PregnancyPhase 2/3VACINFL2011NCT01577316
Evaluate the Immunogenicity and Safety of the 2011-2012 Vaccine Against Seasonal Influenza on Pregnant Women
A Phase 2/3 study testing Seasonal influenza vaccination in people with Pregnancy and Investigation or Care in A Nonpregnant Woman, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Mexico.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Pregnancy, Investigation or Care in A Nonpregnant Woman
- What is being tested?
- Seasonal influenza vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2012to Dec 2013
- Phase
- Phase 2/3
- 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 39 years
- Women only
- No healthy volunteers
- Adult
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
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Institute of Public Health
Cuernavaca, Morelos, 62100
Leticia Ferreyra-Reyes, MD, (52)5554871000 ext. 4312, freyes.ld@gmail.com
Renata Baez-Saldaña, MD
About this study
Official title: 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.
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.
- Being tested
- Seasonal influenza vaccination
- Keywords
- vaccination, Influenza, Immunogenicity, Safety
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal influenza vaccinationBiological
Also called Be recruited and will continue in parallel both groups
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Woman | Experimental | Pregnant Woman Receives: Biological: Seasonal influenza vaccination |
| Nonpregnant women | Experimental | 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. Receives: Biological: Seasonal influenza vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 30 minutes immediate, day 1, 3, 5,7,11, 15 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
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 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
- Responsible party
- Principal investigator, Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Lourdes Garcia Garcia, DCs, Principal investigator, Instituto Nacional de Salud Publica, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577316
- Sponsor's protocol ID
- CI 1059_1170
- Acronym
- VACINFL2011
- Status last verified
- Apr 2012
- First submitted
- 11 Apr 2012
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Immunogenicity and Safety of the 2011-2012 Vaccine Against Seasonal Influenza on Pregnant Women
- ClinicalTrials.gov ID
- NCT01577316
- Acronym / sponsor ID
- VACINFL2011 / CI 1059_1170
- Keywords
- vaccination, Influenza, Immunogenicity, Safety
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 13 Apr 2012 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Woman | Experimental | Biological: Seasonal influenza vaccinationPregnant Woman |
| Nonpregnant women | Experimental | Biological: Seasonal influenza vaccination2011-2012 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Seasonal influenza vaccinationAlso: Be recruited and will continue in parallel both groups2011-2012 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. | Biological | Nonpregnant women, Pregnant Woman |
Primary outcome
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
1 secondary outcome
Adverse events
Time frame: 30 minutes immediate, day 1, 3, 5,7,11, 15 and 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
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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.
Lourdes Garcia Garcia, DCs principal investigator
Instituto Nacional de Salud Publica, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Seasonal influenza vaccination in people with Pregnancy and Investigation or Care in A Nonpregnant Woman, run by Instituto Nacional de Salud Publica, Mexico 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?
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: status not confirmed, as of the sponsor's last update on 13 Apr 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferreyra-Reyes Leticia, MD ((52) 55 548710 00 ext. 4312, freyes.ld@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity (time frame: Day 28). 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 13 Apr 2012.