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OpenTrials
Completed

NCT Number: NCT00192387

Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T)

The primary objective of this study was to determine the proportion of subjects, seronegative to all three strains of influenza, as defined by a serum hemagglutination inhibition antibodies (HAI) antibody titer of <1:10, who shed each vaccine virus strain following a single dose of CAIV-T.

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Key information

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Monroe Clinic

Monroe, Wisconsin, 53566, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children at least 6 months of age and less than or equal to 18 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
  • whose parent/legal guardian has provided written informed consent after the nature of the study has been explained;
  • who, along with their parent or legal guardian, will be available for the two month duration of the trial (from enrollment to study completion).

Exclusion criteria

  • whose parents or legal guardians are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
  • with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
  • with Down's syndrome or other known cytogenetic disorders;
  • with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; intranasal steroids or cytotoxic agents;
  • have an immunosuppressed or an immunocompromised individual living in the same household;
  • with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
  • who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational);
  • with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.

Note: A pregnant household member is not considered a contraindication to enrollment.

Treatment and study plan

CAIV-T, Liquid

Biological

Primary outcomes

  1. Measurement of influenza-specific immune response following receipt of CAIV-T.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate Viral Shedding in Healthy Children (6 Mos and Less Than or Equal to 18 Months of Age) Vaccinated With Two Doses of Liquid Formulation of Influenza Virus Vaccine, Live Cold Adapted (CAIV-T)

Important dates

Study start
2001
Study completion
2001
First posted
Sep 19, 2005
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.