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Randomized Controlled Trial
. 2008 Dec;153(6):764-70.
doi: 10.1016/j.jpeds.2008.05.060. Epub 2008 Jul 14.

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  1 , Elisabeth A M Sanders, Arno W Hoes, Anton M van Loon, Eelko Hak
Affiliations
Randomized Controlled Trial

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 et al. J Pediatr. 2008 Dec.

Abstract

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.

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Figures

Figure
Figure
Flowchart of the trial.
See this image and copyright information in PMC

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