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. 2021 May 10;175(7):e210347. doi: 10.1001/jamapediatrics.2021.0347

Table. Strain-Stratified Vaccine Protection During the 2-Year Efficacy Period.

Characteristic RV1 RV5
Observations, No. RR or OR (95% CI)a P valueb Observations, No. RR or OR (95% CI)a P valueb
RCTsc
High-income countries
Single-antigen vaccine type strain 4 0.054 (0.022-0.130) NA 4 0.056 (0.036-0.088) NA
Single-antigen nonvaccine type strain 9 0.123 (0.076-0.198) .11 2 0.098 (0.010-0.945) .63
Middle-income countries
Homotypic strain 3 0.248 (0.139-0.444) NA NA NA NA
Partly heterotypic strain 7 0.200 (0.131-0.306) .56 NA NA NA
Fully heterotypic strain 3 0.333 (0.191-0.581) .47 NA NA NA
Single-antigen vaccine type strain 4 0.293 (0.196-0.438) NA 13 0.533 (0.423-0.672) NA
Single-antigen nonvaccine type strain 10 0.204 (0.151-0.276) .16 8 0.443 (0.285-0.690) .47
Low-income countries
Single-antigen vaccine type strain 2 0.558 (0.315-0.991) NA NA NA NA
Single-antigen nonvaccine type strain 6 0.485 (0.336-0.701) .69 NA NA NA
Case-control studiesd
High-income countries
Homotypic strain 3 0.096 (0.030-0.313) NA 2 0.156 (0.091-0.268) NA
Partly heterotypic strain 3 0.188 (0.063-0.555) .41 3 0.135 (0.041-0.445) .83
Fully heterotypic strain 3 0.178 (0.107-0.295) .35 NA NA NA
Single-antigen vaccine type strain NA NA NA 3 0.165 (0.101-0.271) NA
Single-antigen nonvaccine type strain NA NA NA 2 0.215 (0.105-0.441) .56
Middle-income countries
Homotypic strain 2 0.116 (0.065-0.217) NA NA NA NA
Partly heterotypic strain 4 0.457 (0.264-0.579) .001 NA NA NA
Fully heterotypic strain 6 0.335 (0.197-0.569) .005 NA NA NA
Single-antigen vaccine type strain 2 0.458 (0.147-1.427) NA 5 0.354 (0.249-0.503) NA
Single-antigen nonvaccine type strain 4 0.592 (0.310-1.129) .70 3 0.176 (0.039-0.793) .38
Low-income countries
Single-antigen vaccine type strain 1 0.201 (0.065-0.617) NA NA NA NA
Single-antigen nonvaccine type strain 2 0.516 (0.232-1.147) .21 NA NA NA
Cohort studiese
Middle-income countries
Homotypic strain 2 0.276 (0.096-0.794) NA NA NA NA
Partly heterotypic strain 3 0.436 (0.183-1.039) .25 NA NA NA
Fully heterotypic strain 4 0.429 (0.185-0.996) .26 NA NA NA

Abbreviations: NA, not applicable; OR, odds ratio; RCTs, randomized clinical trials; RR, relative risk; RV1, monovalent rotavirus vaccine; RV5, pentavalent rotavirus vaccine; RVGE, rotavirus gastroenteritis.

a

Relative risks are used in the RCT portion of this Table, and ORs are used in the case-control studies portion.

b

P values were the differences of vaccine protection against partly heterotypic or fully heterotypic strains compared with homotypic strains; the differences of vaccine protection against single-antigen nonvaccine type strains compared with single-antigen vaccine type strains.