Pertussis Infection MedDRA version: 20.0 Level: PT Classification code 10034738 Term: Pertussis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Boostrix
Product Name: Boostrix
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Trade Name: Infanrix hexa
Product Name: Infanrix hexa
Pharmaceutical Form: Powder and s
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Mothers • Only adult mothers who are generally healthy and with no chronic disease with regular therapy will be offered to be included. Infants • Infants born with = 37 weeks of gestational age • Written informed consent given by parent(s) or legal guardian(s) who is aged =18 years • Parent(s) or legal guardian(s) willing and able to comply with the requirements of the protocol for the duration of the study. • Infants due to receive their primary aP immunizations, aged up to 3 months (+- 4 days) • Maternal immunization: Exclusively for Arm 1: Received dTap vaccine during the current pregnancy Exclusively for Arm 2: Not received dTap during the current pregnancy Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Mothers • Mothers who have received dTap vaccine during the last 2 years are excluded. • Mothers will be excluded if there is any condition which in the opinion of the investigator may interfere with the ability to fulfill study requirements (this may include plans to move house and language comprehension). • Receipt of immunosuppressive treatment during pregnancy or known HIV positivity are also reasons for exclusion. Infats • Birth weight 0.5 ml/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed. • Administration of immunoglobulin and/or any blood products since birth or planned administration during the study period • History of allergy to any component of the vaccine • History of pertussis disease/whooping cough confirmed by laboratory analysis (serology, culture or other available methods)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate Pertussis Toxin (PT) specific antibody responses, 1 month following the second aP vaccine given at 5 months of age to infants whose mothers have (Arm 1) or have not (Arm 2) received a pertussis booster vaccine during pregnancy;Secondary Objective: 1. To assess the effect of baseline PT, FHA and PRN specific IgG antibody responses on the PT, FHA and PRN antibody responses in infants in Arm 1 vs Arm 2. 2. To compare pertussis antigen-specific plasma B-cell frequencies at 5 months + 7 days of age in infants from Arm 1 vs Arm 2 3. To compare pertussis antigen-specific memory B-cell frequencies at 6 months of age in infants from Arm 1 vs Arm 2. 4. To compare pertussis antigen specific T-cell responses at 6 months of age, in infants primed in Arm 1 vs Arm 2 groups 5. To compare serological responses to the non-pertussis vaccines (Hib, diphtheria, tetanus, pneumococcus, polio) in infants in Arm 1 vs Arm 2 groups. 6. Assessment of pertussis specific functional antibodies in infants in Arm 1 vs Arm 2. 7. To compare humoral, cellular, and functional immunity against pertussis, diphtheria and tetanus in children and in mothers between Arm 1 and Arm 2 when children are 3 years old. ;Primary end point(s): PT-specific IgG antibody GMC at 6 months in infants from Arm 1 versus Arm 2 groups.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.The difference in PT, FHA and PRN IgG antibody GMC in cord blood (Finland) and at 3 and 6 months of age in Arm 1 vs Arm 2 groups. (*) 2. Pertussis antigen-specific plasma B-cell frequencies at 5 month + 7 days of age measured by ELISpot in the Arm 1 vs Arm 2 infants. (*) 3. Pertussis antigen-specific memory B-cell frequencies at 6 months of age measured by ELISpot in the Arm 1 vs Arm 2 infants. (*) 4. Pertussis antigen-specific T-cell responses determined by cytokine analysis either from pertussis antigen stimulated whole blood samples/PBMC's and/or supernatants. (*) 5.Hib, diphtheria, tetanus, pneumococcal and polio-specific antibody responses at baseline and 6 months in Arm 1 vs Arm 2 infants. (*) 6. Assays of pertussis specific functional antibodies may include: PT neutralization; adherence inhibition; bacterial agglutination; bactericidal activity; bacterial opsonization and phagocytosis undertaken on plasma samples taken at 3 (prior to immunisation) and 6 months of age (1 month after the second dose). (*) 7. Same methods as above measured when children are 36 months old.;Timepoint(s) of evaluation of this end point: 1. at 3 and 6 months of age 2. at 5 month + 7 days of age 3. at 6 months of age 4. at 3 months and 6 months 5. at 3 months and 6 months 6. at 3 (prior to immunisation) and 6 months of age (1 month after the second dose 7. at 36 months of age | — |
Countries
Finland
Contacts
Public ContactPediatric clinic
Turku University Hospital
Outcome results
None listed