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Safety and immune responses in children after concurrent or sequential 2009 H1N1 and 2009-2010 seasonal trivalent influenza vaccinations.
J Infect Dis 2012; 206(6):828-37JI

Abstract

BACKGROUND

Administering 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.

METHODS

Children 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.

RESULTS

All 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.

CONCLUSIONS

Vaccines 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.

Authors+Show Affiliations

Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, St. Louis, MO 63104, USA. freyse@slu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

22802432

Citation

Frey, Sharon E., et al. "Safety and Immune Responses in Children After Concurrent or Sequential 2009 H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations." The Journal of Infectious Diseases, vol. 206, no. 6, 2012, pp. 828-37.
Frey SE, Bernstein DI, Gerber MA, et al. Safety and immune responses in children after concurrent or sequential 2009 H1N1 and 2009-2010 seasonal trivalent influenza vaccinations. J Infect Dis. 2012;206(6):828-37.
Frey, S. E., Bernstein, D. I., Gerber, M. A., Keyserling, H. L., Munoz, F. M., Winokur, P. L., ... Belshe, R. B. (2012). Safety and immune responses in children after concurrent or sequential 2009 H1N1 and 2009-2010 seasonal trivalent influenza vaccinations. The Journal of Infectious Diseases, 206(6), pp. 828-37. doi:10.1093/infdis/jis445.
Frey SE, et al. Safety and Immune Responses in Children After Concurrent or Sequential 2009 H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations. J Infect Dis. 2012 Sep 15;206(6):828-37. PubMed PMID: 22802432.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immune responses in children after concurrent or sequential 2009 H1N1 and 2009-2010 seasonal trivalent influenza vaccinations. AU - Frey,Sharon E, AU - Bernstein,David I, AU - Gerber,Michael A, AU - Keyserling,Harry L, AU - Munoz,Flor M, AU - Winokur,Patricia L, AU - Turley,Christine B, AU - Rupp,Richard E, AU - Hill,Heather, AU - Wolff,Mark, AU - Noah,Diana L, AU - Ross,Allison C, AU - Cress,Gretchen, AU - Belshe,Robert B, Y1 - 2012/07/16/ PY - 2012/7/18/entrez PY - 2012/7/18/pubmed PY - 2012/12/10/medline SP - 828 EP - 37 JF - The Journal of infectious diseases JO - J. Infect. Dis. VL - 206 IS - 6 N2 - BACKGROUND: Administering 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. METHODS: Children 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. RESULTS: All 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. CONCLUSIONS: Vaccines 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. SN - 1537-6613 UR - https://www.unboundmedicine.com/medline/citation/22802432/Safety_and_immune_responses_in_children_after_concurrent_or_sequential_2009_H1N1_and_2009_2010_seasonal_trivalent_influenza_vaccinations_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1093/infdis/jis445 DB - PRIME DP - Unbound Medicine ER -