Field Trial of Maternal Influenza Immunization in Asia - Full Text View

Sponsor:	Children's Hospital Medical Center, Cincinnati
Collaborators:	Bill and Melinda Gates Foundation Seattle Children's Hospital Tribhuvan University, Nepal Johns Hopkins Bloomberg School of Public Health
Information provided by (Responsible Party):	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT01034254

Purpose

The overall goal of this project is to carry out a field trial to assess the safety and effectiveness of maternal immunization with influenza vaccine in reduction of maternal and infant morbidity in Asia.

Condition	Intervention	Phase
Influenza Human	Biological: influenza vaccine Biological: saline placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Field Trial of Maternal Influenza Immunization in Asia

Resource links provided by NLM:

MedlinePlus related topics: Fever Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:

The incidence of influenza and influenza-like febrile illness episodes among pregnant women and their newborn infants in women randomized to receive either influenza vaccine or control during pregnancy. [ Time Frame: 2 annual recruitment cycles coinciding with flu seasons ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the distribution of cause of febrile illness in pregnant/lactating study women and their infants. [ Time Frame: 2 annual recruitment cycles ] [ Designated as safety issue: No ]
To compare the indirect protection of influenza vaccine on influenza-like and influenza-specific febrile illness rates in families of study women. [ Time Frame: 2 annual recruiting cycles ] [ Designated as safety issue: No ]
To assess the passive transfer of influenza-specific antibody from mother to infant among study women. [ Time Frame: 2 annual recruiting cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	3000
Study Start Date:	November 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: influenza vaccine	Biological: influenza vaccine Pregnant women will receive FDA approved influenza vaccine.
Placebo Comparator: saline placebo	Biological: saline placebo Vaccination of pregnant women with saline placebo.

Eligibility

Ages Eligible for Study:	15 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

mid to late pregnancy

Exclusion Criteria:

do not intend to deliver in the study area
previous pregnancy in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034254

Contacts

Contact: Mark C Steinhoff, MD

513-636-1736

Mark.Steinhoff@chmc.org

Locations

Nepal
Institute of Medicine, Tribhuvan Univerisity	Recruiting
Kathmandu, Nepal
Contact: Prakash S Shrestha, MD 441-2202

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Bill and Melinda Gates Foundation

Seattle Children's Hospital

Tribhuvan University, Nepal

Johns Hopkins Bloomberg School of Public Health

Investigators

Principal Investigator:

Mark C Steinhoff, MD

Children's Hospital Medical Center, Cincinnati

More Information

Publications:

Cox S, Posner SF, McPheeters M, Jamieson DJ, Kourtis AP, Meikle S. Hospitalizations with respiratory illness among pregnant women during influenza season. Obstet Gynecol. 2006 Jun;107(6):1315-22.

Dodds L, McNeil SA, Fell DB, Allen VM, Coombs A, Scott J, MacDonald N. Impact of influenza exposure on rates of hospital admissions and physician visits because of respiratory illness among pregnant women. CMAJ. 2007 Feb 13;176(4):463-8.

Englund JA. Maternal immunization with inactivated influenza vaccine: rationale and experience. Vaccine. 2003 Jul 28;21(24):3460-4. Review.

Greenwood B. Maternal immunisation in developing countries. Vaccine. 2003 Jul 28;21(24):3436-41. Review.

Healy CM, Baker CJ. Maternal immunization. Pediatr Infect Dis J. 2007 Oct;26(10):945-8. Review. No abstract available.

Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900.

Mak TK, Mangtani P, Leese J, Watson JM, Pfeifer D. Influenza vaccination in pregnancy: current evidence and selected national policies. Lancet Infect Dis. 2008 Jan;8(1):44-52. Review.

Zaman K, Roy E, Arifeen SE, Rahman M, Raqib R, Wilson E, Omer SB, Shahid NS, Breiman RE, Steinhoff MC. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008 Oct 9;359(15):1555-64. Epub 2008 Sep 17.

MacDonald NE, Riley LE, Steinhoff MC. Influenza immunization in pregnancy. Obstet Gynecol. 2009 Aug;114(2 Pt 1):365-8.

Tamma PD, Ault KA, del Rio C, Steinhoff MC, Halsey NA, Omer SB. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol. 2009 Dec;201(6):547-52. Epub 2009 Oct 21.

Pickering LK, Baker CJ, Freed GL, Gall SA, Grogg SE, Poland GA, Rodewald LE, Schaffner W, Stinchfield P, Tan L, Zimmerman RK, Orenstein WA; Infectious Diseases Society of America. Immunization programs for infants, children, adolescents, and adults: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Sep 15;49(6):817-40.

Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NS; Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008. MMWR Recomm Rep. 2008 Aug 8;57(RR-7):1-60.

Responsible Party:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT01034254 History of Changes
Other Study ID Numbers:	Mothers'Gift 241 Field Trial
Study First Received:	December 16, 2009
Last Updated:	February 7, 2012
Health Authority:	United States: Institutional Review Board; Nepal: Ethics Committee

Keywords provided by Children's Hospital Medical Center, Cincinnati:

influenza
immunization
pregnancy
efficacy

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012