Phase 3
Completed N=1,357
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
Source: ClinicalTrials.gov NCT00972816 ↗Enrolled (actual)
1,357
Serious AEs
1.8%
Results posted
Jan 2011
Primary outcomePrimary: Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations — 11; 9; 13; 11 percentage of subjects
Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations |
11; 9; 13; 11; 15; 9 | — |
| SECONDARY Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group |
8.5; 7.3; 8.7; 8.7; 9.1; 7.5 | — |
| SECONDARY Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. |
73; 22; 83; 100; 44; 73 | — |
| SECONDARY Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 |
6.22; 12; 22; 15; 5.42; 5.99 | — |
| SECONDARY Antibody Response Based on Baseline Seropositivity |
81; 39; 79; 90; 54; 78 | — |
| SECONDARY Geometric Mean Titers (GMTs) Based on Baseline Seropositivity |
5; 5; 5.1; 5.1; 5; 5 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination |
62; 43; 52; 86; 47; 65 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination |
53; 35; 46; 59; 42; 57 | — |
| SECONDARY Number of Participants Reporting Unsolicited Adverse Events (AEs) |
98; 80; 80; 85; 86; 93 | — |
Eligibility Criteria
Inclusion Criteria
- Children 3 to < 9 years 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 (NCT00972816). 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.