Safety, Tolerability, and Immunogenicity of a 3-dose Regi... | NCT04016714

ID	Type	Description	Link
V114-026	Other Identifier	Merck Protocol Number
2018-003788-70	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
V114	Experimental	Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants will also receive other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who will receive a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Drug: V114 Drug: Vaxelis™ Drug: M-M-R®II Drug: VARIVAX™
Prevenar 13™	Active Comparator	Participants will receive a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants will also receive other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who will receive a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Drug: Prevenar 13™ Drug: Vaxelis™ Drug: M-M-R®II Drug: VARIVAX™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
V114	Drug	15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a Solicited Injection-site Adverse Event	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.	Day 1 to Day 14 after each vaccination
Percentage of Participants With a Solicited Systemic Adverse Event	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).	Day 1 to Day 14 after each vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event	A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.	Up to approximately 6 months after Dose 3 (up to approximately 16 months)
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3	The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay.

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3	Antigen-specific response rates in participants administered V114 concomitantly with Vaxelis™ were compared with response rates in participants administered Prevenar 13™ concomitantly with Vaxelis™, and the percentages of participants meeting specified Vaxelis™ antigen responses recorded. Antigens in Vaxelis™ include: diphtheria toxoid, tetanus toxoid, pertussis toxin (PT), pertussis filamentous hemagglutinin (FHA), pertussis fimbriae 2/3 (FIM 2/3), pertussis pertactin (PRN), Haemophilus influenzae type b polyribosylribitol phosphate (Hib-PRP), hepatitis B surface antigen (HBsAg), and poliovirus serotypes 1, 2, and 3.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is male or female, approximately 3 months of age, from 70 days to 111 days inclusive, at the time of signing the informed consent.
Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria:

Was born prior to 37 weeks of gestation.
Has a history of invasive pneumococcal disease (IPD) or known history of other culture positive pneumococcal disease.
Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid containing vaccine.
Has any contraindication to the concomitant study vaccines being administered in the study.
Has a known or suspected impairment of immunological function.
Has a history of congenital or acquired immunodeficiency.
Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection.
Has, or his/her mother has, a documented hepatitis B surface antigen - positive test.
Has known or history of functional or anatomic asplenia.
Has failure to thrive based on the clinical judgement of the investigator.
Has a bleeding disorder contraindicating intramuscular vaccination.
Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders).
Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
Has received a dose of any pneumococcal vaccine prior to study entry.
Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry.
Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenza type b conjugate vaccine, poliovirus vaccine, or any other combination thereof, prior to study entry.
Has received a blood transfusion or blood products, including immunoglobulins.
Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case by-case basis for approval by the Sponsor.
Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study.
Is or has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital ( Site 0003)		Hvidovre	Capital Region	2650	Denmark
Aarhus Universitetshosp. Skejby ( Site 0002)

PubMed Identifier	Type	Citation	Retractions
36841723	Result	Benfield T, Ramet M, Valentini P, Seppa I, Dagan R, Richmond P, Mercer S, Churchill C, Lupinacci R, McFetridge R, Park J, Wittke F, Banniettis N, Musey L, Bickham K, Kaminski J. Safety, tolerability, and immunogenicity of V114 pneumococcal vaccine compared with PCV13 in a 2+1 regimen in healthy infants: A phase III study (PNEU-PED-EU-2). Vaccine. 2023 Apr 6;41(15):2456-2465. doi: 10.1016/j.vaccine.2023.02.041. Epub 2023 Feb 24.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 14, 2021

Arm/Group Information

ID	Title	Description
BG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
BG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With a Solicited Injection-site Adverse Event

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.

All randomized participants who received at least 1 dose of study vaccination

Posted

Number

Percentage of participants

Day 1 to Day 14 after each vaccination

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
OG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

Units	Counts
Participants	OG000595 OG001594

Title

Denominators

Categories

Injection-site erythema

Title	Measurements
	OG00060.0 OG00165.5

Injection-site induration

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Injection-site erythema	Miettinen & Nurminen method		= 0.050		Difference in percentage vs Prevenar 13™	-5.5			2-Sided	95	-11.0	0.0					Other
OG000 OG001	Injection-site induration	Miettinen & Nurminen method

Primary

Percentage of Participants With a Solicited Systemic Adverse Event

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).

All randomized participants who received at least 1 dose of study vaccination

Posted

Number

Percentage of participants

Day 1 to Day 14 after each vaccination

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
OG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

Primary

Percentage of Participants With a Vaccine-related Serious Adverse Event

A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.

All randomized participants who received at least 1 dose of study vaccination

Posted

Number

Percentage of participants

Up to approximately 6 months after Dose 3 (up to approximately 16 months)

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
OG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

Primary

Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3

The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay.

All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype

Posted

Number

Percentage of participants

30 days after Dose 3

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
OG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

Primary

Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3

The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

30 days after Dose 3

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
OG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

Secondary

Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3

Antigen-specific response rates in participants administered V114 concomitantly with Vaxelis™ were compared with response rates in participants administered Prevenar 13™ concomitantly with Vaxelis™, and the percentages of participants meeting specified Vaxelis™ antigen responses recorded. Antigens in Vaxelis™ include: diphtheria toxoid, tetanus toxoid, pertussis toxin (PT), pertussis filamentous hemagglutinin (FHA), pertussis fimbriae 2/3 (FIM 2/3), pertussis pertactin (PRN), Haemophilus influenzae type b polyribosylribitol phosphate (Hib-PRP), hepatitis B surface antigen (HBsAg), and poliovirus serotypes 1, 2, and 3.

Posted

Number

Percentage of participants

30 days after Dose 3

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
OG001	Prevenar 13™

Secondary

Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2

Posted

Number

Percentage of participants

30 days after Dose 2

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
OG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

Secondary

GMC of Serotype-specific IgG 30 Days After Dose 2

Posted

Geometric Mean

95% Confidence Interval

μg/mL

30 days after Dose 2

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
OG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

Secondary

Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3

OPA for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was measured using a multiplex opsonophagocytic assay (MOPA).

All randomized participants in the OPA Subset without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype

Posted

Number

95% Confidence Interval

Percentage of participants

30 days after Dose 3

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
OG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

Secondary

Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3

Sera from participants was used to measure GMT of the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA.

Posted

Geometric Mean

95% Confidence Interval

Titer

30 days after Dose 3

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
OG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	1	595	30	595	590	595
EG001	Prevenar 13™	Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	0	596	28	594	592	594

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Laryngomalacia	Congenital, familial and genetic disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0011 events1 affected594 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0011 events1 affected594 at risk
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected595 at risk EG0012 events2 affected594 at risk
Food allergy	Immune system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Arthritis infective	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0011 events1 affected594 at risk
Bacterial infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Bronchiolitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Bronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected595 at risk EG0011 events1 affected594 at risk
Cystitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Gastroenteritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0012 events2 affected594 at risk
Gastroenteritis adenovirus	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0011 events1 affected594 at risk
Laryngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0013 events3 affected594 at risk
Pertussis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Pyelonephritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected595 at risk EG0015 events2 affected594 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0013 events3 affected594 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0011 events1 affected594 at risk
Respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0011 events1 affected594 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0011 events1 affected594 at risk
Rhinitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0011 events1 affected594 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Viral infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0012 events2 affected594 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0011 events1 affected594 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0002 events1 affected595 at risk EG0010 events0 affected594 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0011 events1 affected594 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Epilepsy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Febrile convulsion	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0011 events1 affected594 at risk
Infantile spasms	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Partial seizures	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0011 events1 affected594 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0011 events1 affected594 at risk
Tremor	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected595 at risk EG0011 events1 affected594 at risk
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected595 at risk EG0010 events0 affected594 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00082 events69 affected595 at risk EG00189 events70 affected594 at risk
Teething	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00060 events47 affected595 at risk EG00167 events50 affected594 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00038 events31 affected595 at risk EG00141 events38 affected594 at risk
Injection site erythema	General disorders	MedDRA 24.1	Systematic Assessment	EG000613 events357 affected595 at risk EG001658 events389 affected594 at risk
Injection site induration	General disorders	MedDRA 24.1	Systematic Assessment	EG000658 events339 affected595 at risk EG001679 events351 affected594 at risk
Injection site pain	General disorders	MedDRA 24.1	Systematic Assessment	EG000646 events375 affected595 at risk EG001595 events354 affected594 at risk
Injection site swelling	General disorders	MedDRA 24.1	Systematic Assessment	EG000444 events276 affected595 at risk EG001417 events262 affected594 at risk
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG000728 events318 affected595 at risk EG001762 events330 affected594 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00080 events70 affected595 at risk EG001101 events84 affected594 at risk
Body temperature increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00074 events51 affected595 at risk EG00191 events61 affected594 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG000632 events326 affected595 at risk EG001686 events346 affected594 at risk
Somnolence	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001,118 events460 affected595 at risk EG0011,085 events463 affected594 at risk
Irritability	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0002,266 events573 affected595 at risk EG0012,304 events559 affected594 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG000130 events100 affected595 at risk EG001173 events127 affected594 at risk

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
C538862	13-valent pneumococcal vaccine
C000617220	Vaxelis
D022542	Measles-Mumps-Rubella Vaccine
D019433	Chickenpox Vaccine

ID	Term
D017778	Vaccines, Combined
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D008458	Measles Vaccine
D014765	Viral Vaccines
D009108	Mumps Vaccine
D012411	Rubella Vaccine
D022283	Herpesvirus Vaccines