ward will receive one 0.05 ml dose of Mycobacterium bovis BCG live attenuated vaccine BCG-Denmark 1331 (Statens Serum Institute) by intradermal injection in the left deltoid region. Dependent on national supply, infants will receive oral polio vaccine (OPV) at the time of BCG-vaccination.
NOTE: By 1st of July 2016, infants in this arm has received BCG-Japan due to a worldwide shortage of BCG-Denmark because of a halt in production of this vaccine at the Statens Serum Institut in Copenhagen. Receives: Biological: BCG-Denmark 1331 (Statens Serum Institute) |
| BCG-RUSSIA | Active comparator | Infants randomised to receive BCG-RUSSIA at dismissal from the Maternity Ward will receive one 0.05 ml dose Mycobacterium bovis BCG live attenuated vaccine BCG-Russia-I (Serum Institute of India) by intradermal injection in the left deltoid region. Dependent on national supply, infants will receive oral polio vaccine (OPV) at the time of BCG-vaccination. Receives: Biological: BCG-Russia-I (Serum Institute of India) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admission
Measured: 6 weeks after birth
Secondary outcomes (5)
Mortality
Reported exclusively for a subgroup of infants with regular house visits
Measured: 6 weeks
BCG scar frequency
Reported exclusively for a subgroup of infants with regular house visits
Measured: 6 months
PPD (tuberculin response)
Reported exclusively for a subgroup of infants with regular house visits
Measured: 6 months
Adverse events (abscesses/ulcers)
Adverse events to the vaccines will be evaluated for a subgroup of infants with regular house visits
Measured: 6 months
Hospital admission during neonatal period
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study start8 Dec 2014
- Primary completion24 Nov 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for MorbidityStudies 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
- 12,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut
- Responsible party
- Sponsor
- Investigators
- Peter Aaby, Prof., Principal investigator, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447536
- Sponsor's protocol ID
- BCGSTRAIN
- Acronym
- BCGSTRAIN
- Status last verified
- Dec 2020
- First submitted
- 20 Apr 2015
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Wardlaw T, You D, Newby H, Anthony D, Chopra M. Child survival: a message of hope but a call for renewed commitment in UNICEF report. Reprod Health. 2013 Dec 11;10:64. doi: 10.1186/1742-4755-10-64.
PubMed 24325885Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.
PubMed 15752534Penfold S, Willey BA, Schellenberg J. Newborn care behaviours and neonatal survival: evidence from sub-Saharan Africa. Trop Med Int Health. 2013 Nov;18(11):1294-316. doi: 10.1111/tmi.12193. Epub 2013 Sep 24.
PubMed 24112377Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sorensen S, Whittle H, Benn CS. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.
PubMed 21673035Biering-Sorensen S, Aaby P, Napirna BM, Roth A, Ravn H, Rodrigues A, Whittle H, Benn CS. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289.
PubMed 22189537Roth A, Gustafson P, Nhaga A, Djana Q, Poulsen A, Garly ML, Jensen H, Sodemann M, Rodriques A, Aaby P. BCG vaccination scar associated with better childhood survival in Guinea-Bissau. Int J Epidemiol. 2005 Jun;34(3):540-7. doi: 10.1093/ije/dyh392. Epub 2005 Jan 19.
PubMed 15659474Garly ML, Martins CL, Bale C, Balde MA, Hedegaard KL, Gustafson P, Lisse IM, Whittle HC, Aaby P. BCG scar and positive tuberculin reaction associated with reduced child mortality in West Africa. A non-specific beneficial effect of BCG? Vaccine. 2003 Jun 20;21(21-22):2782-90. doi: 10.1016/s0264-410x(03)00181-6.
PubMed 12798618Roth A, Sodemann M, Jensen H, Poulsen A, Gustafson P, Weise C, Gomes J, Djana Q, Jakobsen M, Garly ML, Rodrigues A, Aaby P. Tuberculin reaction, BCG scar, and lower female mortality. Epidemiology. 2006 Sep;17(5):562-8. doi: 10.1097/01.ede.0000231546.14749.ab.
PubMed 16878042Behr MA. BCG--different strains, different vaccines? Lancet Infect Dis. 2002 Feb;2(2):86-92. doi: 10.1016/s1473-3099(02)00182-2.
PubMed 11901655Ritz N, Curtis N. Mapping the global use of different BCG vaccine strains. Tuberculosis (Edinb). 2009 Jul;89(4):248-51. doi: 10.1016/j.tube.2009.03.002. Epub 2009 Jun 18.
PubMed 19540166Behr MA. Correlation between BCG genomics and protective efficacy. Scand J Infect Dis. 2001;33(4):249-52. doi: 10.1080/003655401300077180.
PubMed 11345214Ritz N, Hanekom WA, Robins-Browne R, Britton WJ, Curtis N. Influence of BCG vaccine strain on the immune response and protection against tuberculosis. FEMS Microbiol Rev. 2008 Aug;32(5):821-41. doi: 10.1111/j.1574-6976.2008.00118.x. Epub 2008 Jul 9.
PubMed 18616602Anderson EJ, Webb EL, Mawa PA, Kizza M, Lyadda N, Nampijja M, Elliott AM. The influence of BCG vaccine strain on mycobacteria-specific and non-specific immune responses in a prospective cohort of infants in Uganda. Vaccine. 2012 Mar 9;30(12):2083-9. doi: 10.1016/j.vaccine.2012.01.053. Epub 2012 Jan 31.
PubMed 22300718Biai S, Rodrigues A, Nielsen J, Sodemann M, Aaby P. Vaccination status and sequence of vaccinations as risk factors for hospitalisation among outpatients in a high mortality country. Vaccine. 2011 May 9;29(20):3662-9. doi: 10.1016/j.vaccine.2011.03.016. Epub 2011 Apr 6.
PubMed 21440640Aaby P, Whittle H, Benn CS. Vaccine programmes must consider their effect on general resistance. BMJ. 2012 Jun 14;344:e3769. doi: 10.1136/bmj.e3769. No abstract available.
PubMed 22700785
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Different BCG Strains on Early Life Hospital Admissions in Guinea-Bissau: A Randomised Trial
- ClinicalTrials.gov ID
- NCT02447536
- Acronym / sponsor ID
- BCGSTRAIN / BCGSTRAIN
- Conditions
- Morbidity, Bacille Calmette-Guérin
- Keywords
- Immunization, Morbidity, Mortality, BCG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,006 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- Statens Serum Institut
- Study start
- 8 Dec 2014 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 May 2015 (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.
The investigators aim to conduct a randomised controlled trial comparing two Bacille Calmette-Guérin (BCG) strains currently used in Guinea-Bissau, the Danish and the Russian, in terms of prevention of neonatal and early life morbidity and mortality, immune responses and adverse events related to BCG vaccination. The primary outcome will be hospital admissions within 6 weeks of age.
Detailed description
BACKGROUND At the Bandim Health Project (www.bandim.org) in Guinea-Bissau, we observed that Bacille Calmette-Guérin (BCG) vaccination at birth is associated with survival benefits which cannot be explained by prevention of tuberculosis (TB), which is rare during the first year of life. There is mounting evidence that the beneficial effects of BCG on neonatal mortality stems from non-specific beneficial immune training, also termed heterologous immunity. This way, BCG immunisation possibly confers enhanced protection against a broad range of severe infections such as pneumonia and septicemia.
In addition, observational studies from Guinea-Bissau suggest that BCG-vaccinated children who produced a scar upon immunisation have significantly better survival than BCG-vaccinated children who did not produce a scar. The pattern is the same with regard to PPD (tuberculin) skin test. While correct BCG-vaccination technique is undoubtedly important for scarring, several studies have shown that the strain of BCG might be important as well.
Globally, BCG coverage exceeds 90%, making BCG the most widely used vaccine in the world. According to UNICEF, the annual demand for the BCG vaccine was 130 million doses in 2013. Several different vaccine strains are being used, yet few studies have compared the different strains. However, several animal and human studies have shown that these genetically diverse vaccine strains induce different protective efficacy against TB, risk of adverse events and susceptibility to anti-TB drugs. Recently, a large observational study based in Uganda showed that there were significant differences between BCG strains concerning the response to specific mycobacteria and non-specific immune responses. In particular, BCG-Denmark was associated with a much higher rate of scarring (93%) than BCG-Russia (52%), but also a higher rate of adverse events in terms of ulcers and abscesses (1.8% versus 0.3%).
OBJECTIVE We aim to compare the effect of two strains of BCG (BCG-Denmark, BCG-Russia) provided at birth to children born at the National Hospital Simão Mendes (HNSM) on subsequent hospitalisations. Furthermore, mortality in the first 6 weeks and adverse events at 2 and 6 months of age will be reported for all children, and BCG scar frequency (2 and 6 months) and PPD response (6 months) will be reported for a proportion of the infants.
METHODS The study will be conducted by the Bandim Health Project (BHP). The BHP maintains a health and demographic surveillance system (HDSS) in 6 districts of the capital in Guinea-Bissau covering approximately 102,000 inhabitants. All houses in the HDSS are visited monthly and all pregnancies and births are registered.
Study participants will be enrolled at the National Hospital and followed up through the HDSS and by telephone interviews as well as through hospital records. The study will be individually randomised, with 1:1 randomisation between the two strains (BCG-Denmark, BCG-Russia). During a two year inclusion period, we expect to be able to include at least 12,000 children, i.e. 6,000 in each BCG strain group. Of these, around 25% will reside within the HDSS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCG-DENMARK | Active comparator | Biological: BCG-Denmark 1331 (Statens Serum Institute)Infants randomised to receive BCG-DENMARK at dismissal from the Maternity Ward will receive one 0.05 ml dose of Mycobacterium bovis BCG live attenuated vaccine BCG-Denmark 1331 (Statens Serum Institute) by intradermal injection in the left deltoid region. Dependent on national supply, infants will receive oral polio vaccine (OPV) at the time of BCG-vaccination. NOTE: By 1st of July 2016, infants in this arm has received BCG-Japan due to a worldwide shortage of BCG-Denmark because of a halt in production of this vaccine at the Statens Serum Institut in Copenhagen. |
| BCG-RUSSIA | Active comparator | Biological: BCG-Russia-I (Serum Institute of India)Infants randomised to receive BCG-RUSSIA at dismissal from the Maternity Ward will receive one 0.05 ml dose Mycobacterium bovis BCG live attenuated vaccine BCG-Russia-I (Serum Institute of India) by intradermal injection in the left deltoid region. Dependent on national supply, infants will receive oral polio vaccine (OPV) at the time of BCG-vaccination. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Newborn infants at the HNSM maternity ward.
Key exclusion criteria (1 listed)
- Infants included in another randomized trial of BCG. Infants with a severe congenital abnormality.
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 |
|---|---|---|
| BCG-Denmark 1331 (Statens Serum Institute)See above | Biological | BCG-DENMARK |
| BCG-Russia-I (Serum Institute of India)See above | Biological | BCG-RUSSIA |
Primary outcome
Hospital admission
Time frame: 6 weeks after birth
5 secondary outcomes
Mortality
Time frame: 6 weeks
BCG scar frequency
Time frame: 6 months
PPD (tuberculin response)
Time frame: 6 months
Adverse events (abscesses/ulcers)
Time frame: 6 months
Hospital admission during neonatal period
Time frame: 4 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 16 Dec 2020.
- Background: PubMed 24325885Wardlaw T, You D, Newby H, Anthony D, Chopra M. Child survival: a message of hope but a call for renewed commitment in UNICEF report. Reprod Health. 2013 Dec 11;10:64. doi: 10.1186/1742-4755-10-64.
- Background: PubMed 15752534Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.
- Background: PubMed 24112377Penfold S, Willey BA, Schellenberg J. Newborn care behaviours and neonatal survival: evidence from sub-Saharan Africa. Trop Med Int Health. 2013 Nov;18(11):1294-316. doi: 10.1111/tmi.12193. Epub 2013 Sep 24.
- Background: PubMed 21673035Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sorensen S, Whittle H, Benn CS. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.
- Background: PubMed 22189537Biering-Sorensen S, Aaby P, Napirna BM, Roth A, Ravn H, Rodrigues A, Whittle H, Benn CS. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289.
- Background: PubMed 15659474Roth A, Gustafson P, Nhaga A, Djana Q, Poulsen A, Garly ML, Jensen H, Sodemann M, Rodriques A, Aaby P. BCG vaccination scar associated with better childhood survival in Guinea-Bissau. Int J Epidemiol. 2005 Jun;34(3):540-7. doi: 10.1093/ije/dyh392. Epub 2005 Jan 19.
- Background: PubMed 12798618Garly ML, Martins CL, Bale C, Balde MA, Hedegaard KL, Gustafson P, Lisse IM, Whittle HC, Aaby P. BCG scar and positive tuberculin reaction associated with reduced child mortality in West Africa. A non-specific beneficial effect of BCG? Vaccine. 2003 Jun 20;21(21-22):2782-90. doi: 10.1016/s0264-410x(03)00181-6.
- Background: PubMed 16878042Roth A, Sodemann M, Jensen H, Poulsen A, Gustafson P, Weise C, Gomes J, Djana Q, Jakobsen M, Garly ML, Rodrigues A, Aaby P. Tuberculin reaction, BCG scar, and lower female mortality. Epidemiology. 2006 Sep;17(5):562-8. doi: 10.1097/01.ede.0000231546.14749.ab.
- Background: PubMed 11901655Behr MA. BCG--different strains, different vaccines? Lancet Infect Dis. 2002 Feb;2(2):86-92. doi: 10.1016/s1473-3099(02)00182-2.
- Background: PubMed 19540166Ritz N, Curtis N. Mapping the global use of different BCG vaccine strains. Tuberculosis (Edinb). 2009 Jul;89(4):248-51. doi: 10.1016/j.tube.2009.03.002. Epub 2009 Jun 18.
- Background: PubMed 11345214Behr MA. Correlation between BCG genomics and protective efficacy. Scand J Infect Dis. 2001;33(4):249-52. doi: 10.1080/003655401300077180.
- Background: PubMed 18616602Ritz N, Hanekom WA, Robins-Browne R, Britton WJ, Curtis N. Influence of BCG vaccine strain on the immune response and protection against tuberculosis. FEMS Microbiol Rev. 2008 Aug;32(5):821-41. doi: 10.1111/j.1574-6976.2008.00118.x. Epub 2008 Jul 9.
- Individual participant dataSharing planned: Yes
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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.
Peter Aaby, Prof. 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 BCG-Denmark 1331 (Statens Serum Institute) and BCG-Russia-I (Serum Institute of India) in people with Morbidity and Bacille Calmette-Guérin, 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 1 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 16 Dec 2020. 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?
Hospital admission (time frame: 6 weeks after birth). 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 NCT02447536, which also lists 18 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 16 Dec 2020.