Influenza Vaccine in Premature Infants

NCT00455169 | Completed

• 1 other identifier: URRSRB15397A
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 5

Brief Summary

Background. Influenza is increasingly recognized as causing severe respiratory illness in children. High-risk infants, like former premature infants, and particularly those with lung disease, have influenza hospitalization rates about five times higher than healthy children. Influenza vaccine does not protect young children against influenza as well as it does healthy adults. A small study that measured antibodies (proteins that protect against infection) to influenza suggested that premature infants get even less protection from influenza vaccine than full-term infants. More information about influenza vaccine in premature infants is needed. The overall goals of this project are to collect information about the how well the influenza vaccine induces antibody production, and to develop the collaborative network of centers necessary for a larger trial of influenza vaccine in premature infants. Objective and Hypotheses. The objective of this study is to measure the amount of protective antibody produced by influenza vaccine in premature (less than 30 weeks' \[about 7 months\] gestation at birth), extremely-low-birth-weight (1000 grams \[2¼ pounds\] or less at birth) infants. Influenza vaccine needs to be given yearly. We will assess premature infants during their first series of influenza vaccines. We hypothesize that the levels of antibody will be lower in premature infants receiving their first series of influenza vaccine than in full-term infants. Design. We will measure the immune response in premature and full term infants. During the 2007-2008 influenza season, a total of 92 subjects, divided among 2 groups (premature infants 6-17 months old receiving their first influenza vaccine series and full-term infants 6-17 months old receiving their first influenza vaccine series) will be recruited at a consortium of five centers (the University of Rochester, the University of Texas Southwestern Medical Center, Wake Forest University, the University of Miami and the State University of New York at Buffalo), receive 2 doses of influenza vaccine, and have antibody and immune cell responses to each vaccine component measured 4-6 weeks after the second dose of vaccine. Potential Impact. If this study and future investigations suggested ways to improve premature infants influenza vaccine responses, they could lead to changes in recommendations for the number or timing of vaccine doses or of the type of vaccine used in this high-risk group.

Conditions

Influenza; Infant, Premature

Keywords

Influenza; Infant, Premature; Immunization; Vaccination

Study Arms (2)

1

Premature infants

Biological: Trivalent Inactivated Influenza Vaccine

2

Full term infants

Biological: Trivalent Inactivated Influenza Vaccine

Interventions

Trivalent Inactivated Influenza Vaccine BIOLOGICAL

Influenza vaccine

1; 2

Eligibility Criteria

• Age: 6 Months - 17 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Premature infants \< 30 week's gestation, \< 1001 grams' birth weight or full-term infants 37-42 week's gestation \>2500 grams' birth weight

You may qualify if:

• (a) Former premature (\< 30 weeks' gestation at birth), ELBW (\<1001 grams' birth weight) infant, 6 months, 0 days - 17 months, 31 days of age., OR (b) Former full term (37-42 weeks' gestation at birth), normal birth weight (\>2500 grams' birth weight) infant, 6 months, 0 days - 17 months, 31 days of age.
• No prior influenza immunization.
• Eligible for influenza immunization.
• Parental permission.
• Agreement of primary care provider.
• Parents likely to be able to comply with study visits.

You may not qualify if:

• Known immunodeficiency.
• Systemic corticosteroid administration at time of study enrollment.
• Requiring supplemental oxygen.
• Contraindication to influenza immunization (e.g. egg allergy).
• Physician-diagnosed influenza illness in the current influenza season.
• Any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the subject.

Sponsors & Collaborators

• University of Rochester: lead
• Thrasher Research Fund: collaborator
• University of Miami: collaborator
• Wake Forest University Health Sciences: collaborator
• State University of New York at Buffalo: collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (5)

University of Miami

Miami, Florida, 33101, United States

Location

State University of New York at Buffalo

Buffalo, New York, 14222, United States

Location

University of Rochester

Rochester, New York, 14534, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• D'Angio CT, Heyne RJ, Duara S, Holmes LC, O'Shea TM, Wang H, Wang D, Sanchez PJ, Welliver RC, Ryan RM, Schnabel KC, Hall CB; Premature Infant Vaccine Collaborative. Immunogenicity of trivalent influenza vaccine in extremely low-birth-weight, premature versus term infants. Pediatr Infect Dis J. 2011 Jul;30(7):570-4. doi: 10.1097/INF.0b013e31820c1fdf.

  PMID: 21273938 DERIVED

Biospecimen

Retention: NONE RETAINED

No retention

MeSH Terms

Conditions

Influenza, Human; Premature Birth

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Carl T D'Angio, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2007
• First Posted: April 3, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

US (5)