Table 2.

Crude (cOR) and Adjusted Odds Ratios (aOR) for the Relationship between IIV3 Vaccination during Pregnancy and 6-month Infant Development for the Five ASQ-3 Domains

ASQ-3 Screening Domain	Not On Schedule^a n (%)	cOR	95% CI	aOR^b	95% CI	p-value
Communication^c
Vaccinated during pregnancy (n=799)	51 (6.4%)	0.90	0.56–1.44	0.95	0.57–1.57	0.69
Not vaccinated during pregnancy (n=426)	30 (7.0%)	Ref		Ref
Total (n=1225)^d	81 (6.6%)	NA		NA

Gross Motor^c
Vaccinated during pregnancy (n=799)	86 (10.8%)	0.89	0.61–1.28	0.92	0.62–1.37	0.69
Not vaccinated during pregnancy (n=426)	51 (12.0%)	Ref		Ref
Total (n=1225)^d	137 (11.1%)	NA		NA

Fine Motor^c
Vaccinated during pregnancy (n=789)	70 (8.9%)	1.14	0.74–1.75	1.01	0.64–1.61	0.95
Not vaccinated during pregnancy (n=418)	33 (7.9%)	Ref		Ref
Total (n=1207)^d,e	103 (8.5%)	NA		NA

Problem Solving^c,f
Vaccinated during pregnancy (n=798)	49 (6.1%)	0.86	0.54–1.38	0.82	0.49–1.37	0.46
Not vaccinated during pregnancy (n=426)	30 (7.0%)	Ref		Ref
Total (n=1224)^d	79 (6.5%)	NA		NA

Personal Social^c,g
Vaccinated during pregnancy (n=799)	80 (10.0%)^*	0.68	0.48–0.97	0.72	0.49–1.06	0.09
Not vaccinated during pregnancy (n=426)	60 (14.1%)	Ref		Ref
Total (n=1225)^d,e	140 (11.4%)	NA		NA

Not on schedule is defined as ASQ-3 scores in the respective domain indicating the need for monitoring or the need for further assessment.

All ORs adjusted for study site, infant age (month) when ASQ-3 was completed, month of conception (Apr-Oct vs. Nov-Mar), trivalent inactivated vaccination (IIV3) in the year prior to pregnancy, high risk medical conditions, and influenza/acute respiratory illness (ARI) status during pregnancy.

There were no significant associations in the reported adjusted models between ARI symptoms/influenza and development for any of the five ASQ-3 domains: (communication: ARI symptoms/influenza positive and ARI/influenza negative compared to no ARI or influenza [aOR: 1.09, 95% CI: 0.32, 3.37, aOR: 0.87, 95% CI: 0.522, 1.46, respectively], gross motor: ARI symptoms/influenza positive and ARI/influenza negative compared to no ARI or influenza [aOR: 0.89, 95% CI: 0.31, 2.59, aOR: 0.98, 95% CI: 0.66, 1.47, respectively], fine motor: ARI symptoms/influenza positive and ARI/influenza negative compared to no ARI or influenza [aOR: 0.78, 95% CI: 0.23, 2.65, aOR: 0.95, 95%CI: 0.61, 1.49], problem solving: ARI/influenza negative compared to no ARI or influenza [aOR:1.03, 95% CI: 0.62, 1.71], personal social: ARI symptoms/influenza positive and ARI/influenza negative compared to no ARI or influenza [aOR: 0.917, 95% CI: 0.31, 2.692, aOR:1.02, 95% CI: 0.69, 1.51, respectively]. No infants of a mother with ARI/influenza positive scored in the “not on schedule” range in the problem solving domain, thus an aOR could not be calculated.

A small percentage of infants scored in the needs further assessment category across the five ASQ-3 domains: (communication: monitor 6%, needs further assessment <1%; gross motor: monitor 9%, needs further assessment 2%; fine motor: monitor 6%, needs further assessment 2%; problem solving: monitor 5%, needs further assessment 1%; personal social: monitor 8%, needs further assessment 3%). The percentages may not add to the reported percentage of infants categorized as not on schedule due to rounding.

Scores for the Fine Motor and Problem Solving Domains could not calculated for 18 infants and 1 infant, respectively due to missing responses resulting in a sample size of 1207 for the Fine Motor Domain and 1224 for the Problem Solving Domain.

Problem Solving domain is additionally adjusted for maternal race/ethnicity.

The Personal Social domain is additionally adjusted for maternal age.

p<0.05

Abbreviations: IIV3, trivalent inactivated influenza vaccination, ASQ-3, Ages and Stages Questionnaire Third Edition; ARI, Acute Respiratory Illness