Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

NCT00464672 | Completed Phase 3 Results DMC

• 2 other identifiers: V71P5IND: 13299
• Study Type: interventional
• Target: 1,893
• Locations: 1 country
• Sites: 2

Brief Summary

This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.

Conditions

Influenza

Keywords

Influenza, Egg-Derived, Healthy Children, Healthy Adolescents, Healthy Adults, Safety, Immunogenicity, Trivalent, Inactivated, Vaccination

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age

  To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.

  21 days after vaccination

• Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age

  Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.

  21 days after vaccination

Secondary Outcomes (10)

• Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age

  7 days after vaccination

• Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age

  21 days after vaccination

• Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age

  21 days after vaccination

• Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age

  21 days after vaccination

• Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age

  7 days after vaccination

Study Arms (2)

Influenza virus vaccine

EXPERIMENTAL

Biological: Influenza virus vaccine

Comparator influenza vaccine

ACTIVE COMPARATOR

Biological: Comparator influenza vaccine

Interventions

Influenza virus vaccine BIOLOGICAL

Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

Influenza virus vaccine

Comparator influenza vaccine BIOLOGICAL

Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

Comparator influenza vaccine

Eligibility Criteria

• Age: 3 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy subjects 3 to 64 years of age

You may not qualify if:

• Receipt of other investigational products within 3 months or other vacine within 1 month;
• Allergy to eggs, egg products, or any other vaccine component;
• Laboratory confirmed influenza disease within 6 months;
• Have previously received an influenza vaccination (3 to 8 years only);

Sponsors & Collaborators

• Novartis: lead
• Novartis Vaccines: collaborator

Study Sites (2)

Site 2: C1425AWK

Buenos Aires, Argentina

Location

Site 1: X5000BJH

Córdoba, Argentina

Location

Related Publications (1)

• Tregnaghi MW, Stamboulian D, Vanadia PC, Tregnaghi JP, Calvari M, Fragapane E, Casula D, Pellegrini M, Groth N. Immunogenicity, safety, and tolerability of two trivalent subunit inactivated influenza vaccines: a phase III, observer-blind, randomized, controlled multicenter study. Viral Immunol. 2012 Jun;25(3):216-25. doi: 10.1089/vim.2011.0063.

  PMID: 22691101 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Novartis Vaccines and Diagnostics
• Organization: Novartis Vaccines and Diagnostics

RegContactVacUS.nvdit@Novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: April 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 1, 2015
• Results First Posted: May 5, 2010

Record last verified: 2015-09

Locations

AR (2)