Trial Outcomes & Findings for Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED) (NCT NCT03921424)
NCT ID: NCT03921424
Last Updated: 2023-06-07
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
Through 14 Days after Vaccination 1 (Up to Day 14)
Results posted on
2023-06-07
Participant Flow
407 participants were randomized in a 1:1 ratio to receive either V114 or Prevnar 13™ on Day 1 and PNEUMOVAX™23 at Week 8.
Participant milestones
| Measure |
V114
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
204
|
|
Overall Study
Vaccination 1 - (Day 1)
|
203
|
204
|
|
Overall Study
Vaccination 2 - (Week 8)
|
203
|
202
|
|
Overall Study
COMPLETED
|
203
|
201
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
V114
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal By Parent/Guardian
|
0
|
2
|
Baseline Characteristics
Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
Baseline characteristics by cohort
| Measure |
V114
n=203 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
n=204 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Total
n=407 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.7 years
STANDARD_DEVIATION 2.7 • n=93 Participants
|
12.6 years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
12.7 years
STANDARD_DEVIATION 2.9 • n=27 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
Children (2-11 years)
|
60 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
122 Participants
n=27 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
143 Participants
n=93 Participants
|
142 Participants
n=4 Participants
|
285 Participants
n=27 Participants
|
|
Age, Customized
Adults (18-64 years)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=93 Participants
|
99 Participants
n=4 Participants
|
195 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=93 Participants
|
105 Participants
n=4 Participants
|
212 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
201 Participants
n=93 Participants
|
203 Participants
n=4 Participants
|
404 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
62 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
128 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
88 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
166 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Through 14 Days after Vaccination 1 (Up to Day 14)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling.
Outcome measures
| Measure |
V114
n=203 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
n=204 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™
Injection site redness/erythema
|
9.4 Percentage of Participants
95% Confidence Interval 5.7 • Interval 5.7 to 14.2
|
5.9 Percentage of Participants
95% Confidence Interval 3.1 • Interval 3.1 to 10.0
|
|
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™
Injection site hard lump/induration
|
10.3 Percentage of Participants
95% Confidence Interval 6.5 • Interval 6.5 to 15.4
|
6.4 Percentage of Participants
95% Confidence Interval 3.4 • Interval 3.4 to 10.7
|
|
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™
Injection site tenderness/pain
|
55.2 Percentage of Participants
95% Confidence Interval 48.1 • Interval 48.1 to 62.1
|
53.9 Percentage of Participants
95% Confidence Interval 46.8 • Interval 46.8 to 60.9
|
|
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™
Injection site swelling
|
28.6 Percentage of Participants
95% Confidence Interval 22.5 • Interval 22.5 to 35.3
|
21.6 Percentage of Participants
95% Confidence Interval 16.1 • Interval 16.1 to 27.9
|
PRIMARY outcome
Timeframe: Through 14 Days after Vaccination 1 (Up to Day 14)Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria.
Outcome measures
| Measure |
V114
n=203 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
n=204 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™
Joint pain/arthralgia
|
9.4 Percentage of Participants
95% Confidence Interval 5.7 • Interval 5.7 to 14.2
|
10.3 Percentage of Participants
95% Confidence Interval 6.5 • Interval 6.5 to 15.3
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™
Tiredness/fatigue
|
7.9 Percentage of Participants
95% Confidence Interval 4.6 • Interval 4.6 to 12.5
|
8.3 Percentage of Participants
95% Confidence Interval 4.9 • Interval 4.9 to 13.0
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™
Headache
|
14.8 Percentage of Participants
95% Confidence Interval 10.2 • Interval 10.2 to 20.4
|
10.8 Percentage of Participants
95% Confidence Interval 6.9 • Interval 6.9 to 15.9
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™
Muscle pain/myalgia
|
34.0 Percentage of Participants
95% Confidence Interval 27.5 • Interval 27.5 to 41.0
|
25.5 Percentage of Participants
95% Confidence Interval 19.7 • Interval 19.7 to 32.0
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™
Hives or welts/urticaria
|
0.5 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 2.7
|
1.5 Percentage of Participants
95% Confidence Interval 0.3 • Interval 0.3 to 4.2
|
PRIMARY outcome
Timeframe: Through 6 Months after Vaccination 1 (Up to Day 194)Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not analyzed for Vaccination 2.
An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is an other important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following Vaccination 1 (with either V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) through completion of study participation was reported.
Outcome measures
| Measure |
V114
n=203 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
n=204 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study
Vaccination 1
|
0.0 Percentage of Participants
Interval 0.0 to 1.8
|
0.0 Percentage of Participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study
Vaccination 2
|
0.0 Percentage of Participants
Interval 0.0 to 1.8
|
0.0 Percentage of Participants
Interval 0.0 to 1.8
|
PRIMARY outcome
Timeframe: Day 30Population: All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses.
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Outcome measures
| Measure |
V114
n=203 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
n=204 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 18C (Shared)
|
5.18 μg/mL
Interval 4.32 to 6.2
|
5.15 μg/mL
Interval 4.29 to 6.18
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 1 (Shared)
|
2.17 μg/mL
Interval 1.89 to 2.48
|
3.26 μg/mL
Interval 2.82 to 3.77
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 3 (Shared)
|
1.05 μg/mL
Interval 0.93 to 1.19
|
0.84 μg/mL
Interval 0.73 to 0.97
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 4 (Shared)
|
2.59 μg/mL
Interval 2.23 to 3.0
|
4.27 μg/mL
Interval 3.57 to 5.11
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 5 (Shared)
|
2.94 μg/mL
Interval 2.44 to 3.54
|
2.78 μg/mL
Interval 2.3 to 3.37
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 6A (Shared)
|
7.98 μg/mL
Interval 6.3 to 10.11
|
7.56 μg/mL
Interval 6.06 to 9.45
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 6B (Shared)
|
11.44 μg/mL
Interval 9.07 to 14.43
|
6.92 μg/mL
Interval 5.45 to 8.79
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 7F (Shared)
|
4.84 μg/mL
Interval 4.1 to 5.71
|
5.00 μg/mL
Interval 4.29 to 5.83
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 9V (Shared)
|
4.15 μg/mL
Interval 3.56 to 4.85
|
4.78 μg/mL
Interval 4.03 to 5.66
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 14 (Shared)
|
20.38 μg/mL
Interval 16.39 to 25.35
|
18.29 μg/mL
Interval 14.43 to 23.17
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 19A (Shared)
|
14.20 μg/mL
Interval 11.81 to 17.07
|
14.78 μg/mL
Interval 12.45 to 17.54
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 19F (Shared)
|
9.76 μg/mL
Interval 8.03 to 11.85
|
8.61 μg/mL
Interval 7.28 to 10.18
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 23F (Shared)
|
6.71 μg/mL
Interval 5.42 to 8.31
|
6.35 μg/mL
Interval 5.14 to 7.85
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 22F (Unique to V114)
|
9.28 μg/mL
Interval 7.76 to 11.09
|
0.24 μg/mL
Interval 0.2 to 0.29
|
|
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 33F (Unique to V114)
|
4.53 μg/mL
Interval 3.8 to 5.39
|
0.29 μg/mL
Interval 0.25 to 0.33
|
SECONDARY outcome
Timeframe: Through 14 Days after Vaccination 2 (Up to Day 84)Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this outcome measure.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23 (PPV23), the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling.
Outcome measures
| Measure |
V114
n=203 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
n=202 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site redness/erythema
|
10.3 Percentage of Participants
95% Confidence Interval 6.5 • Interval 6.5 to 15.4
|
12.4 Percentage of Participants
95% Confidence Interval 8.2 • Interval 8.2 to 17.7
|
|
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site hard lump/induration
|
18.2 Percentage of Participants
95% Confidence Interval 13.2 • Interval 13.2 to 24.2
|
13.4 Percentage of Participants
95% Confidence Interval 9.0 • Interval 9.0 to 18.8
|
|
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site tenderness/pain
|
51.7 Percentage of Participants
95% Confidence Interval 44.6 • Interval 44.6 to 58.8
|
55.0 Percentage of Participants
95% Confidence Interval 47.8 • Interval 47.8 to 61.9
|
|
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23
Injection site swelling
|
47.3 Percentage of Participants
95% Confidence Interval 40.3 • Interval 40.3 to 54.4
|
34.7 Percentage of Participants
95% Confidence Interval 28.1 • Interval 28.1 to 41.7
|
SECONDARY outcome
Timeframe: Through 14 Days after Vaccination 2 (Up to Day 84)Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this outcome measure.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria.
Outcome measures
| Measure |
V114
n=203 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
n=202 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Joint pain/arthralgia
|
12.8 Percentage of Participants
95% Confidence Interval 8.5 • Interval 8.5 to 18.2
|
8.4 Percentage of Participants
95% Confidence Interval 5.0 • Interval 5.0 to 13.1
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Tiredness/fatigue
|
12.3 Percentage of Participants
95% Confidence Interval 8.1 • Interval 8.1 to 17.6
|
11.4 Percentage of Participants
95% Confidence Interval 7.4 • Interval 7.4 to 16.6
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Headache
|
10.3 Percentage of Participants
95% Confidence Interval 6.5 • Interval 6.5 to 15.4
|
9.4 Percentage of Participants
95% Confidence Interval 5.8 • Interval 5.8 to 14.3
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Muscle pain/myalgia
|
43.3 Percentage of Participants
95% Confidence Interval 36.4 • Interval 36.4 to 50.5
|
39.1 Percentage of Participants
95% Confidence Interval 32.3 • Interval 32.3 to 46.2
|
|
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
Hives or welts/urticaria
|
0.0 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.8
|
0.5 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 2.7
|
SECONDARY outcome
Timeframe: Day 30Population: All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses.
The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
Outcome measures
| Measure |
V114
n=203 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
n=204 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 1 (Shared)
|
353.4 Titers (1/dil)
Interval 278.4 to 448.7
|
398.3 Titers (1/dil)
Interval 313.5 to 506.1
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 3 (Shared)
|
330.0 Titers (1/dil)
Interval 284.4 to 383.0
|
301.5 Titers (1/dil)
Interval 255.5 to 355.7
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 4 (Shared)
|
6078.3 Titers (1/dil)
Interval 5106.1 to 7235.4
|
9172.8 Titers (1/dil)
Interval 7582.8 to 11096.1
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 5 (Shared)
|
847.6 Titers (1/dil)
Interval 671.1 to 1070.4
|
642.1 Titers (1/dil)
Interval 490.9 to 839.9
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 6A (Shared)
|
14274.6 Titers (1/dil)
Interval 12014.1 to 16960.4
|
11915.4 Titers (1/dil)
Interval 10160.9 to 13973.0
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 6B (Shared)
|
17636.5 Titers (1/dil)
Interval 14728.7 to 21118.3
|
15052.9 Titers (1/dil)
Interval 12719.6 to 17814.2
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 7F (Shared)
|
17574.4 Titers (1/dil)
Interval 15234.2 to 20274.0
|
18519.3 Titers (1/dil)
Interval 16010.9 to 21420.8
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 9V (Shared)
|
4800.0 Titers (1/dil)
Interval 4201.0 to 5484.4
|
5879.7 Titers (1/dil)
Interval 4853.9 to 7122.2
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 14 (Shared)
|
18444.3 Titers (1/dil)
Interval 15257.3 to 22297.0
|
17920.8 Titers (1/dil)
Interval 14874.4 to 21591.2
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 18C (Shared)
|
4556.2 Titers (1/dil)
Interval 3794.1 to 5471.5
|
3543.0 Titers (1/dil)
Interval 2919.6 to 4299.5
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 19A (Shared)
|
8176.4 Titers (1/dil)
Interval 6778.3 to 9862.8
|
8690.2 Titers (1/dil)
Interval 7382.3 to 10229.8
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 19F (Shared)
|
3711.8 Titers (1/dil)
Interval 3178.0 to 4335.2
|
3277.6 Titers (1/dil)
Interval 2833.1 to 3791.8
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 23F (Shared)
|
11693.1 Titers (1/dil)
Interval 9483.8 to 14417.1
|
11933.8 Titers (1/dil)
Interval 9597.5 to 14838.8
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 22F (Unique to V114)
|
10791.3 Titers (1/dil)
Interval 9157.2 to 12716.9
|
503.1 Titers (1/dil)
Interval 330.1 to 766.8
|
|
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
Serotype 33F (Unique to V114)
|
36357.0 Titers (1/dil)
Interval 31146.2 to 42439.6
|
5520.6 Titers (1/dil)
Interval 4659.5 to 6540.9
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses.
The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
Outcome measures
| Measure |
V114
n=203 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
n=202 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 1 (Shared)
|
326.4 Titers (1/dil)
Interval 267.0 to 399.0
|
337.0 Titers (1/dil)
Interval 272.3 to 417.1
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 3 (Shared)
|
327.2 Titers (1/dil)
Interval 278.9 to 383.9
|
384.8 Titers (1/dil)
Interval 333.0 to 444.6
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 4 (Shared)
|
5445.7 Titers (1/dil)
Interval 4663.7 to 6358.8
|
7526.8 Titers (1/dil)
Interval 6309.7 to 8978.7
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 5 (Shared)
|
985.6 Titers (1/dil)
Interval 813.6 to 1193.8
|
939.5 Titers (1/dil)
Interval 737.3 to 1197.3
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 6A (Shared)
|
10208.7 Titers (1/dil)
Interval 8703.8 to 11973.7
|
10699.8 Titers (1/dil)
Interval 9010.5 to 12705.7
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 6B (Shared)
|
13774.8 Titers (1/dil)
Interval 11661.6 to 16271.0
|
12745.8 Titers (1/dil)
Interval 10887.3 to 14921.6
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 7F (Shared)
|
17415.9 Titers (1/dil)
Interval 15091.4 to 20098.5
|
19140.5 Titers (1/dil)
Interval 16778.5 to 21835.0
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 9V (Shared)
|
5135.9 Titers (1/dil)
Interval 4328.2 to 6094.3
|
6152.2 Titers (1/dil)
Interval 5219.6 to 7251.4
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 14 (Shared)
|
17207.5 Titers (1/dil)
Interval 14074.5 to 21037.9
|
16461.2 Titers (1/dil)
Interval 13695.1 to 19785.9
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 18C (Shared)
|
3635.1 Titers (1/dil)
Interval 3103.0 to 4258.5
|
3369.0 Titers (1/dil)
Interval 2844.0 to 3990.9
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 19A (Shared)
|
7613.7 Titers (1/dil)
Interval 6414.6 to 9036.9
|
8838.0 Titers (1/dil)
Interval 7592.6 to 10287.6
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 19F (Shared)
|
3694.8 Titers (1/dil)
Interval 3212.9 to 4248.9
|
3904.4 Titers (1/dil)
Interval 3382.3 to 4507.1
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 23F (Shared)
|
10216.7 Titers (1/dil)
Interval 8465.7 to 12329.8
|
10086.0 Titers (1/dil)
Interval 8334.0 to 12206.2
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 22F (Unique to V114)
|
8756.1 Titers (1/dil)
Interval 7419.0 to 10334.1
|
6958.0 Titers (1/dil)
Interval 5941.5 to 8148.5
|
|
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 33F (Unique to V114)
|
34173.6 Titers (1/dil)
Interval 29554.9 to 39514.0
|
30651.0 Titers (1/dil)
Interval 26240.5 to 35802.8
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants included participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient serum volume to perform the analyses.
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Outcome measures
| Measure |
V114
n=203 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™
n=202 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 5 (Shared)
|
3.01 μg/mL
Interval 2.58 to 3.52
|
3.24 μg/mL
Interval 2.75 to 3.82
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 1 (Shared)
|
2.58 μg/mL
Interval 2.31 to 2.88
|
3.33 μg/mL
Interval 2.95 to 3.75
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 3 (Shared)
|
1.10 μg/mL
Interval 0.97 to 1.24
|
1.08 μg/mL
Interval 0.94 to 1.24
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 4 (Shared)
|
2.36 μg/mL
Interval 2.08 to 2.69
|
3.61 μg/mL
Interval 3.09 to 4.23
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 6A (Shared)
|
4.67 μg/mL
Interval 3.74 to 5.84
|
4.91 μg/mL
Interval 3.94 to 6.11
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 6B (Shared)
|
7.12 μg/mL
Interval 5.75 to 8.81
|
4.96 μg/mL
Interval 3.96 to 6.22
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 7F (Shared)
|
4.10 μg/mL
Interval 3.55 to 4.72
|
4.27 μg/mL
Interval 3.71 to 4.92
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 9V (Shared)
|
3.69 μg/mL
Interval 3.2 to 4.25
|
4.52 μg/mL
Interval 3.89 to 5.24
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 14 (Shared)
|
18.88 μg/mL
Interval 15.43 to 23.09
|
19.89 μg/mL
Interval 16.0 to 24.72
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 18C (Shared)
|
3.75 μg/mL
Interval 3.18 to 4.43
|
4.11 μg/mL
Interval 3.48 to 4.85
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 19A (Shared)
|
11.23 μg/mL
Interval 9.48 to 13.31
|
12.19 μg/mL
Interval 10.38 to 14.32
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 19F (Shared)
|
8.56 μg/mL
Interval 7.26 to 10.08
|
7.98 μg/mL
Interval 6.83 to 9.33
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 23F (Shared)
|
4.40 μg/mL
Interval 3.63 to 5.34
|
4.83 μg/mL
Interval 3.96 to 5.88
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 22F (Unique to V114)
|
8.18 μg/mL
Interval 7.1 to 9.42
|
10.32 μg/mL
Interval 8.67 to 12.29
|
|
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
Serotype 33F (Unique to V114)
|
3.76 μg/mL
Interval 3.23 to 4.38
|
6.18 μg/mL
Interval 5.23 to 7.3
|
Adverse Events
V114
Serious events: 1 serious events
Other events: 158 other events
Deaths: 0 deaths
Prevnar 13™
Serious events: 1 serious events
Other events: 138 other events
Deaths: 0 deaths
V114 (Post-PNEUMOVAX™23)
Serious events: 2 serious events
Other events: 152 other events
Deaths: 0 deaths
Prevnar 13™ (Post-PNEUMOVAX™23)
Serious events: 2 serious events
Other events: 154 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114
n=203 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1).
|
Prevnar 13™
n=204 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1).
|
V114 (Post-PNEUMOVAX™23)
n=203 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™ (Post-PNEUMOVAX™23)
n=202 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|---|---|
|
Eye disorders
Serous retinal detachment
|
0.00%
0/203 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.49%
1/204 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/203 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/202 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/203 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/204 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.49%
1/203 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/202 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/203 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/204 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/203 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.50%
1/202 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/203 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/204 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.49%
1/203 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/202 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/203 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/204 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/203 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.50%
1/202 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.49%
1/203 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/204 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/203 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
0.00%
0/202 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
Other adverse events
| Measure |
V114
n=203 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1).
|
Prevnar 13™
n=204 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1).
|
V114 (Post-PNEUMOVAX™23)
n=203 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
Prevnar 13™ (Post-PNEUMOVAX™23)
n=202 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
7.9%
16/203 • Number of events 16 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
8.3%
17/204 • Number of events 19 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
12.3%
25/203 • Number of events 30 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
11.4%
23/202 • Number of events 23 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
General disorders
Injection site erythema
|
9.4%
19/203 • Number of events 20 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
5.9%
12/204 • Number of events 13 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
10.3%
21/203 • Number of events 21 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
12.4%
25/202 • Number of events 25 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
General disorders
Injection site induration
|
10.3%
21/203 • Number of events 22 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
6.4%
13/204 • Number of events 13 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
18.2%
37/203 • Number of events 37 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
13.4%
27/202 • Number of events 27 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
General disorders
Injection site pain
|
55.2%
112/203 • Number of events 122 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
53.9%
110/204 • Number of events 117 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
51.7%
105/203 • Number of events 110 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
55.0%
111/202 • Number of events 117 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
General disorders
Injection site swelling
|
28.6%
58/203 • Number of events 59 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
21.6%
44/204 • Number of events 49 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
47.3%
96/203 • Number of events 97 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
34.7%
70/202 • Number of events 70 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
19/203 • Number of events 20 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
10.3%
21/204 • Number of events 24 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
12.8%
26/203 • Number of events 26 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
8.4%
17/202 • Number of events 17 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
34.0%
69/203 • Number of events 72 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
25.5%
52/204 • Number of events 56 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
43.3%
88/203 • Number of events 91 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
39.1%
79/202 • Number of events 80 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
|
Nervous system disorders
Headache
|
14.8%
30/203 • Number of events 34 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
10.8%
22/204 • Number of events 28 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
10.3%
21/203 • Number of events 25 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
9.4%
19/202 • Number of events 22 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and All-Cause Mortality: Through 6 months after Vaccination 1 (Up to Day 194).
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER