Trial Outcomes & Findings for Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders (NCT NCT04080531)
NCT ID: NCT04080531
Last Updated: 2025-02-28
Results Overview
HAI in blood at week 21 for all variants
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
165 participants
Primary outcome timeframe
21 weeks
Results posted on
2025-02-28
Participant Flow
Participant milestones
| Measure |
Arm I (Trivalent Influenza Vaccine, Prevnar)
Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
Pneumococcal 13-valent Conjugate Vaccine: Given IM
Trivalent Influenza Vaccine: Given IM
|
Arm II (Trivalent Influenza Vaccine, Prevnar)
Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
Pneumococcal 13-valent Conjugate Vaccine: Given IM
Trivalent Influenza Vaccine: Given IM
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
85
|
|
Overall Study
COMPLETED
|
64
|
81
|
|
Overall Study
NOT COMPLETED
|
16
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders
Baseline characteristics by cohort
| Measure |
Arm I (Trivalent Influenza Vaccine, Prevnar)
n=80 Participants
Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
Pneumococcal 13-valent Conjugate Vaccine: Given IM
Trivalent Influenza Vaccine: Given IM
|
Arm II (Trivalent Influenza Vaccine, Prevnar)
n=85 Participants
Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
Pneumococcal 13-valent Conjugate Vaccine: Given IM
Trivalent Influenza Vaccine: Given IM
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 11.60 • n=99 Participants
|
62.8 years
STANDARD_DEVIATION 9.68 • n=107 Participants
|
62.35 years
STANDARD_DEVIATION 10.63 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=99 Participants
|
85 participants
n=107 Participants
|
165 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 21 weeksHAI in blood at week 21 for all variants
Outcome measures
| Measure |
Arm I (Trivalent Influenza Vaccine, Prevnar)
n=80 Participants
Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
Pneumococcal 13-valent Conjugate Vaccine: Given IM
Trivalent Influenza Vaccine: Given IM
|
Arm II (Trivalent Influenza Vaccine, Prevnar)
n=85 Participants
Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.
Pneumococcal 13-valent Conjugate Vaccine: Given IM
Trivalent Influenza Vaccine: Given IM
|
|---|---|---|
|
Seroprotection Based on Hemagglutination Antibody Inhibition (HAI)
|
32 Participants
|
22 Participants
|
Adverse Events
Arm I (Trivalent Influenza Vaccine, Prevnar)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Arm II (Trivalent Influenza Vaccine, Prevnar)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place