Phase 2
N=600
A Study of Influenza Virus Vaccines in Children and Adults
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00988143 ↗Enrolled (actual)
600
Serious AEs
0.3%
Results posted
Dec 2013
Primary outcome: Primary: Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. — 4; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 2009-2010 Trivalent Influenza Virus Vaccine (Biological); 2008-2009 Trivalent Influenza Virus Vaccine (Biological); Quadrivalent Influenza Virus Vaccine (Biological)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. |
4; 0; 0; 0; 0; 0 | — |
| PRIMARY Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. |
114; NA; 101; NA; 135; 155 | — |
| PRIMARY Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. |
151; 161; 339; 304 | — |
Summary
The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults.
Primary Objective:
To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults.
Observational Objectives:
* To describe the safety of the 2009-2010 TIV among subjects ≥6 months to <5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age.
* To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to <5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.
Eligibility Criteria
Inclusion Criteria
- Subject is ≥ 6 months to 6 months to < 5 years of age:
- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Personal or immediate family history of congenital immune deficiency.
- Developmental delay, neurologic disorder, or seizure disorder.
- Chronic medical, congenital, or developmental disorder.
- Known HIV-positive mother.
For subjects 18 years of age and older:
- Immunocompromising condition; immunosuppressive therapy (including systemic steroid use for two weeks or more); cancer chemotherapy or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past six months.
- Diabetes mellitus requiring pharmacological control.
- Person deprived of freedom by an administrative or court order (having legal or medical guardian).
- 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 subject's ability to comply with trial procedures.
- Any subject with the following conditions is not eligible for enrollment. However, the subject may be enrolled subsequently if the condition has resolved and enrollment is still ongoing and the subject meets all other inclusion/exclusion criteria:
- An acute illness with or without fever in the 72 hours preceding enrollment in the trial.
- Clinically significant findings in vital signs or review of systems (Investigator judgment).
- Received any vaccinations within the preceding 14 days.
- Participation in any other interventional clinical trial within 30 days prior to enrollment.
- Receipt of blood or blood products within the three months preceding enrollment in the study.
Data sourced from ClinicalTrials.gov (NCT00988143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.