A Phase 2 interventional study of Tetanus and Diphtheria Toxoids Adsorbed and Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide in Clostridium Difficile Immunisation, Diphtheria and Diphtheria Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in 2 countries. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention
This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety, immunogenicity, and effect on infant immune responses of a single dose of Tetanus diphtheria acellular pertussis vaccine (Tdap) in pregnant women in Mali. 200 healthy pregnant women, ages 18 through 39 years, inclusive, who meet all eligibility criteria will be randomly allocated in a 2:1 ratio to receive either Tdap (BOOSTRIX) or Tetanus diphtheria toxoid (Td) at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). For the fetuses of pregnant subjects, GA will be established by ultrasound, whenever possible, in combination with date of last menstrual period (LMP), when available, and fundal height. Study duration is 21 months: approximately 2 months in the start-up period, 6 months enrolling subjects, and 13 months (3-7 months while pregnant and 6 months postpartum) from last subject vaccinated until she and her infant complete follow-up. The primary objectives of this study are: 1) to assess the safety and tolerability of a single 0.5 mL intramuscular injection of BOOSTRIX in pregnant women; 2) to assess the safety of a single maternal BOOSTRIX vaccination on the fetus and infant; 3) to assess the level of Pertussis Toxin (PT) antibody at birth among infants whose mothers received a single dose of BOOSTRIX or Td while pregnant.
This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety, immunogenicity, and effect on infant immune responses of a single dose of Tetanus diphtheria acellular pertussis vaccine (Tdap) in pregnant women in Mali. 200 healthy pregnant women, ages 18 through 39 years, inclusive, who meet all eligibility criteria will be randomly allocated in a 2:1 ratio to receive either Tdap (BOOSTRIX) or Tetanus diphtheria toxoid (Td) at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). For the fetuses of pregnant subjects, GA will be established by ultrasound, whenever possible, in combination with date of last menstrual period (LMP), when available, and fundal height. Study duration is 21 months: approximately 2 months in the start-up period, 6 months enrolling subjects, and 13 months (3-7 months while pregnant and 6 months postpartum) from last subject vaccinated until she and her infant complete follow-up. The primary objectives of this study are: 1) to assess the safety and tolerability of a single 0.5 mL intramuscular injection of BOOSTRIX in pregnant women; 2) to assess the safety of a single maternal BOOSTRIX vaccination on the fetus and infant; 3) to assess the level of Pertussis Toxin (PT) antibody at birth among infants whose mothers received a single dose of BOOSTRIX or Td while pregnant. The secondary objectives are: 1) to assess the antibody response to BOOSTRIX vaccine antigens in pregnant women one month after receipt of BOOSTRIX, at the time of delivery, and at 6 months after delivery; 2) to compare the antibody levels of BOOSTRIX vaccine antigens at birth (cord blood) and 6 weeks of age (before receiving any infant doses of Diphtheria, Tetanus, and whole-cell Pertussis (DTwP)) in infants whose mothers received BOOSTRIX or Td during pregnancy; 3) to assess placental antibody transfer by determining the ratio of maternal and infant BOOSTRIX -specific antibody responses at delivery; 4) to assess interference with infant antibody responses to DTwP either prior to the second dose of the primary DTwP series, at approximately 10 weeks of age (in 1/2 of subjects), or approximately one month after the third dose of the primary DTwP series, at approximately 18 weeks of age (in 1/2 of subjects), and at 6 months of age (all subjects).
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 399 is below the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Provide written consent after the nature of the study has been explained according to local regulatory requirements and prior to any study procedures*.
*Prior to obtaining individual for each subject, the investigators will obtain community consent by discussing the trial with all the appropriate local groups, as necessary, to obtain permission to approach the subjects. Written, informed consent for participation in the trial will be obtained by the investigators from all individual subjects. The consent forms will be written in French, the official language of Mali, and will be translated into Bambara, the most prevalent of the local languages, and recorded on audiotape.
In good health as determined by medical history, targeted physical examination* (physical examination performed as part of routine antenatal care of a study-specific brief exam may be used to determine eligibility), vital signs (oral temperature \< 37.8 degrees Celsius; pulse 55 to 100 beats per minute (bpm), inclusive; systolic blood pressure 90 to 140 millimeters of mercury (mm Hg), inclusive; diastolic blood pressure 55 to 90 mm Hg, inclusive), and clinical judgment of the investigator.
*If indicated based on medical history, to evaluate acute or currently ongoing chronic medical diagnoses or conditions that would affect the assessment of eligibility and safety of subjects. Chronic medical diagnoses or conditions being actively managed must be within acceptable limits in the last 180 days. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and the study vaccination are acceptable provided the subject is asymptomatic, condition stable, and there is no additional risk to the subject or interference with the evaluation of responses to the study vaccination.
Exclusion Criteria:
Fever (oral temperature > / = 37.8 degrees Celsius/100.0 degrees Fahrenheit) or other acute illness within 3 days prior to study vaccination*.
*An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
Receipt of an experimental agent or device within 30 days prior to vaccination, or the expected receipt of an experimental agent* (other than BOOSTRIX) during this trial-reporting period.
*Experimental agents include vaccines, drugs, biologics, devices, blood products, and medications. Subjects who have received a licensed product, as a subject in a clinical trial, within 30 days prior to vaccination or who are expecting to enroll in such a trial during the study period will also be excluded. Observational studies, surveys, and other studies that do not involve experimental agents or devices are allowed.
High risk for serious obstetrical complication (refer to ACOG Practice Bulletins for definitions, as necessary)*.
*Including the following: (a) gestational hypertension (well controlled history of essential or gestational hypertension, as evidenced by normal BPs as defined above, is allowed), (b) gestational diabetes not controlled by diet and exercise (the use of insulin or glyburide to control gDM, at the time of enrollment, is exclusionary), (c) current pre-eclampsia or eclampsia, (d) known current multiple gestation, (e)history of preterm delivery before EGA 35 weeks 0 days or current preterm labor, and/or (f) known intrauterine fetal growth restriction (defined as ultrasound confirmation of an estimated fetal weight that is less than the 10th percentile for gestational age).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.5 ml single dose of Tdap (Tetanus, Diphtheria, Acellular Pertussis Vaccine), BOOSTRIX administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). N=133
Biological: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide
0.5 ml single dose of Td (Tetanus, Diphtheria Toxoid) administered intramuscularly to pregnant women at 14 0/7 weeks through 26 6/7 weeks estimated GA. N=67
Biological: Tetanus and Diphtheria Toxoids Adsorbed
Drug page: Tetanus and Diphtheria Toxoids Adsorbed
Used for active immunization of adults and children 7 years of age and older against diphtheria and tetanus.
A sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on Aluminum hydroxide.
Number of Pregnant Women Reporting Related Serious Adverse Events (SAEs) and Unrelated SAEs
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of first study vaccination through approximately 6 months after the first study vaccination
Time frame: Study Day 1 through Day 180 (6-months post-partum)
Number of Pregnant Women Reporting Pregnancy-Specific Adverse Events (AEs)
Pregnancy related AEs include: pregnancy loss (graded as severe \[grade 3\] if occurred), bleeding during pregnancy prior to the onset of labor, postpartum hemorrhage, postabortal endometritis/salpingitis, preterm rupture of membranes, preterm contractions/labor/delivery, poor fetal growth, hypertension, preeclampsia/eclampsia, chorioamnionitis, postpartum endometriosis, gestational diabetes mellitus, and/or pregnancy-related clinical AE not previously identified in this list.
Time frame: Study Day 1 through Day 180 (6-months post-partum)
Number of Infants Reporting Related SAEs and Unrelated SAEs
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of birth through 6 months of age.
Time frame: Birth Day through 6 months of age
Number of Infants Reporting Pregnancy-specific AEs
Infant pregnant related AEs include: preterm birth, low birth weight, neonatal complications in a term infant, congenital anomalies/birth defects, and/or clinical AE in the newborn not identified previously in this list.
Time frame: Birth Day through 6 months of age
Number of Pregnant Women Reporting Solicited Injection Site and Systemic Reactogenicity Events
Local AEs solicited on a memory aid provided to participants included Pain, Tenderness, Ecchymosis (functional grade based on interference with daily activities), Ecchymosis (any measured value \>0mm), Erythema (functional grade), Erythema (any measured value \>0mm), Induration (functional grade), and Induration (any measured value \>0mm). Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, Allergic reaction, and Nausea. Participants are considered reporting the local or systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Time frame: Pre-Dose Day 1, Post-Dose Day 1, Day 4, Day 8
Number of Pregnant Women Reporting Unsolicited Non-serious AEs
Frequency of all unsolicited non-serious AEs from day of study vaccination (Day 1) to Day 31, compared between those who received BOOSTRIX and those who received Td.
Time frame: Day 1 through Day 31
Geometric Mean Concentration (GMC) of Serum IgG Antibodies to Pertussis Toxin (PT) in Infants Born to Women Receiving BOOSTRIX or Td
Geometric Mean Concentration (GMC) of serum IgG antibodies to PT as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td. DTwP is Diphtheria, Tetanus, and whole cell Pertussis vaccine.
Time frame: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age
GMC of Serum IgG Antibodies to PT in Pregnant Women Receiving BOOSTRIX or Td
GMC of serum IgG antibodies to PT as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.
Time frame: Pre-dose Day 1, One month after vaccination, at delivery, Day 180 (approximately 6 months after delivery)
GMC of Serum IgG Antibodies to Filamentous Hemagglutinin (FHA) in Pregnant Women Receiving BOOSTRIX or Td
GMC of serum IgG antibodies to FHA as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.
Time frame: Pre-dose Day 1, One month after vaccination, at delivery, Day 180 (approximately 6 months after delivery)
GMC of Serum IgG Antibodies to Pertactin (PRN) in Pregnant Women Receiving BOOSTRIX or Td
GMC of serum IgG antibodies to PRN as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.
Time frame: Pre-dose Day 1, One month after vaccination, at delivery, Day 180 (approximately 6 months after delivery)
GMC of Serum IgG Antibodies to Tetanus in Pregnant Women Receiving BOOSTRIX or Td
GMC of serum IgG antibodies to Tetanus as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.
Time frame: Pre-dose Day 1, One month after vaccination, at delivery, Day 180 (approximately 6 months after delivery)
GMC of Serum IgG Antibodies to Diphtheria in Pregnant Women Receiving BOOSTRIX or Td
GMC of serum IgG antibodies to Diphtheria as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.
Time frame: Pre-dose Day 1, One month after vaccination, at delivery, Day 180 (approximately 6 months after delivery)
GMC of Serum IgG Antibodies to FHA in Infants Born to Women Receiving BOOSTRIX or Td
GMC of serum IgG antibodies to FHA as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.
Time frame: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age
GMC of Serum IgG Antibodies to PRN in Infants Born to Women Receiving BOOSTRIX or Td
GMC of serum IgG antibodies to PRN as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.
Time frame: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age
GMC of Serum IgG Antibodies to Tetanus in Infants Born to Women Receiving BOOSTRIX or Td
GMC of serum IgG antibodies to Tetanus as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.
Time frame: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age
GMC of Serum IgG Antibodies to Diphtheria in Infants Born to Women Receiving BOOSTRIX or Td
GMC of serum IgG antibodies to Diphtheria as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.
Time frame: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age
GMC of Serum IgG Antibodies to Fimbriae 2/3 (FIM 2/3) in Infants Born to Women Receiving BOOSTRIX or Td
GMC of serum IgG antibodies to FIM 2/3 as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.
Time frame: Birth Day, Prior to receipt of first dose of DTwP (approximately 6 weeks of age), One month after receipt of first dose of DTwP (approximately 10 weeks of age), One month after receipt of last dose of DTwP (approximately 18 weeks of age), 6 months of age
Geometric Mean Ratio (GMR) of Maternal and Infant-specific Tdap-specific Antibodies
GMR of maternal and infant-specific Tdap-specific antibodies (PT, FHA, PRN, tetanus, diphtheria) as measured by ELISA at delivery/birth after intrapartum receipt of BOOSTRIX versus Td. GMR represents the geometric mean ratio in infant antibody concentration at birth to maternal antibody concentration at delivery.
Time frame: Time of delivery
Participants recruited for this study include pregnant women in their first and second trimesters, 18 to 39 years of age, inclusive, who met all eligibility criteria and were deemed to be in good health. The infants of the pregnant participants were also enrolled and followed from birth to 6 months of age. Participants were enrolled between 24JAN2019 and 03JAN2020.
| Milestone | BOOSTRIX - Maternal | Td - Maternal | BOOSTRIX - Infant | Td - Infant |
|---|---|---|---|---|
| Started | 134 | 67 | 131 | 67 |
| Completed | 130 | 67 | 123 | 64 |
| Not completed | 4 | 0 | 8 | 3 |
| Withdrew: Death | 1 | 0 | 8 | 3 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 |
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of first study vaccination through approximately 6 months after the first study vaccination
| Participants | BOOSTRIX - Maternal | Td - Maternal |
|---|---|---|
| Related SAEs | 0 | 0 |
| Unrelated SAEs | 20 | 10 |
Pregnancy related AEs include: pregnancy loss (graded as severe \[grade 3\] if occurred), bleeding during pregnancy prior to the onset of labor, postpartum hemorrhage, postabortal endometritis/salpingitis, preterm rupture of membranes, preterm contractions/labor/delivery, poor fetal growth, hypertension, preeclampsia/eclampsia, chorioamnionitis, postpartum endometriosis, gestational diabetes mellitus, and/or pregnancy-related clinical AE not previously identified in this list.
| Participants | BOOSTRIX - Maternal | Td - Maternal |
|---|---|---|
| Mild AEs | 5 | 1 |
| Moderate AEs | 8 | 7 |
| Severe AEs | 13 | 5 |
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of birth through 6 months of age.
| Participants | BOOSTRIX - Infant | Td - Infant |
|---|---|---|
| Related SAEs | 0 | 0 |
| Unrelated SAEs | 13 | 6 |
Infant pregnant related AEs include: preterm birth, low birth weight, neonatal complications in a term infant, congenital anomalies/birth defects, and/or clinical AE in the newborn not identified previously in this list.
| Participants | BOOSTRIX - Infant | Td - Infant |
|---|---|---|
| Mild AEs | 0 | 0 |
| Moderate AEs | 15 | 5 |
| Severe AEs | 6 | 2 |
Local AEs solicited on a memory aid provided to participants included Pain, Tenderness, Ecchymosis (functional grade based on interference with daily activities), Ecchymosis (any measured value \>0mm), Erythema (functional grade), Erythema (any measured value \>0mm), Induration (functional grade), and Induration (any measured value \>0mm). Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, Allergic reaction, and Nausea. Participants are considered reporting the local or systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
| Participants | BOOSTRIX - Maternal | Td - Maternal |
|---|---|---|
| Pre-Dose | 0 | 0 |
| Post-dose | 3 | 4 |
| Day 4 | 6 | 8 |
| Day 8 | 0 | 0 |
Frequency of all unsolicited non-serious AEs from day of study vaccination (Day 1) to Day 31, compared between those who received BOOSTRIX and those who received Td.
| Participants | BOOSTRIX - Maternal | Td - Maternal |
|---|---|---|
| Number of Pregnant Women Reporting Unsolicited Non-serious AEs | 6 | 2 |
Geometric Mean Concentration (GMC) of serum IgG antibodies to PT as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td. DTwP is Diphtheria, Tetanus, and whole cell Pertussis vaccine.
| IU/mL | BOOSTRIX - Infant | Td - Infant |
|---|---|---|
| At birth | 55.4 (46.2 to 66.6) | 7.9 (5.4 to 11.5) |
| Prior to receipt of first dose of DTwP (approximately 6 weeks of age) | 21.0 (17.3 to 25.5) | 4.3 (3.0 to 6.2) |
| One month after receipt of first dose of DTwP (approximately 10 weeks of age) | 15.0 (11.4 to 19.7) | 5.1 (3.3 to 8.1) |
| One month after receipt of last dose of DTwP (approximately 18 weeks of age) | 20.2 (13.7 to 29.9) | 77.2 (32.2 to 184.8) |
| 6 months of age | 17.3 (12.8 to 23.4) | 67.1 (35.5 to 126.7) |
GMC of serum IgG antibodies to PT as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.
| IU/mL | BOOSTRIX - Maternal | Td - Maternal |
|---|---|---|
| Pre-vaccination | 9.1 (7.5 to 11.1) | 9.8 (7.3 to 13.1) |
| One month after vaccination | 90.0 (76.8 to 105.6) | 10.4 (7.8 to 13.9) |
| Delivery | 47.0 (40.1 to 55.1) | 10.1 (7.4 to 13.6) |
| 6 months after delivery | 40.9 (33.3 to 50.2) | 12.2 (8.2 to 18.2) |
GMC of serum IgG antibodies to FHA as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.
| IU/mL | BOOSTRIX - Maternal | Td - Maternal |
|---|---|---|
| Pre-vaccination | 28.6 (24.4 to 33.6) | 27.1 (21.5 to 34.2) |
| One month after vaccination | 545.3 (463.6 to 641.4) | 29.5 (23.7 to 36.8) |
| Delivery | 321.5 (275.0 to 375.8) | 30.6 (24.8 to 37.7) |
| 6 months after delivery | 259.0 (205.3 to 326.6) | 34.9 (24.7 to 49.3) |
GMC of serum IgG antibodies to PRN as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.
| IU/mL | BOOSTRIX - Maternal | Td - Maternal |
|---|---|---|
| Pre-vaccination | 5.6 (4.4 to 6.9) | 4.6 (3.5 to 6.0) |
| One month after vaccination | 255.3 (186.4 to 349.9) | 4.7 (3.6 to 6.2) |
| Delivery | 164.6 (121.0 to 224.1) | 5.1 (3.7 to 7.1) |
| 6 months after delivery | 97.1 (61.5 to 153.5) | 5.1 (3.5 to 7.6) |
GMC of serum IgG antibodies to Tetanus as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.
| IU/mL | BOOSTRIX - Maternal | Td - Maternal |
|---|---|---|
| Pre-vaccination | 1.3 (1.0 to 1.7) | 1.3 (0.9 to 1.9) |
| One month after vaccination | 6.6 (5.8 to 7.4) | 10.4 (8.8 to 12.2) |
| Delivery | 3.3 (2.9 to 3.8) | 4.6 (3.9 to 5.5) |
| 6 months after delivery | 2.9 (2.3 to 3.6) | 3.8 (3.1 to 4.5) |
GMC of serum IgG antibodies to Diphtheria as measured by Enzyme-Linked Immunosorbent Assay (ELISA) between women vaccinated with BOOSTRIX or Td.
| IU/mL | BOOSTRIX - Maternal | Td - Maternal |
|---|---|---|
| Pre-vaccination | 0.2 (0.1 to 0.2) | 0.2 (0.1 to 0.2) |
| One month after vaccination | 1.3 (1.1 to 1.6) | 1.5 (1.1 to 2.0) |
| Delivery | 0.8 (0.6 to 0.9) | 0.9 (0.6 to 1.2) |
| 6 months after delivery | 0.6 (0.5 to 0.9) | 0.9 (0.6 to 1.4) |
GMC of serum IgG antibodies to FHA as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.
| IU/mL | BOOSTRIX - Infant | Td - Infant |
|---|---|---|
| At birth | 387.5 (327.9 to 457.9) | 28.4 (22.2 to 36.3) |
| Prior to receipt of first dose of DTwP (approximately 6 weeks of age) | 143.5 (121.8 to 169.1) | 13.3 (10.1 to 17.6) |
| One month after receipt of first dose of DTwP (approximately 10 weeks of age) | 89.4 (70.7 to 113.2) | 8.7 (6.2 to 12.3) |
| One month after receipt of last dose of DTwP (approximately 18 weeks of age) | 46.2 (37.8 to 56.4) | 22.5 (15.9 to 31.7) |
| 6 months of age | 23.9 (19.2 to 29.8) | 20.7 (14.2 to 30.2) |
GMC of serum IgG antibodies to PRN as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.
| IU/mL | BOOSTRIX - Infant | Td - Infant |
|---|---|---|
| At birth | 184.5 (130.6 to 260.6) | 4.0 (2.7 to 5.9) |
| Prior to receipt of first dose of DTwP (approximately 6 weeks of age) | 72.6 (51.7 to 101.9) | 1.8 (1.3 to 2.7) |
| One month after receipt of first dose of DTwP (approximately 10 weeks of age) | 47.1 (33.2 to 66.8) | 4.5 (3.1 to 6.6) |
| One month after receipt of last dose of DTwP (approximately 18 weeks of age) | 48.6 (34.9 to 67.8) | 80.2 (52.2 to 123.1) |
| 6 months of age | 28.4 (21.6 to 37.3) | 39.1 (28.2 to 54.2) |
GMC of serum IgG antibodies to Tetanus as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.
| IU/mL | BOOSTRIX - Infant | Td - Infant |
|---|---|---|
| At birth | 4.1 (3.5 to 4.8) | 5.9 (5.0 to 7.0) |
| Prior to receipt of first dose of DTwP (approximately 6 weeks of age) | 1.4 (1.2 to 1.6) | 2.0 (1.7 to 2.4) |
| One month after receipt of first dose of DTwP (approximately 10 weeks of age) | 0.8 (0.6 to 0.9) | 1.1 (0.9 to 1.3) |
| One month after receipt of last dose of DTwP (approximately 18 weeks of age) | 0.9 (0.6 to 1.2) | 1.5 (0.9 to 2.4) |
| 6 months of age | 0.8 (0.6 to 1.1) | 1.0 (0.7 to 1.4) |
GMC of serum IgG antibodies to Diphtheria as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.
| IU/mL | BOOSTRIX - Infant | Td - Infant |
|---|---|---|
| At birth | 0.8 (0.7 to 1.0) | 0.9 (0.7 to 1.3) |
| Prior to receipt of first dose of DTwP (approximately 6 weeks of age) | 0.3 (0.2 to 0.4) | 0.3 (0.2 to 0.4) |
| One month after receipt of first dose of DTwP (approximately 10 weeks of age) | 0.2 (0.1 to 0.3) | 0.2 (0.1 to 0.3) |
| One month after receipt of last dose of DTwP (approximately 18 weeks of age) | 0.2 (0.2 to 0.3) | 0.4 (0.2 to 0.6) |
| 6 months of age | 0.2 (0.1 to 0.2) | 0.1 (0.1 to 0.2) |
GMC of serum IgG antibodies to FIM 2/3 as measured by Enzyme-Linked Immunosorbent Assay (ELISA) at birth between infants born to women vaccinated with BOOSTRIX or Td.
| IU/mL | BOOSTRIX - Infant | Td - Infant |
|---|---|---|
| At birth | 23.9 (17.8 to 32.0) | 15.2 (9.8 to 23.8) |
| Prior to receipt of first dose of DTwP (approximately 6 weeks of age) | 9.5 (7.1 to 12.7) | 6.9 (4.5 to 10.4) |
| One month after receipt of first dose of DTwP (approximately 10 weeks of age) | 10.9 (7.8 to 15.3) | 6.8 (4.8 to 9.7) |
| One month after receipt of last dose of DTwP (approximately 18 weeks of age) | 254.0 (153.3 to 420.6) | 517.6 (292.2 to 916.8) |
| 6 months of age | 274.3 (191.7 to 392.6) | 465.6 (316.7 to 684.6) |
GMR of maternal and infant-specific Tdap-specific antibodies (PT, FHA, PRN, tetanus, diphtheria) as measured by ELISA at delivery/birth after intrapartum receipt of BOOSTRIX versus Td. GMR represents the geometric mean ratio in infant antibody concentration at birth to maternal antibody concentration at delivery.
| ratio | BOOSTRIX - Infant | Td - Infant |
|---|---|---|
| Pertussis Toxin (PT) | 1.2 (1.1 to 1.2) | 0.8 (0.7 to 0.9) |
| Filamentous Hemagluttin (FHA) | 1.2 (1.2 to 1.3) | 0.9 (0.8 to 1.0) |
| Pertactin (PRN) | 1.1 (1.1 to 1.2) | 0.8 (0.7 to 0.9) |
| Tetanus | 1.2 (1.2 to 1.3) | 1.3 (1.2 to 1.3) |
| Diphtheria | 1.1 (1.0 to 1.1) | 1.1 (1.0 to 1.1) |
Collected over Study vaccine-related Serious Adverse Events (SAE) occurring from the time of study vaccination through 6 months postpartum (180 days of life for the infant visit) for pregnant participants and infants were collected. Solicited Adverse Events (AEs) were collected from time of study vaccination through 7 days after study vaccination (Day 8). Unsolicited non-serious AEs were collected from time of study vaccination through approximately 30 days after study vaccination (Day 31).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BOOSTRIX - Maternal | 1/133 (0.8%) | 20/133 (15%) | 35/133 (26.3%) |
| Td - Maternal | 0/67 (0%) | 10/67 (14.9%) | 24/67 (35.8%) |
| BOOSTRIX - Infant | 8/126 (6.3%) | 13/126 (10.3%) | 0/126 (0%) |
| Td - Infant | 3/66 (4.5%) | 6/66 (9.1%) | 0/66 (0%) |
| Event | BOOSTRIX - Maternal | Td - Maternal | BOOSTRIX - Infant | Td - Infant |
|---|---|---|---|---|
| Preterm BirthPregnancy, puerperium and perinatal conditions | 0/133 | 0/67 | 7/126 | 4/66 |
| Preterm DeliveryPregnancy, puerperium and perinatal conditions | 8/133 | 4/67 | 0/126 | 0/66 |
| Neonatal InfectionInfections and infestations | 0/133 | 0/67 | 5/126 | 1/66 |
| Fetal DistressPregnancy, puerperium and perinatal conditions | 4/133 | 0/67 | 0/126 | 0/66 |
| Spontaneous AbortionPregnancy, puerperium and perinatal conditions | 3/133 | 0/67 | 0/126 | 0/66 |
| Perinatal AnoxiaRespiratory, thoracic and mediastinal disorders | 0/133 | 0/67 | 2/126 | 1/66 |
| PneumoniaInfections and infestations | 0/133 | 0/67 | 2/126 | 0/66 |
| Acute Respiratory InfectionInfections and infestations | 0/133 | 0/67 | 0/126 | 1/66 |
| Postpartum HemorrhagePregnancy, puerperium and perinatal conditions | 2/133 | 0/67 | 0/126 | 0/66 |
| StillbirthPregnancy, puerperium and perinatal conditions | 2/133 | 1/67 | 0/126 | 0/66 |
| Event | BOOSTRIX - Maternal | Td - Maternal | BOOSTRIX - Infant | Td - Infant |
|---|---|---|---|---|
| Blood pressure diastolic increasedInvestigations | 20/133 | 11/67 | 0/126 | 0/66 |
| Injection site painGeneral disorders | 9/133 | 10/67 | 0/126 | 0/66 |
| Heart rate increasedInvestigations | 10/133 | 6/67 | 0/126 | 0/66 |
| Blood pressure systolic increasedInvestigations | 7/133 | 2/67 | 0/126 | 0/66 |
Population includes all maternal participants who received the study vaccine or infants born to mothers who received the study vaccine.
| Age, Categorical(Participants) | BOOSTRIX - Maternal | Td - Maternal | BOOSTRIX - Infant | Td - Infant | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 126 | 66 | 192 |
| Between 18 and 65 years | 133 | 67 | 0 | 0 | 200 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | BOOSTRIX - Maternal | Td - Maternal | BOOSTRIX - Infant | Td - Infant | Total |
|---|---|---|---|---|---|
| Mothers | 25.7 ± 5.6 | 25.4 ± 5.4 | — | — | 25.6 ± 5.5 |
| Infants | — | — | 0 ± 0 | 0 ± 0 | 0 ± 0 |
| Sex: Female, Male(Participants) | BOOSTRIX - Maternal | Td - Maternal | BOOSTRIX - Infant | Td - Infant | Total |
|---|---|---|---|---|---|
| Female | 133 | 67 | 58 | 34 | 292 |
| Male | 0 | 0 | 68 | 32 | 100 |
| Ethnicity (NIH/OMB)(Participants) | BOOSTRIX - Maternal | Td - Maternal | BOOSTRIX - Infant | Td - Infant | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 133 | 67 | 126 | 66 | 392 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BOOSTRIX - Maternal | Td - Maternal | BOOSTRIX - Infant | Td - Infant | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 133 | 67 | 126 | 66 | 392 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | BOOSTRIX - Maternal | Td - Maternal | BOOSTRIX - Infant | Td - Infant | Total |
|---|---|---|---|---|---|
| Mali | 133 | 67 | 126 | 66 | 392 |
| Gestational Age (GA) at Vaccination (weeks)(Participants) | BOOSTRIX - Maternal | Td - Maternal | BOOSTRIX - Infant | Td - Infant | Total |
|---|---|---|---|---|---|
| 14-17 weeks | 58 | 35 | — | — | 93 |
| 18-21 weeks | 42 | 12 | — | — | 54 |
| 22-26 weeks | 33 | 20 | — | — | 53 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2019 to primary completion in Jul 2020, 17 months.
Results were first posted in Jan 2023, 2 years 6 months after primary completion. A results delay was requested in Jun 2021.
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