Phase 2
Completed N=407
Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older
Source: ClinicalTrials.gov NCT02464163 ↗Enrolled (actual)
407
Serious AEs
3.3%
Results posted
Oct 2017
Primary outcomePrimary: Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic. — 11; 9; 15; 1 Participants
Summary
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic. |
11; 9; 15; 1 | — |
| SECONDARY Reactogenicity Immediately After Each Injection, Extending to Day 7 |
37; 33; 33; 27; 30; 30 | — |
| SECONDARY Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine |
0; 0; 1; 0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adults, regardless of gender, aged 18 years and above
- Able to give written informed consent to participate.
- Body temperature 38º C or >100º F) within three days prior to study enrollment (enrollment may be delayed for full recovery, if acceptable to investigator).
- Persons currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication) or have received an experimental agent within 1 month prior to enrollment in this study, or who expect to receive another experimental agent during participation, or intend to donate blood during the 42-day primary study period.
- Persons who received immunoglobulin or another blood product within the 3 months prior to enrollment in this study. Persons who expect to receive immunoglobulin or another blood product during the 42-day primary period of this study.
Data sourced from ClinicalTrials.gov (NCT02464163). 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. Informational only — not medical advice.