Diphtheria-Tetanus-acellular Pertussis Vaccines
Conditions
Brief summary
The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45 years. Infants born to mothers enrolled in this study will be followed-up in two separate clinical studies: 201330 \[DTPA (BOOSTRIX)-048 PRI\] and 201334 \[DTPA (BOOSTRIX)-049 BST: 048\].
Detailed description
The protocol was amended to include Spain in the study. The reasons for the Spain-specific amendment are listed below: * Based on the feedback from the Spanish Ethics Committee, the evaluation related to the acceptance of cocooning was added in the protocol. * The objectives and endpoints to include cocooning were added in the protocol. * The eligibility criteria for participation of household contacts were defined in the protocol. * The study procedures for household contacts were included.
Interventions
BIOLOGICALBoostrix™
One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.
DRUGSaline placebo
One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
for study subjects: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure, as per local regulations. * A healthy pregnant woman between, and including, 18 and 45 years of age at the time of screening. * Pregnant subjects at 27 0/7-36 6/7 weeks (completed 27 weeks but not 37 weeks) of gestation at the time of vaccination (Visit 1), as established by ultrasound examination. * Not at high risk for complications, as determined by the obstetrical algorithm for identification of eligible subjects and the Obstetrical Risk Assessment Form. * No significant foetal abnormalities, as observed by the level II ultrasound testing conducted after 18 weeks of gestation. * Nuchal translucency scan, serum testing and any other prenatal tests, if conducted, should suggest normal pregnancy. * Willing to have the infant born immunised with Infanrix hexa and Prevenar 13, as per national recommendations, in the follow-up clinical studies DTPA (BOOSTRIX)-048 PRI and DTPA (BOOSTRIX)-049 BST: 048. * Subjects who do not plan to give their child for adoption or place the child in care. Inclusion criteria for household contacts in Spain: * Household contacts living in the same house as that of the infant. * Household contacts or parent(s)/LAR(s) of the household contacts who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. reporting of SAEs). * Written informed consent obtained from the household contacts or the parent(s)/LAR(s) prior to vaccination, as per local regulations. * Household contacts who are eligible to receive a booster dose of DTP-containing vaccine according to the Summary of Product Characteristics (SmPC) of Boostrix and according to the local governmental recommendations in Spain. * Female household contacts of non-childbearing potential may be enrolled in the study. \- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female household contacts of childbearing potential may be enrolled in the study , if the household contact * has practiced adequate contraception for 30 days prior to vaccination, * has a negative pregnancy test on the day of vaccination and * has agreed to continue adequate contraception for 2 months after receiving the vaccine dose.
Exclusion criteria
for study subjects: * Subjects diagnosed with multiple pregnancies (twins, triplets etc.). * Previous vaccination containing diphtheria, tetanus or pertussis antigens or diphtheria and tetanus toxoids at any time during the current pregnancy. * Women with co-morbid medical or obstetric conditions that in the opinion of the investigator have the potential to complicate the pregnancy course and outcomes. * Gestational diabetes as determined by glucose tolerance test conducted after 20 weeks of gestation, as per local recommendations of the country. * History of early onset (\<34 weeks of gestation) of eclampsia/pre-eclampsia in previous pregnancy. * History of major congenital anomalies in previous pregnancies. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine anytime during the current pregnancy or planned use during the study period. * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. * Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed. * Administration of long-acting immune-modifying drugs at any time during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period within the period starting 30 days before and 30 days after the dose of vaccine with the exception of seasonal influenza vaccine that can be administered anytime during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). * Serious underlying medical condition \[e.g., immunosuppressive disease or therapy, human immunodeficiency virus infection, collagen vascular disease, epilepsy, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, infections including TORCHES (toxoplasmosis, rubella, cytomegalovirus, herpes simplex, syphilis) infections\]. * History of an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine. * History of transient thrombocytopenia or neurological complications (for convulsions or hypotonic-hyporesponsive episodes) following an earlier immunisation against diphtheria and/or tetanus * Significant mental illness (e.g. schizophrenia, psychosis and major depression). * Family history (first degree relatives only) of congenital anomalies, recurrent pregnancy losses (two or more consecutive losses) and unexplained neonatal death(s) in the subject. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * History of febrile illness within the past 72 hours. * History of physician-diagnosed or laboratory-confirmed pertussis within the past five years. * Anything that would prevent subject from completing the study or put the subject at risk, as determined by the investigator. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine, or planned administration during the study period, with the exception of anti-D (Rh)-immunoglobulin. * History of chronic excessive alcohol consumption and/or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples | At delivery - Visit 3 (anytime after 28 weeks of gestation) | Antibody concentrations were assessed by Enzyme-linked immunosorbent assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in International units per mililiter (IU/mL) for the following assay cut-offs: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | From Day 0 (Visit 1) to Month 2 post-delivery (Visit 4, end of the study). | Listed pregnancy-related adverse events of interest/ neonate-related events of interest included gestational diabetes, pregnancy-related hypertension, premature rupture of mem-branes, preterm premature rupture of membranes, premature labour, premature uterine contractions, intrauterine growth restriction/poor foetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine haemorrhage, maternal death, preterm birth, neonatal death, small for gestational age, neonatal hypoxic ischaemic encephalopathy and failure to thrive/growth deficiency were reported. |
| Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | One month post vaccination (Day 30) during pregnancy | A seroprotected subject against diphteria and tetanus was a subject with antibody concentration ≥ 0.1 IU/mL. A seropositive subject was a subjects with antibody concentration ≥ 2.693 IU/mL for anti-PT, ≥ 2.046 IU/mL for anti-FHA and ≥ 2.187 IU/mL for anti-PRN. |
| Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | One month post vaccination (Day 30) during pregnancy | Antibody concentrations were determined by ELISA, tabulated as GMCs and expressed in IU/mL. |
| Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | One month post vaccination (Day 30) during pregnancy | Vaccine response for anti-D and anti-T was defined as: for initially seronegative subjects (S-) with pre-vaccination concentration below cut-off: \< 0.1 IU/mL) was an antibody concentration at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) with pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration. |
| Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | One month post vaccination (Day 30) during pregnancy | Vaccine response to PT, FHA and PRN antigens is defined as: for subjects with pre-vaccination antibody concentration below the assay cut-off (S-), post-vaccination anti-body concentration ≥ 4 times the assay cut-off; for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off (S+), post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration, and for subjects with pre-vaccination antibody concentration ≥4 times the assay cut-off (S+), post-vaccination antibody concentration ≥2 times the pre-vaccination antibody concentration. |
| Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples | At delivery - Visit 3 (anytime after 27 eligible weeks of gestation) | For this assay the anti-PT, anti-FHA and anti-PRN seropositivity status was determined from the cord blood samples. The seropositivity cut-offs were the following: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN. |
| Percentage of Subjects by Pregnancy Outcomes | From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). | Pregnancy outcomes included live birth with no congenital anomalies, live birth with congenital anomalies, still birth with no congenital anomalies, still birth with congenital anomalies, elective termination with no congenital anomalies and elective termination with congenital anomalies. No subjects with still birth or elective termination of infant were reported. |
| Percentage of Subjects With Solicited General AEs | During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache and fever \[defined as oral, axillary or tympanic temperature ≥ 37.5 degrees Celsius (°C) or rectal temperature ≥ 38.0 °C\]. Any = any report of the specified symptom irrespective of intensity grade. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3. |
| Percentage of Subjects With Unsolicited AEs | Within 31 days (Day 0 - Day 30) after each vaccination | An unsolicited AE was any AE that was not solicited using a subject diary and that was spontaneously communicated by the subject. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3. |
| Percentage of Infants With Unsolicited AEs | From delivery to Month 2 post delivery (Visit 4, end of the study). | An unsolicited AE was any AE that was not solicited using a subject diary and that was spontaneously communicated by the subject. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. |
| Number of Subjects With Serious AEs (SAEs) | From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). | A SAE was any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject. |
| Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain | From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). | This analysis assessed the vaccination status of the household contacts (who accepted, received or refused vaccination) and also the reasons for refusal (not coming to site, refused to be vaccinated, unspecified) as part of an assessment of cocooning among the eligible household contacts. |
| Percentage of Household Contacts With SAEs | During the 31-day (Days 0-30) follow-up period post-vaccination (Boostrix administered preferably 2 weeks before the birth of the infant, Visit 3). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Percentage of Subjects With Solicited Local Adverse Events (AEs) | During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy | Assessed solicited local symptoms were pain, redness and swelling. Any = any report of the specified symptom irrespective of intensity grade. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3. |
Countries
Australia, Canada, Czechia, Finland, Italy, Spain
Participant flow
Recruitment details
A total of 725 pregnant subjects were screened of which 690 were randomized to 2 groups. Of these, 2 subjects were withdrawn before vaccination. Therefore 688 subjects were enrolled: 1 subject was excluded from the statistical analysis, leaving 687 subjects that comprised the Total Vaccinated cohort.
Pre-assignment details
Safety was assessed for infants born to vaccinated subjects as well as safety of dTap vaccination in the vaccinated pregnant subjects. There was also an assessment of the acceptance rate of a single dose of Boostrix among 723 eligible household contacts of the infants born to pregnant women enrolled in Spain, as part of an assessment of cocooning.
Participants by arm
| Arm | Count |
|---|---|
| dTpa Group - Mother This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours). | 341 |
| Control Group - Mother This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours). | 346 |
| Total | 687 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to follow-up (complete vaccination) | 6 | 5 |
| Overall Study | Lost to follow-up (partial vaccination) | 1 | 0 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Serious Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Control Group - Mother | Total | dTpa Group - Mother |
|---|---|---|---|
| Age, Continuous | 32.5 Years STANDARD_DEVIATION 4.3 | 32.6 Years STANDARD_DEVIATION 4.35 | 32.7 Years STANDARD_DEVIATION 4.4 |
| Race/Ethnicity, Customized African Heritage / African American | 9 Participants | 12 Participants | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Unspecified | 9 Participants | 19 Participants | 10 Participants |
| Race/Ethnicity, Customized White - Arabic / North African Heritage | 7 Participants | 10 Participants | 3 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 319 Participants | 633 Participants | 314 Participants |
| Sex/Gender, Customized Female | 346 Participants | 687 Participants | 341 Participants |
| Sex/Gender, Customized Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 341 | 0 / 346 | 0 / 341 | 0 / 346 | 0 / 608 |
| other Total, other adverse events | 321 / 341 | 303 / 346 | 33 / 341 | 29 / 346 | 0 / 608 |
| serious Total, serious adverse events | 51 / 341 | 52 / 346 | 52 / 341 | 45 / 346 | 0 / 608 |
Outcome results
Primary
Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples
Antibody concentrations were assessed by Enzyme-linked immunosorbent assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in International units per mililiter (IU/mL) for the following assay cut-offs: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN.
Time frame: At delivery - Visit 3 (anytime after 28 weeks of gestation)
Population: The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration, who had cord blood collected at least 21 days post-vaccination and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 3 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| dTpa Group - Mother | Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples | Anti-PT | 46.9 IU/mL |
| dTpa Group - Mother | Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples | Anti-FHA | 366.1 IU/mL |
| dTpa Group - Mother | Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples | Anti-PRN | 301.8 IU/mL |
| Control Group - Mother | Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples | Anti-PT | 5.5 IU/mL |
| Control Group - Mother | Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples | Anti-FHA | 22.7 IU/mL |
| Control Group - Mother | Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples | Anti-PRN | 14.6 IU/mL |
Comparison: GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.95% CI: [7.02, 10.2]2-sample t-test
Comparison: GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.95% CI: [13.48, 19.24]2-sample t-test
Comparison: GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.95% CI: [15.86, 26.88]2-sample t-test
Secondary
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were determined by ELISA, tabulated as GMCs and expressed in IU/mL.
Time frame: One month post vaccination (Day 30) during pregnancy
Population: The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| dTpa Group - Mother | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-T | 8.43 IU/mL |
| dTpa Group - Mother | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 317.5 IU/mL |
| dTpa Group - Mother | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 45.6 IU/mL |
| dTpa Group - Mother | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 283.6 IU/mL |
| dTpa Group - Mother | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-D | 2.19 IU/mL |
| Control Group - Mother | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 10.5 IU/mL |
| Control Group - Mother | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-D | 0.23 IU/mL |
| Control Group - Mother | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-T | 0.98 IU/mL |
| Control Group - Mother | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 4.1 IU/mL |
| Control Group - Mother | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 15 IU/mL |
Secondary
Number of Subjects With Serious AEs (SAEs)
A SAE was any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).
Population: The analysis was done on the TVC, which included all subjects with the study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dTpa Group - Mother | Number of Subjects With Serious AEs (SAEs) | 51 Participants |
| Control Group - Mother | Number of Subjects With Serious AEs (SAEs) | 52 Participants |
| dTpa Group - Infant | Number of Subjects With Serious AEs (SAEs) | 52 Participants |
| Control Group - Infant | Number of Subjects With Serious AEs (SAEs) | 45 Participants |
| Household Group | Number of Subjects With Serious AEs (SAEs) | 0 Participants |
Secondary
Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain
This analysis assessed the vaccination status of the household contacts (who accepted, received or refused vaccination) and also the reasons for refusal (not coming to site, refused to be vaccinated, unspecified) as part of an assessment of cocooning among the eligible household contacts.
Time frame: From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).
Population: This analysis was done on the Total cohort for household contacts in Spain, which included all eligible household contacts of the infants born to pregnant women vaccinated in Spain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group - Mother | Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain | Accepted vaccination | 84.4 Percentage of household contacts |
| dTpa Group - Mother | Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain | Received vaccination | 84.1 Percentage of household contacts |
| dTpa Group - Mother | Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain | Refused vaccination | 15.6 Percentage of household contacts |
| dTpa Group - Mother | Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain | Not coming to site | 1.4 Percentage of household contacts |
| dTpa Group - Mother | Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain | Refused to be vaccinated | 13.4 Percentage of household contacts |
| dTpa Group - Mother | Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain | Unspecified | 0.8 Percentage of household contacts |
Secondary
Percentage of Household Contacts With SAEs
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: During the 31-day (Days 0-30) follow-up period post-vaccination (Boostrix administered preferably 2 weeks before the birth of the infant, Visit 3).
Population: This analysis was done on the Total cohort for household contacts which included all eligible household contacts of the infants born to pregnant women vaccinated in Spain. For the analysis of safety, all vaccinated household contacts are considered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| dTpa Group - Mother | Percentage of Household Contacts With SAEs | 0 Percentage of subjects |
Secondary
Percentage of Infants With Unsolicited AEs
An unsolicited AE was any AE that was not solicited using a subject diary and that was spontaneously communicated by the subject. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time frame: From delivery to Month 2 post delivery (Visit 4, end of the study).
Population: The analysis was done on the TVC of Mother, which included all subjects with the study vaccine administration documented and who had returned their diary cards.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| dTpa Group - Mother | Percentage of Infants With Unsolicited AEs | 26.4 Percentage of subjects |
| Control Group - Mother | Percentage of Infants With Unsolicited AEs | 22.3 Percentage of subjects |
Secondary
Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples
For this assay the anti-PT, anti-FHA and anti-PRN seropositivity status was determined from the cord blood samples. The seropositivity cut-offs were the following: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN.
Time frame: At delivery - Visit 3 (anytime after 27 eligible weeks of gestation)
Population: The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration, who had cord blood collected at least 21 days post-vaccination and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 3 were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group - Mother | Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples | Anti-PT | 98.6 Percentage of subjects |
| dTpa Group - Mother | Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples | Anti-FHA | 100 Percentage of subjects |
| dTpa Group - Mother | Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples | Anti-PRN | 99.7 Percentage of subjects |
| Control Group - Mother | Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples | Anti-PT | 68.8 Percentage of subjects |
| Control Group - Mother | Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples | Anti-FHA | 96.6 Percentage of subjects |
| Control Group - Mother | Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples | Anti-PRN | 88 Percentage of subjects |
Secondary
Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN
A seroprotected subject against diphteria and tetanus was a subject with antibody concentration ≥ 0.1 IU/mL. A seropositive subject was a subjects with antibody concentration ≥ 2.693 IU/mL for anti-PT, ≥ 2.046 IU/mL for anti-FHA and ≥ 2.187 IU/mL for anti-PRN.
Time frame: One month post vaccination (Day 30) during pregnancy
Population: The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group - Mother | Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | Anti-T | 100 Percentage of subjects |
| dTpa Group - Mother | Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 100 Percentage of subjects |
| dTpa Group - Mother | Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 98.6 Percentage of subjects |
| dTpa Group - Mother | Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 100 Percentage of subjects |
| dTpa Group - Mother | Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | Anti-D | 97.6 Percentage of subjects |
| Control Group - Mother | Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 84.5 Percentage of subjects |
| Control Group - Mother | Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | Anti-D | 70.6 Percentage of subjects |
| Control Group - Mother | Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | Anti-T | 96.6 Percentage of subjects |
| Control Group - Mother | Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 61.3 Percentage of subjects |
| Control Group - Mother | Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 94.5 Percentage of subjects |
Secondary
Percentage of Subjects by Pregnancy Outcomes
Pregnancy outcomes included live birth with no congenital anomalies, live birth with congenital anomalies, still birth with no congenital anomalies, still birth with congenital anomalies, elective termination with no congenital anomalies and elective termination with congenital anomalies. No subjects with still birth or elective termination of infant were reported.
Time frame: From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).
Population: This analysis was performed on the Total Vaccinated cohort (TVC) which included all subjects with the study vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group - Mother | Percentage of Subjects by Pregnancy Outcomes | Live infant No apparent congenital anomaly | 97.4 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects by Pregnancy Outcomes | Live infant congenital anomaly | 2.6 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects by Pregnancy Outcomes | Lost to follow-up | 0 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects by Pregnancy Outcomes | Live infant No apparent congenital anomaly | 97.4 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects by Pregnancy Outcomes | Live infant congenital anomaly | 2.3 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects by Pregnancy Outcomes | Lost to follow-up | 0.3 Percentage of subjects |
Secondary
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest
Listed pregnancy-related adverse events of interest/ neonate-related events of interest included gestational diabetes, pregnancy-related hypertension, premature rupture of mem-branes, preterm premature rupture of membranes, premature labour, premature uterine contractions, intrauterine growth restriction/poor foetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine haemorrhage, maternal death, preterm birth, neonatal death, small for gestational age, neonatal hypoxic ischaemic encephalopathy and failure to thrive/growth deficiency were reported.
Time frame: From Day 0 (Visit 1) to Month 2 post-delivery (Visit 4, end of the study).
Population: This analysis was performed on the TVC which included all subjects with the study vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Intrauterine growth restriction/poor foetal growth | 1.5 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Pre-eclampsia | 0.3 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Pregnancy-related hypertension | 1.2 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Premature labour | 3.8 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Premature rupture of membranes | 3.8 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Premature uterine contractions | 0.6 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Preterm birth | 3.2 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Preterm premature rupture of membranes | 1.2 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Small for gestational age | 0.6 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Vaginal or intrauterine haemorrhage | 2.6 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Preterm premature rupture of membranes | 2 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Intrauterine growth restriction/poor foetal growth | 0.6 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Premature uterine contractions | 0.9 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Pre-eclampsia | 1.4 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Vaginal or intrauterine haemorrhage | 2.9 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Pregnancy-related hypertension | 1.4 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Preterm birth | 2.6 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Premature labour | 3.2 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Small for gestational age | 0.6 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest | Premature rupture of membranes | 4.3 Percentage of subjects |
Secondary
Percentage of Subjects With Solicited General AEs
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache and fever \[defined as oral, axillary or tympanic temperature ≥ 37.5 degrees Celsius (°C) or rectal temperature ≥ 38.0 °C\]. Any = any report of the specified symptom irrespective of intensity grade. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3.
Time frame: During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy
Population: The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group - Mother | Percentage of Subjects With Solicited General AEs | Any Fatigue, Dose 1 | 43.6 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited General AEs | Any Gastrointestinal symptom, Dose 1 | 17.9 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited General AEs | Any Headache, Dose 1 | 24.8 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited General AEs | Any Temperature/(Axillary) (°C), Dose 1 | 1.2 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited General AEs | Any Fatigue, Dose 2 | 40.1 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited General AEs | Any Gastrointestinal symptom, Dose 2 | 9.9 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited General AEs | Any Headache, Dose 2 | 23.1 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited General AEs | Any Temperature/(Axillary) (°C), Dose 2 | 4.6 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited General AEs | Any Temperature/(Axillary) (°C), Dose 2 | 9.1 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited General AEs | Any Fatigue, Dose 1 | 36.3 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited General AEs | Any Fatigue, Dose 2 | 46.2 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited General AEs | Any Gastrointestinal symptom, Dose 1 | 15.2 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited General AEs | Any Headache, Dose 2 | 23.6 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited General AEs | Any Headache, Dose 1 | 22.8 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited General AEs | Any Gastrointestinal symptom, Dose 2 | 12.7 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited General AEs | Any Temperature/(Axillary) (°C), Dose 1 | 0.9 Percentage of subjects |
Secondary
Percentage of Subjects With Solicited Local Adverse Events (AEs)
Assessed solicited local symptoms were pain, redness and swelling. Any = any report of the specified symptom irrespective of intensity grade. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3.
Time frame: During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy
Population: The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Pain, Dose 1 | 86.3 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Redness (mm), Dose 1 | 28.7 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Swelling (mm), Dose 1 | 25.1 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Pain, Dose 2 | 12.7 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Redness (mm), Dose 2 | 10.5 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Swelling (mm), Dose 2 | 5.2 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Redness (mm), Dose 2 | 29.7 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Pain, Dose 1 | 14.6 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Pain, Dose 2 | 62.7 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Redness (mm), Dose 1 | 12.8 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Swelling (mm), Dose 2 | 26.4 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Solicited Local Adverse Events (AEs) | Any Swelling (mm), Dose 1 | 3.5 Percentage of subjects |
Secondary
Percentage of Subjects With Unsolicited AEs
An unsolicited AE was any AE that was not solicited using a subject diary and that was spontaneously communicated by the subject. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3.
Time frame: Within 31 days (Day 0 - Day 30) after each vaccination
Population: The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group - Mother | Percentage of Subjects With Unsolicited AEs | Any unsolicited AE, Dose 1 | 38.7 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Unsolicited AEs | Any unsolicited AE, Dose 2 | 30.7 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Unsolicited AEs | Any unsolicited AE, Dose 1 | 35.5 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Unsolicited AEs | Any unsolicited AE, Dose 2 | 32.2 Percentage of subjects |
Secondary
Percentage of Subjects With Vaccine Response to Anti-D and Anti-T
Vaccine response for anti-D and anti-T was defined as: for initially seronegative subjects (S-) with pre-vaccination concentration below cut-off: \< 0.1 IU/mL) was an antibody concentration at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) with pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration.
Time frame: One month post vaccination (Day 30) during pregnancy
Population: The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-D, Total | 71.1 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-D, S- | 64.1 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-D, S+ | 75 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-T, S- | 100 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-T, S+ | 67.8 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-T, Total | 69.1 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-T, S+ | 0 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-T, S- | 0 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-D, S- | 0 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-T, Total | 0 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-D, S+ | 0 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-D and Anti-T | Anti-D, Total | 0 Percentage of subjects |
Secondary
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
Vaccine response to PT, FHA and PRN antigens is defined as: for subjects with pre-vaccination antibody concentration below the assay cut-off (S-), post-vaccination anti-body concentration ≥ 4 times the assay cut-off; for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off (S+), post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration, and for subjects with pre-vaccination antibody concentration ≥4 times the assay cut-off (S+), post-vaccination antibody concentration ≥2 times the pre-vaccination antibody concentration.
Time frame: One month post vaccination (Day 30) during pregnancy
Population: The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, S- | 82.6 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, S+ (<4 cut-off) | 90.7 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, S+ (≥4 cut-off) | 93.1 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, Total | 87.8 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, S- | 100 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, S+ (<4 cut-off) | 100 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, S+ (≥4 cut-off) | 89.9 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, Total | 93.4 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, S- | 86.7 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, S+ (<4 cut-off) | 95.9 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, S+ (≥4 cut-off) | 86.2 Percentage of subjects |
| dTpa Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN Total | 89.6 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, S+ (≥4 cut-off) | 1.2 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, S- | 0.9 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, S+ (≥4 cut-off) | 1.9 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, S+ (<4 cut-off) | 0 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, S+ (<4 cut-off) | 0 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, S+ (≥4 cut-off) | 3 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, Total | 1.4 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, Total | 1 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN Total | 0.7 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, S- | 0 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, S- | 0 Percentage of subjects |
| Control Group - Mother | Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, S+ (<4 cut-off) | 0 Percentage of subjects |