Pregnant WomenPhase 2/3NCT00553228
Pertussis Maternal Immunization Study
A Phase 2/3 study testing Tdap and Td in people with Pregnant Women, run by Scott Halperin at 1 site in Canada.
Trial summary
The purpose of this study is to assess whether immunization against pertussis in the mid third trimester of pregnancy provides passive protection to the infant by transfer of IgG transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk, sufficient to protect the infant against pertussis… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Tdap and Td
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to 9 Dec 2015
- Phase
- Phase 2/3
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women 18 years of age and over.
- Women who, at ≥30-<32 weeks gestation, are at low risk for complications as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form.
- Signed, informed consent.
Who cannot join
- Failure to meet eligibility criteria as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form.
- History of significant medical disorder (such as bleeding disorders, cancer, autoimmune disease, immunodeficiency (including HIV-infected individuals, transplant recipients), seizure disorder or significant psychiatric illness, drug or alcohol dependence).
- Receipt of any high-dose daily corticosteroids (inhaled steroids are acceptable) within 2 weeks of study entry. High dose is defined as a dose of ≥20 mg of prednisone daily or equivalent.
- History of physician-diagnosed or laboratory-confirmed pertussis within the past 5 years.
- Personal history (verbal or documented) of ever having received Tdap.
- Personal history (verbal or documented) of having received Td immunization within the past 2 years.
Show all 11Show fewer
- History of febrile illness (>37.8ºC orally) within the past 72 hours (immunization may be deferred).
- History of sensitivity to any component of Tdap.
- Receipt of blood products or immunoglobulin within 3 months of study entry (except RH-negative women who receive immunoglobulin during pregnancy are eligible).
- Receipt of any vaccines within 2 weeks of study vaccine (except influenza vaccine which may be given concurrently).
- Failure to give written, informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Trial Research Center - Canadian Center for Vaccinology
Halifax, Nova Scotia, B3K 6R8
About this study
Official title: Immunization of Women With Diphtheria and Tetanus Toxoids Combined With Acellular Pertussis (Tdap) During the Mid Third Trimester of Pregnancy: An Evaluation of the Potential for Immunological Protection for the Neonate
The purpose of this study is to assess whether immunization against pertussis in the mid third trimester of pregnancy provides passive protection to the infant by transfer of IgG transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk, sufficient to protect the infant against pertussis disease in the critical neonatal period, without suppressing the infant's immune response to active immunization and disease
Read the detailed description
The purpose of this study is to assess the potential of providing initial immunological protection to the neonate by providing passive placentally transferred serum antibodies and breast milk antibodies against pertussis antigens (PT, FHA, PRN, FIM). This will be accomplished by
- determining the rate of maternal antibody decline from time of immunization until 12 months postpartum by measuring antibody levels in serum, saliva, and breast milk at specified intervals;
- determining levels of antibody transferred to the neonate relative to the interval from immunization to delivery;
- comparing levels of transplacentally transferred antibody with those achieved after the first, second, and third dose of the primary immunization series; and
- determining whether maternal immunization interferes with active antibody production following licensed DTaP-IPV-Hib in infants of women immunized during the mid third trimester of pregnancy.
- Conditions
- Pregnant Women
- Being tested
- Tdap, Td
- Keywords
- maternal immunization, whooping cough, pertussis
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TdapBiological
Also called Adacel
0.5 mL IM once at visit #2
TdBiological
Also called Diphtheria and tetanus toxoids, adsorbed
0.5 mL IM once at visit #2
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | Tdap Receives: Biological: Tdap |
| group 2 | Active comparator | Td Receives: Biological: Td |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of serum IgG antibody levels against PT, FHA, PRN, FIM between Tdap and Td groups
Measured: birth, 2, 4, 6, 7, 12, and 13 months of age
Secondary outcomes (1)
Safety of Tdap in pregnancy including pregnancy outcome and developmental assessment.
Measured: developmental screening at 1 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startNov 2007
- Primary completion9 Dec 2015
- Study completion9 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scott Halperin
- Sponsor type
- University, hospital or other
- Collaborators
- IWK Health Centre, Sanofi Pasteur, a Sanofi Company
- Responsible party
- Sponsor-investigator, Scott Halperin, Dalhousie University
- Investigators
- Scott A Halperin, MD, Principal investigator, Dalhousie Univeristy - Canadian Center for Vaccinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553228
- Sponsor's protocol ID
- DAL07-01
- Status last verified
- Aug 2020
- First submitted
- 2 Nov 2007
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brousseau N, Angers-Goulet ME, Bastien R, Ye L, Sadarangani M, Halperin SA. Vaccination during pregnancy and modulation of IgG response to pertussis vaccines in infants: The impact of different vaccine formulations. Vaccine. 2024 Apr 2;42(9):2138-2143. doi: 10.1016/j.vaccine.2024.03.015. Epub 2024 Mar 8.
PubMed 38461048Halperin SA, Langley JM, Ye L, MacKinnon-Cameron D, Elsherif M, Allen VM, Smith B, Halperin BA, McNeil SA, Vanderkooi OG, Dwinnell S, Wilson RD, Tapiero B, Boucher M, Le Saux N, Gruslin A, Vaudry W, Chandra S, Dobson S, Money D. A Randomized Controlled Trial of the Safety and Immunogenicity of Tetanus, Diphtheria, and Acellular Pertussis Vaccine Immunization During Pregnancy and Subsequent Infant Immune Response. Clin Infect Dis. 2018 Sep 14;67(7):1063-1071. doi: 10.1093/cid/ciy244.
PubMed 30010773
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunization of Women With Diphtheria and Tetanus Toxoids Combined With Acellular Pertussis (Tdap) During the Mid Third Trimester of Pregnancy: An Evaluation of the Potential for Immunological Protection for the Neonate
- ClinicalTrials.gov ID
- NCT00553228
- Acronym / sponsor ID
- DAL07-01
- Conditions
- Pregnant Women
- Keywords
- maternal immunization, whooping cough, pertussis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Scott HalperinUniversity, hospital or other
- Collaborators
- IWK Health Centre, Sanofi Pasteur, a Sanofi Company
- Study start
- Nov 2007
- Primary completion
- 9 Dec 2015 (actual)
- Study completion
- 9 Dec 2015 (actual)
- First posted
- 5 Nov 2007 (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 assess whether immunization against pertussis in the mid third trimester of pregnancy provides passive protection to the infant by transfer of IgG transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk, sufficient to protect the infant against pertussis disease in the critical neonatal period, without suppressing the infant's immune response to active immunization and disease
Detailed description
The purpose of this study is to assess the potential of providing initial immunological protection to the neonate by providing passive placentally transferred serum antibodies and breast milk antibodies against pertussis antigens (PT, FHA, PRN, FIM). This will be accomplished by
- determining the rate of maternal antibody decline from time of immunization until 12 months postpartum by measuring antibody levels in serum, saliva, and breast milk at specified intervals;
- determining levels of antibody transferred to the neonate relative to the interval from immunization to delivery;
- comparing levels of transplacentally transferred antibody with those achieved after the first, second, and third dose of the primary immunization series; and
- determining whether maternal immunization interferes with active antibody production following licensed DTaP-IPV-Hib in infants of women immunized during the mid third trimester of pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Biological: TdapTdap |
| group 2 | Active comparator | Biological: TdTd |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women 18 years of age and over.
- Women who, at ≥30-<32 weeks gestation, are at low risk for complications as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form.
- Signed, informed consent.
Key exclusion criteria (11 listed)
- Failure to meet eligibility criteria as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form.
- History of significant medical disorder (such as bleeding disorders, cancer, autoimmune disease, immunodeficiency (including HIV-infected individuals, transplant recipients), seizure disorder or significant psychiatric illness, drug or alcohol dependence).
- Receipt of any high-dose daily corticosteroids (inhaled steroids are acceptable) within 2 weeks of study entry. High dose is defined as a dose of ≥20 mg of prednisone daily or equivalent.
- History of physician-diagnosed or laboratory-confirmed pertussis within the past 5 years.
- Personal history (verbal or documented) of ever having received Tdap.
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 |
|---|---|---|
| TdapAlso: Adacel0.5 mL IM once at visit #2 | Biological | group I |
| TdAlso: Diphtheria and tetanus toxoids, adsorbed0.5 mL IM once at visit #2 | Biological | group 2 |
Primary outcome
Comparison of serum IgG antibody levels against PT, FHA, PRN, FIM between Tdap and Td groups
Time frame: birth, 2, 4, 6, 7, 12, and 13 months of age
1 secondary outcome
Safety of Tdap in pregnancy including pregnancy outcome and developmental assessment.
Time frame: developmental screening at 1 year 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 27 Aug 2020.
- Derived from this study: PubMed 38461048Brousseau N, Angers-Goulet ME, Bastien R, Ye L, Sadarangani M, Halperin SA. Vaccination during pregnancy and modulation of IgG response to pertussis vaccines in infants: The impact of different vaccine formulations. Vaccine. 2024 Apr 2;42(9):2138-2143. doi: 10.1016/j.vaccine.2024.03.015. Epub 2024 Mar 8.
- Derived from this study: PubMed 30010773Halperin SA, Langley JM, Ye L, MacKinnon-Cameron D, Elsherif M, Allen VM, Smith B, Halperin BA, McNeil SA, Vanderkooi OG, Dwinnell S, Wilson RD, Tapiero B, Boucher M, Le Saux N, Gruslin A, Vaudry W, Chandra S, Dobson S, Money D. A Randomized Controlled Trial of the Safety and Immunogenicity of Tetanus, Diphtheria, and Acellular Pertussis Vaccine Immunization During Pregnancy and Subsequent Infant Immune Response. Clin Infect Dis. 2018 Sep 14;67(7):1063-1071. doi: 10.1093/cid/ciy244.
- Canadian Center for Vaccinology Home PageLink provided by the sponsor.
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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.
Scott A Halperin, MD principal investigator
Dalhousie Univeristy - Canadian Center for Vaccinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tdap and Td in people with Pregnant Women, run by Scott Halperin at 1 site in Canada.
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 3 inclusion and 11 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 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Comparison of serum IgG antibody levels against PT, FHA, PRN, FIM between Tdap and Td groups (time frame: birth, 2, 4, 6, 7, 12, and 13 months of age). 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 NCT00553228, which also lists 2 linked publications.
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 27 Aug 2020.