Trial Outcomes & Findings for Vaccinating Children After Chemotherapy (NCT NCT02447718)
NCT ID: NCT02447718
Last Updated: 2022-06-24
Results Overview
The percentage of participants with protective titres (with protective level defined as ≥0.35 ug/ml, as per World Health Organization criteria) to PCV13 serotypes will be assessed at 2 months and 12-15 months post PCV13+PPV23 and compared to baseline levels.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
156 participants
Primary outcome timeframe
Pre-vaccination Baseline, 2 months and 12-15 months
Results posted on
2022-06-24
Participant Flow
Participants were recruited based on physician referral across 10 pediatric centres. Controls were recruited at 3 centres. Participants were enrolled between November 2015 to September 2017.
155 of the 156 participants recruited met inclusion criteria. Of the 78 participants with ALL recruited, 1 did not meet inclusion criteria and 3 withdrew consent prior to study start. All of the 78 control participants met inclusion criteria.
Participant milestones
| Measure |
Experimental
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
78
|
|
Overall Study
Received Prevnar®13
|
74
|
0
|
|
Overall Study
Received Pediacel®
|
73
|
0
|
|
Overall Study
Received Pneumovax® 23
|
73
|
0
|
|
Overall Study
COMPLETED
|
66
|
78
|
|
Overall Study
NOT COMPLETED
|
12
|
0
|
Reasons for withdrawal
| Measure |
Experimental
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Screen Failure
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental
n=74 Participants
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
n=78 Participants
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.1 years
n=74 Participants
|
8.3 years
n=78 Participants
|
8.2 years
n=152 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=74 Participants
|
38 Participants
n=78 Participants
|
75 Participants
n=152 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=74 Participants
|
40 Participants
n=78 Participants
|
77 Participants
n=152 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
74 Participants
n=74 Participants
|
78 Participants
n=78 Participants
|
152 Participants
n=152 Participants
|
|
ALL disease risk category
Standard risk
|
40 Participants
n=74 Participants • Only collected for ALL participants
|
—
|
40 Participants
n=74 Participants • Only collected for ALL participants
|
|
ALL disease risk category
High risk
|
27 Participants
n=74 Participants • Only collected for ALL participants
|
—
|
27 Participants
n=74 Participants • Only collected for ALL participants
|
|
ALL disease risk category
Very high risk
|
6 Participants
n=74 Participants • Only collected for ALL participants
|
—
|
6 Participants
n=74 Participants • Only collected for ALL participants
|
|
ALL disease risk category
Unknown
|
1 Participants
n=74 Participants • Only collected for ALL participants
|
—
|
1 Participants
n=74 Participants • Only collected for ALL participants
|
|
Treatment Protocol
Children's Oncology Group
|
49 Participants
n=74 Participants • Only collected for ALL participants
|
—
|
49 Participants
n=74 Participants • Only collected for ALL participants
|
|
Treatment Protocol
Dana Farber Cancer Institute
|
25 Participants
n=74 Participants • Only collected for ALL participants
|
—
|
25 Participants
n=74 Participants • Only collected for ALL participants
|
|
Interval from last chemotherapy to serology
|
6 months
n=74 Participants • Only collected for ALL participants
|
—
|
6 months
n=74 Participants • Only collected for ALL participants
|
|
Total white blood cell count at enrollment
|
6.5 cells x10^9/l
n=69 Participants • Only collected for participants with AL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
—
|
6.5 cells x10^9/l
n=69 Participants • Only collected for participants with AL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
|
Total lymphocyte count at enrollment
|
2.3 cells x10^9/l
n=73 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
—
|
2.3 cells x10^9/l
n=73 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
|
Lymphocyte subsets at enrollment
CD3+ T cells
|
1.4 cells x10^9/l
n=60 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
—
|
1.4 cells x10^9/l
n=60 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
|
Lymphocyte subsets at enrollment
CD4+ T cells
|
0.8 cells x10^9/l
n=60 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
—
|
0.8 cells x10^9/l
n=60 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
|
Lymphocyte subsets at enrollment
CD8+ T cells
|
0.5 cells x10^9/l
n=60 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
—
|
0.5 cells x10^9/l
n=60 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
|
Lymphocyte subsets at enrollment
NK cells (CD56+/CD16+)
|
0.2 cells x10^9/l
n=60 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
—
|
0.2 cells x10^9/l
n=60 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
|
Lymphocyte subsets at enrollment
CD19+ B cells
|
0.6 cells x10^9/l
n=60 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
—
|
0.6 cells x10^9/l
n=60 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
|
Total serum IgG at enrollment
|
8.5 g/l
n=71 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
—
|
8.5 g/l
n=71 Participants • Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.
|
|
Previous doses of PCV
0
|
19 Participants
n=74 Participants
|
9 Participants
n=78 Participants
|
28 Participants
n=152 Participants
|
|
Previous doses of PCV
1-2
|
10 Participants
n=74 Participants
|
2 Participants
n=78 Participants
|
12 Participants
n=152 Participants
|
|
Previous doses of PCV
≥3
|
45 Participants
n=74 Participants
|
66 Participants
n=78 Participants
|
111 Participants
n=152 Participants
|
|
Previous doses of PCV
Unknown
|
0 Participants
n=74 Participants
|
1 Participants
n=78 Participants
|
1 Participants
n=152 Participants
|
|
Previous doses of PCV
Received more than ≥1 dose at ≥12 months of age
|
44 Participants
n=74 Participants
|
62 Participants
n=78 Participants
|
106 Participants
n=152 Participants
|
|
Previous doses of PCV
Received more than ≥1 dose PCV13
|
34 Participants
n=74 Participants
|
38 Participants
n=78 Participants
|
72 Participants
n=152 Participants
|
|
Previous doses of DTaP or Tdap
0
|
2 Participants
n=74 Participants
|
0 Participants
n=78 Participants
|
2 Participants
n=152 Participants
|
|
Previous doses of DTaP or Tdap
1-3
|
12 Participants
n=74 Participants
|
1 Participants
n=78 Participants
|
13 Participants
n=152 Participants
|
|
Previous doses of DTaP or Tdap
4
|
36 Participants
n=74 Participants
|
17 Participants
n=78 Participants
|
53 Participants
n=152 Participants
|
|
Previous doses of DTaP or Tdap
≥5
|
24 Participants
n=74 Participants
|
60 Participants
n=78 Participants
|
84 Participants
n=152 Participants
|
|
Previous doses of varicella vaccine
0
|
17 Participants
n=74 Participants
|
11 Participants
n=78 Participants
|
28 Participants
n=152 Participants
|
|
Previous doses of varicella vaccine
1
|
48 Participants
n=74 Participants
|
26 Participants
n=78 Participants
|
74 Participants
n=152 Participants
|
|
Previous doses of varicella vaccine
≥2
|
9 Participants
n=74 Participants
|
40 Participants
n=78 Participants
|
49 Participants
n=152 Participants
|
|
Previous doses of varicella vaccine
Unknown
|
0 Participants
n=74 Participants
|
1 Participants
n=78 Participants
|
1 Participants
n=152 Participants
|
|
Interval from last vaccine to baseline blood draw
DTaP/Tdap-containing vaccine
|
6.0 years
STANDARD_DEVIATION 2.7 • n=74 Participants
|
3.7 years
STANDARD_DEVIATION 2.5 • n=78 Participants
|
4.85 years
STANDARD_DEVIATION 2.6 • n=152 Participants
|
|
Interval from last vaccine to baseline blood draw
PCV
|
5.4 years
STANDARD_DEVIATION 2.3 • n=74 Participants
|
7.2 years
STANDARD_DEVIATION 3.4 • n=78 Participants
|
6.3 years
STANDARD_DEVIATION 2.85 • n=152 Participants
|
|
Interval from last vaccine to baseline blood draw
Varicella
|
6.5 years
STANDARD_DEVIATION 3.2 • n=74 Participants
|
5.2 years
STANDARD_DEVIATION 4.2 • n=78 Participants
|
5.85 years
STANDARD_DEVIATION 3.7 • n=152 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination Baseline, 2 months and 12-15 monthsPopulation: Participants analyzed equaled the overall number of ALL participants that completed the study and had analyzable serology collected at 2 months and 12-15 months post-vaccination.
The percentage of participants with protective titres (with protective level defined as ≥0.35 ug/ml, as per World Health Organization criteria) to PCV13 serotypes will be assessed at 2 months and 12-15 months post PCV13+PPV23 and compared to baseline levels.
Outcome measures
| Measure |
Experimental
n=66 Participants
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
|---|---|---|
|
Percentage of Participants With Protective Titres to PCV13 Serotypes Post-immunization With PCV13+PPV23
2 months post-PCV13
|
40 Participants
|
—
|
|
Percentage of Participants With Protective Titres to PCV13 Serotypes Post-immunization With PCV13+PPV23
12-15 months post-PCV13
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0The number of participants with protective titres (≥0.35 ug/ml) to PCV7 serotypes at baseline will be compared to age-matched controls.
Outcome measures
| Measure |
Experimental
n=73 Participants
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
n=78 Participants
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
|---|---|---|
|
Number of Participants With Protective Titres to PCV7 Serotypes at Baseline
|
4 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Day 0Baseline geometric mean titers (GMT) and percentage of subjects with protective titres to pneumococcal serotypes in children with ALL versus age-matched controls.
Outcome measures
| Measure |
Experimental
n=73 Participants
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
n=78 Participants
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
|---|---|---|
|
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Pneumococcal Serotype 1
|
0.19 mg/L
Interval 0.16 to 0.22
|
0.52 mg/L
Interval 0.41 to 0.66
|
|
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Pneumococcal Serotype 3
|
0.17 mg/L
Interval 0.14 to 0.21
|
1.01 mg/L
Interval 0.72 to 1.42
|
|
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Pneumococcal Serotype 4
|
0.19 mg/L
Interval 0.16 to 0.22
|
0.54 mg/L
Interval 0.43 to 0.68
|
|
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Pneumococcal Serotype 6B
|
0.38 mg/L
Interval 0.29 to 0.5
|
1.20 mg/L
Interval 0.92 to 1.57
|
|
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Pneumococcal Serotype 7F
|
0.26 mg/L
Interval 0.2 to 0.33
|
0.7 mg/L
Interval 0.57 to 0.87
|
|
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Pneumococcal Serotype 9V
|
0.45 mg/L
Interval 0.37 to 0.55
|
0.92 mg/L
Interval 0.77 to 1.1
|
|
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Pneumococcal Serotype 14
|
0.46 mg/L
Interval 0.35 to 0.59
|
1.76 mg/L
Interval 1.24 to 2.5
|
|
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Pneumococcal Serotype 18C
|
0.21 mg/L
Interval 0.16 to 0.27
|
0.49 mg/L
Interval 0.38 to 0.62
|
|
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Pneumococcal Serotype 19F
|
0.99 mg/L
Interval 0.77 to 1.26
|
3.21 mg/L
Interval 2.73 to 3.76
|
|
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Pneumococcal Serotype 23F
|
0.29 mg/L
Interval 0.23 to 0.36
|
1.15 mg/L
Interval 0.87 to 1.52
|
SECONDARY outcome
Timeframe: Prevaccination baseline, 2 months, 12-15 monthsPopulation: A total of 73 participants received DTaP-IPV-Hib, 67 provided a follow up sample at 2 months post-vaccination and 66 provided a follow up sample at 12 months post-vaccination.
Baseline, Short-term (baseline - 2 months after vaccination) and long-term (baseline - 12-15 months) vaccine responses to DTaP-IPV-Hib will be measured using GMT ratios.
Outcome measures
| Measure |
Experimental
n=73 Participants
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
|---|---|---|
|
Immune Responses to Pertussis Toxin Following DTaP-IPV-Hib Booster Vaccination
Baseline - 12-15 months post-vaccination
|
10.39 EU/ml
Interval 7.76 to 13.91
|
—
|
|
Immune Responses to Pertussis Toxin Following DTaP-IPV-Hib Booster Vaccination
Pre-vaccination Baseline
|
4.10 EU/ml
Interval 3.67 to 4.58
|
—
|
|
Immune Responses to Pertussis Toxin Following DTaP-IPV-Hib Booster Vaccination
Baseline - 2 months post-vaccination
|
30.67 EU/ml
Interval 22.25 to 42.29
|
—
|
SECONDARY outcome
Timeframe: Day 0Baseline geometric mean titers (95% confidence intervals) reported as IU/ml in children with ALL versus controls
Outcome measures
| Measure |
Experimental
n=73 Participants
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
n=78 Participants
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
|---|---|---|
|
Baseline Tetanus Toxoid Antibody Titers in Children With ALL Versus Controls
|
0.16 IU/ml
Interval 0.12 to 0.2
|
1.73 IU/ml
Interval 1.26 to 2.37
|
SECONDARY outcome
Timeframe: Day 0Baseline geometric mean titers (95% confidence intervals) reported as IU/ml in children with ALL versus controls
Outcome measures
| Measure |
Experimental
n=73 Participants
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
n=78 Participants
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
|---|---|---|
|
Baseline Pertussis Toxin Titers in Children With ALL Versus Healthy Controls
|
4.10 EU/ml
Interval 3.67 to 4.58
|
10.35 EU/ml
Interval 8.15 to 13.16
|
SECONDARY outcome
Timeframe: Day 0Geometric mean titers (95% confidence interval) in AI (antibody index)
Outcome measures
| Measure |
Experimental
n=73 Participants
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
n=78 Participants
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
|---|---|---|
|
Baseline Varicella Titers in Children With ALL Versus Controls.
|
0.33 Antibody index
Interval 0.24 to 0.45
|
1.00 Antibody index
Interval 0.77 to 1.29
|
SECONDARY outcome
Timeframe: baseline, 2 months, 12-15 monthsPopulation: Participants with analyzable data at each timepoint were included
Baseline, short-term (baseline to 2 months after vaccination) and long-term (baseline to 12-15 months) vaccine responses to DTaP-IPV-Hib will be measured using GMTs with 95% confidence intervals
Outcome measures
| Measure |
Experimental
n=73 Participants
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
|
Healthy Control
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
|
|---|---|---|
|
Immune Responses to Tetanus Toxoid Following DTaP-IPV-Hib Immunization
Pre-vaccination Baseline
|
0.16 IU/ml
Interval 0.12 to 0.2
|
—
|
|
Immune Responses to Tetanus Toxoid Following DTaP-IPV-Hib Immunization
Baseline - 2 months post-vaccination
|
4.00 IU/ml
Interval 2.57 to 6.22
|
—
|
|
Immune Responses to Tetanus Toxoid Following DTaP-IPV-Hib Immunization
Baseline - 12-15 months post-vaccination
|
1.08 IU/ml
Interval 0.77 to 1.52
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: days 8-10 and 30-33Adverse Events Following Immunization requiring healthcare visit or leading to \>=1 day of disability will be captured through structured telephone interviews on days 8-10 and 30-33 after each immunization
Outcome measures
| Measure |
Experimental
n=74 Participants
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Prevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Pneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
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Healthy Control
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
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|---|---|---|
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Number of Participants With Adverse Events Following Immunization Requiring Healthcare Visit or Leading to >=1 Day of Disability
Possibly related to vaccination
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3 Participants
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—
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Number of Participants With Adverse Events Following Immunization Requiring Healthcare Visit or Leading to >=1 Day of Disability
Unrelated to vaccination
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7 Participants
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—
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Number of Participants With Adverse Events Following Immunization Requiring Healthcare Visit or Leading to >=1 Day of Disability
No AEFI requiring healthcare visit or leading to >=1 day of disability
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64 Participants
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—
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Adverse Events
DTaP-IPV-HiB+PCV13
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
PPV23
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DTaP-IPV-HiB+PCV13
n=74 participants at risk
DTaP-IPV-Hib: diphtheria-tetanus-acellular pertussis-inactivated polio-H. influenzae type b vaccine
PCV13: 13-valent pneumococcal conjugate vaccine
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PPV23
n=73 participants at risk
PPV23: 23-valent pneumococcal polysaccharide vaccine
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|---|---|---|
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Skin and subcutaneous tissue disorders
Pain/erythema/swelling at injection site
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70.3%
52/74 • AEFI was captured through structured telephone interviews on days 8-10 and 30-33 after each immunization
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse Events were not monitored for Healthy Controls as they did not receive the interventions, they provided baseline data only.
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61.6%
45/73 • AEFI was captured through structured telephone interviews on days 8-10 and 30-33 after each immunization
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse Events were not monitored for Healthy Controls as they did not receive the interventions, they provided baseline data only.
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General disorders
Systemic symptoms
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24.3%
18/74 • AEFI was captured through structured telephone interviews on days 8-10 and 30-33 after each immunization
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse Events were not monitored for Healthy Controls as they did not receive the interventions, they provided baseline data only.
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16.4%
12/73 • AEFI was captured through structured telephone interviews on days 8-10 and 30-33 after each immunization
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse Events were not monitored for Healthy Controls as they did not receive the interventions, they provided baseline data only.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place