Influenza vaccine response in children 6-59 months residing in malaria endemic area of Malawi

• Register: ISRCTN
• Last refreshed on: 7 October 2019
• Main ID: ISRCTN51364654
• Date of registration: 19/01/2016
• Prospective Registration: No
• Primary sponsor: University of Liverpool
• Public title: Influenza vaccine response in children 6-59 months residing in malaria endemic area of Malawi
• Scientific title: A non-randomized immunogenicity trial of World Health Organization (WHO) Pre-qualified Inactivated Influenza Vaccine (IIV) in children age 6 to 59 months residing in a malaria endemic area of Malawi
• Date of first enrolment: 18/01/2016
• Target sample size: 1300
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN51364654
• Study type: Interventional
• Study design: Single-centre community-based non-randomized prospective interventional immunogenicity trial (Prevention)
• Phase: Not Specified

Countries of recruitment

Malawi

Contacts

• Name: Ingrid Peterson

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 6 to 59 months
2. Resident in study village for the past 12 months (or since birth if less than 12 months old)
3. Is not currently enrolled in another intervention study
4. Parent/guardian provides informed consent by signature or thumb print

Exclusion criteria:
1. History of allergic reaction to any component of the study vaccines
2. History of allergic reaction to egg
3. History of bleeding disorders
4. History of Guillain-Barré Syndrome
5. Residence outside the study area or planning to relocate out in the 3 months following enrolment
6. Used immunosuppressive medication within 45 days of study entry (inhaled and topical corticosteroids permitted)
7. Received immunoglobulin or blood products within 45 days of study entry
8. Parent/guardian unable to give informed consent (for example due to mental disability)
9. Temperature 37.5°C or higher Axillary/38°C Oral or reported fever (prior 48 hours) on the day of vaccination
10. Acutely ill (respiratory symptoms, diarrhoea or vomiting within the past 24 hours)
11. Influenza vaccination in previous 12 months
12. Weigh less than 5 kg


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Response to influenza vaccine of children with and without asymptomatic malaria parasitemia.
Infections and Infestations

Intervention(s)

The trial will enroll a total of 1300 children from approximately 30 rural villages in Chikhwawa District, in Southern Malawi, where each village has about 100-150 households . The study will enroll participants at a baseline visit, with two follow-up visits at Days 28 and 56. All study participants will receive IIV vaccine at days 0 and 28; participants’ immunological response to the vaccine will be assessed at Days 28 and 56. Malaria parasitaemia will be assessed in participants at each study visit.
Study subjects will be followed up at Day 3 post-vaccination to assess fever, injection site reactions and other adverse events (AEs). Children with AEs at Day 3 will be followed up through Day 7 to ensure that the AE has resolved. Parents/guardians will be asked to contact study staff in the event of serious clinical events or fever in the study participant at any time throughout the study.

Primary Outcome(s)

Immunogenicity is measured using blood sampling at baseline (prior to immunisation) and at 28 and 56 days after the initial immunisation.

Secondary Outcome(s)

Safety of the immunisation is determined by recording the number and percentage of solicited and un-solicited AEs occurring within 7 days of vaccination as reported by parents/guardians in a diary card and at a check-up appointment on day 3 and day 31.

Secondary ID(s)

UoL001120 (University of Liverpool Sponsorship number)

Source(s) of Monetary Support

Centers for Disease Control and Prevention

Ethics review

Status:
Approval date:
Contact:

National Health Sciences Research Committee (Malawi), 10/03/2015, ref: 1343

Results

• Results available: Yes
• Date Completed: 01/02/2017