Immunogenicity & Safety Study of GSK Biologicals' Combine... | NCT00751348

NCT00751348

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

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
PRIORIX-TETRA GROUP	Experimental	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.	Biological: Priorix-Tetra®
PRIORIX + VARILRIX GROUP	Active Comparator	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.	Biological: PriorixTM Biological: VarilrixTM

Name	Type	Description	Arm Group Labels	Other Names
PriorixTM	Biological	Subcutaneous administration in left upper arm	PRIORIX + VARILRIX GROUP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values	Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.	At 42 days post-vaccination

Secondary Outcomes

Measure	Description	Time Frame
Antibody Concentrations Against Measles	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).	At 42-days post-vaccination
Antibody Concentrations Against Mumps

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including 11 and 24 months of age, at the time of the vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after the study vaccine dose with the exception of inactivated vaccines such as pneumococcal, Haemophilus influenzae type b conjugate vaccines, inactivated influenza, hepatitis A or B vaccine or diphtheria/tetanus-containing vaccines which can be administered up to eight days before the study vaccine dose.
Previous vaccination against measles, mumps, rubella and/or varicella.
History of measles, mumps, rubella and/or varicella/zoster diseases.
Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Rectal temperature ≥ 38°C or axillary temperature ≥ 37.5°C at the time of vaccination.
Residence in the same household as a high risk person e.g.:
New-born infants (0-4 weeks of age)
Pregnant women who have a negative history of chickenpox
Persons with known immunodeficiency

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bucheon-si		420-767	South Korea
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Sung-Ho Cha et al. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella (MMRV) vaccine: an open-labeled, randomized trial in healthy Korean children. Abstract presented at the Fall Meeting of Korean Vaccine Society (KVS). Seoul, Korea, 31 August 2013.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
110876	Individual Participant Data Set	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
FG001	Priorix + Varilrix Group

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
BG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
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

Months

Title

Denominators

Categories

Title	Measurements
	BG00012.4± 1.4 BG00112.5± 1.65 BG00212.43± 1.49

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000128 BG00176 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Asian-East Asian Heritage

Title	Measurements
	BG000313 BG001159 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

Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values

Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.

Posted

Count of Participants

Participants

At 42 days post-vaccination

ID	Title	Description
OG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
OG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Units	Counts
Participants	OG000300 OG001157

Title

Denominators

Categories

Anti-Measles

- ParticipantsOG000300
- ParticipantsOG001156

Title	Measurements
	OG000294

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	Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-measles seroconversion rates.	Fisher Exact		<0.05	The P-value for all reactogenicity comparisons was below (<) 0.05.	Difference in percentage	-1.36			2-Sided	95	-3.77	1.66					Non-Inferiority	Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-measles was above -10%.

Secondary

Antibody Concentrations Against Measles

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At 42-days post-vaccination

ID	Title	Description
OG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
OG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Units	Counts
Participants

Secondary

Antibody Concentrations Against Mumps

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).

Posted

Geometric Mean

95% Confidence Interval

U/mL

At 42-days post-vaccination

ID	Title	Description
OG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
OG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Units	Counts
Participants

Secondary

Antibody Concentrations Against Rubella

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At 42-days post-vaccination

ID	Title	Description
OG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
OG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Units	Counts
Participants

Secondary

Antibody Titers Against Varicela Viruses

Antibody titers were presented as geometric mean titers (GMTs).

Posted

Geometric Mean

95% Confidence Interval

Titers

At 42-days post-vaccination

ID	Title	Description
OG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
OG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Units	Counts
Participants

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptoms sheet filled in.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) post-vaccination period

ID	Title	Description
OG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
OG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Units	Counts

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms assessed were fever [defined as rectal temperature ≥38.0 degrees Celsius (°C)], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.

Posted

Count of Participants

Participants

During the 43-day (Days 0-42) post-vaccination period

ID	Title	Description
OG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
OG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

Within the 43-day (Days 0-42) post-vaccination period

ID	Title	Description
OG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
OG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

During the entire study period (from Day 0 up to Day 43 or Day 57)

ID	Title	Description
OG000	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
OG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Units	Counts

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	Priorix-Tetra Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.	0	313	25	313	243	313
EG001	Priorix + Varilrix Group	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.	0	161	12	161	113	161

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected313 at risk EG0010 affected161 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected313 at risk EG0011 affected161 at risk
Febrile convulsion	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected313 at risk EG0010 affected161 at risk
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected313 at risk EG0010 affected161 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected313 at risk EG0011 affected161 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected313 at risk EG0011 affected161 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected313 at risk EG0011 affected161 at risk
Acute tonsillitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected313 at risk EG0010 affected161 at risk
Bronchiolitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0003 affected313 at risk EG0012 affected161 at risk
Bronchopneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0006 affected313 at risk EG0013 affected161 at risk
Croup infectious	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 affected313 at risk EG0010 affected161 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0005 affected313 at risk EG0016 affected161 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected313 at risk EG0010 affected161 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 affected313 at risk EG0010 affected161 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected313 at risk EG0011 affected161 at risk
Herpangina	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected313 at risk EG0010 affected161 at risk
Otitis media	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected313 at risk EG0010 affected161 at risk
Otitis media acute	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0003 affected313 at risk EG0011 affected161 at risk
Pharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0005 affected313 at risk EG0011 affected161 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0004 affected313 at risk EG0011 affected161 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected313 at risk EG0011 affected161 at risk
Rhinitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected313 at risk EG0010 affected161 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected313 at risk EG0011 affected161 at risk
Viral rash	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected313 at risk EG0010 affected161 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain	General disorders	MedDRA 13.0	Systematic Assessment	EG00015 affected310 at risk EG00110 affected159 at risk
Redness	General disorders	MedDRA 13.0	Systematic Assessment	EG00026 affected310 at risk EG00121 affected159 at risk
Fever	General disorders	MedDRA 13.0	Systematic Assessment	EG000202 affected310 at risk EG00182 affected159 at risk
Rash	General disorders	MedDRA 13.0	Systematic Assessment	EG00033 affected310 at risk EG00116 affected159 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00063 affected313 at risk EG00125 affected161 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00031 affected313 at risk EG00114 affected161 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00028 affected313 at risk EG00113 affected161 at risk
Pharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00027 affected313 at risk EG00110 affected161 at risk
Bronchitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00026 affected313 at risk EG00111 affected161 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00021 affected313 at risk EG00110 affected161 at risk
Otitis media acute	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00013 affected313 at risk EG0019 affected161 at risk

ID	Term
D008457	Measles
D002644	Chickenpox
D009107	Mumps
D012409	Rubella

Ancestor Terms

ID	Term
D018185	Morbillivirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus 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

ID	Term
C577557	Priorix-Tetra vaccine

Units	Counts
Participants	OG000313 OG001161