An Open Label, Phase-III Study to Evaluate the Safety and Immunogenicity of Influenza Vaccine

Phase 3

Completed

• Conditions: Healthy Human Volunteers for achievement of titers for Influenza type A

• Registration Number: CTRI/2011/05/001730
• Lead Sponsor: G C CHEMIE PHARMIE LTD

Brief Summary

The studywill be conducted after obtaining written informed consent from the subjects.Incase of pediatrics and adolescent subjects; parents or Legally AcceptableRepresentative (LAR) would sign the ICF. The subjects will undergo medicalscreening during pre-study visit (Visit 1). Screening will include completeclinical evaluation (medical history, general examination, record of height,weight and vital signs).

Enrolledadult subjects will receive a single dose of 0.5 ml of vaccine and pediatric& adolescent subjects will receive a single dose of 0.25 ml of vaccine (Day0) by intramuscular injection on the lateral aspect of arm in the deltoidmuscle. Blood sample will be collected for pre-immunization titers beforevaccination. Safety evaluation will be done for 3 hours on the vaccination day.Subjects will then be followed up using standardized diary card for 28 dayspost-vaccination for untoward AE/ADR and the same will be recorded in the CRF.At visit 3 (day 28+7), blood sample will be collected post-immunization titers.Clinical safety evaluation will also be done.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-22
• Last Update Posted: 2012-01-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Volunteers who are able and are willing to comply with the protocol and have signed IEC/IRB approved “Informed Consent Forms (ICF)” voluntarily.
• Incase of pediatric and adolescent volunteers subject’s Legally Acceptable Representative have to sign ICF.” Healthy male or non-pregnant, non-lactating female or pediatric or adolescent volunteers, ≥ 6 months of age or older on the day of inclusion and not older than 64 years.
• Subjects with normal heath as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
• Volunteers who have not received influenza containing vaccines within five years.
• Willing to give written informed consent and fulfill all study requirements.
• Have a degree of understanding such that the subject can communicate intelligibly with the investigator and study coordinator.
• Female volunteers of child bearing potential require a “Negative Urine Pregnancy Test” and must be willing to practice acceptable method of contraception or surgically sterile during the study and 6 weeks after the completion of study.

Exclusion Criteria

• Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol.
• Self-reported history of severe adverse event to any influenza vaccine.
• Acute febrile disease within the 72 hours, or axillary temperature 37.5°C the day of inclusion, prior to vaccination (37.0°C) Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.) Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
• Any vaccination within the 28 days preceding Visit 1 or scheduled between Visit 1 and Visit 4.
• Receipt of blood or blood products within the 3 months preceding enrollment in the study.
• Diabetes mellitus requiring pharmacological control.
• Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for 2 weeks) or cancer therapy within the month preceding Visit 1 or ongoing Immunoglobulin injection within the 3 months.
• Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration) Subject having received extracted pituitary hormones.
• For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
• Current use of alcohol or recreational drugs that may interfere with the subjects ability to comply with trial procedures.
• Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
• Volunteers planning to leave the area of study site before completion of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of all adverse events	Visit 1 | Day -7 to -1 | (Screening ) | Visit 2 Day 0 | (Vaccination) | Visit 3 Day 28+7 | (Post-Vaccination)
SAEs during the study period	Visit 1 | Day -7 to -1 | (Screening ) | Visit 2 Day 0 | (Vaccination) | Visit 3 Day 28+7 | (Post-Vaccination)
Common Solicited local and systemic reactions	Visit 1 | Day -7 to -1 | (Screening ) | Visit 2 Day 0 | (Vaccination) | Visit 3 Day 28+7 | (Post-Vaccination)
Unsolicited AEs (including abnormal laboratory value)	Visit 1 | Day -7 to -1 | (Screening ) | Visit 2 Day 0 | (Vaccination) | Visit 3 Day 28+7 | (Post-Vaccination)

Secondary Outcome Measures

Name	Time	Method
Proportion/percentage of subjects achieving significant immune response against all three components of Influenza vaccine, 4 weeks after single dose of vaccination.	Visit 1

Trial Locations

Locations (1)

Kulkarni Nursing Home; 🇮🇳 Raigarh, MAHARASHTRA, India

Kulkarni Nursing Home

🇮🇳Raigarh, MAHARASHTRA, India

Dr S V Kulkarni

Principal investigator

9325008557

drcsvk61@rediffmail.com