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Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02225587
Recruitment Status : Completed
First Posted : August 26, 2014
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Pneumococcal Infections
Interventions Biological: Prevnar 13™
Biological: Pneumovax™ 23
Biological: Placebo
Enrollment 400
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Period Title: Overall Study
Started [1] 200 200
Vaccination 2 [2] 188 185
Vaccination 3 [3] 172 164
Completed 172 162
Not Completed 28 38
Reason Not Completed
Adverse Event             5             5
Lost to Follow-up             5             5
Non-Compliance With Study Drug             1             0
Physician Decision             2             0
Protocol Violation             1             0
Participant Moved             1             0
Withdrawal by Subject             13             28
[1]
Received Vaccination 1
[2]
Received Vaccination 2
[3]
Received Vaccination 3
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 Total
Hide Arm/Group Description Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. Total of all reporting groups
Overall Number of Baseline Participants 200 200 400
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 200 participants 400 participants
64.1  (8.6) 64.2  (8.9) 64.2  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 400 participants
Female
112
  56.0%
107
  53.5%
219
  54.8%
Male
88
  44.0%
93
  46.5%
181
  45.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 400 participants
Hispanic or Latino
40
  20.0%
35
  17.5%
75
  18.8%
Not Hispanic or Latino
158
  79.0%
164
  82.0%
322
  80.5%
Unknown or Not Reported
2
   1.0%
1
   0.5%
3
   0.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 400 participants
American Indian or Alaska Native
1
   0.5%
3
   1.5%
4
   1.0%
Asian
2
   1.0%
2
   1.0%
4
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.5%
1
   0.3%
Black or African American
14
   7.0%
23
  11.5%
37
   9.3%
White
176
  88.0%
163
  81.5%
339
  84.8%
More than one race
7
   3.5%
8
   4.0%
15
   3.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With an Adverse Event (AE)
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time Frame Up to 14 days after any vaccination (Up to 28 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 198 199
Measure Type: Number
Unit of Measure: Percentage of participants
89.9 84.4
2.Primary Outcome
Title Percentage of Participants With an Injection-site Adverse Event
Hide Description An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness.
Time Frame Up to 14 days after any vaccination (Up to 28 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 198 199
Measure Type: Number
Unit of Measure: Percentage of participants
86.4 77.9
3.Primary Outcome
Title Percentage of Participants With a Systemic Adverse Event
Hide Description Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness.
Time Frame Up to 14 days after any vaccination (Up to 28 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 198 199
Measure Type: Number
Unit of Measure: Percentage of participants
76.8 74.4
4.Primary Outcome
Title Percentage of Participants With a Serious Adverse Event (SAE)
Hide Description A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose.
Time Frame Up to 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 198 199
Measure Type: Number
Unit of Measure: Percentage of participants
4.5 5.5
5.Primary Outcome
Title Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death
Hide Description A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. The investigator determined whether the SAE or death was related to vaccine treatment.
Time Frame Up to 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 198 199
Measure Type: Number
Unit of Measure: Percentage of participants
0 0
6.Primary Outcome
Title Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time Frame Up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 198 199
Measure Type: Number
Unit of Measure: Percentage of participants
2.5 2.5
7.Primary Outcome
Title Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12
Hide Description Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAX™ 23, were measured by the multiplex opsonophagocytic activity 4 (MOPA-4) assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 172 172
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Serotype 22F Number Analyzed 166 participants 157 participants
1766.3
(1303.2 to 2394.1)
39.0
(28.3 to 53.7)
Serotype 33F Number Analyzed 172 participants 172 participants
10413.0
(8178.9 to 13257.4)
1189.9
(898.6 to 1575.6)
8.Primary Outcome
Title Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12
Hide Description Vaccine-induced functional antibodies to serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which are contained in both Prevnar 13™ and PNEUMOVAX™ 23, were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 172 179
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Serotype 1 Number Analyzed 168 participants 173 participants
81.7
(60.4 to 110.7)
57.1
(41.1 to 79.3)
Serotype 3 Number Analyzed 151 participants 155 participants
43.4
(33.7 to 55.9)
17.5
(13.5 to 22.5)
Serotype 4 Number Analyzed 171 participants 176 participants
1079.3
(885.7 to 1315.2)
780.0
(629.1 to 967.1)
Serotype 5 Number Analyzed 171 participants 178 participants
198.6
(145.6 to 271.0)
148.4
(107.9 to 204.1)
Serotype 6B Number Analyzed 170 participants 179 participants
1956.9
(1575.3 to 2431.0)
1148.1
(889.0 to 1482.6)
Serotype 7F Number Analyzed 172 participants 179 participants
2250.8
(1889.3 to 2681.5)
1751.8
(1422.4 to 2157.6)
Serotype 9V Number Analyzed 164 participants 175 participants
1472.3
(1190.9 to 1820.2)
1017.6
(790.8 to 1309.4)
Serotype 14 Number Analyzed 172 participants 178 participants
2106.8
(1689.6 to 2627.0)
1945.0
(1572.9 to 2405.1)
Serotype 18C Number Analyzed 171 participants 175 participants
2101.9
(1732.6 to 2550.0)
1587.1
(1259.1 to 2000.5)
Serotype 19A Number Analyzed 172 participants 179 participants
1785.8
(1506.1 to 2117.6)
1425.9
(1164.7 to 1745.8)
Serotype 19F Number Analyzed 171 participants 178 participants
1051.0
(862.1 to 1281.3)
627.2
(490.5 to 802.2)
Serotype 23F Number Analyzed 164 participants 176 participants
1155.6
(867.2 to 1539.9)
716.9
(521.1 to 986.3)
9.Secondary Outcome
Title Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 8
Hide Description Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 43 47
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Serotype 1 Number Analyzed 42 participants 44 participants
100.7
(50.5 to 200.9)
54.7
(27.5 to 108.5)
Serotype 3 Number Analyzed 39 participants 45 participants
52.8
(32.2 to 86.5)
27.8
(16.6 to 46.5)
Serotype 4 Number Analyzed 43 participants 46 participants
1075.7
(671.4 to 1723.5)
1051.0
(696.0 to 1587.0)
Serotype 5 Number Analyzed 43 participants 47 participants
350.5
(193.2 to 636.1)
143.9
(77.7 to 266.3)
Serotype 6A Number Analyzed 43 participants 47 participants
3945.3
(2301.9 to 6762.2)
4024.1
(2622.8 to 6174.1)
Serotype 6B Number Analyzed 42 participants 47 participants
2154.2
(1325.4 to 3501.3)
1259.7
(707.3 to 2243.5)
Serotype 7F Number Analyzed 43 participants 47 participants
3830.5
(2654.6 to 5527.2)
2064.0
(1287.4 to 3309.0)
Serotype 9V Number Analyzed 43 participants 47 participants
1555.6
(988.7 to 2447.6)
1606.5
(1064.5 to 2424.6)
Serotype 14 Number Analyzed 42 participants 46 participants
2417.0
(1547.8 to 3774.1)
1586.4
(901.6 to 2791.3)
Serotype 18C Number Analyzed 43 participants 47 participants
1890.8
(1313.3 to 2722.1)
1563.7
(857.8 to 2850.3)
Serotype 19A Number Analyzed 43 participants 46 participants
2102.3
(1567.6 to 2819.5)
1819.8
(1300.2 to 2547.0)
Serotype 19F Number Analyzed 43 participants 46 participants
1039.4
(646.0 to 1672.2)
640.4
(378.1 to 1084.9)
Serotype 22F Number Analyzed 42 participants 43 participants
116.4
(54.9 to 246.8)
30.9
(16.6 to 57.5)
Serotype 23F Number Analyzed 43 participants 46 participants
1245.8
(656.9 to 2362.5)
779.8
(414.3 to 1467.8)
Serotype 33F Number Analyzed 42 participants 47 participants
1515.4
(914.3 to 2511.5)
1984.0
(1207.9 to 3259.0)
10.Secondary Outcome
Title Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 26
Hide Description Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 44 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Serotype 1 Number Analyzed 43 participants 48 participants
39.7
(20.4 to 77.4)
18.9
(10.7 to 33.3)
Serotype 3 Number Analyzed 34 participants 43 participants
19.6
(12.0 to 32.1)
9.2
(6.2 to 13.7)
Serotype 4 Number Analyzed 42 participants 47 participants
737.1
(451.9 to 1202.1)
788.4
(535.3 to 1161.1)
Serotype 5 Number Analyzed 43 participants 46 participants
114.4
(58.5 to 223.4)
65.6
(36.2 to 118.8)
Serotype 6A Number Analyzed 42 participants 47 participants
1843.2
(1111.0 to 3057.8)
1152.9
(655.0 to 2029.3)
Serotype 6B Number Analyzed 44 participants 45 participants
1157.0
(639.0 to 2094.7)
1125.1
(689.7 to 1835.6)
Serotype 7F Number Analyzed 44 participants 48 participants
1204.9
(832.1 to 1744.8)
770.7
(499.5 to 1189.2)
Serotype 9V Number Analyzed 42 participants 45 participants
698.2
(437.7 to 1113.8)
806.5
(500.9 to 1298.7)
Serotype 14 Number Analyzed 43 participants 47 participants
1458.2
(949.2 to 2240.1)
1373.9
(879.5 to 2146.1)
Serotype 18C Number Analyzed 44 participants 45 participants
914.2
(594.3 to 1406.2)
691.1
(383.1 to 1246.7)
Serotype 19A Number Analyzed 43 participants 48 participants
1024.3
(749.4 to 1400.1)
806.3
(539.3 to 1205.6)
Serotype 19F Number Analyzed 43 participants 47 participants
563.7
(344.0 to 923.7)
228.9
(126.1 to 415.5)
Serotype 22F Number Analyzed 41 participants 45 participants
1228.3
(733.3 to 2057.4)
45.2
(23.5 to 86.7)
Serotype 23F Number Analyzed 43 participants 46 participants
653.8
(315.8 to 1353.4)
366.6
(195.9 to 685.9)
Serotype 33F Number Analyzed 44 participants 46 participants
4672.8
(2968.8 to 7354.7)
1151.4
(660.4 to 2007.6)
11.Secondary Outcome
Title Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 30
Hide Description Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
Time Frame Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description:
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
Overall Number of Participants Analyzed 88 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Serotype 1 Number Analyzed 86 participants 89 participants
36.0
(23.2 to 55.9)
43.4
(28.8 to 65.5)
Serotype 3 Number Analyzed 77 participants 86 participants
13.9
(10.2 to 18.9)
32.8
(23.8 to 45.2)
Serotype 4 Number Analyzed 87 participants 93 participants
803.6
(601.2 to 1074.2)
1060.0
(796.2 to 1411.3)
Serotype 5 Number Analyzed 87 participants 93 participants
81.5
(51.1 to 130.0)
117.3
(83.5 to 164.9)
Serotype 6A Number Analyzed 85 participants 91 participants
1673.9
(1141.5 to 2454.5)
1782.7
(1255.1 to 2532.1)
Serotype 6B Number Analyzed 84 participants 92 participants
1330.3
(911.8 to 1940.8)
1343.6
(993.3 to 1817.3)
Serotype 7F Number Analyzed 87 participants 93 participants
877.7
(683.3 to 1127.5)
1248.4
(955.3 to 1631.4)
Serotype 9V Number Analyzed 87 participants 93 participants
628.9
(444.3 to 890.4)
1134.8
(841.4 to 1530.5)
Serotype 14 Number Analyzed 87 participants 93 participants
1762.9
(1257.3 to 2471.7)
1963.3
(1441.9 to 2673.4)
Serotype 18C Number Analyzed 88 participants 92 participants
779.3
(582.9 to 1041.8)
1125.6
(843.5 to 1502.1)
Serotype 19A Number Analyzed 87 participants 94 participants
845.5
(649.5 to 1100.6)
1256.1
(1027.9 to 1535.0)
Serotype 19F Number Analyzed 88 participants 93 participants
349.1
(236.9 to 514.5)
880.8
(663.9 to 1168.6)
Serotype 22F Number Analyzed 81 participants 92 participants
1124.7
(751.7 to 1682.9)
982.1
(642.6 to 1501.0)
Serotype 23F Number Analyzed 86 participants 93 participants
574.3
(367.6 to 897.2)
755.6
(521.6 to 1094.4)
Serotype 33F Number Analyzed 86 participants 94 participants
5917.9
(4199.6 to 8339.4)
7853.5
(5521.3 to 11171.0)
Time Frame Up to 30 Weeks
Adverse Event Reporting Description Participants who received at least 1 dose of study intervention. Adverse Events, including injection specific Adverse Events, were pre-specified to be monitored/assessed per vaccination sequence group, and are therefore reported per vaccination sequence group..
 
Arm/Group Title Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Hide Arm/Group Description Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs. Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.
All-Cause Mortality
Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Affected / at Risk (%) Affected / at Risk (%)
Total   1/200 (0.50%)      0/200 (0.00%)    
Hide Serious Adverse Events
Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/200 (4.50%)      11/200 (5.50%)    
Cardiac disorders     
Angina pectoris  1  1/200 (0.50%)  1 0/200 (0.00%)  0
Atrial fibrillation  1  1/200 (0.50%)  1 0/200 (0.00%)  0
Coronary artery disease  1  1/200 (0.50%)  1 0/200 (0.00%)  0
Myocardial infarction  1  2/200 (1.00%)  2 0/200 (0.00%)  0
Acute coronary syndrome  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Gastrointestinal disorders     
Pancreatitis  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Colitis  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Colitis ulcerative  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Infections and infestations     
Pneumonia  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/200 (0.50%)  1 2/200 (1.00%)  2
Gastrointestinal neoplasm  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Squamous cell carcinoma  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Urethral cancer  1  1/200 (0.50%)  1 0/200 (0.00%)  0
Bowen's disease  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Glioblastoma  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Nervous system disorders     
Cerebrovascular accident  1  0/200 (0.00%)  0 2/200 (1.00%)  3
Brain injury  1  1/200 (0.50%)  1 0/200 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/200 (0.00%)  0 1/200 (0.50%)  1
Dyspnoea  1  1/200 (0.50%)  1 0/200 (0.00%)  0
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   177/200 (88.50%)      165/200 (82.50%)    
General disorders     
Fatigue  1  100/200 (50.00%)  209 89/200 (44.50%)  159
Injection site erythema  1  99/200 (49.50%)  138 72/200 (36.00%)  93
Injection site pain  1  168/200 (84.00%)  357 151/200 (75.50%)  289
Injection site swelling  1  111/200 (55.50%)  173 78/200 (39.00%)  111
Musculoskeletal and connective tissue disorders     
Arthralgia  1  58/200 (29.00%)  105 55/200 (27.50%)  80
Myalgia  1  123/200 (61.50%)  210 115/200 (57.50%)  184
Nervous system disorders     
Headache  1  78/200 (39.00%)  140 60/200 (30.00%)  114
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
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Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02225587    
Other Study ID Numbers: V110-029
2013-003027-11 ( EudraCT Number )
V110-029 ( Other Identifier: Merck )
First Submitted: August 22, 2014
First Posted: August 26, 2014
Results First Submitted: November 26, 2019
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020