DiphtheriaPhase 1NCT00707148
Pertussis Vaccine in Healthy Pregnant Women
A Phase 1 study testing Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed in people with Diphtheria and Pertussis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
The purpose of this study is to look at the safety and immunogenicity of a combination vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Read more about this study
- Who is it for?
- Ages Up to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Pertussis, Tetanus
- What is being tested?
- Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2009to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 Up to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant subjects must meet all inclusion criteria in order to be eligible to participate in the study.
- 18 - 45 years of age
- In the 30th-32nd week of a pregnancy at low risk for complications as determined by the Obstetrical Risk Assessment Form [ORAF] and the following criteria:
- All Pregnant Women:
- Second trimester or later ultrasound with no significant abnormalities.
- Alpha fetal protein (AFP) testing, one of the following:
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- Normal maternal serum AFP performed at 15-20 weeks' gestation (either as part of the quad screen or separately)
- Abnormal maternal serum AFP at 15-20 weeks' gestation followed by an amniocentesis demonstrating no chromosomal abnormalities AND either normal amniotic fluid AFP or normal amniotic fluid acetylcholinesterase (AChE) levels.
- If a serum AFP test is not performed, one of the following:
- A level II ultrasound with no significant abnormalities ii. A normal amniotic fluid AFP test AND an amniocentesis demonstrating no chromosomal abnormalities must be documented.
- Pregnant Women 40-45 years of age: no chromosomal abnormalities identified by diagnostic testing [chorionic villus sampling (CVS) or amniocentesis].
- Pregnant Women 18-39 years of age: at least one of the following:
- Level II ultrasound with no significant abnormalities
- No chromosomal abnormalities identified by diagnostic testing (CVS or amniocentesis)
- Pregnancy estimated to be at low risk (< 1 in 270) for Down's syndrome (trisomy 21), trisomy 13 and trisomy 18 by appropriate first or second trimester screening test. Appropriate screening test includes any one of the following:
- first trimester screening (nuchal translucency measurement, pregnancy-associated plasma protein A (PAPP-A), and beta- human chorionic gonadotropin (B-hCG) ii. first trimester screening and second trimester quad screen, with risk estimated using an integrated, sequential, or contingency approach iii. second trimester quad screen alone
- Intend to be available for follow-up visits and phone call access through 13 months following delivery
- Willing to have infant immunized with Pentacel vaccine at 2, 4, 6, and 12 months of age
- Willing to give written informed consent
- Non-pregnant subjects must meet all inclusion criteria in order to be eligible to participate in the study.
- 18-39 years of age or 40-45 years of age
- Intend to be available for a follow-up visit and phone call access through 6 months following receipt of Adacel vaccine
- Willing to give written informed consent
- Must fulfill one of the following: (i) she is not able to bear children because she has been surgically sterilized (tubal ligation, bilateral oophorectomy or hysterectomy) for at least one year or is at least 1 year post-menopausal or (ii) she agrees to practice effective methods of contraception including, but not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods, birth control pills, patches or hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices), during the study period between enrollment and 30 days following receipt of the vaccine. (If subject is of childbearing potential, the method of birth control will be documented.)
- For a female subject of childbearing potential, must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination
Who cannot join
- Pregnant subjects who meet any exclusion criteria at baseline will be excluded from the study.
- Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
- Significant mental illness (e.g. schizophrenia, psychosis, major depression).
- Currently smoking or using illegal substances.
- History of a febrile illness (greater than or equal to 100.4 degrees Fahrenheit or 38 degrees Celsius) within the past 72 hours for antepartum injection or febrile illness (greater than or equal to 100.4 degrees Fahrenheit or 38 degrees Celsius) within 24 hours for postpartum injection.
- Previous severe reaction to any vaccine.
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- Receipt of tetanus-diphtheria toxoid immunization within the past 2 years.
- Receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap) immunization ever.
- Receipt of a vaccine (excluding influenza), blood product (excluding Rhogam) or experimental medicine within the 4 weeks prior to antepartum injection through 4 weeks following post-partum injection. However, measles-mumps-rubella vaccine is permitted post-partum.
- Receipt of or plans to receive influenza vaccine within the 2 weeks prior to or following antepartum injection.
- Deemed high risk for serious obstetrical complication as determined by the Obstetrical Risk Assessment Form.
- Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
- Non-pregnant subjects who meet any exclusion criteria at baseline will be excluded from the study.
- Serious underlying medical condition (e.g., immunosuppressive disease or therapy, HIV infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
- Significant mental illness (e.g. schizophrenia, psychosis, major depression).
- Currently smoking or using illegal substances.
- History of a febrile illness (greater than or equal to 100.4 degrees Fahrenheit or 38 degrees Celsius) within the past 24 hours.
- Previous severe reaction to any vaccine.
- Receipt of tetanus-diphtheria toxoid immunization within the past 2 years.
- Receipt of Tdap immunization ever.
- Receipt of or plans to receive an investigational or licensed vaccine (excluding influenza), blood product or experimental medicine within the 4 weeks prior to Adacel vaccination through 4 weeks following Adacel vaccination
- Receipt of or plans to receive influenza vaccine within the 2 weeks prior to or following Adacel vaccination.
- Intends to become pregnant during the study period between enrollment and 30 days following receipt of the vaccine.
- Anything in the opinion of the investigator that would prevent a volunteer from completing the study or put the volunteer at risk.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University Medical Center - Duke Perinatal Clinic
Durham, North Carolina, 27705
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411
Group Health Research Institute - Seattle
Seattle, Washington, 98101-1466
Seattle Children's Hospital - Infectious Diseases
Seattle, Washington, 98105-3901
About this study
Official title: Safety and Immunogenicity of Tdap Vaccine in Healthy Pregnant Women, Safety in Their Neonates, and Effect of Maternal Immunization on Infant Immune Responses to DTaP Vaccine
The purpose of this study is to look at the safety and immunogenicity of a combination vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of the newborn infant and the effect of the mother's vaccination on the infants' immune responses prior to vaccinating infants with another combination vaccine to protect against diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old. Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo, inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood samples will be collected from the mother and infant, along with the baby's growth measurements. Participation for mother infant pairs is about 15 months and about 7 months for non-pregnant women.
Read the detailed description
Pertussis, "whooping cough", caused by the gram negative pleomorphic bacillus, Bordetella pertussis, is a highly contagious, potentially life-threatening respiratory illness that has re-emerged in the United States (US) as a cause of morbidity and mortality in infants less than 6 months of age as well as morbidity in adolescents and adults. Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) immunization of women in the third trimester of pregnancy represents an opportunity to protect the vulnerable very young infants through passively acquired maternal pertussis specific antibodies. Tdap vaccine is being evaluated for this purpose since there is no monovalent acellular pertussis (aP) vaccine available in the U.S. This is a multi-site, randomized, double masked, cross-over study in 48 healthy pregnant women, 18-45 years of age who will be randomized (2:1) into two groups. One group will receive a single dose of Tdap vaccine at 30-32 weeks of gestation and a postpartum dose of saline. The other group will receive saline at 30-32 weeks of gestation and a postpartum dose of Tdap vaccine. On May 30, 2008 the Advisory Committee on Immunization Practices (ACIP) issued a recommendation for use of Tdap in pregnant and postpartum women: "Pregnant women (including women who are breastfeeding) who have not received a dose of Tdap previously should receive Tdap after delivery and before discharge from the hospital or birthing center if 2 years or more have elapsed since the most recent administration of Td." This study design provides a control for the evaluation of the safety of Tdap vaccine administered during pregnancy and provides compliance with the ACIP recommendation. Immune responses to Tdap vaccine measured in antepartum and postpartum women enrolled in this clinical trial will be compared. Also, immune responses of the 32 pregnant women antenatally immunized with Tdap will be compared to those in approximately 32 healthy non-pregnant women contemporaneously enrolled into 2 age groups (18-39 years and 40-45 years) that are equal to the pregnant women. The purpose of this study is to evaluate the safety of Tdap vaccine in pregnant women and their neonates and the effect of maternal immunization on the infant immune response to DTaP vaccinations. The safety of and immune response to Tdap vaccine in the 32 pregnant women immunized antenatally will be compared to that in approximately 32 non-pregnant women enrolled contemporaneously. The primary objectives of this phase I study are: to evaluate the safety of a single 0.5 mL intramuscular injection of Tdap vaccine in healthy pregnant women vaccinated at 30-32 weeks of gestation compared to women immunized postpartum and a non-pregnant control group; and to evaluate the safety of maternal Tdap immunization in neonates. Secondary objectives are: to assess the immunogenicity of Tdap vaccine in healthy pregnant women compared to women immunized postpartum and a non-pregnant control group; to determine the efficiency of placental transport of maternal pertussis specific antibodies to the neonate; to assess the persistence of the maternal pertussis specific antibodies in infants just prior to receiving the first dose of DTaP [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate] vaccine for infants); and to assess the effects of maternal immunization with Tdap vaccine on infant immune responses to DTaP vaccinations. Study duration will be approximately 3 years. Subject participation will be approximately 15 months (for each mother-infant pair) and 7 months for non-pregnan
- Conditions
- Diphtheria, Pertussis, Tetanus
- Being tested
- Placebo, Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
- Keywords
- pertussis, diptheria, tetanus, vaccine, Tdap
- Medical subject headings
- Diphtheria, Whooping Cough, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Saline (0.9% NaCl) administered as a single 0.5 mL intramuscular injection into the deltoid.
Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbedBiological
Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap). Administered as a single 0.5 mL intramuscular injection into the deltoid.
| Study group | Role | What they receive |
|---|---|---|
| Group 2: Control | Active comparator | 16 pregnant women to receive: antepartum: saline; postpartum; Tdap vaccine. Receives: Drug: Placebo; Biological: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed |
| Group 1: Intervention | Experimental | 32 pregnant women to receive: antepartum: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) vaccine; postpartum: saline. Receives: Drug: Placebo; Biological: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed |
| Group 3: Control | Active comparator | 32 non-pregnant women to receive a single dose of Tdap vaccine. Receives: Biological: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of injection site and systemic reactions following injections.
Measured: Recorded 0 to 7 days after injection.
Frequency of vaccine-associated adverse events (AEs).
Measured: 30 minutes post-injection, Day 0, 1-2, 7, 4 weeks post-injection, delivery, Day 1-2, 7, and 2 and 4 months post-delivery. Infant AEs: Delivery, 2, 4, 7, and 13 months. Non-pregnant: Day 0, 1-2, 7, 4 weeks and 6 months.
Frequency of vaccine-associated serious adverse events (SAEs).
Measured: Maternal SAEs through 4 months post delivery and infant SAEs from delivery to 13 months. Non-pregnant SAEs: Day 0 through to 6 months post-injection.
Infant growth measurements (fronto-occipital circumference [FOC], length and weight).
Measured: At delivery and at 2, 7 and 13 months of age.
Bayley III developmental screening of infants.
Measured: At age 13 months.
Incidence of pertussis infection captured by surveillance for adverse events (AEs) and serious adverse events (SAEs).
Measured: Duration of study, captured by surveillance for AEs and SAEs. Antepartum: Day 1-2 and 7; 4 weeks; delivery. Postpartum: Day 1-2 and 7; Month 2, 4,7, and 13.
Secondary outcomes (1)
Concentrations of immunoglobulin G (IgG) for pertussis toxin (PT), pertactin (PRN), fimbrial proteins (FIM), filamentous hemagglutinin (FHA), tetanus toxoid (TT), and diphtheria toxoid (DT).
Measured: Mother: blood samples collected before and 4 weeks after antepartum injection, at hospital admission for delivery and at the 2 month post delivery visit. Infant: collected at delivery (cord), 2, 7 and 13 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707148
- Sponsor's protocol ID
- 05-0048
- Other IDs
- H-19633, HHSN272200800002C
- Status last verified
- Aug 2012
- First submitted
- 26 Jun 2008
- Last updated
- 25 Jul 2014
- Results posted
- No
Publications
Munoz FM, Bond NH, Maccato M, Pinell P, Hammill HA, Swamy GK, Walter EB, Jackson LA, Englund JA, Edwards MS, Healy CM, Petrie CR, Ferreira J, Goll JB, Baker CJ. Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. JAMA. 2014 May 7;311(17):1760-9. doi: 10.1001/jama.2014.3633.
PubMed 24794369
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Tdap Vaccine in Healthy Pregnant Women, Safety in Their Neonates, and Effect of Maternal Immunization on Infant Immune Responses to DTaP Vaccine
- ClinicalTrials.gov ID
- NCT00707148
- Acronym / sponsor ID
- 05-0048
- Conditions
- Diphtheria, Pertussis, Tetanus
- Keywords
- pertussis, diptheria, tetanus, vaccine, Tdap
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Not posted in the source record
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 look at the safety and immunogenicity of a combination vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of the newborn infant and the effect of the mother's vaccination on the infants' immune responses prior to vaccinating infants with another combination vaccine to protect against diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old. Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo, inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood samples will be collected from the mother and infant, along with the baby's growth measurements. Participation for mother infant pairs is about 15 months and about 7 months for non-pregnant women.
Detailed description
Pertussis, "whooping cough", caused by the gram negative pleomorphic bacillus, Bordetella pertussis, is a highly contagious, potentially life-threatening respiratory illness that has re-emerged in the United States (US) as a cause of morbidity and mortality in infants less than 6 months of age as well as morbidity in adolescents and adults. Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) immunization of women in the third trimester of pregnancy represents an opportunity to protect the vulnerable very young infants through passively acquired maternal pertussis specific antibodies. Tdap vaccine is being evaluated for this purpose since there is no monovalent acellular pertussis (aP) vaccine available in the U.S. This is a multi-site, randomized, double masked, cross-over study in 48 healthy pregnant women, 18-45 years of age who will be randomized (2:1) into two groups. One group will receive a single dose of Tdap vaccine at 30-32 weeks of gestation and a postpartum dose of saline. The other group will receive saline at 30-32 weeks of gestation and a postpartum dose of Tdap vaccine. On May 30, 2008 the Advisory Committee on Immunization Practices (ACIP) issued a recommendation for use of Tdap in pregnant and postpartum women: "Pregnant women (including women who are breastfeeding) who have not received a dose of Tdap previously should receive Tdap after delivery and before discharge from the hospital or birthing center if 2 years or more have elapsed since the most recent administration of Td." This study design provides a control for the evaluation of the safety of Tdap vaccine administered during pregnancy and provides compliance with the ACIP recommendation. Immune responses to Tdap vaccine measured in antepartum and postpartum women enrolled in this clinical trial will be compared. Also, immune responses of the 32 pregnant women antenatally immunized with Tdap will be compared to those in approximately 32 healthy non-pregnant women contemporaneously enrolled into 2 age groups (18-39 years and 40-45 years) that are equal to the pregnant women. The purpose of this study is to evaluate the safety of Tdap vaccine in pregnant women and their neonates and the effect of maternal immunization on the infant immune response to DTaP vaccinations. The safety of and immune response to Tdap vaccine in the 32 pregnant women immunized antenatally will be compared to that in approximately 32 non-pregnant women enrolled contemporaneously. The primary objectives of this phase I study are: to evaluate the safety of a single 0.5 mL intramuscular injection of Tdap vaccine in healthy pregnant women vaccinated at 30-32 weeks of gestation compared to women immunized postpartum and a non-pregnant control group; and to evaluate the safety of maternal Tdap immunization in neonates. Secondary objectives are: to assess the immunogenicity of Tdap vaccine in healthy pregnant women compared to women immunized postpartum and a non-pregnant control group; to determine the efficiency of placental transport of maternal pertussis specific antibodies to the neonate; to assess the persistence of the maternal pertussis specific antibodies in infants just prior to receiving the first dose of DTaP [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate] vaccine for infants); and to assess the effects of maternal immunization with Tdap vaccine on infant immune responses to DTaP vaccinations. Study duration will be approximately 3 years. Subject participation will be approximately 15 months (for each mother-infant pair) and 7 months for non-pregnan
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 2: Control | Active comparator | Drug: Placebo, Biological: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed16 pregnant women to receive: antepartum: saline; postpartum; Tdap vaccine. |
| Group 1: Intervention | Experimental | Drug: Placebo, Biological: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed32 pregnant women to receive: antepartum: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) vaccine; postpartum: saline. |
| Group 3: Control | Active comparator | Biological: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed32 non-pregnant women to receive a single dose of Tdap vaccine. |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (25 listed)
- Pregnant subjects must meet all inclusion criteria in order to be eligible to participate in the study.
- 18 - 45 years of age
- In the 30th-32nd week of a pregnancy at low risk for complications as determined by the Obstetrical Risk Assessment Form [ORAF] and the following criteria:
- Second trimester or later ultrasound with no significant abnormalities.
- Alpha fetal protein (AFP) testing, one of the following:
Key exclusion criteria (24 listed)
- Pregnant subjects who meet any exclusion criteria at baseline will be excluded from the study.
- Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
- Significant mental illness (e.g. schizophrenia, psychosis, major depression).
- Currently smoking or using illegal substances.
- History of a febrile illness (greater than or equal to 100.4 degrees Fahrenheit or 38 degrees Celsius) within the past 72 hours for antepartum injection or febrile illness (greater than or equal to 100.4 degrees Fahrenheit or 38 degrees Celsius) within 24 hours for postpartum injection.
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 |
|---|---|---|
| PlaceboSaline (0.9% NaCl) administered as a single 0.5 mL intramuscular injection into the deltoid. | Drug | Group 1: Intervention, Group 2: Control |
| Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbedTetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap). Administered as a single 0.5 mL intramuscular injection into the deltoid. | Biological | Group 1: Intervention, Group 2: Control, Group 3: Control |
Primary outcome
Incidence of injection site and systemic reactions following injections.
Time frame: Recorded 0 to 7 days after injection.
Frequency of vaccine-associated adverse events (AEs).
Time frame: 30 minutes post-injection, Day 0, 1-2, 7, 4 weeks post-injection, delivery, Day 1-2, 7, and 2 and 4 months post-delivery. Infant AEs: Delivery, 2, 4, 7, and 13 months. Non-pregnant: Day 0, 1-2, 7, 4 weeks and 6 months.
Frequency of vaccine-associated serious adverse events (SAEs).
Time frame: Maternal SAEs through 4 months post delivery and infant SAEs from delivery to 13 months. Non-pregnant SAEs: Day 0 through to 6 months post-injection.
Infant growth measurements (fronto-occipital circumference [FOC], length and weight).
Time frame: At delivery and at 2, 7 and 13 months of age.
Bayley III developmental screening of infants.
Time frame: At age 13 months.
Incidence of pertussis infection captured by surveillance for adverse events (AEs) and serious adverse events (SAEs).
Time frame: Duration of study, captured by surveillance for AEs and SAEs. Antepartum: Day 1-2 and 7; 4 weeks; delivery. Postpartum: Day 1-2 and 7; Month 2, 4,7, and 13.
1 secondary outcome
Concentrations of immunoglobulin G (IgG) for pertussis toxin (PT), pertactin (PRN), fimbrial proteins (FIM), filamentous hemagglutinin (FHA), tetanus toxoid (TT), and diphtheria toxoid (DT).
Time frame: Mother: blood samples collected before and 4 weeks after antepartum injection, at hospital admission for delivery and at the 2 month post delivery visit. Infant: collected at delivery (cord), 2, 7 and 13 months of age.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Results publication: PubMed 24794369Munoz FM, Bond NH, Maccato M, Pinell P, Hammill HA, Swamy GK, Walter EB, Jackson LA, Englund JA, Edwards MS, Healy CM, Petrie CR, Ferreira J, Goll JB, Baker CJ. Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. JAMA. 2014 May 7;311(17):1760-9. doi: 10.1001/jama.2014.3633.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed in people with Diphtheria and Pertussis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
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 25 inclusion and 24 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 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of injection site and systemic reactions following injections. (time frame: Recorded 0 to 7 days after injection.). The study lists 6 primary outcomes in all. 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 NCT00707148, 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 25 Jul 2014.