Diphtheria-Tetanus-acellular Pertussis VaccinesPhase 4NCT02377349
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women
A Phase 4 study testing Boostrix™ in people with Diphtheria-Tetanus-acellular Pertussis Vaccines, run by GlaxoSmithKline at 35 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diphtheria-Tetanus-acellular Pertussis Vaccines
- What is being tested?
- Boostrix™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 688 participants
- Where
- 35 sitesin 6 countries
- Study dates
- 14 Oct 2015to 24 Oct 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 19Show fewer
- 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.
- 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.
Who cannot join
- 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.
Show all 38Show fewer
- 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.
- 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.
Trial locations and contacts
35 sites in 6 countries.
35 sites in 6 countries
Spain12 sites
GSK Investigational Site
Antequera/Málaga, 29200
GSK Investigational Site
Aravaca, 28023
GSK Investigational Site
Boadilla del Monte, 28660
GSK Investigational Site
Burgos, 09006
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Majadahonda (Madrid), 28222
GSK Investigational Site
Málaga, Andalusia, 29004
GSK Investigational Site
Móstoles, 28938
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Seville, 41940
Canada5 sites
GSK Investigational Site
Calgary, Alberta, T3B 6A8
GSK Investigational Site
Greater Sudbury, Ontario, P3A 1W8
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Montreal, Quebec, H3T 1C5
GSK Investigational Site
Mount Royal, Quebec, H3P 3W3
Czechia5 sites
GSK Investigational Site
Brno, 613 00
GSK Investigational Site
Hradec Králové, 500 02
GSK Investigational Site
Ostrava - Vitkovice, 703 84
GSK Investigational Site
Prague, 14059
GSK Investigational Site
Prague, 14700
Finland5 sites
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
Italy5 sites
GSK Investigational Site
Milan, Lombardy, 20122
GSK Investigational Site
Milan, Lombardy, 20142
GSK Investigational Site
Milan, Lombardy, 20154
GSK Investigational Site
Novara, Piedmont, 28100
GSK Investigational Site
Turin, Piedmont, 10126
Australia3 sites
GSK Investigational Site
Carlton, Victoria, 3053
GSK Investigational Site
Fitzroy, Victoria, 3065
GSK Investigational Site
Parkville, Victoria, 3052
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' dTpa Vaccine, Boostrix™ (263855) in Pregnant Women
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.
- Being tested
- Boostrix™, Saline placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boostrix™Biological
One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.
Saline placeboDrug
One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.
| Study group | Role | What they receive |
|---|---|---|
| dTpa Group | Experimental | 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). Receives: Biological: Boostrix™; Drug: Saline placebo |
| Control Group | Placebo comparator | 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). Receives: Biological: Boostrix™; Drug: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At delivery - Visit 3 (anytime after 28 weeks of gestation)
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start14 Oct 2015
- Primary completion14 Aug 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diphtheria-Tetanus-acellular Pertussis VaccinesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377349
- Sponsor's protocol ID
- 116945
- Other IDs
- 2014-001119-38, 2014
- Status last verified
- Jan 2020
- First submitted
- 26 Feb 2015
- Last updated
- 28 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
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 at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' dTpa Vaccine, Boostrix™ (263855) in Pregnant Women
- ClinicalTrials.gov ID
- NCT02377349
- Acronym / sponsor ID
- 116945
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2015 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dTpa Group | Experimental | Biological: Boostrix™, Drug: Saline placeboThis 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). |
| Control Group | Placebo comparator | Biological: Boostrix™, Drug: Saline placeboThis 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (38 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boostrix™One dose administered intramuscularly in the deltoid muscle of the non-dominant arm. | Biological | Control Group, dTpa Group |
| Saline placeboOne dose administered intramuscularly in the deltoid muscle of the non-dominant arm. | Drug | Control Group, dTpa Group |
Primary outcome
Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples
Time frame: 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.
14 secondary outcomes
Percentage of Subjects by Pregnancy Outcomes
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
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
Time frame: One month post vaccination (Day 30) during pregnancy
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: One month post vaccination (Day 30) during pregnancy
Percentage of Subjects With Vaccine Response to Anti-D and Anti-T
Time frame: One month post vaccination (Day 30) during pregnancy
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
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
Time frame: At delivery - Visit 3 (anytime after 27 eligible weeks of gestation)
Percentage of Subjects With Solicited Local Adverse Events (AEs)
Time frame: During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy
Percentage of Subjects With Solicited General AEs
Time frame: During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy
Percentage of Subjects With Unsolicited AEs
Time frame: Within 31 days (Day 0 - Day 30) after each vaccination
Percentage of Infants With Unsolicited AEs
Time frame: From delivery to Month 2 post delivery (Visit 4, end of the study).
Number of Subjects With Serious AEs (SAEs)
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
Time frame: From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).
Percentage of Household Contacts With SAEs
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31776029Perrett 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.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
Related trials for Diphtheria-Tetanus-acellular Pertussis Vaccines
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
Not yet recruitingObservational study
A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
Diphtheria, Tetanus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Boostrix™ in people with Diphtheria-Tetanus-acellular Pertussis Vaccines, run by GlaxoSmithKline at 35 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Spain, Canada, Czechia, Finland, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples (time frame: At delivery - Visit 3 (anytime after 28 weeks of gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.