Immunogenicity and Safety of Havrix™ Co-Administered With... | NCT00197236

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Havrix Group	Active Comparator	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Biological: Havrix™
Infanrix + ActHIB→Havrix Group	Experimental	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.	Biological: Havrix™ Biological: Infanrix™ Biological: ActHIB™
Havrix + Infanrix + ActHIB Group	Active Comparator	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Biological: Havrix™ Biological: Infanrix™ Biological: ActHIB™

Name	Type	Description	Arm Group Labels	Other Names
Havrix™	Biological	2 intramuscular injections, 6 months apart	Havrix + Infanrix + ActHIB Group Havrix Group Infanrix + ActHIB→Havrix Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix	Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).	31 days following the second dose of Havrix™
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects	Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.	31 days following the administration of Infanrix™ and ActHIB
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)	Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.	31 days following the administration of Infanrix™ and ActHIB

Secondary Outcomes

Measure	Description	Time Frame
Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)	GMCs are expressed as International Units per milliliter (IU/mL).	31 days following the administration of Infanrix™ and ActHIB
Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol
A male or female child 12 or 13 months of age at the time of entry into the Enrolment Phase,
Subjects must have previously received three doses each of DTaP and Hib vaccines during the first year of life. The three doses of DTaP vaccine must have been administered as either Infanrix™ or Pediarix™ and the three doses of Hib vaccine must have been administered as ActHIB™, HibTITER™, OmniHIB™.
Subjects who, at 15 months of age, will have had at least six months elapse since their third dose of Infanrix™ or Pediarix™,
Written informed consent obtained from the parents or guardian of the subject,
Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and
Parents/guardian of the subject must have a telephone or be able to be contacted by telephone.

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 31 days preceding the first dose of study vaccine, or planned use during the study period,
Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period.
Planned administration or administration of any vaccine not foreseen by the study protocol during the period 42 days before and 31 days after each dose of study vaccine(s).
Previous vaccination against DTaP using a commercially-available brand other than Infanrix™ or Pediarix™ or against Hib using a commercially-available brand other than ActHIB™, HibTITER™ or OmniHIB™.
Previous vaccination with more than three doses of DTaP-containing vaccines or more than three doses of Hib-containing vaccines.
Previous vaccination against hepatitis A,
History or known exposure to hepatitis A,
History of diphtheria, tetanus, pertussis and/or Haemophilus influenza type b,
Known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenza type b within 31 days prior to the start of the study,
History of non-response to any vaccine in the current routine immunization schedule,
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,
A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix™, Infanrix™ or ActHIB™ including 2-phenoxyethanol, neomycin and gelatin,
History of hypersensitivity/allergic reaction to latex
Major congenital defects or serious chronic illness,
History of any neurologic disorder
Acute disease at the time of vaccination.
Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period, i.e., the Enrolment Phase, the Active Phase and the Extended Safety Follow-up Phase

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Phoenix	Arizona	85029	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
21494175	Background	Trofa AF, Klein NP, Paul IM, Michaels MG, Goessler M, Chandrasekaran V, Blatter M. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with Diphtheria-tetanus-acellular pertussis and haemophilus influenzae type B vaccines in children 15 months of age. Pediatr Infect Dis J. 2011 Sep;30(9):e164-9. doi: 10.1097/INF.0b013e31821b8a7d.

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
208109/232	Study Protocol	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
FG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
BG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
BG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix

Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity including subjects who had at least one study vaccine administered and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Posted

Count of Participants

Participants

31 days following the second dose of Havrix™

ID	Title	Description
OG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Units	Counts
Participants	OG00088 OG00184 OG00277

Title

Denominators

Categories

Title	Measurements
	OG00088 OG00184 OG00277

Primary

Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects

Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.

Posted

Count of Participants

Participants

31 days following the administration of Infanrix™ and ActHIB

ID	Title	Description
OG000	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
OG002	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.

Primary

Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)

Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.

Posted

Count of Participants

Participants

31 days following the administration of Infanrix™ and ActHIB

ID	Title	Description
OG000	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
OG002	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.

Secondary

Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)

GMCs are expressed as International Units per milliliter (IU/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

31 days following the administration of Infanrix™ and ActHIB

ID	Title	Description
OG000	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
OG002	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.

Units	Counts

Secondary

Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)

GMCs are expressed as microgram/milliliter (µg/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

31 days following the administration of Infanrix™ and ActHIB

ID	Title	Description
OG000	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
OG002	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.

Units	Counts

Secondary

Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)

Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.

Posted

Count of Participants

Participants

31 days following the administration of Infanrix™ and ActHIB

ID	Title	Description
OG000	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
OG002	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.

Secondary

Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix

Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.

Posted

Count of Participants

Participants

31 days following the first dose of Havrix™

ID	Title	Description
OG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Secondary

Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix

Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

31 days following the first dose of Havrix™

ID	Title	Description
OG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Secondary

Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix

Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

31 days following the second dose of Havrix™

ID	Title	Description
OG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Units

Secondary

Number of Subjects With Vaccine Response to Havrix™.

Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.

Analysis was performed on the According-to-Protocol cohort for immunogenicity

Posted

Count of Participants

Participants

31 days following the second dose

ID	Title	Description
OG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Secondary

Number of Subjects Reporting Solicited Local Adverse Events (AEs)

Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

4-day period following each dose of study vaccine(s)

ID	Title	Description
OG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Units

Secondary

Number of Subjects Reporting Solicited General Adverse Events (AEs)

Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

4-day period following each dose of study vaccine(s)

ID	Title	Description
OG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Secondary

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

An Adverse Event 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.

The analysis was performed on the Total Vaccinated Cohort

Posted

Count of Participants

Participants

31-day period following each dose of study vaccine(s)

ID	Title	Description
OG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Secondary

Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events

Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.

The analyses were performed on the Total Vaccinated Cohort for the active phase of the study and on the Extended safety follow-up cohort for the 6-month extended follow-up (ESFU) phase.

Posted

Count of Participants

Participants

Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.

ID	Title	Description
OG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
OG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
OG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Other Events (Affected)	Other Events (At Risk)
EG000	Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	5	95	135
EG001	Havrix + Infanrix + ActHIB Group	Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	2	105	127
EG002	Infanrix + ActHIB→Havrix Group	Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.	4	107	132

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0002 affected135 at risk EG0010 affected127 at risk EG0021 affected132 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected135 at risk EG0011 affected127 at risk EG0020 affected132 at risk
Developmental delay	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected135 at risk EG0010 affected127 at risk EG0021 affected132 at risk
Expressive language disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected135 at risk EG0010 affected127 at risk EG0021 affected132 at risk
Arthritis bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected135 at risk EG0010 affected127 at risk EG0020 affected132 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected135 at risk EG0010 affected127 at risk EG0020 affected132 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected135 at risk EG0010 affected127 at risk EG0021 affected132 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected135 at risk EG0010 affected127 at risk EG0020 affected132 at risk
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected135 at risk EG0011 affected127 at risk EG0020 affected132 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected135 at risk EG0010 affected127 at risk EG0021 affected132 at risk
Tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected135 at risk EG0011 affected127 at risk EG0020 affected132 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected135 at risk EG0010 affected127 at risk EG0021 affected132 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0009 affected135 at risk EG0014 affected127 at risk EG0027 affected132 at risk
Teething	Gastrointestinal disorders		Non-systematic Assessment	EG0003 affected135 at risk EG0018 affected127 at risk EG0024 affected132 at risk
Vomiting	Gastrointestinal disorders		Non-systematic Assessment	EG0007 affected135 at risk EG0014 affected127 at risk EG0024 affected132 at risk
Pyrexia	General disorders		Non-systematic Assessment	EG0009 affected135 at risk EG0017 affected127 at risk EG0029 affected132 at risk
Otitis media	Infections and infestations		Non-systematic Assessment	EG00013 affected135 at risk EG00111 affected127 at risk EG00222 affected132 at risk
Upper respiratory tract infection	Infections and infestations		Non-systematic Assessment	EG00018 affected135 at risk EG00118 affected127 at risk EG00216 affected132 at risk
Viral infection	Infections and infestations		Non-systematic Assessment	EG0003 affected135 at risk EG0017 affected127 at risk EG0023 affected132 at risk
Cough	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0008 affected135 at risk EG0014 affected127 at risk EG00214 affected132 at risk
Rhinorrhea	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment	EG0005 affected135 at risk EG0014 affected127 at risk EG00214 affected132 at risk
Pain at the injection site	General disorders		Systematic Assessment	EG00044 affected135 at risk EG00160 affected127 at risk EG00270 affected132 at risk
Redness at the injection site	General disorders		Systematic Assessment	EG00034 affected135 at risk EG00154 affected127 at risk EG00263 affected132 at risk
Swelling at the injection site	General disorders		Systematic Assessment	EG00021 affected135 at risk EG00138 affected127 at risk EG00246 affected132 at risk
Drowsiness	General disorders		Systematic Assessment	EG00044 affected135 at risk EG00150 affected127 at risk EG00253 affected132 at risk
Fever	General disorders		Systematic Assessment	EG00016 affected135 at risk EG00126 affected127 at risk EG00231 affected132 at risk
Irritability	General disorders		Systematic Assessment	EG00056 affected135 at risk EG00162 affected127 at risk EG00270 affected132 at risk
Loss of appetite	General disorders		Systematic Assessment	EG00033 affected135 at risk EG00140 affected127 at risk EG00248 affected132 at risk

ID	Term
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D007239	Infections
D004769	Enterovirus Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D022362	Hepatitis A Vaccines
D022681	Diphtheria-Tetanus-acellular Pertussis Vaccines
C055753	Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate

ID	Term
D014761	Viral Hepatitis Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D010567	Pertussis Vaccine
D001428	Bacterial Vaccines
D004168	Diphtheria Toxoid
D014121	Toxoids
D013745	Tetanus Toxoid
D017778	Vaccines, Combined
D022282	Vaccines, Acellular
D022223	Vaccines, Subunit