Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Ad... | NCT00611559

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infanrix hexa Preservative-Free Formulation Group	Experimental	Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa	Biological: Infanrix™ hexa
Infanrix hexa Preservative-Containing Formulation Group	Active Comparator	Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa	Biological: Infanrix™ hexa
Infanrix penta Preservative-Free Formulation Group	Active Comparator	Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta.	Biological: Infanrix™ penta

Name	Type	Description	Arm Group Labels	Other Names
Infanrix™ penta	Biological	Subjects received a booster dose	Infanrix penta Preservative-Free Formulation Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose	Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)	One month after the booster dose
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose	Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)	One month after the booster dose
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose	Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)	One month after the booster dose
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose	Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)	One month after the booster dose
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose	Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)	One month after the booster dose

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose	Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes	Before (Pre) and one month after (Post) the booster dose

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.
Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (study NCT00320463).
A male or female between, and including 18 and 23 months of age at the time of the booster 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 other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose.
Participation in another clinical study, between the primary study NCT00320463 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study NCT00320463.
Previous booster vaccination against Haemophilus influenzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study NCT00320463.
History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study NCT00320463.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Any of the following adverse events having occurred after previous administration of DTP vaccine:
Hypersensitivity reaction due to the vaccine.
Encephalopathy defined as an acute, severe central nervous system disorder of unknown etiology occurring within 7 days following previous vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
Any of the following adverse events having occurred after previous administration of DTP vaccine:
Temperature of >= 40.0 °C (axillary temperature), within 48 hours of vaccination.
Collapse or shock-like state within 48 hours of vaccination.
Persistent, inconsolable crying lasting >= 3 hours, occurring within 48 hours of vaccination.
Convulsions with or without fever, occurring within 3 days of vaccination

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Murmansk		183046	Russia
GSK Investigational Site

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
110478	Annotated Case Report Form	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
FG001	Infanrix Hexa Preservative-containing Formulation Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
BG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
BG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000111 BG001115 BG00257 BG003283

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 With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose

Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results

Posted

Number

subjects

One month after the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts
Participants	OG00091 OG00192 OG00248

Title

Denominators

Categories

Title	Measurements
	OG00088 OG00192 OG00248

Primary

Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose

Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Number

subjects

One month after the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts

Primary

Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose

Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Number

subjects

One month after the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts

Primary

Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose

Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Number

subjects

One month after the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts
Participants

Primary

Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose

Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

One month after the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Secondary

Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose

Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL

Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Number

subjects

Before (Pre) and one month after (Post) the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Secondary

Anti-HB Antibodies Concentration

Concentration of anti-HB antibodies given as GMC in mIU/mL

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

Before (Pre) and one month after (Post) the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts
Participants

Secondary

Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose

Anti-PRP antibodies cut-off value assessed were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL

Number of subjects with cut-off ≥ 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Number

subjects

Before (Pre) and one month after (Post) the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Secondary

Anti-PRP Antibodies Concentration

Concentration of anti-PRP antibodies given as GMC in µg/mL

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Geometric Mean

95% Confidence Interval

µg/mL

Before (Pre) and one month after (Post) the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts
Participants

Secondary

Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose

Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 IU/mL

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Number

subjects

Before the booster dose administration (at baseline)

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts

Secondary

Anti-diphtheria and Anti-tetanus Antibodies Concentration

Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Geometric Mean

95% Confidence Interval

IU/mL

Before (Pre) and one month after (Post) the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts
Participants

Secondary

Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose

Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were ≥ 5 EL.U/mL

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Number

subjects

Before (Pre) and one month after (Post) the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts

Secondary

Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose

Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

Before the booster dose administration (at baseline)

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts

Secondary

Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose

Anti-poliovirus antibodies cut-off value assessed was ≥ 8 ED50

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Number

subjects

Before the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts
Participants

Secondary

Anti-poliovirus Antibodies Titer

Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT)

Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Posted

Geometric Mean

95% Confidence Interval

titer

Before (Pre) and one month after (Post) the booster dose

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts
Participants

Secondary

Number of Subjects Reporting Solicited Symptoms

Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite

Posted

Number

subjects

Within the 4-day (Day 0-3) post-vaccination period

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts
Participants

Secondary

Number of Subjects Reporting Unsolicited Adverse Events (AE)

An AE is 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.

Posted

Number

subjects

Within the 31-day (Day 0-30) post-vaccination period

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts
Participants

Secondary

Number of Subjects Reporting Serious Adverse Events (SAE)

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above

Posted

Number

subjects

Up to one month after the booster dose administration

ID	Title	Description
OG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa
OG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa
OG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	111	111	59	111
EG001	Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	115	115	62	115
EG002	Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix penta	57	57	26	57

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Pain	General disorders	Systematic Assessment	EG00035 affected111 at risk EG00136 affected115 at risk EG00214 affected57 at risk
Redness	General disorders	Systematic Assessment	EG00054 affected111 at risk EG00154 affected115 at risk EG00222 affected57 at risk
Swelling	General disorders	Systematic Assessment	EG00039 affected111 at risk EG00145 affected115 at risk EG00219 affected57 at risk
Drowsiness	General disorders	Systematic Assessment	EG00021 affected111 at risk EG00118 affected115 at risk EG0028 affected57 at risk
Fever	General disorders	Systematic Assessment	EG00018 affected111 at risk EG00115 affected115 at risk EG0026 affected57 at risk
Irritability	General disorders	Systematic Assessment	EG00021 affected111 at risk EG00121 affected115 at risk EG0024 affected57 at risk
Loss of appetite	General disorders	Systematic Assessment	EG00022 affected111 at risk EG00114 affected115 at risk EG0025 affected57 at risk

Ancestor Terms

ID	Term
D009187	Myelitis
D002494	Central Nervous System Infections
D007239	Infections
D004769	Enterovirus Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D013118	Spinal Cord Diseases
D000090862	Neuroinflammatory Diseases
D009468	Neuromuscular Diseases
D003015	Clostridium Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D006525	Hepatitis, Viral, Human
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D011051	Poliomyelitis
D013742	Tetanus
D004165	Diphtheria
D006509	Hepatitis B