CompletedNCT02377349Updated Jan 28, 2020Results posted

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women

A Phase 4 interventional study of Boostrix™ and Saline placebo in Diphtheria-Tetanus-acellular Pertussis Vaccines, sponsored by GlaxoSmithKline. Completed at 35 sites in 6 countries. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-28.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 688
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Female

Study 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].

Read the 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.

Conditions studied

Diphtheria-Tetanus-acellular Pertussis Vaccines

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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.

Exclusion criteria for household contacts in Spain:

Child in care.
Concurrently participating in another clinical study, at any time during the study period, in which the household contact has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
History of an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine.
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. The preferred route of recording temperature will be axillary in household contacts.
- Household contacts with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Anything that would put the household contact at risk, as determined by the investigator.
Pregnant or lactating household contacts.
Household contacts planning to become pregnant or planning to discontinue contraceptive precautions prior to 2 months post-vaccination.

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Outcomes assessor)
Enrollment: 688 participants (actual)

Study arms

Experimental
dTpa Group
This group will consist of pregnant women who will receive a single dose of Boostrix™ at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and will receive a dose of the placebo post-delivery (within 72 hours).
Biological: Boostrix™ · Drug: Saline placebo
Placebo comparator
Control Group
This group will consist of pregnant women who will receive a single dose of placebo at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and will receive a dose of Boostrix™ post-delivery (within 72 hours).
Biological: Boostrix™ · Drug: Saline placebo

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.

What researchers measure

Primary outcomes

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)

Secondary outcomes

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).
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).
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
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
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
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
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)
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
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
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
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).
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).
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).
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).

Results

Posted Jan 28, 2019

Participant flow

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.

Participant flow — Overall Study
Milestone	dTpa Group - Mother	Control Group - Mother
Started	341	346
Completed	325	335
Not completed	16	11
Withdrew: Serious adverse event	1	0
Withdrew: Protocol violation	3	2
Withdrew: Withdrawal by subject	5	3
Withdrew: Lost to follow-up (partial vaccination)	1	0
Withdrew: Lost to follow-up (complete vaccination)	6	5
Withdrew: Other	0	1

Outcome measures

PrimaryAntibody 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)
Reported as:: Geometric mean · IU/mL

Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples
IU/mL	dTpa Group - Mother	Control Group - Mother
Anti-PT	46.9 (41.2 to 53.3)	5.5 (4.8 to 6.3)
Anti-FHA	366.1 (329 to 407.3)	22.7 (19.7 to 26.2)
Anti-PRN	301.8 (250.9 to 362.9)	14.6 (12.1 to 17.7)

Statistical analysis

dTpa Group - Mother vs Control Group - Mother · 2-sample t-test · Gmc ratio: 8.47 · 95% CI 7.02 to 10.2The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.
dTpa Group - Mother vs Control Group - Mother · 2-sample t-test · Gmc ratio: 16.11 · 95% CI 13.48 to 19.24The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.
dTpa Group - Mother vs Control Group - Mother · 2-sample t-test · Gmc ratio: 20.65 · 95% CI 15.86 to 26.88The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.

SecondaryPercentage 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).
Reported as:: Number · Percentage of subjects

Percentage of Subjects by Pregnancy Outcomes
Percentage of subjects	dTpa Group - Mother	Control Group - Mother
Live infant No apparent congenital anomaly	97.4 (95 to 98.8)	97.4 (95.1 to 98.8)
Live infant congenital anomaly	2.6 (1.2 to 5)	2.3 (1 to 4.5)
Lost to follow-up	0 (0 to 1.1)	0.3 (0 to 1.6)

SecondaryPercentage 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).
Reported as:: Number · Percentage of subjects

Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest
Percentage of subjects	dTpa Group - Mother	Control Group - Mother
Intrauterine growth restriction/poor foetal growth	1.5 (0.5 to 3.4)	0.6 (0.1 to 2.1)
Pre-eclampsia	0.3 (0 to 1.6)	1.4 (0.5 to 3.3)
Pregnancy-related hypertension	1.2 (0.3 to 3)	1.4 (0.5 to 3.3)
Premature labour	3.8 (2 to 6.4)	3.2 (1.6 to 5.6)
Premature rupture of membranes	3.8 (2 to 6.4)	4.3 (2.4 to 7)
Premature uterine contractions	0.6 (0.1 to 2.1)	0.9 (0.2 to 2.5)
Preterm birth	3.2 (1.6 to 5.7)	2.6 (1.2 to 4.9)
Preterm premature rupture of membranes	1.2 (0.3 to 3)	2 (0.8 to 4.1)
Small for gestational age	0.6 (0.1 to 2.1)	0.6 (0.1 to 2.1)
Vaginal or intrauterine haemorrhage	2.6 (1.2 to 5)	2.9 (1.4 to 5.3)

SecondaryPercentage 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
Reported as:: Number · Percentage of subjects

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
Percentage of subjects	dTpa Group - Mother	Control Group - Mother
Anti-D	97.6 (95.1 to 99)	70.6 (65 to 75.8)
Anti-T	100 (98.7 to 100)	96.6 (93.8 to 98.3)
Anti-PT	98.6 (96.5 to 99.6)	61.3 (55.5 to 66.9)
Anti-FHA	100 (98.7 to 100)	94.5 (91.2 to 96.8)
Anti-PRN	100 (98.7 to 100)	84.5 (79.9 to 88.5)

SecondaryAnti-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
Reported as:: Geometric mean · IU/mL

Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
IU/mL	dTpa Group - Mother	Control Group - Mother
Anti-D	2.19 (1.87 to 2.57)	0.23 (0.19 to 0.27)
Anti-T	8.43 (7.72 to 9.2)	0.98 (0.86 to 1.11)
Anti-PT	45.6 (40.4 to 51.5)	4.1 (3.6 to 4.6)
Anti-FHA	317.5 (285 to 353.8)	15 (13.1 to 17.2)
Anti-PRN	283.6 (237.1 to 339.1)	10.5 (8.7 to 12.5)

SecondaryPercentage 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
Reported as:: Number · Percentage of subjects

Percentage of Subjects With Vaccine Response to Anti-D and Anti-T
Percentage of subjects	dTpa Group - Mother	Control Group - Mother
Anti-D, S-	64.1 (54 to 73.3)	0 (0 to 4.3)
Anti-D, S+	75 (68.1 to 81.1)	0 (0 to 1.8)
Anti-D, Total	71.1 (65.5 to 76.3)	0 (0 to 1.3)
Anti-T, S-	100 (73.5 to 100)	0 (0 to 30.8)
Anti-T, S+	67.8 (61.9 to 73.2)	0 (0 to 1.3)
Anti-T, Total	69.1 (63.4 to 74.4)	0 (0 to 1.3)

SecondaryPercentage 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
Reported as:: Number · Percentage of subjects

Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
Percentage of subjects	dTpa Group - Mother	Control Group - Mother
Anti-PT, S-	82.6 (74.7 to 88.9)	0.9 (0 to 5.1)
Anti-PT, S+ (<4 cut-off)	90.7 (83.6 to 95.5)	0 (0 to 3.1)
Anti-PT, S+ (≥4 cut-off)	93.1 (83.3 to 98.1)	3 (0.4 to 10.4)
Anti-PT, Total	87.8 (83.4 to 91.4)	1 (0.2 to 3)
Anti-FHA, S-	100 (79.4 to 100)	0 (0 to 20.6)
Anti-FHA, S+ (<4 cut-off)	100 (95.7 to 100)	0 (0 to 5.5)
Anti-FHA, S+ (≥4 cut-off)	89.9 (84.7 to 93.8)	1.9 (0.5 to 4.8)
Anti-FHA, Total	93.4 (89.9 to 96)	1.4 (0.4 to 3.5)
Anti-PRN, S-	86.7 (73.2 to 94.9)	0 (0 to 8.2)
Anti-PRN, S+ (<4 cut-off)	95.9 (89.9 to 98.9)	0 (0 to 4.2)
Anti-PRN, S+ (≥4 cut-off)	86.2 (79.5 to 91.4)	1.2 (0.2 to 4.4)
Anti-PRN Total	89.6 (85.5 to 92.9)	0.7 (0.1 to 2.5)

SecondaryPercentage 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)
Reported as:: Number · Percentage of subjects

Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples
Percentage of subjects	dTpa Group - Mother	Control Group - Mother
Anti-PT	98.6 (96.5 to 99.6)	68.8 (63.2 to 74.1)
Anti-FHA	100 (98.7 to 100)	96.6 (93.8 to 98.3)
Anti-PRN	99.7 (98.1 to 100)	88 (83.7 to 91.5)

SecondaryPercentage 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
Reported as:: Number · Percentage of subjects

Percentage of Subjects With Solicited Local Adverse Events (AEs)
Percentage of subjects	dTpa Group - Mother	Control Group - Mother
Any Pain, Dose 1	86.3 (82.1 to 89.8)	14.6 (11 to 18.8)
Any Redness (mm), Dose 1	28.7 (23.9 to 33.8)	12.8 (9.5 to 16.8)
Any Swelling (mm), Dose 1	25.1 (20.5 to 30.1)	3.5 (1.8 to 6)
Any Pain, Dose 2	12.7 (9.2 to 16.8)	62.7 (57.3 to 68)
Any Redness (mm), Dose 2	10.5 (7.4 to 14.4)	29.7 (24.8 to 34.9)
Any Swelling (mm), Dose 2	5.2 (3.1 to 8.3)	26.4 (21.7 to 31.5)

SecondaryPercentage 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
Reported as:: Number · Percentage of subjects

Percentage of Subjects With Solicited General AEs
Percentage of subjects	dTpa Group - Mother	Control Group - Mother
Any Fatigue, Dose 1	43.6 (38.2 to 49.1)	36.3 (31.2 to 41.6)
Any Gastrointestinal symptom, Dose 1	17.9 (14 to 22.4)	15.2 (11.6 to 19.5)
Any Headache, Dose 1	24.8 (20.2 to 29.8)	22.8 (18.5 to 27.6)
Any Temperature/(Axillary) (°C), Dose 1	1.2 (0.3 to 3)	0.9 (0.2 to 2.5)
Any Fatigue, Dose 2	40.1 (34.7 to 45.7)	46.2 (40.8 to 51.8)
Any Gastrointestinal symptom, Dose 2	9.9 (6.9 to 13.7)	12.7 (9.3 to 16.8)
Any Headache, Dose 2	23.1 (18.7 to 28.1)	23.6 (19.1 to 28.5)
Any Temperature/(Axillary) (°C), Dose 2	4.6 (2.6 to 7.5)	9.1 (6.2 to 12.7)

SecondaryPercentage 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
Reported as:: Number · Percentage of subjects

Percentage of Subjects With Unsolicited AEs
Percentage of subjects	dTpa Group - Mother	Control Group - Mother
Any unsolicited AE, Dose 1	38.7 (33.5 to 44.1)	35.5 (30.5 to 40.8)
Any unsolicited AE, Dose 2	30.7 (25.8 to 35.9)	32.2 (27.2 to 37.4)

SecondaryPercentage of Infants With Unsolicited AEs

Time frame:: From delivery to Month 2 post delivery (Visit 4, end of the study).
Reported as:: Number · Percentage of subjects

Percentage of Infants With Unsolicited AEs
Percentage of subjects	dTpa Group - Infant	Control Group - Infnat
Percentage of Infants With Unsolicited AEs	26.4 (21.8 to 31.4)	22.3 (18.0 to 27.0)

SecondaryNumber 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).
Reported as:: Count of participants · Participants

Number of Subjects With Serious AEs (SAEs)
Participants	dTpa Group - Mother	Control Group - Mother	dTpa Group - Infant	Control Group - Infant	Household Group
Number of Subjects With Serious AEs (SAEs)	51	52	52	45	0

SecondaryPercentage 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).
Reported as:: Number · Percentage of household contacts

Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain
Percentage of household contacts	Household Group
Accepted vaccination	84.4 (81.5 to 86.9)
Received vaccination	84.1 (81.2 to 86.7)
Refused vaccination	15.6 (13.1 to 18.5)
Not coming to site	1.4 (0.7 to 2.5)
Refused to be vaccinated	13.4 (11 to 16.1)
Unspecified	0.8 (0.3 to 1.8)

SecondaryPercentage 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).
Reported as:: Number · Percentage of subjects

Percentage of Household Contacts With SAEs
Percentage of subjects	Household Group
Percentage of Household Contacts With SAEs	0

Adverse events

Collected over For the Mothers' Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants' Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
dTpa Group-Mother	0/341 (0%)	51/341 (15%)	321/341 (94.1%)
Control Group-Mother	0/346 (0%)	52/346 (15%)	303/346 (87.6%)
dTpa Group - Infant	0/341 (0%)	52/341 (15.2%)	33/341 (9.7%)
Control Group-Infant	0/346 (0%)	45/346 (13%)	29/346 (8.4%)
Household Group	0/608 (0%)	0/608 (0%)	0/608 (0%)

Most frequent serious events

Showing 10 of 93

Most frequent serious events
Event	dTpa Group-Mother	Control Group-Mother	dTpa Group - Infant	Control Group-Infant	Household Group
Premature rupture of membranesPregnancy, puerperium and perinatal conditions	13/341	17/346	0/341	0/346	0/608
Premature babyPregnancy, puerperium and perinatal conditions	0/341	0/346	11/341	9/346	0/608
Premature labourPregnancy, puerperium and perinatal conditions	11/341	11/346	0/341	0/346	0/608
JaundiceHepatobiliary disorders	0/341	0/346	8/341	6/346	0/608
Postpartum haemorrhagePregnancy, puerperium and perinatal conditions	5/341	7/346	0/341	0/346	0/608
Respiratory distressRespiratory, thoracic and mediastinal disorders	0/341	0/346	5/341	4/346	0/608
Pre-eclampsiaPregnancy, puerperium and perinatal conditions	1/341	5/346	0/341	0/346	0/608
Preterm premature rupture of membranesPregnancy, puerperium and perinatal conditions	4/341	5/346	0/341	0/346	0/608
Gestational hypertensionPregnancy, puerperium and perinatal conditions	4/341	4/346	0/341	0/346	0/608
Premature deliveryPregnancy, puerperium and perinatal conditions	4/341	4/346	0/341	0/346	0/608

Most frequent other events

Showing 10 of 213

Most frequent other events
Event	dTpa Group-Mother	Control Group-Mother	dTpa Group - Infant	Control Group-Infant	Household Group
Injection site painGeneral disorders	290/341	223/346	0/341	0/346	0/608
FatigueGeneral disorders	188/341	186/346	0/341	0/346	0/608
HeadacheNervous system disorders	129/341	126/346	0/341	0/346	0/608
Injection site erythemaGeneral disorders	106/341	117/346	0/341	0/346	0/608
Injection site swellingGeneral disorders	91/341	92/346	0/341	0/346	0/608
Gastrointestinal disorderGastrointestinal disorders	78/341	83/346	0/341	0/346	0/608
PyrexiaGeneral disorders	20/341	32/346	0/341	0/346	0/608
Afterbirth painPregnancy, puerperium and perinatal conditions	17/341	20/346	0/341	0/346	0/608
AnaemiaBlood and lymphatic system disorders	11/341	14/346	0/341	0/346	0/608
MastitisInfections and infestations	10/341	14/346	0/341	0/346	0/608

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	dTpa Group - Mother	Control Group - Mother	Total
Mean	32.7 ± 4.4	32.5 ± 4.3	32.6 ± 4.35

Sex/Gender, Customized
Sex/Gender, Customized(Participants)	dTpa Group - Mother	Control Group - Mother	Total
Female	341	346	687
Male	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	dTpa Group - Mother	Control Group - Mother	Total
African Heritage / African American	3	9	12
American Indian or Alaskan Native	2	0	2
Asian - Central/South Asian Heritage	3	0	3
Asian - East Asian Heritage	4	1	5
Asian - Japanese Heritage	1	0	1
Asian - South East Asian Heritage	1	1	2
White - Arabic / North African Heritage	3	7	10
White - Caucasian / European Heritage	314	319	633
Unspecified	10	9	19

Study locations

35 sites

GSK Investigational Site
Carlton, Victoria 3053, Australia
GSK Investigational Site
Fitzroy, Victoria 3065, Australia
GSK Investigational Site
Parkville, Victoria 3052, Australia
GSK Investigational Site
Calgary, Alberta T3B 6A8, Canada
GSK Investigational Site
Halifax, Nova Scotia B3K 6R8, Canada
GSK Investigational Site
Greater Sudbury, Ontario P3A 1W8, Canada
GSK Investigational Site
Montreal, Quebec H3T 1C5, Canada
GSK Investigational Site
Mount Royal, Quebec H3P 3W3, Canada
GSK Investigational Site
Brno, 613 00, Czechia
GSK Investigational Site
Hradec Králové, 500 02, Czechia
GSK Investigational Site
Ostrava - Vitkovice, 703 84, Czechia
GSK Investigational Site
Prague, 14059, Czechia
GSK Investigational Site
Prague, 14700, Czechia
GSK Investigational Site
Kokkola, 67100, Finland
GSK Investigational Site
Oulu, 90220, Finland
GSK Investigational Site
Seinäjoki, 60100, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Milan, Lombardy 20122, Italy
GSK Investigational Site
Milan, Lombardy 20142, Italy
GSK Investigational Site
Milan, Lombardy 20154, Italy
GSK Investigational Site
Novara, Piedmont 28100, Italy
GSK Investigational Site
Turin, Piedmont 10126, Italy
GSK Investigational Site
Málaga, Andalusia 29004, Spain
GSK Investigational Site
Antequera/Málaga, 29200, Spain
GSK Investigational Site
Aravaca, 28023, Spain
GSK Investigational Site
Boadilla del Monte, 28660, Spain
GSK Investigational Site
Burgos, 09006, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Majadahonda (Madrid), 28222, Spain
GSK Investigational Site
Móstoles, 28938, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Seville, 41013, Spain
GSK Investigational Site
Seville, 41940, Spain

References and documents

Publications

Perrett KP, Halperin SA, Nolan T, Martinez Pancorbo C, Tapiero B, Martinon-Torres F, Stranak Z, Virta M, Vanderkooi OG, Kosina P, Encinas Pardilla MB, Cristobal Garcia I, Zuccotti GV, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Marcos Fernandez M, Rodriguez Zambrano MA, Martin Garcia A, Asenjo de la Fuente JE, Camacho Marin MD, de la Calle Fernandez-Miranda M, Romero Espinar Y, Marchisio PG, Manzoni P, Mesaros N. Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial. Vaccine. 2020 Feb 18;38(8):2095-2104. doi: 10.1016/j.vaccine.2019.10.105. Epub 2019 Nov 24. PubMed 31776029 ↗

Study documents

Study protocol · Jul 15, 2015
Statistical analysis plan · Feb 20, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.

Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Data sharing details ↗ · clinicalstudydatarequest.com

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02377349
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Mar 3, 2015
Start date: Oct 14, 2015
Primary completion: Aug 14, 2017
Completion: Oct 24, 2017
Results posted: Jan 28, 2019
Last update: Jan 28, 2020

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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