Phase 1
N=87
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00819013 ↗Enrolled (actual)
87
Serious AEs
3.5%
Results posted
Jan 2012
Primary outcome: Primary: Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. — 2; 2; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Influenza A Vaccine: ACAM FLU-A (Biological); Saline placebo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. |
2; 2; 1; 0; 0; 1 | — |
| PRIMARY Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. |
1; 0; 1; 0; 3; 3 | — |
| PRIMARY Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. |
1; 2; 2; 1; 0; 3 | — |
| PRIMARY Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine |
0; 12; 2; 0; 0; 9 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. |
50.0; 200.0; 67.3; 50.0; 50.0; 146.4 | — |
| SECONDARY Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. |
3; 2; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. |
0; 0; 0; 0; 4; 9 | — |
| SECONDARY Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. |
50.0; 50.0; 50.0; 50.0; 73.5; 135 | — |
| SECONDARY Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. |
1.47; 2.69; 1.32; 1; 1.06; 1.14 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. |
63.9; 53.0; 58.2; 66.9; 367; 1779 | — |
| SECONDARY Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. |
4; 1; 2; 3; 17; 20 | — |
Summary
This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered.
Subjects will be randomized according to a randomization scheme.
Eligibility Criteria
Inclusion Criteria
- Adult males or females 18 - 40 years of age in good general health
Exclusion Criteria
- Known allergies or severe reactions to any of the vaccine components including those to adjuvants
- History of severe allergic reactions, including angioedema;
- History of asthma or recurrent wheezing; (current or within past 2 years);
- History of neurological symptoms or signs following administration of any vaccine;
Data sourced from ClinicalTrials.gov (NCT00819013). 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.