Additional Measles Vaccine at 4 Months of Age

NCT ID: NCT01486355

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an early two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child mortality compared with the WHO strategy of one dose of MV at 9 months.

Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of age1. As in a previous trial it is expected that the beneficial effect is strongest for girls.

Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than children receiving MV at 4 months with no detectable MatAb.

Implications: These hypotheses are based on a previous RCT showing strong beneficial effects of providing an early measles vaccine, in particular among children with MatAb.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Measles Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Mortality Morbidity Hospitalisations/consultations Growth Measles infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early measles vaccine

Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age

Group Type EXPERIMENTAL

Measles vaccine

Intervention Type BIOLOGICAL

Edmonston-Zagreb measles vaccine

No early measles vaccine

Receives only the standard measles vaccine at 9 months of age

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Measles vaccine

Edmonston-Zagreb measles vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children aged 4 to 7 months who received the third dose of pentavalent vaccine at least 4 weeks earlier

Exclusion Criteria

* Malformations
* Severely ill
* Severely malnourished
Minimum Eligible Age

4 Months

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bandim Health Project

OTHER

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bandim Health Project

Bissau, Bissau Region, Guinea-Bissau

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Guinea-Bissau

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Peter Aaby, DMSc

Role: CONTACT

Phone: +45 3268 3950

Email: [email protected]

Christine S Benn, MD, PhD

Role: CONTACT

Phone: +45 3268 8354

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21118875 (View on PubMed)

Nielsen S, Fisker AB, da Silva I, Byberg S, Biering-Sorensen S, Bale C, Barbosa A, Bjerregaard-Andersen M, Hansen NS, Do VA, Baek O, Rasmussen SM, Damkjaer L, Hvidt S, Baltzersen O, Rodrigues A, Martins C, Jensen KJ, Whittle HC, Smits G, van der Klis F, Aaby P, Benn CS. Effect of early two-dose measles vaccination on childhood mortality and modification by maternal measles antibody in Guinea-Bissau, West Africa: A single-centre open-label randomised controlled trial. EClinicalMedicine. 2022 May 27;49:101467. doi: 10.1016/j.eclinm.2022.101467. eCollection 2022 Jul.

Reference Type DERIVED
PMID: 35747181 (View on PubMed)

Hansen NS, Byberg S, Hervig Jacobsen L, Bjerregaard-Andersen M, Jensen AKG, Martins C, Aaby P, Skov Jensen J, Benn CS, Whittle H. Effect of early measles vaccine on pneumococcal colonization: A randomized trial from Guinea-Bissau. PLoS One. 2017 May 17;12(5):e0177547. doi: 10.1371/journal.pone.0177547. eCollection 2017.

Reference Type DERIVED
PMID: 28545041 (View on PubMed)

Christensen LD, Eriksen HB, Biering-Sorensen S, Bale C, Do VA, Andersen A, Martins CL, Sodemann M, Aaby P, Benn CS. The effect of early measles vaccination on thymic size. A randomized study from Guinea-Bissau. Vaccine. 2014 Mar 26;32(15):1641-4. doi: 10.1016/j.vaccine.2014.01.034. Epub 2014 Feb 9.

Reference Type DERIVED
PMID: 24522160 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MVurban

Identifier Type: -

Identifier Source: org_study_id