Effects of influenza plus pneumococcal conjugate vaccination versus influenza vaccination alone in preventing respiratory tract infections in children: a randomized, double-blind, placebo-controlled trial

Angelique G S C Jansen, Elisabeth A M Sanders, Arno W Hoes, Anton M van Loon, Eelko Hak

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    32 Citations (Scopus)


    OBJECTIVE: To evaluate the effects of influenza vaccination with or without heptavalent pneumococcal conjugate vaccination on respiratory tract infections (RTIs) in children.

    STUDY DESIGN: This was a randomized, double-blind, placebo-controlled trial comprising 579 children age 18 to 72 months with a previous history of physician-diagnosed RTI, recruited between 2003 and 2005. The children were assigned to 2 doses of parenteral inactivated trivalent subunit influenza plus heptavalent pneumococcal conjugate vaccination (TIV+PCV7), influenza plus placebo vaccination (TIV+plac), or control hepatitis B virus vaccination plus placebo (HBV+plac). Main outcome measures were febrile RTI and related polymerase chain reaction (PCR)-confirmed influenza, primary care visits, antibiotic prescriptions, and acute otitis media (AOM) episodes.

    RESULTS: During influenza seasons, febrile RTI were reduced by 24% (95% confidence interval [CI] = 1% to 42%) in the TIV+PCV7 group and by 13% (95% CI = -12% to 32%) in the TIV+plac group compared with the control group. The occurrence of PCR-confirmed influenza was reduced by 52% (95% CI = 7% to 75%) in the TIV+PCV7 group and by 51% (95% CI = 3% to 75%) in the TIV+plac group. Episodes of AOM were reduced by 57% (95% CI = 6% to 80%) in the TIV+PCV7 group and by 71% (95% CI = 30% to 88%) in the TIV+plac group. Outside of the influenza seasons, no significant effects of vaccinations were demonstrated on the studied outcomes.

    CONCLUSIONS: During influenza seasons, influenza vaccination with or without pneumococcal conjugate vaccination substantially reduced cases of confirmed influenza and AOM episodes.

    Original languageEnglish
    Pages (from-to)764-770.e2
    Number of pages9
    JournalThe Journal of Pediatrics
    Issue number6
    Publication statusPublished - Dec-2008


    • Acute Disease
    • Child
    • Child, Preschool
    • Cohort Studies
    • Double-Blind Method
    • Drug Therapy, Combination
    • Female
    • Humans
    • Incidence
    • Infant
    • Influenza Vaccines
    • Male
    • Netherlands
    • Otitis Media
    • Pneumococcal Vaccines
    • Respiratory Tract Infections
    • Seasons
    • Vaccines, Conjugate

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