Trial Outcomes & Findings for 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) (NCT NCT02225587)

Last Updated: 2021-11-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

400 participants

Primary outcome timeframe

Up to 14 days after any vaccination (Up to 28 weeks)

Results posted on

2021-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 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 Study STARTED	200	200
Overall Study Vaccination 2	188	185
Overall Study Vaccination 3	172	164
Overall Study COMPLETED	172	162
Overall Study NOT COMPLETED	28	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 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 Study Adverse Event	5	5
Overall Study Lost to Follow-up	5	5
Overall Study Non-Compliance With Study Drug	1	0
Overall Study Physician Decision	2	0
Overall Study Protocol Violation	1	0
Overall Study Participant Moved	1	0
Overall Study Withdrawal by Subject	13	28

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=200 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=200 Participants 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 n=400 Participants Total of all reporting groups
Age, Continuous	64.1 Years STANDARD_DEVIATION 8.6 • n=5 Participants	64.2 Years STANDARD_DEVIATION 8.9 • n=7 Participants	64.2 Years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	107 Participants n=7 Participants	219 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	93 Participants n=7 Participants	181 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants	35 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=5 Participants	164 Participants n=7 Participants	322 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	23 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) White	176 Participants n=5 Participants	163 Participants n=7 Participants	339 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 days after any vaccination (Up to 28 weeks)

Population: 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.

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=198 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=199 Participants 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.
Percentage of Participants With an Adverse Event (AE)	89.9 Percentage of participants	84.4 Percentage of participants

PRIMARY outcome

Timeframe: Up to 14 days after any vaccination (Up to 28 weeks)

An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness.

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=198 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=199 Participants 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.
Percentage of Participants With an Injection-site Adverse Event	86.4 Percentage of participants	77.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 14 days after any vaccination (Up to 28 weeks)

Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness.

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=198 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=199 Participants 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.
Percentage of Participants With a Systemic Adverse Event	76.8 Percentage of participants	74.4 Percentage of participants

PRIMARY outcome

Timeframe: Up to 30 weeks

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.

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=198 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=199 Participants 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.
Percentage of Participants With a Serious Adverse Event (SAE)	4.5 Percentage of participants	5.5 Percentage of participants

PRIMARY outcome

Timeframe: Up to 30 weeks

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=198 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=199 Participants 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.
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death	0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 26 weeks

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=198 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=199 Participants 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.
Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event	2.5 Percentage of participants	2.5 Percentage of participants

PRIMARY outcome

Timeframe: Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=172 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=172 Participants 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.
Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12 Serotype 22F	1766.3 Titer Interval 1303.2 to 2394.1	39.0 Titer Interval 28.3 to 53.7
Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12 Serotype 33F	10413.0 Titer Interval 8178.9 to 13257.4	1189.9 Titer Interval 898.6 to 1575.6

PRIMARY outcome

Timeframe: Week 12

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.

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=172 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=179 Participants 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.
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 1	81.7 Titer Interval 60.4 to 110.7	57.1 Titer Interval 41.1 to 79.3
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 3	43.4 Titer Interval 33.7 to 55.9	17.5 Titer Interval 13.5 to 22.5
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 4	1079.3 Titer Interval 885.7 to 1315.2	780.0 Titer Interval 629.1 to 967.1
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 5	198.6 Titer Interval 145.6 to 271.0	148.4 Titer Interval 107.9 to 204.1
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 6B	1956.9 Titer Interval 1575.3 to 2431.0	1148.1 Titer Interval 889.0 to 1482.6
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 7F	2250.8 Titer Interval 1889.3 to 2681.5	1751.8 Titer Interval 1422.4 to 2157.6
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 9V	1472.3 Titer Interval 1190.9 to 1820.2	1017.6 Titer Interval 790.8 to 1309.4
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 14	2106.8 Titer Interval 1689.6 to 2627.0	1945.0 Titer Interval 1572.9 to 2405.1
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 18C	2101.9 Titer Interval 1732.6 to 2550.0	1587.1 Titer Interval 1259.1 to 2000.5
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 19A	1785.8 Titer Interval 1506.1 to 2117.6	1425.9 Titer Interval 1164.7 to 1745.8
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 19F	1051.0 Titer Interval 862.1 to 1281.3	627.2 Titer Interval 490.5 to 802.2
Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12 Serotype 23F	1155.6 Titer Interval 867.2 to 1539.9	716.9 Titer Interval 521.1 to 986.3

SECONDARY outcome

Timeframe: Week 8

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.

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=43 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=47 Participants 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.
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 Serotype 1	100.7 Titer Interval 50.5 to 200.9	54.7 Titer Interval 27.5 to 108.5
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 Serotype 3	52.8 Titer Interval 32.2 to 86.5	27.8 Titer Interval 16.6 to 46.5
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 Serotype 4	1075.7 Titer Interval 671.4 to 1723.5	1051.0 Titer Interval 696.0 to 1587.0
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 Serotype 5	350.5 Titer Interval 193.2 to 636.1	143.9 Titer Interval 77.7 to 266.3
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 Serotype 6A	3945.3 Titer Interval 2301.9 to 6762.2	4024.1 Titer Interval 2622.8 to 6174.1
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 Serotype 6B	2154.2 Titer Interval 1325.4 to 3501.3	1259.7 Titer Interval 707.3 to 2243.5
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 Serotype 7F	3830.5 Titer Interval 2654.6 to 5527.2	2064.0 Titer Interval 1287.4 to 3309.0
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 Serotype 9V	1555.6 Titer Interval 988.7 to 2447.6	1606.5 Titer Interval 1064.5 to 2424.6
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 Serotype 14	2417.0 Titer Interval 1547.8 to 3774.1	1586.4 Titer Interval 901.6 to 2791.3
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 Serotype 18C	1890.8 Titer Interval 1313.3 to 2722.1	1563.7 Titer Interval 857.8 to 2850.3
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 Serotype 19A	2102.3 Titer Interval 1567.6 to 2819.5	1819.8 Titer Interval 1300.2 to 2547.0
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 Serotype 19F	1039.4 Titer Interval 646.0 to 1672.2	640.4 Titer Interval 378.1 to 1084.9
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 Serotype 22F	116.4 Titer Interval 54.9 to 246.8	30.9 Titer Interval 16.6 to 57.5
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 Serotype 23F	1245.8 Titer Interval 656.9 to 2362.5	779.8 Titer Interval 414.3 to 1467.8
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 Serotype 33F	1515.4 Titer Interval 914.3 to 2511.5	1984.0 Titer Interval 1207.9 to 3259.0

SECONDARY outcome

Timeframe: Week 26

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.

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=44 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=48 Participants 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.
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 Serotype 1	39.7 Titer Interval 20.4 to 77.4	18.9 Titer Interval 10.7 to 33.3
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 Serotype 3	19.6 Titer Interval 12.0 to 32.1	9.2 Titer Interval 6.2 to 13.7
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 Serotype 4	737.1 Titer Interval 451.9 to 1202.1	788.4 Titer Interval 535.3 to 1161.1
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 Serotype 5	114.4 Titer Interval 58.5 to 223.4	65.6 Titer Interval 36.2 to 118.8
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 Serotype 6A	1843.2 Titer Interval 1111.0 to 3057.8	1152.9 Titer Interval 655.0 to 2029.3
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 Serotype 6B	1157.0 Titer Interval 639.0 to 2094.7	1125.1 Titer Interval 689.7 to 1835.6
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 Serotype 7F	1204.9 Titer Interval 832.1 to 1744.8	770.7 Titer Interval 499.5 to 1189.2
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 Serotype 9V	698.2 Titer Interval 437.7 to 1113.8	806.5 Titer Interval 500.9 to 1298.7
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 Serotype 14	1458.2 Titer Interval 949.2 to 2240.1	1373.9 Titer Interval 879.5 to 2146.1
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 Serotype 18C	914.2 Titer Interval 594.3 to 1406.2	691.1 Titer Interval 383.1 to 1246.7
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 Serotype 19A	1024.3 Titer Interval 749.4 to 1400.1	806.3 Titer Interval 539.3 to 1205.6
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 Serotype 19F	563.7 Titer Interval 344.0 to 923.7	228.9 Titer Interval 126.1 to 415.5
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 Serotype 22F	1228.3 Titer Interval 733.3 to 2057.4	45.2 Titer Interval 23.5 to 86.7
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 Serotype 23F	653.8 Titer Interval 315.8 to 1353.4	366.6 Titer Interval 195.9 to 685.9
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 Serotype 33F	4672.8 Titer Interval 2968.8 to 7354.7	1151.4 Titer Interval 660.4 to 2007.6

SECONDARY outcome

Timeframe: Week 30

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.

Outcome measures

Outcome measures
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=88 Participants 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=94 Participants 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.
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 Serotype 33F	5917.9 Titer Interval 4199.6 to 8339.4	7853.5 Titer Interval 5521.3 to 11171.0
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 Serotype 1	36.0 Titer Interval 23.2 to 55.9	43.4 Titer Interval 28.8 to 65.5
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 Serotype 3	13.9 Titer Interval 10.2 to 18.9	32.8 Titer Interval 23.8 to 45.2
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 Serotype 4	803.6 Titer Interval 601.2 to 1074.2	1060.0 Titer Interval 796.2 to 1411.3
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 Serotype 5	81.5 Titer Interval 51.1 to 130.0	117.3 Titer Interval 83.5 to 164.9
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 Serotype 6A	1673.9 Titer Interval 1141.5 to 2454.5	1782.7 Titer Interval 1255.1 to 2532.1
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 Serotype 6B	1330.3 Titer Interval 911.8 to 1940.8	1343.6 Titer Interval 993.3 to 1817.3
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 Serotype 7F	877.7 Titer Interval 683.3 to 1127.5	1248.4 Titer Interval 955.3 to 1631.4
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 Serotype 9V	628.9 Titer Interval 444.3 to 890.4	1134.8 Titer Interval 841.4 to 1530.5
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 Serotype 14	1762.9 Titer Interval 1257.3 to 2471.7	1963.3 Titer Interval 1441.9 to 2673.4
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 Serotype 18C	779.3 Titer Interval 582.9 to 1041.8	1125.6 Titer Interval 843.5 to 1502.1
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 Serotype 19A	845.5 Titer Interval 649.5 to 1100.6	1256.1 Titer Interval 1027.9 to 1535.0
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 Serotype 19F	349.1 Titer Interval 236.9 to 514.5	880.8 Titer Interval 663.9 to 1168.6
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 Serotype 22F	1124.7 Titer Interval 751.7 to 1682.9	982.1 Titer Interval 642.6 to 1501.0
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 Serotype 23F	574.3 Titer Interval 367.6 to 897.2	755.6 Titer Interval 521.6 to 1094.4

Adverse Events

Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo

Serious events: 9 serious events

Other events: 177 other events

Deaths: 1 deaths

Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23

Serious events: 11 serious events

Other events: 165 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=200 participants at risk 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=200 participants at risk 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.
General disorders Fatigue	50.0% 100/200 • Number of events 209 • Up to 30 Weeks 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..	44.5% 89/200 • Number of events 159 • Up to 30 Weeks 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..
General disorders Injection site erythema	49.5% 99/200 • Number of events 138 • Up to 30 Weeks 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..	36.0% 72/200 • Number of events 93 • Up to 30 Weeks 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..
General disorders Injection site pain	84.0% 168/200 • Number of events 357 • Up to 30 Weeks 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..	75.5% 151/200 • Number of events 289 • Up to 30 Weeks 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..
General disorders Injection site swelling	55.5% 111/200 • Number of events 173 • Up to 30 Weeks 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..	39.0% 78/200 • Number of events 111 • Up to 30 Weeks 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..
Musculoskeletal and connective tissue disorders Arthralgia	29.0% 58/200 • Number of events 105 • Up to 30 Weeks 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..	27.5% 55/200 • Number of events 80 • Up to 30 Weeks 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..
Musculoskeletal and connective tissue disorders Myalgia	61.5% 123/200 • Number of events 210 • Up to 30 Weeks 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..	57.5% 115/200 • Number of events 184 • Up to 30 Weeks 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..
Nervous system disorders Headache	39.0% 78/200 • Number of events 140 • Up to 30 Weeks 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..	30.0% 60/200 • Number of events 114 • Up to 30 Weeks 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..

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 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo n=200 participants at risk 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.	Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23 n=200 participants at risk 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.
Cardiac disorders Angina pectoris	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..	0.00% 0/200 • Up to 30 Weeks 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..
Cardiac disorders Atrial fibrillation	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..	0.00% 0/200 • Up to 30 Weeks 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..
Cardiac disorders Coronary artery disease	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..	0.00% 0/200 • Up to 30 Weeks 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..
Cardiac disorders Myocardial infarction	1.0% 2/200 • Number of events 2 • Up to 30 Weeks 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..	0.00% 0/200 • Up to 30 Weeks 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..
Gastrointestinal disorders Pancreatitis	0.00% 0/200 • Up to 30 Weeks 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..	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..
Infections and infestations Pneumonia	0.00% 0/200 • Up to 30 Weeks 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..	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..	1.0% 2/200 • Number of events 2 • Up to 30 Weeks 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..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.00% 0/200 • Up to 30 Weeks 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..	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/200 • Up to 30 Weeks 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..	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..	0.00% 0/200 • Up to 30 Weeks 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..
Nervous system disorders Cerebrovascular accident	0.00% 0/200 • Up to 30 Weeks 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..	1.0% 2/200 • Number of events 3 • Up to 30 Weeks 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..
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/200 • Up to 30 Weeks 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..	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..	0.00% 0/200 • Up to 30 Weeks 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..
Cardiac disorders Acute coronary syndrome	0.00% 0/200 • Up to 30 Weeks 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..	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..
Gastrointestinal disorders Colitis	0.00% 0/200 • Up to 30 Weeks 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..	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..
Gastrointestinal disorders Colitis ulcerative	0.00% 0/200 • Up to 30 Weeks 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..	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/200 • Up to 30 Weeks 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..	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/200 • Up to 30 Weeks 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..	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..
Nervous system disorders Brain injury	0.50% 1/200 • Number of events 1 • Up to 30 Weeks 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..	0.00% 0/200 • Up to 30 Weeks 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..