Immunogenicity & Safety of Hepatitis A Vaccine Co-admin W... | NCT00197015

NCT00197015

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HAV Group	Active Comparator	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)	Biological: Havrix®
HAV+MMR+V Group	Experimental	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9	Biological: Havrix® Biological: M-M-R®II Biological: VARIVAX®
MMR+V→HAV Group	Active Comparator	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)	Biological: Havrix® Biological: M-M-R®II Biological: VARIVAX®

Name	Type	Description	Arm Group Labels	Other Names
Havrix®	Biological	2 doses administered intramuscularly	HAV Group HAV+MMR+V Group MMR+V→HAV Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups.	Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).	31 days following the second dose of Havrix®
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups	Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).	31 days following the second dose of Havrix®
Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups	Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.	42 days following the administration of M-M-R®II and VARIVAX®
Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups	Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).	42 days following administration of M-M-R®II and VARIVAX®

Secondary Outcomes

Measure	Description	Time Frame
Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V→HAV Groups	Titers are given as geometric mean titers (GMTs).	42 days following the administration of M-M-R®II and VARIVAX®
Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups

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 and 13 months of age at the time of entry into the Enrollment Phase
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 42 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. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.) Planned administration or administration of any vaccine not foreseen by the study protocol during the period 31 days before and 31 days after each dose of study vaccine(s).
Previous vaccination against hepatitis A,
History of hepatitis A,
Known exposure to hepatitis A,
Previous vaccination against measles, mumps, rubella and/or varicella,
History of measles, mumps, rubella and/or varicella,
Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study,
Planned chronic use of salicylates during the 6-week period following administration of the doses of study vaccine(s),
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 HavrixTM, M-M-RII or VARIVAXTM, including 2-phenoxyethanol, neomycin and gelatin,
History of anaphylactic or anaphylactoid reactions to egg proteins,
History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the rubber plunger of the HavrixTM needleless pre-filled syringes contain dry natural latex rubber.
Major congenital defects or serious chronic illness,
Active untreated tuberculosis,
History of significant blood dyscrasias
History of any neurologic disorder (a history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject)
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

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Cabot	Arkansas	72023	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21617573	Background	Rinderknecht S, Michaels MG, Blatter M, Gaglani M, Andrews W, Abughali N, Chandreshekaran V, Trofa AF. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with measles-mumps-rubella and varicella vaccines in children less than 2 years of age. Pediatr Infect Dis J. 2011 Oct;30(10):e179-85. doi: 10.1097/INF.0b013e31822256a5.

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
208109/231	Clinical Study Report	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
FG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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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	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
BG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
BG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
BG003	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
	OG0001390.4(1186.3 to 1629.6) OG0021895.2(1682.7 to 2134.5)

Primary

Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups

Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.

Posted

Count of Participants

Participants

31 days following the second dose of Havrix®

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Primary

Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups

Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.

Posted

Count of Participants

Participants

42 days following the administration of M-M-R®II and VARIVAX®

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Primary

Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups

Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.

Posted

Count of Participants

Participants

42 days following administration of M-M-R®II and VARIVAX®

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Secondary

Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V→HAV Groups

Titers are given as geometric mean titers (GMTs).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.

Posted

Geometric Mean

95% Confidence Interval

titers

42 days following the administration of M-M-R®II and VARIVAX®

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Units	Counts

Secondary

Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups

Concentrations are given as geometric mean concentrations (GMCs).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.

Posted

Geometric Mean

95% Confidence Interval

milli-international units per milliliter

42 days following the first dose of Havrix®

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Units	Counts

Secondary

Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups

Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.

Posted

Count of Participants

Participants

42 days following the first dose of Havrix®

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Secondary

Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group

Concentrations are given as geometric mean concentrations (GMCs).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from MMR+V→HAV Group.

Posted

Geometric Mean

95% Confidence Interval

milli-international units per milliliter

31 days following the second dose of Havrix®

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Units	Counts

Secondary

Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V→HAV Group

Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from MMR+V→HAV Group.

Posted

Count of Participants

Participants

31 days following the second dose of Havrix®

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Units

Secondary

Number of Subjects With Vaccine Response to Havrix®

Vaccine response was defined as: 1) a detectable anti-hepatitis A virus (HAV) antibody concentration 31 days following the second dose in subjects who were initially seronegative; and 2) a 2-fold increase in anti-HAV antibody concentrations above the pre-study concentration 31 days following the second dose in subjects who were initially seropositive.

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Count of Participants

Participants

31 days following the second dose of Havrix®

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Secondary

Number of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, rash (local), redness and swelling.

Analysis was performed on the Total Vaccinated cohort, on subjects with available data.

Posted

Count of Participants

Participants

During the 4-day period following each dose of vaccine

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Units	Counts
Participants

Secondary

Number of Subjects Reporting Solicited General Symptoms

Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite and rash (general).

Analysis was performed on the Total Vaccinated cohort, on subjects with available data.

Posted

Count of Participants

Participants

During the 4-day period following each dose of vaccine

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Units	Counts
Participants

Secondary

Number of Subjects Reporting Measles, Mumps, Rubella and Varicella Specific Solicited General Adverse Events

Specific adverse events assessed include papules, vesicles, crusts, parotid/salivary gland swelling and suspected signs of meningitis/febrile seizures.

Analysis was performed on the Total Vaccinated cohort, on subjects from MMR+V→HAV and HAV+MMR+V groups.

Posted

Count of Participants

Participants

During the 43-day period following each dose of vaccine

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Units

Secondary

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms

Analysis was performed on the Total Vaccinated cohort.

Posted

Count of Participants

Participants

During the 31-day period following each dose of vaccine

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Units	Counts

Secondary

Number of Subjects Reporting Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Analysis was performed on the Total Vaccinated cohort.

Posted

Count of Participants

Participants

During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Secondary

Number of Subjects Reporting New Chronic Illnesses

New Chronic illnesses include autoimmune disorders, asthma, type I diabetes, allergies.

Analysis was performed on the Total Vaccinated cohort (for the Active Phase) and the Extended Safety Follow-up cohort (for the Extended Safety Follow-up Phase).

Posted

Count of Participants

Participants

During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Secondary

Number of Subjects Reporting Medically Significant Events

Medically significant events include, but are not limited to, diabetes, autoimmune disease, asthma, allergies and/or conditions prompting emergency room or physician office visits that are not related to well-child care, vaccination or common acute illnesses (e.g., upper respiratory infection, otitis media, pharyngitis, gastroenteritis, injury and visits for routine physical examination).

Analysis was performed on the Total Vaccinated cohort (for the Active Phase) and the Extended Safety Follow-up cohort (for the Extended Safety Follow-up Phase).

Posted

Count of Participants

Participants

During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)

ID	Title	Description
OG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
OG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
OG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HAV Group	Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)	7	324	251	324
EG001	MMR+V→HAV Group	Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)	12	455	366	455
EG002	HAV+MMR+V Group	Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9	16	462	363	462

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dehydratation	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0002 affected324 at risk EG0011 affected455 at risk EG0022 affected462 at risk
Bronchiolitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected455 at risk EG0021 affected462 at risk
Bronchitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected455 at risk EG0021 affected462 at risk
Bronchitis viral	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected455 at risk EG0020 affected462 at risk
Cellulitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected455 at risk EG0020 affected462 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected455 at risk EG0020 affected462 at risk
Mental retardation	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Autism	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Gastroenteritis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected324 at risk EG0011 affected455 at risk EG0020 affected462 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Breathing-related sleep disorder	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Constipation	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected455 at risk EG0020 affected462 at risk
Convulsion	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected324 at risk EG0010 affected455 at risk EG0020 affected462 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Groin abscess	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected324 at risk EG0010 affected455 at risk EG0020 affected462 at risk
Ileus	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected455 at risk EG0020 affected462 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected324 at risk EG0010 affected455 at risk EG0020 affected462 at risk
Localised infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Otitis media	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Otitis media chronic	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Pneumonia	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected455 at risk EG0020 affected462 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected455 at risk EG0020 affected462 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Sudden death	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0010 affected455 at risk EG0021 affected462 at risk
Viral infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected324 at risk EG0011 affected455 at risk EG0020 affected462 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Otitis media	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG00035 affected324 at risk EG00179 affected455 at risk EG00265 affected462 at risk
Pyrexia	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00034 affected324 at risk EG00168 affected455 at risk EG00256 affected462 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG00031 affected324 at risk EG00164 affected455 at risk EG00258 affected462 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00016 affected324 at risk EG00139 affected455 at risk EG00222 affected462 at risk
Teething	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00025 affected324 at risk EG00124 affected455 at risk EG00219 affected462 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00021 affected324 at risk EG00120 affected455 at risk EG00223 affected462 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00020 affected324 at risk EG00122 affected455 at risk EG00217 affected462 at risk
Nasopharyngitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG00019 affected324 at risk EG00119 affected455 at risk EG00219 affected462 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00014 affected324 at risk EG00130 affected455 at risk EG00212 affected462 at risk
Papules	General disorders		Systematic Assessment	EG0000 affected0 at risk EG00123 affected455 at risk EG00223 affected462 at risk
Drowsiness	General disorders		Systematic Assessment	EG00095 affected304 at risk EG001179 affected411 at risk EG002178 affected424 at risk
Fever	General disorders		Systematic Assessment	EG00054 affected304 at risk EG001110 affected411 at risk EG00280 affected424 at risk
Irritability	General disorders		Systematic Assessment	EG000144 affected304 at risk EG001238 affected411 at risk EG002216 affected424 at risk
Loss of appetite	General disorders		Systematic Assessment	EG00094 affected304 at risk EG001170 affected411 at risk EG002154 affected424 at risk
Pain	General disorders		Systematic Assessment	EG000103 affected304 at risk EG001162 affected411 at risk EG002187 affected419 at risk
Redness	General disorders		Systematic Assessment	EG00097 affected304 at risk EG001149 affected411 at risk EG002151 affected419 at risk
Swelling	General disorders		Systematic Assessment	EG00045 affected304 at risk EG00170 affected411 at risk EG00282 affected419 at risk

ID	Term
D006506	Hepatitis A

Ancestor Terms

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
D019433	Chickenpox Vaccine

Units	Counts
Participants	OG0000 OG001247 OG002271

Units	Counts
Participants	OG000194 OG001224 OG002259

Units	Counts
Participants	OG000324 OG001455 OG002462

OG00276.0(70.7 to 81.7)

OG002286.9(252.1 to 326.5)

OG002170.3(152.2 to 190.5)

ID	Term
D014761	Viral Hepatitis Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D022283	Herpesvirus Vaccines