Whooping CoughiMAP3NCT03578120
Immunising Mums Against Pertussis 3
An observational study of Whooping Cough and Maternal Vaccine Exposure, run by St George's, University of London at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Whooping Cough, Maternal Vaccine Exposure, Immunization; Infection
- What is being tested?
- Pre-school booster vaccine
- Type of treatment
- Vaccines
- How many people
- 64 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 24 Apr 2018to 1 Mar 2020
- Phase
- Observational
- 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 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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)
Who may be able to join
- 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
Who cannot join
- Permanent exclusion criteria:
- 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
- Temporary exclusion criteria:
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Gloucestershire NHS Trust
Gloucester
St George's, University of London
London, SW170RE
Oxford Vaccine Group
Oxford
About this study
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.
Read the detailed description
In the UK, all pregnant women are offered a whooping cough-containing vaccine during pregnancy. This protects newborn infants against whooping cough, but there have been some concerns that this vaccination in pregnancy may affect the response to childhood vaccinations.
A preceding study called immunising Mums Against Pertussis 2 (iMAP2) was conducted involving pregnant women randomised to receive one of two different whooping cough-containing vaccines, with a control group also recruited, and the antibody levels in their infants were measured at age 2, 5 and 13 months.
This study, immunising Mums Against Pertussis 3 (iMAP3), is a follow up study of children who participated in iMAP2, to investigate the sustained impact of whooping cough vaccination in pregnancy on childhood vaccine responses.
This study will investigate the antibody levels in these children before and after the routine pre-school booster (DTaP/IPV vaccination) vaccine. It will help the Department of Health continue to ensure the best protection is offered to the population.
Those eligible for the study are children who participated in the iMAP2 study who have reached the age for pre-school booster vaccination (from age 3 years 4 months).
The study period will be approximately 4-6 weeks with two study visits. The first visit will take place when the child is around 3 years and 4 months of age. After informed consent a blood sample will be obtained followed by administration of the pre-school booster vaccine. At the second visit another blood sample will be obtained. These blood tests will measure the level of protective antibody against the components of the pre-school booster vaccine. Visits will take place either in the child's home or at a suitable clinical setting within the study team's sites.
The study will be run by St. George's, University of London, in collaboration with St George's University Hospitals NHS Foundation Trust, Oxford Vaccine Group and Bristol Children's Vaccine Centre.
- Being tested
- Pre-school booster vaccine
- Medical subject headings
- Whooping Cough, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-school booster vaccineBiological
Routine vaccination with pre-school booster vaccine
| Study group | Role | What they receive |
|---|---|---|
| iMAP2 participants where their mothers received REPEVAX | Children who participated in iMAP2 study whose mothers received a pertussis-containing vaccine during pregnancy called REPEVAX Receives: Biological: Pre-school booster vaccine | |
| 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 Receives: Biological: Pre-school booster vaccine | |
| 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 Receives: Biological: Pre-school booster vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To compare anti-pertussis toxin (PT) IgG concentrations at one month after receipt of the pre-school booster vaccine in children born to mothers who received REPEVAX, BOOSTRIX-IPV or no pertussis containing vaccine in pregnancy.
Measured: 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
To compare antibody concentrations to other pertussis antigens [IgG to filamentous haemagglutinin (FHA) and fimbrial antigens 2 and 3 (FIM 2 and 3)], before and one month after receipt of a pre-school booster vaccine in children born to mothers who received REPEVAX, BOOSTRIX-IPV or no pertussis containing vaccine in pregnancy.
Measured: 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
To compare antibody concentrations / titres to tetanus toxoid and diphtheria toxoid before and one month after receipt of a pre-school vaccine in children born to mothers who received REPEVAX, BOOSTRIX-IPV or no pertussis containing vaccine in pregnancy.
Measured: Up to a maximum of 3 years from the date of the last recruited participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start24 Apr 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Whooping CoughStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, University Hospitals Bristol and Weston NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Paul T Heath, MBBS FRCPCH, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578120
- Sponsor's protocol ID
- 17.0269
- Acronym
- iMAP3
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2018
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radia K, Sapuan S, Grassly N, Andrews N, Ramsay M, Saliba V, Stephens L, Martin J, Jones C, Miller E, Heath PT. An observational, cohort, multi-centre, open label phase IV extension study comparing IPV immune responses to preschool dTaP-IPV booster vaccines in children whose mothers received or did not receive an IPV-containing pertussis vaccine during pregnancy in England. Vaccine. 2026 Mar 19;76:128306. doi: 10.1016/j.vaccine.2026.128306. Epub 2026 Feb 13.
PubMed 41690287Sapuan 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.
PubMed 36272877
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunising Mums Against Pertussis 3
- ClinicalTrials.gov ID
- NCT03578120
- Acronym / sponsor ID
- iMAP3 / 17.0269
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- University of Oxford, University Hospitals Bristol and Weston NHS Foundation Trust
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Jul 2018 (actual)
- 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 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.
Detailed description
In the UK, all pregnant women are offered a whooping cough-containing vaccine during pregnancy. This protects newborn infants against whooping cough, but there have been some concerns that this vaccination in pregnancy may affect the response to childhood vaccinations.
A preceding study called immunising Mums Against Pertussis 2 (iMAP2) was conducted involving pregnant women randomised to receive one of two different whooping cough-containing vaccines, with a control group also recruited, and the antibody levels in their infants were measured at age 2, 5 and 13 months.
This study, immunising Mums Against Pertussis 3 (iMAP3), is a follow up study of children who participated in iMAP2, to investigate the sustained impact of whooping cough vaccination in pregnancy on childhood vaccine responses.
This study will investigate the antibody levels in these children before and after the routine pre-school booster (DTaP/IPV vaccination) vaccine. It will help the Department of Health continue to ensure the best protection is offered to the population.
Those eligible for the study are children who participated in the iMAP2 study who have reached the age for pre-school booster vaccination (from age 3 years 4 months).
The study period will be approximately 4-6 weeks with two study visits. The first visit will take place when the child is around 3 years and 4 months of age. After informed consent a blood sample will be obtained followed by administration of the pre-school booster vaccine. At the second visit another blood sample will be obtained. These blood tests will measure the level of protective antibody against the components of the pre-school booster vaccine. Visits will take place either in the child's home or at a suitable clinical setting within the study team's sites.
The study will be run by St. George's, University of London, in collaboration with St George's University Hospitals NHS Foundation Trust, Oxford Vaccine Group and Bristol Children's Vaccine Centre.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iMAP2 participants where their mothers received REPEVAX | – | Biological: Pre-school booster vaccineChildren who participated in iMAP2 study whose mothers received a pertussis-containing vaccine during pregnancy called REPEVAX |
| iMAP2 participants where their mothers received BOOSTRIX-IPV | – | Biological: Pre-school booster vaccineChildren 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 | – | Biological: Pre-school booster vaccineChildren who participated in iMAP2 study whose mothers did not receive a pertussis-containing vaccine during pregnancy |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Permanent exclusion criteria:
- Temporary exclusion criteria:
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 |
|---|---|---|
| Pre-school booster vaccineRoutine vaccination with pre-school booster vaccine | Biological | iMAP2 participants where their mothers received BOOSTRIX-IPV, iMAP2 participants where their mothers received REPEVAX, iMAP2 participants where their mothers received no vaccine |
Primary outcome
Fold-difference in anti-PT IgG geometric mean concentration (GMC) in children prior to booster vaccination
Time frame: Up to a maximum of 3 years from the date of the last recruited participant
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.
3 secondary outcomes
Fold-difference in anti-PT IgG geometric mean concentration (GMC) in children one month after booster vaccination
Time frame: 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
Time frame: 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
Time frame: Up to a maximum of 3 years from the date of the last recruited participant
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 11 Apr 2022.
- Derived from this study: PubMed 41690287Radia K, Sapuan S, Grassly N, Andrews N, Ramsay M, Saliba V, Stephens L, Martin J, Jones C, Miller E, Heath PT. An observational, cohort, multi-centre, open label phase IV extension study comparing IPV immune responses to preschool dTaP-IPV booster vaccines in children whose mothers received or did not receive an IPV-containing pertussis vaccine during pregnancy in England. Vaccine. 2026 Mar 19;76:128306. doi: 10.1016/j.vaccine.2026.128306. Epub 2026 Feb 13.
- Derived from this study: PubMed 36272877Sapuan 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.
- Individual participant dataSharing planned: No
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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.
Paul T Heath, MBBS FRCPCH principal investigator
St George's, University of London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Whooping Cough and Maternal Vaccine Exposure, run by St George's, University of London at 3 sites in United Kingdom.
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 3 inclusion and 7 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 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Fold-difference in anti-PT IgG geometric mean concentration (GMC) in children prior to booster vaccination (time frame: Up to a maximum of 3 years from the date of the last recruited participant). 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 NCT03578120, which also lists 2 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 11 Apr 2022.