Trial reportThe Journal of infectious diseases2012
Immunogenicity and safety of varying dosages of a monovalent 2009 H1N1 influenza vaccine given with and without AS03 adjuvant system in healthy adults and older persons.
Trial report in The Journal of infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00963157 (A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of a Sanofi Pasteur H1N1 Influenza Vaccine Administered at Different Dose Levels Given With and Without GlaxoSmithKline AS03 Adjuvant), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of a Sanofi Pasteur H1N1 Influenza Vaccine Administered at Different Dose Levels Given With and Without GlaxoSmithKline AS03 Adjuvant
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.
- Low-dose aspirin use does not diminish the immune response to monovalent H1N1 influenza vaccine in older adults.Epidemiology and infection · 2016Pooled it
- Immunogenicity and Safety of AS03-Adjuvanted H7N9 Influenza Vaccine in Adults (18-64 and ≥65 Years): A Phase 1/2, Randomized, Placebo-Controlled Trial.Influenza and other respiratory viruses · 2024Trial
- Long-Term Persistence of Cell-Mediated and Humoral Responses to A(H1N1)pdm09 Influenza Virus Vaccines and the Role of the AS03 Adjuvant System in Adults during Two Randomized Controlled Trials.Clinical and vaccine immunology : CVI · 2017Trial
- Immunogenicity and Safety of an AS03-Adjuvanted H7N9 Pandemic Influenza Vaccine in a Randomized Trial in Healthy Adults.The Journal of infectious diseases · 2016Trial
- Trial
- Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials.BMC infectious diseases · 2013Trial
- Trial
- Pre-existing hemagglutinin-specific antibody levels are associated with B-cell repertoire maturation and antibody breadth after influenza vaccination.Virologica Sinica · 2026Article
- Historical Advances in Clinical Trial Design and Expanding Representation as the New Frontier for Innovation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Review
- From Yesterday to Tomorrow: How Vaccine Platforms Have Shaped the Vaccine and Treatment Evaluation Units.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Vaccine adjuvants: current status, research and development, licensing, and future opportunities.Journal of materials chemistry. B · 2024Review
- Factors influencing the immunogenicity of influenza vaccines.Human vaccines & immunotherapeutics · 2021Review
- Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults.NPJ vaccines · 2021Article
- The Importance of Vaccinating Children and Pregnant Women against Influenza Virus Infection.Pathogens (Basel, Switzerland) · 2019Review
- Recalling the Future: Immunological Memory Toward Unpredictable Influenza Viruses.Frontiers in immunology · 2019Review
- The Doctrine of Original Antigenic Sin: Separating Good From Evil.The Journal of infectious diseases · 2017Review
- Vaccine-generated lung tissue-resident memory T cells provide heterosubtypic protection to influenza infection.JCI insight · 2016Article
- Influenza virus vaccination and kidney graft rejection: causality or coincidence.Clinical kidney journal · 2015Article
- A molecular mucosal adjuvant to enhance immunity against pneumococcal infection in the elderly.Immune network · 2015Review
Corrections and comments
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Authors and funding
15 authors at 9 institutions in 1 country.
Funding
Abstract
backgroundAdjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines.
methodsThis trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults ≥ 18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 µg, 7.5 µg, or 15 µg with AS03 or 7.5 µg or 15 µg without adjuvant).
resultsThe study population included 544 persons <65 years of age and 245 persons ≥ 65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 µg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 µg adjuvanted group with the 15 µg unadjuvanted group.
conclusionsAS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated. ClinicalTrials.gov NCT00963157.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.