CClinicalTrials.gg
Status unknownNCT01577316VACINFL2011Updated Apr 13, 2012

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

A Phase 2/3 interventional study of Seasonal influenza vaccination in Pregnancy and Investigation or Care in A Nonpregnant Woman, sponsored by Instituto Nacional de Salud Publica, Mexico. Status unknown at 1 site in Mexico. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2012-04-13.

Sponsored by Instituto Nacional de Salud Publica, Mexico · Phase 2/3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
240
Allocation
Non-randomized
Ages
18 Years to 39 Years
Sex
Female
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Study summary

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.

Read the 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.

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Conditions studied

  • Pregnancy
  • Investigation or Care in A Nonpregnant Woman

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Keywords

  • vaccination
  • Influenza
  • Immunogenicity
  • Safety
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 240 is close to the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Instituto Nacional de Salud Publica, Mexico is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Pregnant Woman

    Pregnant Woman

    Biological: Seasonal influenza vaccination

  • 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.

    Biological: Seasonal influenza vaccination

Interventions

  • BiologicalSeasonal influenza vaccination

    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.

    Also known as: Be recruited and will continue in parallel both groups

06

What researchers measure

Primary outcomes

  1. Immunogenicity

    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

    Time frame: Day 28

Secondary outcomes

  1. Adverse events

    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.

    Time frame: 30 minutes immediate, day 1, 3, 5,7,11, 15 and 28

07

Study locations

1 site
  • National Institute of Public Health
    Cuernavaca, Morelos 62100, Mexico
    • Leticia Ferreyra-Reyes, MD · Contact · freyes.ld@gmail.com · (52)5554871000
    • 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 · Sub investigator
    • Samuel Ponce de Leon-Rosales, MD · Principal investigator
    • Maria Eugenia Jiménez-Corona, DSc · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01577316
Lead sponsor
Instituto Nacional de Salud Publica, Mexico
Collaborators
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Responsible party
Ma. de Lourdes Garcia Garcia (Director of the Center of Research in Infectious Diseases, Instituto Nacional de Salud Publica, Mexico) — Principal investigator
First posted
Apr 13, 2012
Start date
Apr 2012
Primary completion
Dec 2012 (estimated)
Completion
Dec 2013 (estimated)
Last update
Apr 13, 2012

Study contacts

Ferreyra-Reyes Leticia, MD
Contact
freyes.ld@gmail.com
(52) 55 548710 00 ext. 4312
Lourdes Garcia Garcia, DCs
principal investigator · Instituto Nacional de Salud Publica, Mexico

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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