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Trivalent inactivated influenza virus vaccine given to two-month-old children: an off-season pilot study.
Pediatr Infect Dis J. 2009 Dec; 28(12):1099-104.PI

Abstract

BACKGROUND

Although children less than 6 months of age have the highest risk for hospitalization related to influenza infection, influenza vaccine is not approved for these children.

METHODS

In an open-label, off-season study, healthy 6 to 12 week and 6-month-old children received 2 doses of the 2004 to 2005 trivalent inactivated influenza vaccine (TIV) administered 1 month apart along with other routine pediatric vaccines. Safety was assessed by parental diaries (n = 393). Immunogenicity analyses (n = 293) were performed on sera obtained before vaccination and 1 month after the second dose of TIV. Outcomes included the frequencies of subjects with injection site and systemic reactions and seroprotection rates to TIV antigens.

RESULTS

Injection site reactions and fevers were generally mild and resolved within 3 days. Postvaccination seroprotection rates (titer > or = 1:40) in the 6- to 12-week-old and 6-month-old groups were 46% and 69% to A/New Caledonia (H1N1), 59% and 79% to A/Wyoming (H3N2), and 5% and 22% to B/Jiangsu (P < 0.001, all comparisons). For seronegative 6- to 12-week-olds whose mothers had not received TIV during pregnancy, postvaccination seroprotective titers to A/New Caledonia (H1N1) were achieved in 70% (38/54) and to A/Wyoming (H3N2) in 68% (23/34) of infants.

CONCLUSIONS

TIV was well tolerated and safe when administered to children at both 6 to 12 weeks and 6 months of age. The antibody response was lower in the younger children, probably related to antibody suppression from passively acquired antibodies from mothers. In 6- to 12-week-olds without preexisting antibody, seroresponses to influenza A antigens approached those of 6-month-old children.

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Authors+Show Affiliations

Walter EB
Department of Pediatrics, Duke University Medical Center, Durham, NC, USA. walte002@mc.duke.edu
Englund JA
No affiliation info available
Blatter M
No affiliation info available
Nyberg J
No affiliation info available
Ruben FL
No affiliation info available
Decker MD
No affiliation info available
GRC27 Study Team
No affiliation info available

MeSH

Analysis of VarianceChi-Square DistributionHemagglutination Inhibition TestsHumansImmunization ScheduleInfantInfluenza VaccinesInfluenza, HumanMothersPilot ProjectsVaccines, Inactivated

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19935270

Citation

Walter, Emmanuel B., et al. "Trivalent Inactivated Influenza Virus Vaccine Given to Two-month-old Children: an Off-season Pilot Study." The Pediatric Infectious Disease Journal, vol. 28, no. 12, 2009, pp. 1099-104.
Walter EB, Englund JA, Blatter M, et al. Trivalent inactivated influenza virus vaccine given to two-month-old children: an off-season pilot study. Pediatr Infect Dis J. 2009;28(12):1099-104.
Walter, E. B., Englund, J. A., Blatter, M., Nyberg, J., Ruben, F. L., & Decker, M. D. (2009). Trivalent inactivated influenza virus vaccine given to two-month-old children: an off-season pilot study. The Pediatric Infectious Disease Journal, 28(12), 1099-104. https://doi.org/10.1097/INF.0b013e3181b0c0ca
Walter EB, et al. Trivalent Inactivated Influenza Virus Vaccine Given to Two-month-old Children: an Off-season Pilot Study. Pediatr Infect Dis J. 2009;28(12):1099-104. PubMed PMID: 19935270.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Trivalent inactivated influenza virus vaccine given to two-month-old children: an off-season pilot study. AU - Walter,Emmanuel B, AU - Englund,Janet A, AU - Blatter,Mark, AU - Nyberg,Jack, AU - Ruben,Frederick L, AU - Decker,Michael D, AU - ,, PY - 2009/11/26/entrez PY - 2009/11/26/pubmed PY - 2010/3/3/medline SP - 1099 EP - 104 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 28 IS - 12 N2 - BACKGROUND: Although children less than 6 months of age have the highest risk for hospitalization related to influenza infection, influenza vaccine is not approved for these children. METHODS: In an open-label, off-season study, healthy 6 to 12 week and 6-month-old children received 2 doses of the 2004 to 2005 trivalent inactivated influenza vaccine (TIV) administered 1 month apart along with other routine pediatric vaccines. Safety was assessed by parental diaries (n = 393). Immunogenicity analyses (n = 293) were performed on sera obtained before vaccination and 1 month after the second dose of TIV. Outcomes included the frequencies of subjects with injection site and systemic reactions and seroprotection rates to TIV antigens. RESULTS: Injection site reactions and fevers were generally mild and resolved within 3 days. Postvaccination seroprotection rates (titer > or = 1:40) in the 6- to 12-week-old and 6-month-old groups were 46% and 69% to A/New Caledonia (H1N1), 59% and 79% to A/Wyoming (H3N2), and 5% and 22% to B/Jiangsu (P < 0.001, all comparisons). For seronegative 6- to 12-week-olds whose mothers had not received TIV during pregnancy, postvaccination seroprotective titers to A/New Caledonia (H1N1) were achieved in 70% (38/54) and to A/Wyoming (H3N2) in 68% (23/34) of infants. CONCLUSIONS: TIV was well tolerated and safe when administered to children at both 6 to 12 weeks and 6 months of age. The antibody response was lower in the younger children, probably related to antibody suppression from passively acquired antibodies from mothers. In 6- to 12-week-olds without preexisting antibody, seroresponses to influenza A antigens approached those of 6-month-old children. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/19935270/Trivalent_inactivated_influenza_virus_vaccine_given_to_two_month_old_children:_an_off_season_pilot_study_ L2 - https://doi.org/10.1097/INF.0b013e3181b0c0ca DB - PRIME DP - Unbound Medicine ER -