Duration of Infant Protection Against Influenza Illness Conferred by Maternal Immunization: Secondary Analysis of a Randomized Clinical Trial

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Abstract

Importance

Influenza immunization of women during pregnancy protects the young infants against influenza illness. The duration of this protection remains unclear.

Objective

To evaluate the duration of infant protection conferred by maternal immunization and its association with transplacental antibody transfer.

Design, Setting, and Participants

Infants born to women who participated in a randomized, double-blind, placebo-controlled clinical trial in 2011 and 2012 on the safety, immunogenicity, and efficacy of trivalent inactivated influenza vaccine (IIV3) during pregnancy were followed up during the first 6 months of life for polymerase chain reaction (PCR)–confirmed influenza illness. In a secondary analysis of a subset of infants, hemagglutination inhibition (HAI) antibodies were measured. The study was performed at a single center in South Africa. The secondary analysis was performed in October 2014.

Exposure

Maternal immunization for influenza.

Main Outcomes and Measures

The vaccine’s efficacy against PCR-confirmed influenza illness and the percentage of infants with HAI titers of 1:40 or more by age group.

Results

There were 1026 infants (47.2% female) born to IIV3 recipients and 1023 infants (47.3% female) born to placebo recipients who were included in the analysis of the vaccine’s efficacy. The vaccine’s efficacy against PCR-confirmed influenza illness was highest among infants 8 weeks of age or younger at 85.6% (95% CI, 38.3%-98.4%) and decreased with increasing age to 25.5% (95% CI, −67.9% to 67.8%) among infants 8 to 16 weeks of age and to 30.3% (95% CI, −154.9% to 82.6%) among infants 16 to 24 weeks of age. Similarly, in the IIV3 group, the percentage of infants with HAI titers of 1:40 or more to the influenza vaccine strains decreased from more than 56% in the first week of life to less than 40% at 16 weeks of age and less than 10.0% at 24 weeks of age.

Conclusions and Relevance

Maternal immunization conferred protection against infection in the infants for a limited period during early life. The lack of protection beyond 8 weeks of age correlated with a decrease in maternally derived antibodies.

Trial Registration

clinicaltrials.gov Identifier: NCT01306669

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