Evaluate the Immunogenicity and Safety of the 2011-2012 Vaccine Against Seasonal Influenza on Pregnant Women (VACINFL2011)

April 12, 2012 updated by: Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico

Clinical Trial to Evaluate the Immunogenicity and Safety of the 2011-2012 Vaccine Against Seasonal Influenza on Pregnant Women

The hypothesis proposed in this study is that the 2011-2012 Seasonal Influenza Vaccine (including H3N2 and H1N1 subtypes of serotype A strain over the serotype B) administered to 15ug (without adjuvant) via intramuscular in pregnant women will be safe and immunogenic.

Study Overview

Detailed Description

Despite the fact that influenza vaccination of pregnant women is amply recommended, coverage of influenza vaccination is low. In general, there are few studies on safety of the vaccine to this group, particularly during the first three months of pregnancy or evaluating trivalent vaccines containing inactivated pandemic 2009 H1N1 virus. Studies are controversial regarding passage of maternal antibodies and protection to the newborn. The investigators propose to evaluate safety and immunogenicity of 2011-2012 seasonal trivalent influenza vaccine (Northern hemisphere)(containing an A/California/7/2009 (H1N1)-like virus; an A/Perth/16/2009 (H3N2)-like virus; a B/Brisbane/60/2008-like virus) produced by Sanofi Pasteur. Study design is a Phase II/III, two arm, non-randomized clinical trial. The investigators will recruit 120 pregnant women, 18 to 39 years of age, 14 to 34 week pregnant and 120 non-pregnant women. Trivalent influenza vaccine (0.5ml) will be administered IM in the deltoid zone. Participants will be observed for 30 min post-vaccination for acute adverse reactions and periodically during the 60 days post-vaccination for reactogenicity, adverse effects and severe adverse effects. Baseline and 28 day influenza antibodies will be measured by hemagglutination and microneutralization. Umbilical cord blood (10ml) will be drawn during delivery. Newborns will be followed monthly for growth and morbidity up to six months of age. If necessary, they will be referred for appropriate clinical care. Main outcome will be seroconversion and seroresponse at 28 days post vaccination. Results will be adjusted by study group and other relevant covariables.Safety will be analyzed according to type, severity and study group.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

I.Selection Criteria in pregnant women

I.a.Inclusion Criteria

  1. Pregnant women aged 18 to 39 years
  2. Have made at least one prenatal visit to confirm the pregnancy
  3. Available for follow-up time
  4. To be from 14 to 34 weeks of gestation
  5. If recruitment is conducted between August and November 2011, patient could have
  6. Received the Seasonal Influence Vaccine from previous period, but not the H1N1 vaccine
  7. Agree to participate in the study and provide informed consent
  8. Good health according to the clinical evaluation of the participant, confirming: heart
  9. Rate less than 100', systolic blood pressure less than 140 mm Hg, and diastolic less or
  10. Equal than 90 mmHg, and oral temperature less or equal than 37.4° C
  11. Normal physical exam and laboratory test within 28 days prior to recruitment
  12. HIV-negative test

I. b.Exclusion criteria

  1. Preeclampsia or eclampsia
  2. Treatment with immunosuppressive drugs
  3. Receipt of blood products, 120 days prior to HIV screening
  4. Receipt of immunoglobulin 60 days prior to screening for HIV
  5. Have received live attenuated vaccines 30 days prior of vaccination
  6. Have received inactivated vaccines within 14 days prior to vaccination
  7. Treatment of latent or active tuberculosis
  8. Autoimmune disease or immunodeficiency
  9. Contraindication to receiving seasonal influenza vaccine
  10. Vaccine side effects
  11. History of angioedema.
  12. Unstable asthma
  13. Diabetes
  14. Thyroidectomy or thyroid disease in the last 12 months
  15. Idiopathic urticaria
  16. Hypertension not well-controlled with treatment
  17. Medically diagnosed bleeding diathesis, coagulopathy or platelet disorder
  18. Active malignant tumor or in not-effective treatment
  19. Asplenia
  20. Allergic reaction to antibiotics
  21. Guillain Barre
  22. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • an A/California/7/2009 (H1N1)pdm09-like virus;
  • an A/Victoria/361/2011 (H3N2)-like virus;
  • a B/Wisconsin/1/2010-like virus.
Other Names:
  • Be recruited and will continue in parallel both groups
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:

  • an A/California/7/2009 (H1N1)pdm09-like virus;
  • an A/Victoria/361/2011 (H3N2)-like virus;
  • a B/Wisconsin/1/2010-like virus.
Other Names:
  • Be recruited and will continue in parallel both groups

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lourdes Garcia Garcia, DCs, Instituto Nacional de Salud Publica, Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

April 13, 2012

Last Update Submitted That Met QC Criteria

April 12, 2012

Last Verified

April 1, 2012

More Information

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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