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Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination

ConditionPrevention of Influenza
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-59
SponsorChangchun BCHT Biotechnology Co.

About this trial

A Clinical Trial to Evaluate the Protective Efficacy and Safety of a Nasal Spray Live Attenuated Influenza Vaccine (LAIV) in Adults Aged 18-59 Years Post-Vaccination

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy participants aged 18-59 years

Capable of providing informed consent in person

Willing and able to comply with all clinical trial requirements

Disqualifiers

Axillary temperature >37.0°C on enrollment day *

Received any influenza vaccine within the past 6 months or plans to receive other influenza vaccines during the trial

History of laboratory-confirmed influenza (by clinical, serological, or microbiological methods) within the past 6 months

Female participants of childbearing potential with positive urine pregnancy test, currently breastfeeding, or planning pregnancy within 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo Group

    Biological/Vaccine

    Each human dose: 0.2 mL

  • Test Group

    Biological/Vaccine

    Each human dose is 0.2 mL

Treatment groups

6,680 Participants
are divided into 2 treatment groups
Group A: Nasal Spray Live Attenuated Influenza VaccineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Protective Efficacy

To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed influenza in participants aged 18-59 years at 14 days post-vaccination

Time frame
at 14 days post-vaccination

Secondary outcomes

1

Protective Efficacy

To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed vaccine-matched influenza in participants aged 18-59 years at 14 days post-vaccination

Time frame
at 14 days post-vaccination
2

Protective Efficacy

To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed influenza in participants aged 18-59 years post-vaccination

Time frame
Throughout the entire study period
3

Protective Efficacy

To evaluate the protective efficacy of a nasal spray live attenuated influenza vaccine (LAIV) against laboratory-confirmed, vaccine-matched influenza in participants aged 18-59 years post-vaccination

Time frame
Throughout the entire study period
4

Safety

Incidence of solicited adverse events (local and systemic) within 14 days post-vaccination

Time frame
14 days post-vaccination

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changchun BCHT Biotechnology Co.

Lead sponsor

Hubei Provincial Center for Disease Control and Prevention

Collaborator

Center for Disease Control and Prevention, Fujian

Collaborator

Zhejiang Provincial Center for Disease Control and Prevention

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: