Phase 3
N=654
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00996307 ↗Enrolled (actual)
654
Serious AEs
3.4%
Results posted
May 2011
Primary outcome: Primary: Antibody Responses After the First and Second Vaccinations — 19; 9; 15; 19 Percentages of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MF59-eH1N1_f (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody Responses After the First and Second Vaccinations |
19; 9; 15; 19; 79; 37 | — |
| PRIMARY Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination |
0; 0; 1; 0; 1; 1 | — |
| SECONDARY Immunogenicity Measurement by Geometric Mean Titers (GMT) |
10; 7.27; 9.29; 11; 83; 20 | — |
| SECONDARY Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 |
73; 37; 78; 44; 75; 22 | — |
| SECONDARY Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 |
11; 7.95; 9.94; 12; 10; 6.52 | — |
| SECONDARY Antibody Response Based on Baseline Seropositivity |
72; 31; 82; 39; 77; 36 | — |
| SECONDARY Geometric Mean Titers (GMTs) Based on Baseline Seropositivity |
5.06; 5.07; 5.01; 5.06; 53; 35 | — |
| SECONDARY Antibody Persistence by Geometric Mean Titers (GMT) |
10; 7.27; 9.29; 11; 176; 33 | — |
Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
Eligibility Criteria
Inclusion Criteria
- Children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months
Exclusion Criteria
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination
For additional entry criteria, please refer to protocol
Data sourced from ClinicalTrials.gov (NCT00996307). 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.