NCT01577316

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_2 pregnancy

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_2 pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

April 11, 2012

Last Update Submit

April 12, 2012

Conditions

PregnancyInvestigation or Care in A Nonpregnant Woman

Keywords

vaccinationInfluenzaImmunogenicitySafety

Outcome Measures

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

    Day 28

Secondary Outcomes (1)

  • Adverse events

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

Study Arms (2)

Pregnant Woman

EXPERIMENTAL

Pregnant Woman

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.

Biological: Seasonal influenza vaccination

Interventions

Seasonal influenza vaccinationBIOLOGICAL

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
Nonpregnant womenPregnant Woman

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +41 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Public Health

Cuernavaca, Morelos, 62100, Mexico

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Lourdes Garcia Garcia, DCs

    Instituto Nacional de Salud Publica, Mexico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferreyra-Reyes Leticia, MD

CONTACT

(52) 55 548710 00freyes.ld@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Center of Research in Infectious Diseases

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 13, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations

ME(1)