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

This is an interventional prevention trial for Pregnancy focused on measuring vaccination, Influenza, Immunogenicity, Safety Read More

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