Safety, Tolerability, and Immunogenicity of Measles, Mump... | NCT01536405

ID	Type	Description	Link
P20930

Status Module

Label	Type	Description	Intervention Names
MMRV (AMP)	Experimental	Participants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)	Biological: MMRV (AMP)
MMRV (2006 process)	Active Comparator	Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process	Biological: MMRV (2006 process)

Name	Type	Description	Arm Group Labels	Other Names
MMRV (AMP)	Biological	Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.	MMRV (AMP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL	Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)	Six weeks after vaccination 1
Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL	Sera were tested for measles virus IgG antibody levels by an ELISA	Six weeks after vaccination 1
Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL	Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)	Six weeks after vaccination 1
Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)	Sera were tested for rubella virus IgG antibody levels by an ELISA	Six weeks after vaccination 1
Geometric Mean Titer (GMT) of VZV Antibodies	Sera were tested for VZV IgG antibody levels by gpELISA	Six weeks after vaccination 1
Geometric Mean Titer (GMT) of Measles Virus Antibodies	Sera were tested for measles virus IgG antibody levels by ELISA	Six weeks after vaccination 1
Geometric Mean Titer (GMT) of Mumps Virus Antibodies	Sera were tested for mumps virus IgG antibody levels by ELISA

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)		Up to 42 days after each vaccination
Percentage of Participants With Zoster-like Rash		Up to 42 days after each vaccination

Eligibility Module

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

PubMed Identifier	Type	Citation	Retractions
27149048	Result	Marshall GS, Senders SD, Shepard J, Twiggs JD, Gardner J, Hille D, Hartzel J, Valenzuela R, Stek JE, Helmond FA. A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process. Hum Vaccin Immunother. 2016 Aug 2;12(8):2188-2196. doi: 10.1080/21645515.2016.1165374. Epub 2016 May 5.

ID	Type	URL	Comment
	CSR Synopsis	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
FG001	MMRV (2006 Process)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
BG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000706 BG001706 BG0021412

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 Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL

Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)

The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results

Posted

Number

95% Confidence Interval

Percentage of participants

Six weeks after vaccination 1

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000586 OG001589

Title

Denominators

Categories

Title	Measurements
	OG00097.3(95.6 to 98.4) OG00193.0(90.7 to 95.0)

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		Miettinen and Nurminen		<0.001		Risk Difference (RD)	4.2			2-Sided	95	1.8	6.8			RD = MMRV (AMP) - MMRV (2006 process)		Non-Inferiority or Equivalence	The non-inferiority evaluation is based on the lower bound of the 2-sided 95% confidence interval (CI) on the risk difference excluding a decrease >= the prespecified criterion of 10 percentage points

Primary

Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL

Sera were tested for measles virus IgG antibody levels by an ELISA

The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results

Posted

Number

95% Confidence Interval

Percentage of participants

Six weeks after vaccination 1

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Primary

Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL

Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)

The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results

Posted

Number

95% Confidence Interval

Percentage of participants

Six weeks after vaccination 1

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Primary

Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)

Sera were tested for rubella virus IgG antibody levels by an ELISA

The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella serology results

Posted

Number

95% Confidence Interval

Percentage of participants

Six weeks after vaccination 1

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Primary

Geometric Mean Titer (GMT) of VZV Antibodies

Sera were tested for VZV IgG antibody levels by gpELISA

The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results

Posted

Geometric Mean

95% Confidence Interval

ELISA units/mL

Six weeks after vaccination 1

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Primary

Geometric Mean Titer (GMT) of Measles Virus Antibodies

Sera were tested for measles virus IgG antibody levels by ELISA

The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

Six weeks after vaccination 1

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Primary

Geometric Mean Titer (GMT) of Mumps Virus Antibodies

Sera were tested for mumps virus IgG antibody levels by ELISA

The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results

Posted

Geometric Mean

95% Confidence Interval

Mumps Ab units/mL

Six weeks after vaccination 1

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Primary

Geometric Mean Titer (GMT) of Rubella Virus Antibodies

Sera were tested for rubella virus IgG antibody levels by ELISA

The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella virus serology results

Posted

Geometric Mean

95% Confidence Interval

IU/mL

Six weeks after vaccination 1

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Primary

Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

The population analyzed included participants who received >=1 study vaccination and had follow-up safety data

Posted

Number

Percentage of participants

Up to 5 days after vaccination 1

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

The population analyzed included participants who received >=1 study vaccination and had follow-up safety data

Posted

Number

Percentage of participants

Up to 42 days after each vaccination

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Zoster-like Rash

The population analyzed included participants who received >=1 study vaccination and had follow-up safety data

Posted

Number

Percentage of participants

Up to 42 days after each vaccination

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Mumps-like Symptoms

The population analyzed included participants who received >=1 study vaccination and had follow-up safety data

Posted

Number

Percentage of participants

Up to 42 days after each vaccination

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Measles-like Rash

The population analyzed included participants who received >=1 study vaccination and had follow-up safety data

Posted

Number

Percentage of participants

Up to 42 days after each vaccination

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Rubella-like Rash

The population analyzed included participants who received >=1 study vaccination and had follow-up safety data

Posted

Number

Percentage of participants

Up to 42 days after each vaccination

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Varicella-like Rash

The population analyzed included participants who received >=1 study vaccination and had follow-up safety data

Posted

Number

Percentage of participants

Up to 42 days after each vaccination

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With an Injection-site Adverse Event

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.

The population analyzed included participants who received >=1 study vaccination and had follow-up safety data

Posted

Number

Percentage of participants

Up to 5 days after each vaccination

ID	Title	Description
OG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
OG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Pyrexia	General disorders	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Abscess limb	Infections and infestations	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Bronchiolitis	Infections and infestations	MedDRA 16	EG0001 events1 affected682 at risk EG0012 events2 affected683 at risk
Cellulitis staphylcoccal	Infections and infestations	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Croup infectious	Infections and infestations	MedDRA 16	EG0001 events1 affected682 at risk EG0012 events2 affected683 at risk
Gastroenteritis	Infections and infestations	MedDRA 16	EG0002 events2 affected682 at risk EG0010 events0 affected683 at risk
Groin abscess	Infections and infestations	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Lobar pneumonia	Infections and infestations	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Otitis media	Infections and infestations	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Pneumonia	Infections and infestations	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Pneumonia viral	Infections and infestations	MedDRA 16	EG0000 events0 affected682 at risk EG0012 events2 affected683 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Staphylococcal abscess	Infections and infestations	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 16	EG0001 events1 affected682 at risk EG0011 events1 affected683 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Vulval abscess	Infections and infestations	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Exposure via direct contact	Injury, poisoning and procedural complications	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Exposure via ingestion	Injury, poisoning and procedural complications	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Foreign body aspiration	Injury, poisoning and procedural complications	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16	EG0002 events2 affected682 at risk EG0010 events0 affected683 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Juvenile idiopathic arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Febrile convulsion	Nervous system disorders	MedDRA 16	EG0005 events4 affected682 at risk EG0011 events1 affected683 at risk
Status epilepticus	Nervous system disorders	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16	EG0001 events1 affected682 at risk EG0013 events3 affected683 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16	EG0000 events0 affected682 at risk EG0011 events1 affected683 at risk
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA 16	EG0000 events0 affected682 at risk EG0012 events1 affected683 at risk
Kawasaki's disease	Vascular disorders	MedDRA 16	EG0001 events1 affected682 at risk EG0010 events0 affected683 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Conjunctivitis	Eye disorders	MedDRA 16	EG00052 events48 affected682 at risk EG00147 events46 affected683 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16	EG00098 events77 affected682 at risk EG001107 events91 affected683 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16	EG00077 events60 affected682 at risk EG00172 events61 affected683 at risk
Injection site erythema	General disorders	MedDRA 16	EG000344 events254 affected682 at risk EG001258 events199 affected683 at risk
Injection site pain	General disorders	MedDRA 16	EG000267 events208 affected682 at risk EG001243 events187 affected683 at risk
Injection site swelling	General disorders	MedDRA 16	EG000190 events156 affected682 at risk EG001146 events123 affected683 at risk
Pyrexia	General disorders	MedDRA 16	EG000349 events225 affected682 at risk EG001360 events235 affected683 at risk
Gastroenteritis	Infections and infestations	MedDRA 16	EG00032 events29 affected682 at risk EG00143 events41 affected683 at risk
Nasopharyngitis	Infections and infestations	MedDRA 16	EG00065 events55 affected682 at risk EG00176 events66 affected683 at risk
Otitis media	Infections and infestations	MedDRA 16	EG000177 events128 affected682 at risk EG001179 events128 affected683 at risk
Otitis media acute	Infections and infestations	MedDRA 16	EG00072 events56 affected682 at risk EG00157 events44 affected683 at risk
Pharyngitis	Infections and infestations	MedDRA 16	EG00047 events40 affected682 at risk EG00143 events35 affected683 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16	EG000210 events159 affected682 at risk EG001212 events163 affected683 at risk
Viral infection	Infections and infestations	MedDRA 16	EG00052 events44 affected682 at risk EG00164 events57 affected683 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16	EG000113 events87 affected682 at risk EG001118 events101 affected683 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16	EG00078 events58 affected682 at risk EG00164 events53 affected683 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 16	EG00076 events62 affected682 at risk EG001106 events77 affected683 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 16	EG00050 events48 affected682 at risk EG00155 events47 affected683 at risk

ID	Term
D018185	Morbillivirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D019351	Rubulavirus Infections
D010309	Parotitis
D010305	Parotid Diseases
D012466	Salivary Gland Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D018355	Rubivirus Infections
D014036	Togaviridae Infections
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections

ID	Term
C050102	measles, mumps, rubella, varicella vaccine
D000249	Adenosine Monophosphate

ID	Term
D000227	Adenine Nucleotides
D011685	Purine Nucleotides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D009711	Nucleotides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012265	Ribonucleotides

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MMRV (AMP)	Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)			21	682	574	682
EG001	MMRV (2006 Process)	Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process			18	683	572	683