- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01577316
Evaluate the Immunogenicity and Safety of the 2011-2012 Vaccine Against Seasonal Influenza on Pregnant Women (VACINFL2011)
Clinical Trial to Evaluate the Immunogenicity and Safety of the 2011-2012 Vaccine Against Seasonal Influenza on Pregnant Women
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Ferreyra-Reyes Leticia, MD
- Phone Number: 4312 (52) 55 548710 00
- Email: freyes.ld@gmail.com
Study Locations
-
-
Morelos
-
Cuernavaca, Morelos, Mexico, 62100
- National Institute of Public Health
-
Contact:
- Leticia Ferreyra-Reyes, MD
- Phone Number: 4312 (52)5554871000
- Email: freyes.ld@gmail.com
-
Sub-Investigator:
- Renata Baez-Saldaña, MD
-
Sub-Investigator:
- Elizabeth Ferreira-Guerrero, MD
-
Sub-Investigator:
- Leticia Ferreyra-Reyes, MD
-
Sub-Investigator:
- Guadalupe Delgado-Sánchez, MPH
-
Sub-Investigator:
- Luis Pablo Cruz-Hervert, MSc
-
Principal Investigator:
- Samuel Ponce de Leon-Rosales, MD
-
Sub-Investigator:
- Maria Eugenia Jiménez-Corona, DSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
I.Selection Criteria in pregnant women
I.a.Inclusion Criteria
- Pregnant women aged 18 to 39 years
- Have made at least one prenatal visit to confirm the pregnancy
- Available for follow-up time
- To be from 14 to 34 weeks of gestation
- If recruitment is conducted between August and November 2011, patient could have
- Received the Seasonal Influence Vaccine from previous period, but not the H1N1 vaccine
- Agree to participate in the study and provide informed consent
- Good health according to the clinical evaluation of the participant, confirming: heart
- Rate less than 100', systolic blood pressure less than 140 mm Hg, and diastolic less or
- Equal than 90 mmHg, and oral temperature less or equal than 37.4° C
- Normal physical exam and laboratory test within 28 days prior to recruitment
- HIV-negative test
I. b.Exclusion criteria
- Preeclampsia or eclampsia
- Treatment with immunosuppressive drugs
- Receipt of blood products, 120 days prior to HIV screening
- Receipt of immunoglobulin 60 days prior to screening for HIV
- Have received live attenuated vaccines 30 days prior of vaccination
- Have received inactivated vaccines within 14 days prior to vaccination
- Treatment of latent or active tuberculosis
- Autoimmune disease or immunodeficiency
- Contraindication to receiving seasonal influenza vaccine
- Vaccine side effects
- History of angioedema.
- Unstable asthma
- Diabetes
- Thyroidectomy or thyroid disease in the last 12 months
- Idiopathic urticaria
- Hypertension not well-controlled with treatment
- Medically diagnosed bleeding diathesis, coagulopathy or platelet disorder
- Active malignant tumor or in not-effective treatment
- Asplenia
- Allergic reaction to antibiotics
- Guillain Barre
- Psychiatric condition that difficult adherence to protocol
II.Selection criteria in nonpregnant woman
II. a.Inclusion criteria
- Nonpregnant woman aged 18 to 39 years
- Negative pregnancy test 24 hours prior to administration of the vaccine
- Agree to participate in the study and provide informed consent
- Good health according to the clinical evaluation of participant, confirming: heart rate
- less than 100 ', systolic blood pressure less than 140 mmHg, diastolic less than or equal
- to 90 mmHg, and oral temperature less than or equal to 37.4°C
- Normal physical exam and laboratory test within 28 days prior to recruitment
- HIV-negative test
- Agree to not get pregnant during the study and follow an effective contraceptive
- method
- Good health, determined this by history
- Receive the seasonal influenza vaccine at least two weeks prior to inclusion in this study
II. b.Exclusion criteria
- Being in treatment with immunosuppressive drugs
- Receipt of blood products, 120 days prior to HIV screening
- Receipt of immunoglobulin 60 days prior to screening for HIV
- Have received live attenuated vaccines 30 days of vaccination
- Have received inactivated vaccines within 14 days prior to vaccination
- Treatment of latent or active tuberculosis
- Autoimmune disease or immunodeficiency
- Contraindication to receiving seasonal influenza vaccine
- Vaccine side effects
- History of angioedema
- Unstable asthma
- Diabetes Type 2
- Thyroidectomy or thyroid disease requiring treatment in the past 12 months.
- Idiopathic urticaria
- Hypertension not well-controlled with treatment
- Medically diagnosed bleeding diathesis, coagulopathy or platelet disorder
- Active malignant tumor
- Convulsive condition
- Anatomic or functional asplenia
- Allergic reaction to antibiotics
- Guillain Barre
- Psychiatric condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pregnant Woman
|
2011-2012 Seasonal Trivalent Inactivated Influenza Vaccine (include A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens) administered to 15ug without adjuvant, via intramuscular in pregnant and nonpregnant women. It is recommended that vaccines for use in the 2012-2013 influenza season (northern hemisphere winter) contain the following:
Other Names:
|
Experimental: Nonpregnant women
2011-2012 Seasonal Influenza Vaccine (include A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens) administered to 15ug without adjuvant, via intramuscular in pregnant and nonpregnant women.
|
2011-2012 Seasonal Trivalent Inactivated Influenza Vaccine (include A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens) administered to 15ug without adjuvant, via intramuscular in pregnant and nonpregnant women. It is recommended that vaccines for use in the 2012-2013 influenza season (northern hemisphere winter) contain the following:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity
Time Frame: Day 28
|
The results of this analysis will determine whether the vaccine provides protection based on the immunogenicity provided by the vaccine.
They identify specific antibodies against influenza virus A (H1N1), will carry out the serological techniques by hemagglutination inhibition and microneutralization.
The immunogenicity analysis will be measured by seroconversion and seroresponse
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 30 minutes immediate, day 1, 3, 5,7,11, 15 and 28
|
Monitoring of pregnant women will be at monthly intervals until the time of the birth. Pregnant women and nonpregnant are going to be monitored for 30 min after vaccination to monitor immediate clinical reactions, and at 28 days after completing a self-registration of possible events associated with vaccination, as well as follow-up home visits on days 1, 3, 5, 7, 11, 15, 21, and 28. At day 28, will be made a complete clinical evaluation and blood sampling for assessment of immunogenicity. |
30 minutes immediate, day 1, 3, 5,7,11, 15 and 28
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lourdes Garcia Garcia, DCs, Instituto Nacional de Salud Publica, Mexico
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CI 1059_1170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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