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

A randomised controlled trial comparing two pertussis-containing vaccines in pregnancy and vaccine responses in UK mothers and their infants (immunising Mums Against Pertussis, iMAP2) - iMAP2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004495-34-GB

Enrollment

360

Registered

2014-03-13

Start date

2014-03-11

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No 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

Interventions

Trade Name: Repevax Product Name: Repevax Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or Proposed INN: Diphtheria Toxoid

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 Õ A confirmed anaphylactic reaction to any component of the vaccine Õ A 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"

Design outcomes

Primary

Measure	Time frame
Main Objective: Technical version - To compare anti-Pertussis Toxin (PT) IgG responses following primary immunisation with an acellular pertussis- containing vaccine in infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIX-IPV in pregnancy. Lay version - to compare the amount of antibody against a particular part of the whooping cough vaccine in babies born to mothers given either Repevax or Boostrix-IPV whilst they were pregnant. ; Secondary Objective: Technical version: Infant: 1. To compare antibody responses to pertussis antigens (concentration of IgG antibody to PT, pertactin (PRN), filamentous haemagglutinnin (FHA) and fimbrial antigens 2 and 3 (FIM 2 and 3]), tetanus toxoid and diphtheria toxoid at birth amongst infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIX-IPV in pregnancy 2. To compare antibody responses to pertussis antigens [IgG to PT, PRN, FHA and FIM 2 and 3], Hib antigen [PRP], tetanus toxoid and diphtheria toxoid; meningococcal serogroup C serum bactericidal antibody titres and meningococcal serogroup C-specific IgG concentrations; 13 serotype-specific pneumococcal IgG concentrations and functional pneumococcal antibody studies at 2, 5 and 13 months of age (just before and one month after primary immunization and one month after booster vaccines) in infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received ; Primary end point(s): Technical version: Fold-difference in anti-PT IgG GMC in infants at 5 months of age whose mothers received either REPEVAX or BOOSTRIX-IPV Lay version: Comparison of whooping cough antibody levels in babies at 5 months of age depending on which vaccine their mother had. ;Timepoint(s) of evaluation	—

Measure

Time frame

Main Objective: Technical version - To compare anti-Pertussis Toxin (PT) IgG responses following primary immunisation with an acellular pertussis- containing vaccine in infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIX-IPV in pregnancy. Lay version - to compare the amount of antibody against a particular part of the whooping cough vaccine in babies born to mothers given either Repevax or Boostrix-IPV whilst they were pregnant. ; Secondary Objective: Technical version: Infant: 1. To compare antibody responses to pertussis antigens (concentration of IgG antibody to PT, pertactin (PRN), filamentous haemagglutinnin (FHA) and fimbrial antigens 2 and 3 (FIM 2 and 3]), tetanus toxoid and diphtheria toxoid at birth amongst infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIX-IPV in pregnancy 2. To compare antibody responses to pertussis antigens [IgG to PT, PRN, FHA and FIM 2 and 3], Hib antigen [PRP], tetanus toxoid and diphtheria toxoid; meningococcal serogroup C serum bactericidal antibody titres and meningococcal serogroup C-specific IgG concentrations; 13 serotype-specific pneumococcal IgG concentrations and functional pneumococcal antibody studies at 2, 5 and 13 months of age (just before and one month after primary immunization and one month after booster vaccines) in infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received ; Primary end point(s): Technical version: Fold-difference in anti-PT IgG GMC in infants at 5 months of age whose mothers received either REPEVAX or BOOSTRIX-IPV Lay version: Comparison of whooping cough antibody levels in babies at 5 months of age depending on which vaccine their mother had. ;Timepoint(s) of evaluation

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Secondary

Measure	Time frame
Secondary end point(s): • Concentration (GMC) of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3), tetanus toxoid and diphtheria toxoid in infants at birth whose mothers received either REPEVAX or BOOSTRIX-IPV • Concentration (GMC) of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3); anti-PRP IgG [Hib antigen] GMC and proportion of infants with GMC ? 0.15 and ? 1.0 ug/ml; anti-tetanus toxoid IgG GMC; anti-diphtheria toxoid IgG GMC; meningococcal serogroup C serum bactericidal antibody titres (GMT) and proportion of infants with GMT ? 8 and ?128; meningococcal serogroup C-specific IgG GMC; 13 serotype-specific pneumococcal IgG GMCs and functional pneumococcal antibody studies in infants at 2, 5 and 13 months whose mothers received either REPEVAX, BOOSTRIX-IPV or no pertussis-containing vaccine. • Concentration (GMC) of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3), tetanus toxoid and diphtheria toxoid in mothers pre-vaccination and at delivery who received REPEVAX or BOOSTRIX-IPV. • Placental transfer ratio of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3), tetanus toxoid and diphtheria toxoid from mothers to their infants in mothers who received REPEVAX or BOOSTRIX-IPV. • Persistence of pertussis IgG (PT, PRN, FHA and FIM 2 and 3) in mothers at 13 months after delivery in mothers who received either REPEVAX, BOOSTRIX-IPV or no pertussis-containing vaccine • Safety of REPEVAX and BOOSTRIX-IPV in pregnancy, including presence of local reactions and pregnancy outcomes. ; Timepoint(s) of evaluation of this end point: Third trimester of pregnancy in expectant mothers At birth, prior to primary immunisations (age 2 months of age), one month after completion of primary immunisations (5 months of age), after booster vaccinations (13 months of age)	—

Measure

Time frame

Secondary end point(s): • Concentration (GMC) of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3), tetanus toxoid and diphtheria toxoid in infants at birth whose mothers received either REPEVAX or BOOSTRIX-IPV • Concentration (GMC) of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3); anti-PRP IgG [Hib antigen] GMC and proportion of infants with GMC ? 0.15 and ? 1.0 ug/ml; anti-tetanus toxoid IgG GMC; anti-diphtheria toxoid IgG GMC; meningococcal serogroup C serum bactericidal antibody titres (GMT) and proportion of infants with GMT ? 8 and ?128; meningococcal serogroup C-specific IgG GMC; 13 serotype-specific pneumococcal IgG GMCs and functional pneumococcal antibody studies in infants at 2, 5 and 13 months whose mothers received either REPEVAX, BOOSTRIX-IPV or no pertussis-containing vaccine. • Concentration (GMC) of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3), tetanus toxoid and diphtheria toxoid in mothers pre-vaccination and at delivery who received REPEVAX or BOOSTRIX-IPV. • Placental transfer ratio of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3), tetanus toxoid and diphtheria toxoid from mothers to their infants in mothers who received REPEVAX or BOOSTRIX-IPV. • Persistence of pertussis IgG (PT, PRN, FHA and FIM 2 and 3) in mothers at 13 months after delivery in mothers who received either REPEVAX, BOOSTRIX-IPV or no pertussis-containing vaccine • Safety of REPEVAX and BOOSTRIX-IPV in pregnancy, including presence of local reactions and pregnancy outcomes. ; Timepoint(s) of evaluation of this end point: Third trimester of pregnancy in expectant mothers At birth, prior to primary immunisations (age 2 months of age), one month after completion of primary immunisations (5 months of age), after booster vaccinations (13 months of age)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026