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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00192387

Enrollment

Registered

2005-09-19

Start date

2001-09-30

Completion date

2001-12-31

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Brief summary

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.

Interventions

BIOLOGICALCAIV-T, Liquid

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Measurement of influenza-specific immune response following receipt of CAIV-T.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026