Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza

Keywords

live-attenuated vaccineinfluenza vaccine

Outcome Measures

Primary Outcomes (3)

Reactions to vaccine
Number of solicited local and systemic reactions for CodaVax-H1N1 and placebo
6 days
Adverse events (AEs)
Number of subjects with AEs for CodaVax-H1N1 and placebo
30 days
Serious adverse events (SAEs)
Number of subjects with SAEs for CodaVax-H1N1 and placebo
180 days

Secondary Outcomes (9)

HAI antibody titers against A/California/07/2009
Day 0 and 30
Increase in HAI titer against A/California/07/2009
Day 0 and 30
HAI sero-response
Day 0 and 30
Serum IgG response
Day 0 and 30
Increase in serum IgG
Day 0 and 30
+4 more secondary outcomes

Study Arms (2)

Normal Saline Placebo

PLACEBO COMPARATOR

Saline (0.9%)

Biological: Normal Saline Placebo

CodaVax-H1N1

EXPERIMENTAL

Live-attenuated influenza vaccine

Biological: CodaVax-H1N1 influenza vaccine

Interventions

CodaVax-H1N1 influenza vaccineBiological

CodaVax-H1N1, a live attenuated vaccine (LAIV) strain based on the A/California/07/2009 (H1N1) influenza virus, administered once intranasally via a sprayer at a dose of 8 x10\^5 plaque forming units (PFU).

CodaVax-H1N1

Normal Saline PlaceboBiological

Saline (0.9%) administered intranasally via sprayer

Normal Saline Placebo

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Adult volunteers, aged 18 to 45 years (at the time of screening) in good general health in the opinion of the Medical Investigator or delegate, with no significant medical history and no clinically significant abnormal findings at screening.
Participants must use highly effective, double contraception from the Screening Visit and up to the Follow-up Visit (Day 30).

Sponsors & Collaborators

Codagenix, Inc
Industrylead

Study Sites (1)

Q-Pharm Pty Limited

Brisbane, Queensland, 4006, Australia

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Enrollment

33 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, CARE PROVIDER
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 31, 2019

Study Start

May 7, 2019

Actual (reported)

Safety Study of Live Attenuated Influenza Vaccine, CodaVax, Delivered Via Intranasal Spray

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 (9)

Study Arms (2)

Normal Saline Placebo

CodaVax-H1N1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

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 (9)

Study Arms (2)

Normal Saline Placebo

CodaVax-H1N1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations