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Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Pediatric Populations

NCT02100436 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2017-07-06

No results posted yet for this study

Summary

This is a Phase II open-label study in approximately 240, and up to 400, healthy males and non-pregnant females, aged 6 months to 17 years. This study is designed to assess the safety, reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21 days apart of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufactured by sanofi pasteur. Subjects will be stratified by age (approximately 60-100 subjects 6-35 months old, approximately 60-100 subjects 3-8 years old and approximately 60-100 subjects 9-17 years old) to receive 2 doses of vaccine, administered intramuscularly as 15mcg HA/0.5mL dose, approximately 21 days apart. In addition, approximately 60-100 subjects 6-35 months old will receive 2 doses of vaccine, administered intramuscularly as 7.5mcg HA/0.5mL dose, approximately 21 days apart. The duration of the study for each subject will be approximately 7 months.

Conditions

Interventions

BIOLOGICAL

Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203

A unadjuvanted subvirion monovalent inactivated split influenza virus vaccine (H3N2v MIV) produced in eggs. Subjects are enrolled in 3 cohorts stratified by age. 6-35 month old subjects receive 2 doses of H3N2v MIV, intramuscularly (IM) as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25 milliliter (mL) dose, 21 days apart, or 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. 3-8 year old subjects and 9-17 year old subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-11
Primary Completion
2015-03-20
Completion
2015-03-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02100436 on ClinicalTrials.gov