A Study to Evaluate the Safety and Tolerability of V114 a... | NCT03692871

NCT03692871

ID	Type	Description	Link
V114-031	Other Identifier	Merck
2018-003308-38	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

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 approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Biological: V114
Prevnar 13™	Active Comparator	Participants will receive a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Biological: Prevnar 13™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
V114	Biological	V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) 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.	Up to Day 14 after each study 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).	Up to Day 14 after each study 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 6 months after Vaccination 4 (up to 19 months after Vaccination 1)

Secondary Outcomes

Measure	Description	Time Frame
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)	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 Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator
Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
Have 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:

History of Invasive Pneumococcal Disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine
Known or suspected impairment of immunological function
History of congenital or acquired immunodeficiency
Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
Known or history of functional or anatomic asplenia
Failure to thrive based on the clinical judgment of the investigator
Known coagulation disorder contraindicating intramuscular vaccination
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)
Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
Received a dose of any pneumococcal vaccine prior to study entry
Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
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.
Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
Has an immediate family member who is investigational site or Sponsor staff directly involved with this study.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Premier Health Research Center, LLC ( Site 0005)		Downey	California	90240	United States
Beach Pediatrics ( Site 0040)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37309607	Result	Banniettis N, Horn M, Sadarangani M, Patel SM, Greenberg D, Oberdorfer P, Klein NP, Rupp R, Dagan R, Richmond P, Lumley J, Zhou W, Shi Y, Tamms G, Feemster K, Lupinacci R, Musey L, Bickham K; V114-031 (PNEU-LINK) study group. Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. Pediatrics. 2023 Jul 1;152(1):e2022060428. doi: 10.1542/peds.2022-060428.

IPD Sharing Statement Module

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 approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

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	Feb 11, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
BG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

weeks

Title

Denominators

Categories

Title	Measurements
	BG0008.7± 1.5 BG0018.8± 1.5 BG0028.7± 1.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000948 BG001227 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000293 BG00174 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00064 BG00120 BG002

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

Up to Day 14 after each study vaccination

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Units	Counts
Participants	OG0001965 OG001433

Title

Denominators

Categories

Injection-site erythema

Title	Measurements
	OG00043.9 OG00136.0

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		= 0.003		Difference in Percentage	7.9			2-Sided	95	2.8	12.8					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

Up to Day 14 after each study vaccination

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Units	Counts

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 6 months after Vaccination 4 (up to 19 months after Vaccination 1)

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Secondary

Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)

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 Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype

Posted

Geometric Mean

95% Confidence Interval

μg/mL

30 days after Vaccination 3 (approximately 5 months after Vaccination 1)

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Secondary

GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)

Posted

Geometric Mean

95% Confidence Interval

μg/mL

Before Vaccination 4 (10-13 months after Vaccination 1)

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Secondary

GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)

Posted

Geometric Mean

95% Confidence Interval

μg/mL

30 days after Vaccination 4 (11-14 months after Vaccination 1)

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

Secondary

Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only)

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 Prevnar 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. This endpoint was part of a Premature Infant Immunogenicity Substudy.

Posted

Number

95% Confidence Interval

Percentage of participants

30 days after Vaccination 3 (approximately 5 months after Vaccination 1)

ID	Title	Description
OG000	V114	Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
OG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

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 approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	1	1,972	192	1,965	1,807	1,965
EG001	Prevnar 13™	Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	1	437	45	433	395	433

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Congenital absence of bile ducts	Congenital, familial and genetic disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected1,965 at risk EG0010 events0 affected433 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Enteritis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected1,965 at risk EG0010 events0 affected433 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0008 events8 affected1,965 at risk EG0011 events1 affected433 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Arthritis bacterial	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Atypical pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Bacteraemia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Bronchiolitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00029 events27 affected1,965 at risk EG00110 events7 affected433 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0008 events8 affected1,965 at risk EG0012 events2 affected433 at risk
Bronchitis viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Cellulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Coxsackie viral infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Croup infectious	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected1,965 at risk EG0010 events0 affected433 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected1,965 at risk EG0010 events0 affected433 at risk
Enterovirus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0008 events8 affected1,965 at risk EG0011 events1 affected433 at risk
Escherichia sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0006 events6 affected1,965 at risk EG0011 events1 affected433 at risk
Exanthema subitum	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0007 events7 affected1,965 at risk EG0011 events1 affected433 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00017 events15 affected1,965 at risk EG0010 events0 affected433 at risk
Gastroenteritis adenovirus	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected1,965 at risk EG0010 events0 affected433 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected1,965 at risk EG0010 events0 affected433 at risk
Gastroenteritis shigella	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected1,965 at risk EG0011 events1 affected433 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected1,965 at risk EG0010 events0 affected433 at risk
Herpangina	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected1,965 at risk EG0011 events1 affected433 at risk
Influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected1,965 at risk EG0013 events3 affected433 at risk
Laryngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Mastoiditis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected1,965 at risk EG0010 events0 affected433 at risk
Oral herpes	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Otitis externa	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Pertussis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00013 events12 affected1,965 at risk EG0014 events4 affected433 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected1,965 at risk EG0010 events0 affected433 at risk
Pneumonia parainfluenzae viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected1,965 at risk EG0012 events2 affected433 at risk
Pneumonia viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0007 events7 affected1,965 at risk EG0010 events0 affected433 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Rectal abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00010 events9 affected1,965 at risk EG0014 events4 affected433 at risk
Respiratory syncytial virus bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected1,965 at risk EG0010 events0 affected433 at risk
Respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Tonsillitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected1,965 at risk EG0010 events0 affected433 at risk
Tracheitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected1,965 at risk EG0011 events1 affected433 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected1,965 at risk EG0011 events1 affected433 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Viral infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected1,965 at risk EG0010 events0 affected433 at risk
Viral pharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0011 events1 affected433 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0012 events2 affected433 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Chronic recurrent multifocal osteomyelitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Oligoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Hepatoblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Epilepsy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Febrile convulsion	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected1,965 at risk EG0011 events1 affected433 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Myoclonus	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Paroxysmal choreoathetosis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Seizure	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Sleep disorder	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected1,965 at risk EG0011 events1 affected433 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0011 events1 affected433 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk
Haematoma	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected1,965 at risk EG0010 events0 affected433 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG000235 events188 affected1,965 at risk EG00149 events40 affected433 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG000135 events116 affected1,965 at risk EG00120 events19 affected433 at risk
Injection site erythema	General disorders	MedDRA 23.1	Systematic Assessment	EG0001,528 events863 affected1,965 at risk EG001272 events156 affected433 at risk
Injection site induration	General disorders	MedDRA 23.1	Systematic Assessment	EG000885 events497 affected1,965 at risk EG001205 events111 affected433 at risk
Injection site pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001,580 events843 affected1,965 at risk EG001288 events158 affected433 at risk
Injection site swelling	General disorders	MedDRA 23.1	Systematic Assessment	EG000929 events549 affected1,965 at risk EG001163 events101 affected433 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0001,533 events775 affected1,965 at risk EG001329 events176 affected433 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG000182 events158 affected1,965 at risk EG00141 events37 affected433 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG000139 events129 affected1,965 at risk EG00132 events30 affected433 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001,664 events817 affected1,965 at risk EG001302 events156 affected433 at risk
Somnolence	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0002,696 events1,088 affected1,965 at risk EG001590 events238 affected433 at risk
Irritability	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0005,402 events1,472 affected1,965 at risk EG0011,053 events300 affected433 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG000139 events115 affected1,965 at risk EG00140 events29 affected433 at risk

First MCP Posted Date

ID	Term
D011008	Pneumococcal Infections

ID	Term
C538862	13-valent pneumococcal vaccine

Units	Counts
Participants	OG0001965 OG001433

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