Whooping cough vaccination in pregnancy - assessment of immune responses in mothers and subsequent responses to infant vaccinations in their babies.

Phase 1

• Conditions: o medical condition or disease, instead responses to immunisations against pertussis (whooping cough) in mothers and against pertussis (whooping cough), tetanus, diphtheria, Hib, meningococcal C and pneumococcal in their babies.; MedDRA version: 16.1 Level: PT Classification code 10059080 Term: Vaccination site reaction System Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 16.1 Level: PT Classification code 10054175 Term: Polio immunisation System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.1 Level: PT Classification code 10054131 Term: Tetanus immunisation System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.1 Level: PT Classification code 10069578 Term: Pneumococcal immunisation System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.1 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.1 Level: LLT Classification code 10047976 Term: Whooping cough due to bordetella pertussis (B. pertussis) System Organ Class: 100000004862; MedDRA version: 16.1 Level: PT Classification code 10069577 Term: Pertussis immunisation System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2013-004495-34-GB
• Lead Sponsor: Public Health England

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-13
• Study Completion: 2017-06-30
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 154

Inclusion Criteria

Pregnant women who, at the time of enrolment
•are aged 16- 45 years

Infants of the women recruited will also be seen during the study. They will be given their immunisations according to the routine childhood immunisation schedule and will have blood samples collected as detailed in the clinical procedures section of this form. Their inclusion/ exclusion will be as per the Green Book recommendations by the UK Dept of Health.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Participants may not be included in the study if any of the following apply:
All women:
•Bleeding disorder
•Receipt of any pertussis containing vaccine in the previous 12 months
Women to be vaccinated only (i.e. not the control group):
•Received immunoglobulin or other blood product within the preceding 3 months
•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), including:
Õ A confirmed anaphylactic reaction to a previous dose of diphtheria, tetanus, pertussis or poliomyelitis containing vaccine
ÕA confirmed anaphylactic reaction to any component of the vaccine
ÕA confirmed anaphylactic reaction to a previous dose of diphtheria, tetanus, pertussis or poliomyelitis containing vaccine

Temporary Exclusion Criteria
If the pregnant woman or the baby has an axillary/aural temperature = 38°C, then vaccination and blood sampling will be postponed until resolution of fever. If the pregnant woman or baby is acutely unwell, vaccination will postponed until resolution. Blood sampling will also be postponed for seven days after completion of any antibiotic course.

Infants will be vaccinated under the routine national immunisation schedule in accordance with the inclusion/ exclusion criteria set out in the Department of Health Green Book

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified