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 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.
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.
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 →Instituto Nacional de Salud Publica, Mexico is the lead sponsor of 30 studies on the registry; none are open to participants now.
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I.Selection Criteria in pregnant women
I.a.Inclusion Criteria
I. b.Exclusion criteria
II.Selection criteria in nonpregnant woman
II. a.Inclusion criteria
II. b.Exclusion criteria
Pregnant Woman
Biological: Seasonal influenza vaccination
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
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
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
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
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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Instituto Nacional de Salud Publica, Mexico