Trial Outcomes & Findings for 20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants (NCT NCT04379713)

Last Updated: 2023-06-13

Results Overview

Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\>) 0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1511 participants

Primary outcome timeframe

Within 7 Days after Dose 1

Results posted on

2023-06-13

Participant Flow

A total of 1511 participants were enrolled and randomized to receive 4 doses of 20-valent pneumococcal conjugate vaccine (20vPnC) or 13vPnC of which 7 participants were not vaccinated and 1504 were vaccinated with either 20vPnC or 13vPnC.

Participant milestones

Participant milestones
Measure	20vPnC Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Overall Study STARTED	1006	505
Overall Study Dose 1	1000	504
Overall Study Dose 2	972	492
Overall Study Dose 3	964	483
Overall Study Dose 4	923	462
Overall Study COMPLETED	910	451
Overall Study NOT COMPLETED	96	54

Reasons for withdrawal

Reasons for withdrawal
Measure	20vPnC Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Overall Study Adverse Event	2	0
Overall Study Physician Decision	2	1
Overall Study Protocol Violation	11	6
Overall Study No longer met eligibility criteria	14	11
Overall Study Withdrawal by parent/guardian	36	15
Overall Study Lost to Follow-up	31	21

Baseline Characteristics

20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	20vPnC n=1000 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=503 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	Total n=1503 Participants Total of all reporting groups
Age, Continuous	64.6 Days STANDARD_DEVIATION 8.51 • n=5 Participants	65.0 Days STANDARD_DEVIATION 8.95 • n=7 Participants	64.8 Days STANDARD_DEVIATION 8.66 • n=5 Participants
Sex: Female, Male Female	483 Participants n=5 Participants	259 Participants n=7 Participants	742 Participants n=5 Participants
Sex: Female, Male Male	517 Participants n=5 Participants	244 Participants n=7 Participants	761 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	367 Participants n=5 Participants	193 Participants n=7 Participants	560 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	621 Participants n=5 Participants	303 Participants n=7 Participants	924 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	55 Participants n=5 Participants	15 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) White	868 Participants n=5 Participants	445 Participants n=7 Participants	1313 Participants n=5 Participants
Race (NIH/OMB) More than one race	35 Participants n=5 Participants	21 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 7 Days after Dose 1

Population: Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 1.

Outcome measures

Outcome measures
Measure	20vPnC n=992 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=498 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Redness: Mild	18.0 Percentage of participants 95% Confidence Interval 15.7 • Interval 15.7 to 20.6	16.5 Percentage of participants 95% Confidence Interval 13.3 • Interval 13.3 to 20.0
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Redness: Moderate	3.7 Percentage of participants 95% Confidence Interval 2.6 • Interval 2.6 to 5.1	3.0 Percentage of participants 95% Confidence Interval 1.7 • Interval 1.7 to 4.9
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Swelling: Mild	13.8 Percentage of participants 95% Confidence Interval 11.7 • Interval 11.7 to 16.1	11.2 Percentage of participants 95% Confidence Interval 8.6 • Interval 8.6 to 14.4
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Pain at injection site: Mild	24.8 Percentage of participants 95% Confidence Interval 22.1 • Interval 22.1 to 27.6	25.3 Percentage of participants 95% Confidence Interval 21.5 • Interval 21.5 to 29.4
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Pain at injection site: Moderate	15.5 Percentage of participants 95% Confidence Interval 13.3 • Interval 13.3 to 17.9	16.7 Percentage of participants 95% Confidence Interval 13.5 • Interval 13.5 to 20.2
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Pain at injection site: Severe	0.2 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.7	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Redness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.4	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Swelling: Moderate	6.1 Percentage of participants 95% Confidence Interval 4.7 • Interval 4.7 to 7.8	5.4 Percentage of participants 95% Confidence Interval 3.6 • Interval 3.6 to 7.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Swelling: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.4	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.7

PRIMARY outcome

Timeframe: Within 7 Days after Dose 2

Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.

Outcome measures

Outcome measures
Measure	20vPnC n=952 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=485 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Redness: Mild	20.4 Percentage of participants 95% Confidence Interval 17.9 • Interval 17.9 to 23.1	19.4 Percentage of participants 95% Confidence Interval 16.0 • Interval 16.0 to 23.2
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Redness: Moderate	3.2 Percentage of participants 95% Confidence Interval 2.1 • Interval 2.1 to 4.5	3.9 Percentage of participants 95% Confidence Interval 2.4 • Interval 2.4 to 6.1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Swelling: Mild	13.4 Percentage of participants 95% Confidence Interval 11.3 • Interval 11.3 to 15.8	13.4 Percentage of participants 95% Confidence Interval 10.5 • Interval 10.5 to 16.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Swelling: Moderate	4.4 Percentage of participants 95% Confidence Interval 3.2 • Interval 3.2 to 5.9	5.6 Percentage of participants 95% Confidence Interval 3.7 • Interval 3.7 to 8.0
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Swelling: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.4	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Pain at the injection site: Mild	20.8 Percentage of participants 95% Confidence Interval 18.3 • Interval 18.3 to 23.5	20.2 Percentage of participants 95% Confidence Interval 16.7 • Interval 16.7 to 24.1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Pain at the injection site: Moderate	10.7 Percentage of participants 95% Confidence Interval 8.8 • Interval 8.8 to 12.9	11.8 Percentage of participants 95% Confidence Interval 9.0 • Interval 9.0 to 15.0
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Redness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.4	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Pain at the injection site: Severe	0.7 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 1.5	0.8 Percentage of participants 95% Confidence Interval 0.2 • Interval 0.2 to 2.1

PRIMARY outcome

Timeframe: Within 7 Days after Dose 3

Outcome measures

Outcome measures
Measure	20vPnC n=940 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=477 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Redness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.4	0.2 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Swelling: Mild	12.2 Percentage of participants 95% Confidence Interval 10.2 • Interval 10.2 to 14.5	13.0 Percentage of participants 95% Confidence Interval 10.1 • Interval 10.1 to 16.4
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Swelling: Moderate	4.1 Percentage of participants 95% Confidence Interval 3.0 • Interval 3.0 to 5.6	3.1 Percentage of participants 95% Confidence Interval 1.8 • Interval 1.8 to 5.1
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Swelling: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.4	0.2 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 1.2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Pain at the injection site: Mild	16.3 Percentage of participants 95% Confidence Interval 14.0 • Interval 14.0 to 18.8	16.6 Percentage of participants 95% Confidence Interval 13.3 • Interval 13.3 to 20.2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Pain at the injection site: Moderate	8.3 Percentage of participants 95% Confidence Interval 6.6 • Interval 6.6 to 10.2	10.3 Percentage of participants 95% Confidence Interval 7.7 • Interval 7.7 to 13.4
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Pain at the injection site: Severe	0.1 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Redness: Mild	19.4 Percentage of participants 95% Confidence Interval 16.9 • Interval 16.9 to 22.0	17.0 Percentage of participants 95% Confidence Interval 13.7 • Interval 13.7 to 20.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Redness: Moderate	3.8 Percentage of participants 95% Confidence Interval 2.7 • Interval 2.7 to 5.3	3.1 Percentage of participants 95% Confidence Interval 1.8 • Interval 1.8 to 5.1

PRIMARY outcome

Timeframe: Within 7 Days after Dose 4

Outcome measures

Outcome measures
Measure	20vPnC n=892 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=454 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Redness: Moderate	5.9 Percentage of participants 95% Confidence Interval 4.5 • Interval 4.5 to 7.7	2.4 Percentage of participants 95% Confidence Interval 1.2 • Interval 1.2 to 4.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Redness: Mild	15.1 Percentage of participants 95% Confidence Interval 12.8 • Interval 12.8 to 17.7	19.4 Percentage of participants 95% Confidence Interval 15.8 • Interval 15.8 to 23.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Redness: Severe	0.1 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Swelling: Mild	10.1 Percentage of participants 95% Confidence Interval 8.2 • Interval 8.2 to 12.3	11.5 Percentage of participants 95% Confidence Interval 8.7 • Interval 8.7 to 14.7
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Swelling: Moderate	4.7 Percentage of participants 95% Confidence Interval 3.4 • Interval 3.4 to 6.3	2.9 Percentage of participants 95% Confidence Interval 1.5 • Interval 1.5 to 4.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Swelling: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.4	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.8
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Pain at the injection site: Mild	19.8 Percentage of participants 95% Confidence Interval 17.3 • Interval 17.3 to 22.6	21.8 Percentage of participants 95% Confidence Interval 18.1 • Interval 18.1 to 25.9
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Pain at the injection site: Moderate	10.2 Percentage of participants 95% Confidence Interval 8.3 • Interval 8.3 to 12.4	10.1 Percentage of participants 95% Confidence Interval 7.5 • Interval 7.5 to 13.3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Pain at the injection site: Severe	0.8 Percentage of participants 95% Confidence Interval 0.3 • Interval 0.3 to 1.6	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 0.8

PRIMARY outcome

Timeframe: Within 7 Days after Dose 1

Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Outcome measures

Outcome measures
Measure	20vPnC n=992 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=498 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Drowsiness: Severe	0.5 Percentage of participants Interval 0.2 to 1.2	0.4 Percentage of participants Interval 0.0 to 1.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Irritability: Mild	22.7 Percentage of participants Interval 20.1 to 25.4	22.9 Percentage of participants Interval 19.3 to 26.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >=38.0 degrees C to 38.4 degrees C	6.3 Percentage of participants Interval 4.8 to 7.9	7.8 Percentage of participants Interval 5.6 to 10.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >38.4 degrees C to 38.9 degrees C	2.3 Percentage of participants Interval 1.5 to 3.5	1.8 Percentage of participants Interval 0.8 to 3.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >38.9 degrees C to 40.0 degrees C	0.7 Percentage of participants Interval 0.3 to 1.4	0.2 Percentage of participants Interval 0.0 to 1.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Fever: >40.0 degrees C	0 Percentage of participants Interval 0.0 to 0.4	0 Percentage of participants Interval 0.0 to 0.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Decreased appetite: Mild	14.2 Percentage of participants Interval 12.1 to 16.5	14.7 Percentage of participants Interval 11.7 to 18.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Decreased appetite: Moderate	10.3 Percentage of participants Interval 8.5 to 12.3	8.6 Percentage of participants Interval 6.3 to 11.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Decreased appetite: Severe	0.5 Percentage of participants Interval 0.2 to 1.2	0.4 Percentage of participants Interval 0.0 to 1.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Drowsiness: Mild	48.5 Percentage of participants Interval 45.3 to 51.6	47.4 Percentage of participants Interval 42.9 to 51.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Drowsiness: Moderate	15.8 Percentage of participants Interval 13.6 to 18.2	14.5 Percentage of participants Interval 11.5 to 17.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Irritability: Moderate	41.2 Percentage of participants Interval 38.1 to 44.4	41.4 Percentage of participants Interval 37.0 to 45.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Irritability: Severe	4.3 Percentage of participants Interval 3.2 to 5.8	4.2 Percentage of participants Interval 2.6 to 6.4

PRIMARY outcome

Timeframe: Within 7 Days after Dose 2

Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).

Outcome measures

Outcome measures
Measure	20vPnC n=952 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=485 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Irritability: Mild	23.2 Percentage of participants Interval 20.6 to 26.0	19.8 Percentage of participants Interval 16.3 to 23.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Irritability: Severe	4.2 Percentage of participants Interval 3.0 to 5.7	5.2 Percentage of participants Interval 3.4 to 7.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >=38.0 degrees C to 38.4 degrees C	10.6 Percentage of participants Interval 8.7 to 12.7	8.5 Percentage of participants Interval 6.1 to 11.3
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >38.4 degrees C to 38.9 degrees C	3.6 Percentage of participants Interval 2.5 to 5.0	2.7 Percentage of participants Interval 1.4 to 4.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >38.9 degrees C to 40.0 degrees C	1.4 Percentage of participants Interval 0.7 to 2.3	0.2 Percentage of participants Interval 0.0 to 1.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Fever: >40.0 degrees C	0 Percentage of participants Interval 0.0 to 0.4	0 Percentage of participants Interval 0.0 to 0.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Decreased appetite: Mild	13.4 Percentage of participants Interval 11.3 to 15.8	12.0 Percentage of participants Interval 9.2 to 15.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Decreased appetite: Moderate	9.6 Percentage of participants Interval 7.8 to 11.6	8.2 Percentage of participants Interval 6.0 to 11.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Decreased appetite: Severe	0.7 Percentage of participants Interval 0.3 to 1.5	0.4 Percentage of participants Interval 0.0 to 1.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Drowsiness: Mild	35.3 Percentage of participants Interval 32.3 to 38.4	35.3 Percentage of participants Interval 31.0 to 39.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Drowsiness: Moderate	13.4 Percentage of participants Interval 11.3 to 15.8	13.8 Percentage of participants Interval 10.9 to 17.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Drowsiness: Severe	0.4 Percentage of participants Interval 0.1 to 1.1	1.2 Percentage of participants Interval 0.5 to 2.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Irritability: Moderate	37.3 Percentage of participants Interval 34.2 to 40.4	42.7 Percentage of participants Interval 38.2 to 47.2

PRIMARY outcome

Timeframe: Within 7 Days after Dose 3

Outcome measures

Outcome measures
Measure	20vPnC n=940 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=477 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Drowsiness: Moderate	8.5 Percentage of participants Interval 6.8 to 10.5	9.0 Percentage of participants Interval 6.6 to 12.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Irritability: Mild	22.3 Percentage of participants Interval 19.7 to 25.1	22.2 Percentage of participants Interval 18.6 to 26.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >=38.0 degrees C to 38.4 degrees C	7.4 Percentage of participants Interval 5.9 to 9.3	8.2 Percentage of participants Interval 5.9 to 11.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >38.4 degrees C to 38.9 degrees C	2.9 Percentage of participants Interval 1.9 to 4.2	0.6 Percentage of participants Interval 0.1 to 1.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >38.9 degrees C to 40.0 degrees C	1.3 Percentage of participants Interval 0.7 to 2.2	1.0 Percentage of participants Interval 0.3 to 2.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Fever: >40.0 degrees C	0 Percentage of participants Interval 0.0 to 0.4	0 Percentage of participants Interval 0.0 to 0.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Decreased appetite: Mild	15.0 Percentage of participants Interval 12.8 to 17.4	10.5 Percentage of participants Interval 7.9 to 13.6
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Decreased appetite: Moderate	8.2 Percentage of participants Interval 6.5 to 10.1	6.3 Percentage of participants Interval 4.3 to 8.9
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Decreased appetite: Severe	0.4 Percentage of participants Interval 0.1 to 1.1	0.4 Percentage of participants Interval 0.1 to 1.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Drowsiness: Mild	26.6 Percentage of participants Interval 23.8 to 29.5	27.3 Percentage of participants Interval 23.3 to 31.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Drowsiness: Severe	0.2 Percentage of participants Interval 0.0 to 0.8	0 Percentage of participants Interval 0.0 to 0.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Irritability: Moderate	30.1 Percentage of participants Interval 27.2 to 33.2	29.8 Percentage of participants Interval 25.7 to 34.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Irritability: Severe	2.3 Percentage of participants Interval 1.5 to 3.5	2.7 Percentage of participants Interval 1.5 to 4.6

PRIMARY outcome

Timeframe: Within 7 Days after Dose 4

Outcome measures

Outcome measures
Measure	20vPnC n=892 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=454 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >=38.0 degrees C to 38.4 degrees C	9.8 Percentage of participants Interval 7.9 to 11.9	9.5 Percentage of participants Interval 6.9 to 12.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Drowsiness: Mild	24.2 Percentage of participants Interval 21.4 to 27.2	25.1 Percentage of participants Interval 21.2 to 29.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Irritability: Mild	21.4 Percentage of participants Interval 18.8 to 24.3	22.0 Percentage of participants Interval 18.3 to 26.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >38.4 degrees C to 38.9 degrees C	4.5 Percentage of participants Interval 3.2 to 6.1	4.2 Percentage of participants Interval 2.5 to 6.5
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >38.9 degrees C to 40.0 degrees C	3.7 Percentage of participants Interval 2.6 to 5.2	3.1 Percentage of participants Interval 1.7 to 5.1
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Fever: >40.0 degrees C	0.1 Percentage of participants Interval 0.0 to 0.6	0.2 Percentage of participants Interval 0.0 to 1.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Decreased appetite: Mild	16.1 Percentage of participants Interval 13.8 to 18.7	12.3 Percentage of participants Interval 9.5 to 15.7
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Decreased appetite: Moderate	10.5 Percentage of participants Interval 8.6 to 12.7	11.7 Percentage of participants Interval 8.9 to 15.0
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Decreased appetite: Severe	1.7 Percentage of participants Interval 0.9 to 2.8	1.8 Percentage of participants Interval 0.8 to 3.4
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Drowsiness: Moderate	12.2 Percentage of participants Interval 10.1 to 14.6	10.6 Percentage of participants Interval 7.9 to 13.8
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Drowsiness: Severe	0.7 Percentage of participants Interval 0.2 to 1.5	0.2 Percentage of participants Interval 0.0 to 1.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Irritability: Moderate	31.4 Percentage of participants Interval 28.4 to 34.5	29.7 Percentage of participants Interval 25.6 to 34.2
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Irritability: Severe	2.5 Percentage of participants Interval 1.6 to 3.7	3.3 Percentage of participants Interval 1.9 to 5.4

PRIMARY outcome

Timeframe: From Dose 1 to 1 Month after Dose 3

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	20vPnC n=1000 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=503 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3	29.6 Percentage of participants 95% Confidence Interval 26.8 • Interval 26.8 to 32.5	27.6 Percentage of participants 95% Confidence Interval 23.8 • Interval 23.8 to 31.8

PRIMARY outcome

Timeframe: From Dose 4 to 1 Month after Dose 4

Outcome measures

Outcome measures
Measure	20vPnC n=923 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=461 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4	15.1 Percentage of participants 95% Confidence Interval 12.8 • Interval 12.8 to 17.5	15.8 Percentage of participants 95% Confidence Interval 12.6 • Interval 12.6 to 19.5

PRIMARY outcome

Timeframe: From Dose 1 to 6 Months after Dose 4

A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect and other important medical events.

Outcome measures

Outcome measures
Measure	20vPnC n=1000 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=503 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4	4.4 Percentage of participants 95% Confidence Interval 3.2 • Interval 3.2 to 5.9	5.6 Percentage of participants 95% Confidence Interval 3.7 • Interval 3.7 to 7.9

PRIMARY outcome

Timeframe: From Dose 1 to 6 Months after Dose 4

An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.

Outcome measures

Outcome measures
Measure	20vPnC n=1000 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=503 Participants Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months After Dose 4	2.8 Percentage of participants 95% Confidence Interval 1.9 • Interval 1.9 to 4.0	2.8 Percentage of participants 95% Confidence Interval 1.5 • Interval 1.5 to 4.6

Adverse Events

20vPnC

Serious events: 44 serious events

Other events: 960 other events

Deaths: 0 deaths

13vPnC

Serious events: 28 serious events

Other events: 481 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	20vPnC n=1000 participants at risk Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.	13vPnC n=503 participants at risk Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age.
General disorders Injection site erythema (REDNESS)	45.5% 455/1000 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.	44.5% 224/503 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.
General disorders Injection site pain (PAIN)	60.9% 609/1000 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.	61.4% 309/503 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.
General disorders Injection site swelling (SWELLING)	37.2% 372/1000 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.	35.0% 176/503 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.
General disorders Pyrexia (FEVER)	33.6% 336/1000 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.	31.6% 159/503 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.
Infections and infestations Upper respiratory tract infection	5.9% 59/1000 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.	5.6% 28/503 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.
Metabolism and nutrition disorders Decreased appetite (DECREASED APPETITE)	54.9% 549/1000 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.	49.5% 249/503 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.
Nervous system disorders Hypersomnia (INCREASED SLEEP)	80.9% 809/1000 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.	77.3% 389/503 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.
Psychiatric disorders Irritability (IRRITABILITY)	88.3% 883/1000 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.	85.9% 432/503 • Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4 The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER