Evidence map›Paper›PMID 22802432›Full record

Trial reportThe Journal of infectious diseases2012

Safety and immune responses in children after concurrent or sequential 2009 H1N1 and 2009-2010 seasonal trivalent influenza vaccinations.

Sharon E Frey, David I Bernstein, Michael A Gerber, Harry L Keyserling, Flor M Munoz, Patricia L Winokur, Christine B Turley, Richard E Rupp, Heather Hill, Mark Wolff and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

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 NCT00943202 (Effect of Administration of Licensed TIV Vaccine on the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Previously Primed Infants and Toddlers), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00943202 phase2completednot on this map

Effect of Administration of Licensed TIV Vaccine on the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Previously Primed Infants and Toddlers (Greater Than or Equal to 6 - <36 Months), Children (Greater Than or Equal to 36 Months - 9 Years), and Adolescents (10 - 17 Years)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2010Enrolled531ConditionsInfluenzaArmsInactivated H1N1 Vaccine, Trivalent Inactivated Influenza Vaccine
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Future Goals and Long-term Vision of the Infectious Diseases Clinical Research Consortium/Vaccine and Treatment Evaluation Unit Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  4. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 1 country.

Sharon E FreyDivision of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, St. Louis, MO 63104, USA. freyse@slu.edu
David I Bernstein
Michael A Gerber
Harry L Keyserling
Flor M Munoz
Patricia L Winokur
Christine B Turley
Richard E Rupp
Heather Hill
Mark Wolff
Diana L Noah
Allison C Ross
Gretchen Cress
Robert B Belshe
Children's Healthcare of Atlanta · USCincinnati Children's Hospital Medical Center · USEmmes (United States) · USSaint Louis University · USThe University of Texas Medical Branch at Galveston · USUniversity of Iowa · USBaylor College of Medicine · USSouthern Research Institute · US

Funding

UNIVERSITY OF IOWA CTSA FOR PEDIATRIC RESEARCHUL1RR024979 · NCRR · UNIVERSITY OF IOWA · PI ROSENTHAL, GARY E · 2007 to 2011
$31.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025008 · NCRR · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2007 to 2011
$29.0M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Tolerance Maintenance and its Breakdown in Food AllergyR21AI080002 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CHATILA, TALAL AMINE · 2008 to 2009
$424k
NCATS NIH HHS UL1 TR000454NCRR NIH HHS UL1 RR024979NCRR NIH HHS UL1RR024979NCRR NIH HHS UL1 RR025008NIAID NIH HHS HHSN272200800003CNIAID NIH HHS HHSN272200800005CNIAID NIH HHS HHSN272200800008CNIAID NIH HHS HHSN272200800013CNIAID NIH HHS N01 AI080006NIAID NIH HHS N01AI800002NIAID NIH HHS N01-AI-80002NIAID NIH HHS N01-AI-80006NIAID NIH HHS R21 AI080002
6 · The paper itself

Abstract

backgroundAdministering 2 separate vaccines for seasonal and pandemic influenza was necessary in 2009. Therefore, we conducted a randomized trial of monovalent 2009 H1N1 influenza vaccine (2009 H1N1 vaccine) and seasonal trivalent inactivated influenza vaccine (TIV; split virion) given sequentially or concurrently in previously vaccinated children.

methodsChildren randomized to 4 study groups and stratified by age received 1 dose of seasonal TIV and 2 doses of 2009 H1N1 vaccine in 1 of 4 combinations. Injections were given at 21-day intervals and serum samples for hemagglutination inhibition antibody responses were obtained prior to and 21 days after each vaccination. Reactogenicity and adverse events were monitored.

resultsAll combinations of vaccines were safe in the 531 children enrolled. Generally, 1 dose of 2009 H1N1 vaccine and 1 dose of TIV, regardless of sequence or concurrency of administration, was immunogenic in children ≥ 10 years of age; children <10 years of age required 2 doses of 2009 H1N1 vaccine.

conclusionsVaccines were generally well tolerated. The immune responses to 2009 H1N1 vaccine were adequate regardless of the sequence of vaccination in all age groups but the sequence affected titers to TIV antigens. Two doses of 2009 H1N1 vaccine were required to achieve a protective immune response in children <10 years of age. CLINICAL TRIALS REGISTRATION: NCT00943202.

Indexed as

Immunization ScheduleAdolescentAgingAntibodies, ViralChildChild, PreschoolFemaleHumansInfantInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza B virusInfluenza, HumanInfluenza VaccinesMaleSeasonsAntibodies, ViralInfluenza Vaccines

Identifiers

PMID22802432
PMCPMC3501155
OpenAlexW2161372832

What OpenQuestion holds

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Read underepoch 390

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.