An Early Phase 1 interventional study of Tdap vaccine in Pertussis and Pregnancy Related, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by Mahidol University · Early Phase 1, Interventional, and Prevention
Among 12 studies testing boostrix in Whooping Cough — 2 open to participants now, 2 under way, none of them phase 3. Boostrix · Whooping Cough.
Among the 12 studies testing boostrix in Whooping Cough, this one is the 11th largest by enrollment, is one of 2 that started in 2018, is one of 2 in phase 1, and was the 10th registered.
290 studies on the registry are indexed under Whooping Cough; 23 are open to participants now.
Browse Whooping Cough studies →2 of the 12 studies testing boostrix in Whooping Cough are open now, in 1 country. Recruiting first, the newest first:
Changchun BCHT Biotechnology Co. · Sites in China
Ages 10+ · Healthy volunteers
Changchun BCHT Biotechnology Co.
Ages 10+ · Healthy volunteers
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 13 Whooping Cough studies recruiting now, 2 (15%) set no upper age limit and 10 (77%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2018.
This study's enrollment of 129 is below the median of 400 across 228 interventional studies indexed under Whooping Cough.
Median enrollment 548 across the 12 interventional studies. Of the 10 that completed or were terminated, 8 (80%) have results posted.
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10 of 12 have an industry lead sponsor. The 6 most frequent:
Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
Mahidol University has 5 studies filed under Whooping Cough — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing boostrix in Whooping Cough, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study evaluated the seroprevalence of Bordetella pertussis antibodies and anti-pertussis antibody response after a single dose of reduced-antigen, combined diphtheria, tetanus, and acellular pertussis vaccine (Tdap) in pregnant Thai women.
All seronegative participants received Tdap, while seropositive participants were equally randomized into 2 groups. Half of seropositive participants received Tdap and the other half received tetanus-diphtheria (Td) as standard protocol.
The primary objective of this study was to determine the seroprevalence of anti-pertussis toxin antibodies (anti-PT IgG) among pregnant Thai women. The secondary objectives were to evaluate antibody response after Tdap vaccination between seronegative and seropositive participants and to compare the different antibody titers at delivery among seropositive participants who received Tdap to those who received tetanus-diphtheria vaccine (Td). The sample size calculation was based on the primary objective. Randomized clinical trial was performed for the latter secondary objective.
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.
Exclusion Criteria:
Pregnant women who have any to Tdap vaccine including
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single dose of Tdap vaccine at GA 27 - 36 weeks
Biological: Tdap vaccine
dT vaccine as standard protocol
A single dose of Tdap vaccine at GA 27 - 36 weeks
The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women
Percentage of participants who were seropositive for anti-pertussis toxin antibodies (anti-PT IgG). The overall number of 129 participants is greater than the number of 42 participants include in the Particiant Flow Module because it was the sample size calculated based on the primary objective, which was the seroprevalence of anti-pertussis antibodies in pregnant Thai women. Randomized clinical trial on 42 seropositive participants was performed for one of the secondary objectives, which was to compare the different anti-PT IgG at delivery among seropositive participants who received Tdap to those who received Td.
Time frame: Four months
Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td
Time frame: Eight months
| Milestone | Experimental | Active Comparator |
|---|---|---|
| Started | 21 | 21 |
| Completed | 18 | 13 |
| Not completed | 3 | 8 |
Percentage of participants who were seropositive for anti-pertussis toxin antibodies (anti-PT IgG). The overall number of 129 participants is greater than the number of 42 participants include in the Particiant Flow Module because it was the sample size calculated based on the primary objective, which was the seroprevalence of anti-pertussis antibodies in pregnant Thai women. Randomized clinical trial on 42 seropositive participants was performed for one of the secondary objectives, which was to compare the different anti-PT IgG at delivery among seropositive participants who received Tdap to those who received Td.
| Participants | All Participants |
|---|---|
| The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women | 43 |
| IU/ml | Experimental | Active Comparator |
|---|---|---|
| Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td | 42 (16.7 to 65.2) | -7.4 (-14.3 to -6.3) |
Collected over Through study completion, an average of 11 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/18 (0%) | 0/18 (0%) | 12/18 (66.7%) |
| Active Comparator | 0/13 (0%) | 0/13 (0%) | 12/13 (92.3%) |
| Event | Experimental | Active Comparator |
|---|---|---|
| Prolonged hospitalization of the newborn after birth (more than 7 days)Pregnancy, puerperium and perinatal conditions | 2/18 | 5/13 |
| Gestational diabetesPregnancy, puerperium and perinatal conditions | 2/18 | 3/13 |
| Congenital defectsPregnancy, puerperium and perinatal conditions | 1/18 | 2/13 |
| Preterm deliveryPregnancy, puerperium and perinatal conditions | 2/18 | 0/13 |
| Threatened preterm labor resulting in hospitalizationPregnancy, puerperium and perinatal conditions | 2/18 | 1/13 |
| 1-minute Apgar score of 7 or lessPregnancy, puerperium and perinatal conditions | 2/18 | 1/13 |
| Postpartum hemorrhagePregnancy, puerperium and perinatal conditions | 1/18 | 0/13 |
| Age, Continuous(years) | Experimental | Active Comparator | Total |
|---|---|---|---|
| Mean | 29.8 ± 7.4 | 28.5 ± 6 | 29.2 ± 6.8 |
| Sex/Gender, Customized(Participants) | Experimental | Active Comparator | Total |
|---|---|---|---|
| Female | 18 | 13 | 31 |
| Race and Ethnicity Not Collected(Participants) | Experimental | Active Comparator | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from May 2018 to primary completion in Apr 2019, 11 months.
Results were first posted in Mar 2020, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Boostrix