Trial Outcomes & Findings for Immunogenicity and Reactogenicity of Pneumococcal Polysaccharide and Conjugate Vaccines in Native Elders (NCT NCT00153543)
NCT ID: NCT00153543
Last Updated: 2024-10-01
Results Overview
antibody titers to 5 pneumococcal serotypes
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
86 participants
Primary outcome timeframe
2 months after final dose of vaccine
Results posted on
2024-10-01
Participant Flow
Participant milestones
| Measure |
PPV23
Receive one dose of PPV23
PCV7 + PPV23, 2 months
PCV7 + PPV23, 6 months
|
PCV7 + PPV23, 2 Months
Receive one dose of PCV7 + 1 dose of PPV23 2 months later
PCV7 + PPV23, 6 months
|
PCV7 + PPV23, 6 Months
Receive one dose of PCV7 + 1 dose of PPV23 6 months later
PCV7 + PPV23, 2 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
29
|
|
Overall Study
COMPLETED
|
28
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Reactogenicity of Pneumococcal Polysaccharide and Conjugate Vaccines in Native Elders
Baseline characteristics by cohort
| Measure |
PPV23
n=28 Participants
Receive one dose of PPV23
PCV7 + PPV23, 2 months
PCV7 + PPV23, 6 months
|
PCV7 + PPV23, 2 Months
n=29 Participants
Receive one dose of PCV7 + 1 dose of PPV23 2 months later
PCV7 + PPV23, 6 months
|
PCV7 + PPV23, 6 Months
n=29 Participants
Receive one dose of PCV7 + 1 dose of PPV23 6 months later
PCV7 + PPV23, 2 months
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
58 years
n=7 Participants
|
58 years
n=5 Participants
|
58 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Anti-pneumococcal antibody concentrations
serotype 1
|
0.35 ug/mL
n=5 Participants
|
0.39 ug/mL
n=7 Participants
|
.40 ug/mL
n=5 Participants
|
0.38 ug/mL
n=4 Participants
|
|
Anti-pneumococcal antibody concentrations
serotype 4
|
.14 ug/mL
n=5 Participants
|
.22 ug/mL
n=7 Participants
|
.17 ug/mL
n=5 Participants
|
0.18 ug/mL
n=4 Participants
|
|
Anti-pneumococcal antibody concentrations
serotype 6B
|
1.57 ug/mL
n=5 Participants
|
1.72 ug/mL
n=7 Participants
|
1.67 ug/mL
n=5 Participants
|
1.65 ug/mL
n=4 Participants
|
|
Anti-pneumococcal antibody concentrations
serotype 14
|
2.61 ug/mL
n=5 Participants
|
2.32 ug/mL
n=7 Participants
|
1.9 ug/mL
n=5 Participants
|
2.28 ug/mL
n=4 Participants
|
|
Anti-pneumococcal antibody concentrations
serotype 19F
|
2.36 ug/mL
n=5 Participants
|
2.34 ug/mL
n=7 Participants
|
1.8 ug/mL
n=5 Participants
|
2.17 ug/mL
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 months after final dose of vaccineantibody titers to 5 pneumococcal serotypes
Outcome measures
| Measure |
PPV23
n=28 Participants
Receive one dose of PPV23
PCV7 + PPV23, 2 months
PCV7 + PPV23, 6 months
|
PCV7 + PPV23, 2 Months
n=29 Participants
Receive one dose of PCV7 + 1 dose of PPV23 2 months later
PCV7 + PPV23, 6 months
|
PCV7 + PPV23, 6 Months
n=27 Participants
Receive one dose of PCV7 + 1 dose of PPV23 6 months later
PCV7 + PPV23, 2 months
|
|---|---|---|---|
|
Immune Responses
serotype 4
|
0.78 ug/mL
Interval 0.43 to 1.42
|
1.23 ug/mL
Interval 0.77 to 1.97
|
.8 ug/mL
Interval 0.52 to 1.23
|
|
Immune Responses
serotype 6B
|
4.1 ug/mL
Interval 2.33 to 7.19
|
4.22 ug/mL
Interval 2.45 to 7.29
|
5.05 ug/mL
Interval 2.63 to 9.71
|
|
Immune Responses
serotype 1
|
1.95 ug/mL
Interval 1.21 to 3.15
|
1.69 ug/mL
Interval 1.03 to 2.76
|
1.22 ug/mL
Interval 0.59 to 2.52
|
|
Immune Responses
serotype 14
|
6.62 ug/mL
Interval 3.58 to 12.24
|
6.82 ug/mL
Interval 3.31 to 14.07
|
11.13 ug/mL
Interval 6.26 to 19.82
|
|
Immune Responses
serotype 19F
|
5.05 ug/mL
Interval 3.3 to 7.74
|
6.62 ug/mL
Interval 4.4 to 9.95
|
8.1 ug/mL
Interval 6.22 to 12.53
|
SECONDARY outcome
Timeframe: every day for 3 days after each injectionSystemic and local injection site reactions as measured by participants with follow up with study staff
Outcome measures
| Measure |
PPV23
n=28 Participants
Receive one dose of PPV23
PCV7 + PPV23, 2 months
PCV7 + PPV23, 6 months
|
PCV7 + PPV23, 2 Months
n=29 Participants
Receive one dose of PCV7 + 1 dose of PPV23 2 months later
PCV7 + PPV23, 6 months
|
PCV7 + PPV23, 6 Months
n=29 Participants
Receive one dose of PCV7 + 1 dose of PPV23 6 months later
PCV7 + PPV23, 2 months
|
|---|---|---|---|
|
Number of Participants With Systemic and Injection Site Reactions
any redness at injection site
|
2 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants With Systemic and Injection Site Reactions
any swelling at injection site
|
6 Participants
|
20 Participants
|
17 Participants
|
|
Number of Participants With Systemic and Injection Site Reactions
any arm pain in injected arm
|
20 Participants
|
26 Participants
|
27 Participants
|
|
Number of Participants With Systemic and Injection Site Reactions
All-cause mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Systemic and Injection Site Reactions
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PPV23
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
PCV7 + PPV23, 2 Months
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
PCV7 + PPV23, 6 Months
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PPV23
n=28 participants at risk
Receive one dose of PPV23
PCV7 + PPV23, 2 months
PCV7 + PPV23, 6 months
|
PCV7 + PPV23, 2 Months
n=29 participants at risk
Receive one dose of PCV7 + 1 dose of PPV23 2 months later
PCV7 + PPV23, 6 months
|
PCV7 + PPV23, 6 Months
n=29 participants at risk
Receive one dose of PCV7 + 1 dose of PPV23 6 months later
PCV7 + PPV23, 2 months
|
|---|---|---|---|
|
General disorders
any arm pain in injected arm
|
71.4%
20/28 • Number of events 20 • 1 year
|
89.7%
26/29 • Number of events 26 • 1 year
|
93.1%
27/29 • Number of events 27 • 1 year
|
|
General disorders
any redness at injection site
|
7.1%
2/28 • Number of events 2 • 1 year
|
34.5%
10/29 • Number of events 10 • 1 year
|
24.1%
7/29 • Number of events 7 • 1 year
|
|
General disorders
any swelling at injection site
|
21.4%
6/28 • Number of events 6 • 1 year
|
69.0%
20/29 • Number of events 20 • 1 year
|
58.6%
17/29 • Number of events 17 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place