Immunising Mums Against Pertussis 3
iMAP3
1 other identifier
observational
64
1 country
3
Brief Summary
This study will aim to recruit at least 70 children who participated in the iMAP2 study whose mothers received a pertussis vaccine in pregnancy as part of the iMAP2 trial and at least 15 children born to mothers who did not receive a pertussis vaccine in pregnancy. Blood samples will be obtained prior to and one month after the routine preschool booster vaccination and vaccine responses compared between children whose mothers received one of two pertussis vaccines or no pertussis vaccine in pregnancy. Children will be vaccinated with the routine booster vaccines by the study team on the same visit as the pre-vaccination bloods are taken.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2018
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2018
CompletedStudy Start
First participant enrolled
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
July 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedApril 11, 2022
April 1, 2022
1.9 years
April 19, 2018
April 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Fold-difference in anti-PT IgG geometric mean concentration (GMC) in children prior to booster vaccination
To compare anti-pertussis toxin (PT) IgG concentrations at preschool age (around 3 years 4 months) and before receipt of the routine pre-school booster vaccine, in children born to mothers who received REPEVAX, BOOSTRIX-IPV or no pertussis containing vaccine in pregnancy.
Up to a maximum of 3 years from the date of the last recruited participant
Secondary Outcomes (3)
Fold-difference in anti-PT IgG geometric mean concentration (GMC) in children one month after booster vaccination
Up to a maximum of 3 years from the date of the last recruited participant
GMC of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3) prior to and one month after booster vaccination
Up to a maximum of 3 years from the date of the last recruited participant
Anti-tetanus toxoid IgG GMC and anti-diphtheria toxoid IgG GMC prior to and one month after booster vaccination
Up to a maximum of 3 years from the date of the last recruited participant
Study Arms (3)
iMAP2 participants where their mothers received REPEVAX
Children who participated in iMAP2 study whose mothers received a pertussis-containing vaccine during pregnancy called REPEVAX
iMAP2 participants where their mothers received BOOSTRIX-IPV
Children who participated in iMAP2 study whose mothers receives a pertussis-containing vaccine during pregnancy called BOOSTRIX-IPV
iMAP2 participants where their mothers received no vaccine
Children who participated in iMAP2 study whose mothers did not receive a pertussis-containing vaccine during pregnancy
Interventions
Routine vaccination with pre-school booster vaccine
Eligibility Criteria
Children who participated in the iMAP2 study of age to receive the routine pre-school booster vaccinations (i.e. from 3 years and 4 months of age)
You may qualify if:
- Age eligible for routine pre-school booster vaccinations (i.e. from 3 years and 4 months of age)
- Participated in the iMAP2 trial
- Informed consent by a parent or legal guardian
You may not qualify if:
- Fulfil any of the contraindications to vaccination specified in The Green Book on Immunisation (https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book)
- Received any additional pertussis containing vaccine after the routine 16 week booster
- Previous or concurrent participation in an interventional study other than iMAP2 if, in the opinion of the investigator, this may influence the objectives of this study
- If the child has an axillary/aural temperature ≥ 38°C then vaccination and blood sampling will be postponed until resolution of fever. If the child is acutely unwell, vaccination will be postponed until resolution
- If the child is receiving antibiotics (other than long term prophylaxis) vaccination should be postponed until 48 hours after the conclusion of the course
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Gloucestershire NHS Trust
Gloucester, United Kingdom
St George's, University of London
London, SW170RE, United Kingdom
Oxford Vaccine Group
Oxford, United Kingdom
Related Publications (1)
Sapuan S, Andrews N, Hallis B, Hole L, Jones CE, Matheson M, Miller E, Snape MD, Heath PT. An observational, cohort, multi-centre, open label phase IV extension study comparing preschool DTAP-IPV booster vaccine responses in children whose mothers were randomised to one of two pertussis-containing vaccines or received no pertussis-containing vaccine in pregnancy in England. Vaccine. 2022 Nov 22;40(49):7050-7056. doi: 10.1016/j.vaccine.2022.10.005. Epub 2022 Oct 20.
PMID: 36272877DERIVED
Biospecimen
Venous blood sample to access serum sample to investigate antibody response towards pre-school booster vaccination
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul T Heath, MBBS FRCPCH
St George's, University of London
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2018
First Posted
July 5, 2018
Study Start
April 24, 2018
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
April 11, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share