Safety and Immunogenicity of Trivalent Oral Polio Vaccine in Vaccinated Children and Vaccine-Naïve Infants: A Phase 4 Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Population
2.2. Vaccine and Immunization Procedures
2.3. Study Assessments
2.4. Immunogenicity Assessments
2.5. Safety Assessments
2.6. Statistical Analysis
2.7. Ethics
3. Results
3.1. Study Subjects
3.1.1. Safety Results
3.1.2. Immunogenicity Results
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristic | Children (Group 1) | Infants (Group 2) | ||
---|---|---|---|---|
(N = 50) | (N = 104) | |||
Gender | Male | n (%) | 27 (54.0) | 48 (46.2) |
Female | n (%) | 23 (46.0) | 56 (53.8) | |
Age in weeks | Mean (SD) | 148.3 (59.62) | 5.8 (0.80) | |
Median (Q1, Q3) | 153.0 (101.0, 193.0) | 6.0 (5.0, 6.0) | ||
Range (min, max) | (53, 257) | (5, 8) | ||
Ethnicity | Hispanic | n (%) | 50 (100) | 104 (100) |
Body weight [kg] | N | 50 | 104 | |
Mean (SD) | 14.1 (3.02) | 4.9 (0.51) | ||
Median (Q1, Q3) | 14.2 (12.2, 16.4) | 4.9 (4.5, 5.3) | ||
Range (min, max) | (8.1, 20.0) | (3.7, 6.3) |
Solicited AE | Causally Associated 1 | Severity 2,3 | Group 1 Days 0–7 (N = 50) | Group 2 Days 0–7 (N = 104) | Group 2 Days 28–35 (N = 104) | Group 2 Days 56–63 (N = 104) | Group 2 Total (N = 104) | |
---|---|---|---|---|---|---|---|---|
All | Total | Any | n (%) m | 7 (14.0) 9 | 27 (26.0) 43 | 18 (17.3) 29 | 7 (6.7) 15 | 39 (37.5) 87 |
Causally associated | Any | n (%) m | 0 (0.0) 0 | 7 (6.7) 8 | 4 (3.8) 6 | 3 (2.9) 4 | 12 (11.5) 18 | |
Loss of appetite | Total | Any | n (%) m | 2 (4.0) 2 | 5 (4.8) 5 | 1 (1.0) 1 | 2 (1.9) 2 | 7 (6.7) 8 |
Severe | n (%) m | 0 (0.0) 0 | 1 (1.0) 1 | 0 (0.0) 0 | 0 (0.0) 0 | 1 (1.0) 1 | ||
Causally associated | Any | n (%) m | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | |
Severe | n (%) m | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | ||
Abnormal Crying | Total | Any | n (%) m | 1 (2.0) 1 | 7 (6.7) 7 | 6 (5.8) 8 | 5 (4.8) 5 | 15 (14.4) 20 |
Severe | n (%) m | 0 (0.0) 0 | 1 (1.0) 1 | 0 (0.0) 0 | 1 (1.0) 1 | 2 (1.9) 2 | ||
Causally associated | Any | n (%) m | 0 (0.0) 0 | 2 (1.9) 2 | 3 (2.9) 4 | 2 (1.9) 2 | 6 (5.8) 8 | |
Severe | n (%) m | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 1 (1.0) 1 | 1 (1.0) 1 | ||
Drowsiness | Total | Any | n (%) m | 0 (0.0) 0 | 2 (1.9) 2 | 1 (1.0) 1 | 2 (1.9) 2 | 4 (3.8) 5 |
Severe | n (%) m | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | ||
Causally associated | Any | n (%) m | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 1 (1.0) 1 | 1 (1.0) 1 | |
Severe | n (%) m | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | ||
Fever | Total | Any | n (%) m | 5 (10.0) 5 | 5 (4.8) 6 | 8 (7.7) 9 | 2 (1.9) 2 | 13 (12.5) 17 |
Severe | n (%) m | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | ||
Causally associated | Any | n (%) m | 0 (0.0) 0 | 1 (1.0) 1 | 1 (1.0) 1 | 0 (0.0) 0 | 2 (1.9) 2 | |
Severe | n (%) m | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | ||
Irritability | Total | Any | n (%) m | 0 (0.0) 0 | 6 (5.8) 6 | 3 (2.9) 3 | 3 (2.9) 3 | 9 (8.7) 12 |
Severe | n (%) m | 0 (0.0) 0 | 2 (1.9) 2 | 0 (0.0) 0 | 0 (0.0) 0 | 2 (1.9) 2 | ||
Causally associated | Any | n (%) m | 0 (0.0) 0 | 1 (1.0) 1 | 1 (1.0) 1 | 0 (0.0) 0 | 2 (1.9) 2 | |
Severe | n (%) m | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | ||
Vomiting | Total | Any | n (%) m | 1 (2.0) 1 | 16 (15.4) 17 | 5 (4.8) 7 | 1 (1.0) 1 | 17 (16.3) 25 |
Severe | n (%) m | 0 (0.0) 0 | 2 (1.9) 2 | 0 (0.0) 0 | 0 (0.0) 0 | 2 (1.9) 2 | ||
Causally associated | Any | n (%) m | 0 (0.0) 0 | 4 (3.8) 4 | 0 (0.0) 0 | 1 (1.0) 1 | 4 (3.8) 5 | |
Severe | n (%) m | 0 (0.0) 0 | 1 (1.0) 1 | 0 (0.0) 0 | 0 (0.0) 0 | 1 (1.0) 1 |
Day | Type | Group 1 | Group 2 | |
---|---|---|---|---|
(N = 49) | (N = 104) | |||
0 | 1 | N | 49 | 104 |
Median (log2) (LCI, UCI) | 8.2 (7.2, 9.8) | 4.2 (3.2, 5.5) | ||
GMT (LCI, UCI) | 200.9 (116.2, 343.8) | 35.9 (24.7, 53.2) | ||
2 | N | 49 | 104 | |
Median (log2) (LCI, UCI) | 7.8 (7.2, 8.8) | 3.8 (3.2, 4.2) | ||
GMT (LCI, UCI) | 251.3 (174.0, 360.4) | 16.4 (13.2, 20.6) | ||
3 | N | 49 | 104 | |
Median (log2) (LCI, UCI) | 6.5 (5.8, 7.5) | 2.5 (2.5, 2.5) | ||
GMT (LCI, UCI) | 77.5 (51.2, 116.8) | 8.5 (7.3, 10.0) | ||
28 | 1 | N | 49 | 0 |
Median (log2) (LCI, UCI) | 10.5 (9.17, 10.50) | NC (NC, NC) | ||
GMT (LCI, UCI) | 445.5 (272.7, 710.6) | NC (NC, NC) | ||
2 | N | 49 | 0 | |
Median (log2) (LCI, UCI) | 9.8 (9.5, 10.5) | NC (NC, NC) | ||
GMT (LCI, UCI) | 681.2 (511.1, 882.9) | NC (NC, NC) | ||
3 | N | 49 | 0 | |
Median (log2) (LCI, UCI) | 8.5 (7.8, 9.5) | NC (NC, NC) | ||
GMT (LCI, UCI) | 306.3 (201.7, 452.0) | NC (NC, NC) | ||
84 | 1 | N | 0 | 104 |
Median (log2) (LCI, UCI) | NC (NC, NC) | 10.5 (10.5, 10.5) | ||
GMT (LCI, UCI) | NC (NC, NC) | 650.8 (473.7, 870.6) | ||
2 | N | 0 | 104 | |
Median (log2) (LCI, UCI) | NC (NC, NC) | 10.2 (9.8, 10.2) | ||
GMT (LCI, UCI) | NC (NC, NC) | 712.2 (594.4, 840.3) | ||
3 | N | 0 | 104 | |
Median (log2) (LCI, UCI) | NC (NC, NC) | 8.8 (8.5, 9.5) | ||
GMT (LCI, UCI) | NC (NC, NC) | 352.1 (263.9, 462.9) |
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Mejía, L.R.; Mendez, L.P.; Rüttimann, R.W.; Gast, C.; Bandyopadhyay, A.S. Safety and Immunogenicity of Trivalent Oral Polio Vaccine in Vaccinated Children and Vaccine-Naïve Infants: A Phase 4 Study. Vaccines 2024, 12, 953. https://doi.org/10.3390/vaccines12090953
Mejía LR, Mendez LP, Rüttimann RW, Gast C, Bandyopadhyay AS. Safety and Immunogenicity of Trivalent Oral Polio Vaccine in Vaccinated Children and Vaccine-Naïve Infants: A Phase 4 Study. Vaccines. 2024; 12(9):953. https://doi.org/10.3390/vaccines12090953
Chicago/Turabian StyleMejía, Luis Rivera, Lourdes Peña Mendez, Ricardo W. Rüttimann, Chris Gast, and Ananda Sankar Bandyopadhyay. 2024. "Safety and Immunogenicity of Trivalent Oral Polio Vaccine in Vaccinated Children and Vaccine-Naïve Infants: A Phase 4 Study" Vaccines 12, no. 9: 953. https://doi.org/10.3390/vaccines12090953