Trials Sponsors Conditions Drugs Pricing

Conditions

2009 H1N1 Influenza

Keywords

InfluenzaH1N1

Outcome Measures

Primary Outcomes (3)

The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C
nasal swabs obtained at days 2 post vaccination
The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C
nasal swab at 4 days post vaccination
The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C
nasal swab obtained at 7 days post vaccination

Secondary Outcomes (10)

The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR
swabs will be obtained on day 2 post vaccination
The frequency and magnitude of serum hemagglutination-inhibition (HAI), ELISA, and neutralizing antibody response to vaccine
at day 28
The frequency and magnitude of hemagglutinin-specific mucosal IgA response assessed by ELISA on nasal secretions
day 28
The frequency and magnitude of antibody secreting cell and memory B cells developing after vaccination
on day 7
Development of specific local and systemic symptoms occuring after vaccine
for 7 days post each vaccination
+5 more secondary outcomes

Study Arms (3)

LAIV/LAIV

ACTIVE COMPARATOR

Biological: Live Attenuated H1N1 Influenza Vaccine

IIV/IIV

ACTIVE COMPARATOR

Biological: Influenza A (H1N1) 2009 Monovalent Vaccine

IIV/LAIV

ACTIVE COMPARATOR

Biological: Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live

Interventions

Live Attenuated H1N1 Influenza VaccineBiological

0.2 ml dose of live monovalent vaccine delivered through nasal spray, 2 doses given 28 days apart

Also known as: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal

LAIV/LAIV

Influenza A (H1N1) 2009 Monovalent VaccineBiological

0.5 ml IM, 2 doses given 28 days apart

Eligibility Criteria

Age4 Years - 9 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Aged between 4 and 9 years, inclusive.
Pre-vaccination serum HAI titer to A/California/07/09 of 8 or less

Sponsors & Collaborators

National Institutes of Health (NIH)
NIHcollaborator
University of Rochester
Otherlead

Study Sites (1)

University of Rochester Medical Center, Vaccine Research Unit Room 3-5000

Rochester, New York, 14642, United States

Related Publications (10)

Hancock K, Veguilla V, Lu X, Zhong W, Butler EN, Sun H, Liu F, Dong L, DeVos JR, Gargiullo PM, Brammer TL, Cox NJ, Tumpey TM, Katz JM. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med. 2009 Nov 12;361(20):1945-52. doi: 10.1056/NEJMoa0906453. Epub 2009 Sep 10.
PMID: 19745214BACKGROUND
Shinde V, Bridges CB, Uyeki TM, Shu B, Balish A, Xu X, Lindstrom S, Gubareva LV, Deyde V, Garten RJ, Harris M, Gerber S, Vagasky S, Smith F, Pascoe N, Martin K, Dufficy D, Ritger K, Conover C, Quinlisk P, Klimov A, Bresee JS, Finelli L. Triple-reassortant swine influenza A (H1) in humans in the United States, 2005-2009. N Engl J Med. 2009 Jun 18;360(25):2616-25. doi: 10.1056/NEJMoa0903812. Epub 2009 May 7.
PMID: 19423871BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

John J Treanor, MD
University of Rochester
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

March 30, 2010

First Posted

April 2, 2010

Study Start

March 2010

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

a previous history of vaccination against novel H1N1 virus or a laboratory documented history of previous novel H1N1 infection.
History of egg allergy or allergy to other components of vaccine.
History of wheezing.
immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
has an active neoplastic disease.
has long-term (greater than 2 weeks) use of oral or parenteral steroids, or high-dose inhaled steroids (\>800 mg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
received immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days (or 56 days for vaccine naïve recipients).
has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include chronic conditions recognized as risk factors for influenza complications or as contraindications for live vaccination, including chronic cardiac (exclusive of hypertension) or pulmonary conditions (including asthma), diabetes mellitus, or renal impairment.
has an acute illness or an oral temperature greater than 99.9 degrees F (37.7 degrees C) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated symptoms resolved are eligible to enroll as long as treatment is completed and symptoms resolve \> 3 days prior to enrollment.
is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period.
has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
has a previous history of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccination.
has any condition that the principal investigator (PI) believes may interfere with successful completion of the study.

Study Stopped

Effect of Age and Prior Immunity on Response to H1N1 Vaccines in Children

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (10)

Study Arms (3)

LAIV/LAIV

IIV/IIV

IIV/LAIV

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (10)

Study Arms (3)

LAIV/LAIV

IIV/IIV

IIV/LAIV

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations