PregnancyPhase 2NCT01445743
Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy
A Phase 2 study testing Biological/Vaccine: Tdap Vaccine in people with Pregnancy, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
That is a double-blind randomized trial with parallel control to demonstrate the safety and immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is to determine the safety and immunogenicity of acellular Tdap vaccine. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Biological/Vaccine: Tdap Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2011to Feb 2014
- Phase
- Phase 2
- 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 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 38 years
- Pregnancy between 22 and 32 weeks of gestation
- Covered by Ministry of Health medical security
- Definitive residency in Guadalupe and Benito Juarez cities
- Pregnancy termination in the study's hospital.
- At low risk for complication as determined by the obstetrical risk assessment form (ORAF)
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- Second trimester or later ultrasound with no significant abnormalities
- Intend to be available for follow up visits and phone calls access through 6 months following delivery
- Willing to give written informed consent
Who cannot join
- Serious mental illness. (Schizophrenia, psychosis, major depression).
- Serious underlying medical condition (e.g Degenerative diseases: Diabetes Mellitus,Hypertension and so on.
- Current smoking or use of drugs.
- Receipt of tetanus-diphtheria toxoid immunization within the past 2 years.
- Be considered as a high risk pregnancy for serious obstetrical complication according to the local Obstetrical Risk Assessment Form.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Regional Materno Infantil de alta especialidad, Secretaria de Salud de Nuevo Leon
Guadalupe, Nuevo León, 66000
About this study
Official title: Immunogenicity and Safety of an Acellular DPT Vaccine in Pregnant Women in Nuevo Leon, Mexico
That is a double-blind randomized trial with parallel control to demonstrate the safety and immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is to determine the safety and immunogenicity of acellular Tdap vaccine.
The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine.
Read the detailed description
Type of Study: Clinical, randomized, double-blind, parallel control study. Study Subjects: Pregnant women of 19-38years of age, gestational age of 12-24 weeks, low risk of obstetric complications (according to the Obstetric Risk Assessment Form), normal anatomic ultrasound performed in the second quarter of pregnancy and residence in Guadalupe, and Juarez cities in Nuevo Leon State.
The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline (0.9% Sodium Chloride) solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine by trained personnel.
For both groups, 6 blood samples will be taken. Women: Before and at least 4 weeks after the vaccine or placebo were administered, at hospital admission for delivery. Infant: collected at delivery (cord), 2, 4 and 6 months of age.
Immunogenicity will be compared in both groups by measuring the increase of three of the following antigen-specific antibodies: Pertussis toxin (PT), pertactin (PRN),and fimbriae 2 FIM 2).
Safety Assessment: Each pregnant will be observed at 30 minutes, 24 and 48 hours and one month after the application of the vaccine for side effects.
- Conditions
- Pregnancy
- Being tested
- Biological/Vaccine: Tdap Vaccine
- Keywords
- Tdap Vaccine, Pregnant woman, 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.
Biological/Vaccine: Tdap VaccineBiological
Also called ADACEL
Biological: Tdap Intervention comprises 104 randomly assigned pregnant women who will receive a blinded dose of Tdap vaccine (ADACEL) containing 2.5 ug of detoxified pertussis toxin (PT), filamentous haemagglutinin 5 ug, 3 ug Pertactina; 5 ug Fimbriae type 2 and 3, (in addition to Tetanus Toxoid (5 Lf) and diphtheria toxoid (2Lf) as a single 0.5 mL intramuscular injection into the deltoid.
| Study group | Role | What they receive |
|---|---|---|
| Biological/Vaccine: Tdap Vaccine | Experimental | Biological: Tdap Intervention women will receive a blinded dose of Tdap vaccine (ADACEL) Receives: Biological: Biological/Vaccine: Tdap Vaccine |
| Placebo Comparator: Physiologic Saline solution | Placebo comparator | Administration of Tdap vaccine or placebo as a single 0.5 mL of Saline (0.9% NaCl) solution Receives: Biological: Biological/Vaccine: Tdap Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevation of specific pertussis antibody levels in children of women who were administered the immunization
Elevation of at least three antibodies against either pertussis toxin (PT), pertactin (PRN), fimbrial proteins (FIM), or filamentous hemagglutinin (FHA).
Measured: 18 months
Secondary outcomes (1)
Non interference of acellular vaccine in children
To demonstrate the acellular pertussis immunization non interference in the effective development of pertussis antibodies in children at 2, 4, and 6 months of age.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2012
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose M. Ramirez-Aranda, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Jose M Ramirez, MD; PhD, Principal investigator, Proffesor of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445743
- Sponsor's protocol ID
- EN11-009
- Status last verified
- Feb 2014
- First submitted
- 23 Sep 2011
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of an Acellular DPT Vaccine in Pregnant Women in Nuevo Leon, Mexico
- ClinicalTrials.gov ID
- NCT01445743
- Acronym / sponsor ID
- EN11-009
- Conditions
- Pregnancy
- Keywords
- Tdap Vaccine, Pregnant woman, Pertussis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Oct 2011 (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.
That is a double-blind randomized trial with parallel control to demonstrate the safety and immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is to determine the safety and immunogenicity of acellular Tdap vaccine.
The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine.
Detailed description
Type of Study: Clinical, randomized, double-blind, parallel control study. Study Subjects: Pregnant women of 19-38years of age, gestational age of 12-24 weeks, low risk of obstetric complications (according to the Obstetric Risk Assessment Form), normal anatomic ultrasound performed in the second quarter of pregnancy and residence in Guadalupe, and Juarez cities in Nuevo Leon State.
The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline (0.9% Sodium Chloride) solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine by trained personnel.
For both groups, 6 blood samples will be taken. Women: Before and at least 4 weeks after the vaccine or placebo were administered, at hospital admission for delivery. Infant: collected at delivery (cord), 2, 4 and 6 months of age.
Immunogenicity will be compared in both groups by measuring the increase of three of the following antigen-specific antibodies: Pertussis toxin (PT), pertactin (PRN),and fimbriae 2 FIM 2).
Safety Assessment: Each pregnant will be observed at 30 minutes, 24 and 48 hours and one month after the application of the vaccine for side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological/Vaccine: Tdap Vaccine | Experimental | Biological: Biological/Vaccine: Tdap VaccineBiological: Tdap Intervention women will receive a blinded dose of Tdap vaccine (ADACEL) |
| Placebo Comparator: Physiologic Saline solution | Placebo comparator | Biological: Biological/Vaccine: Tdap VaccineAdministration of Tdap vaccine or placebo as a single 0.5 mL of Saline (0.9% NaCl) solution |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18 to 38 years
- Pregnancy between 22 and 32 weeks of gestation
- Covered by Ministry of Health medical security
- Definitive residency in Guadalupe and Benito Juarez cities
- Pregnancy termination in the study's hospital.
Key exclusion criteria (5 listed)
- Serious mental illness. (Schizophrenia, psychosis, major depression).
- Serious underlying medical condition (e.g Degenerative diseases: Diabetes Mellitus,Hypertension and so on.
- Current smoking or use of drugs.
- Receipt of tetanus-diphtheria toxoid immunization within the past 2 years.
- Be considered as a high risk pregnancy for serious obstetrical complication according to the local Obstetrical Risk Assessment Form.
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 |
|---|---|---|
| Biological/Vaccine: Tdap VaccineAlso: ADACELBiological: Tdap Intervention comprises 104 randomly assigned pregnant women who will receive a blinded dose of Tdap vaccine (ADACEL) containing 2.5 ug of detoxified pertussis toxin (PT), filamentous haemagglutinin 5 ug, 3 ug Pertactina; 5 ug Fimbriae type 2 and 3, (in addition to Tetanus Toxoid (5 Lf) and diphtheria toxoid (2Lf) as a single 0.5 mL intramuscular injection into the deltoid. | Biological | Biological/Vaccine: Tdap Vaccine, Placebo Comparator: Physiologic Saline solution |
Primary outcome
Elevation of specific pertussis antibody levels in children of women who were administered the immunization
Time frame: 18 months
Elevation of at least three antibodies against either pertussis toxin (PT), pertactin (PRN), fimbrial proteins (FIM), or filamentous hemagglutinin (FHA).
1 secondary outcome
Non interference of acellular vaccine in children
Time frame: 18 months
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 14 Feb 2014.
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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.
Jose M Ramirez, MD; PhD principal investigator
Proffesor of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biological/Vaccine: Tdap Vaccine in people with Pregnancy, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 9 inclusion and 5 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 14 Feb 2014. 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 Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Elevation of specific pertussis antibody levels in children of women who were administered the immunization (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2014.