Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Condition:	Hepatitis A
Interventions:	Biological: Havrix™ Biological: Infanrix™ Biological: ActHIB™

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the total of 468 subjects enrolled, only 394 were vaccinated and as such considered as 'started'.

Reporting Groups

	Description
Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
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.
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.

Participant Flow: Overall Study

	Havrix Group	Havrix + Infanrix + ActHIB Group	Infanrix + ActHIB→Havrix Group
STARTED	135	127	132
COMPLETED	121	110	109
NOT COMPLETED	14	17	23
Adverse Event	1	0	1
Lost to Follow-up	5	14	6
Protocol Violation	0	0	1
Withdrawal by Subject	7	3	11
Study drug/medication expiration	1	0	3
Returned out of specified time window	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
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.
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.

Baseline Measures

	Havrix Group	Havrix + Infanrix + ActHIB Group	Infanrix + ActHIB→Havrix Group	Total
Number of Participants [units: participants]	135	127	132	394
Age [units: months] Mean ± Standard Deviation	15.1 ± 0.36	15.1 ± 0.3	15.0 ± 0.21	15.1 ± 0.30
Gender [units: subjects]
Female	55	64	67	186
Male	80	63	65	208

Outcome Measures

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1. Primary:

Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix [ 31 days following the second dose of Havrix™ ]

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2. Primary:

Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects [ 31 days following the administration of Infanrix™ and ActHIB ]

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3. Primary:

Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN) [ 31 days following the administration of Infanrix™ and ActHIB ]

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4. Secondary:

Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC) [ 31 days following the administration of Infanrix™ and ActHIB ]

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5. Secondary:

Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC) [ 31 days following the administration of Infanrix™ and ActHIB ]

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6. Secondary:

Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP) [ 31 days following the administration of Infanrix™ and ActHIB ]

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7. Secondary:

Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix [ 31 days following the first dose of Havrix™ ]

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8. Secondary:

Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix [ 31 days following the first dose of Havrix™ ]

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9. Secondary:

Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix [ 31 days following the second dose of Havrix™ ]

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10. Secondary:

Number of Subjects With Vaccine Response to Havrix™. [ 31 days following the second dose ]

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11. Secondary:

Number of Subjects Reporting Solicited Local Adverse Events (AEs) [ 4-day period following each dose of study vaccine(s) ]

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12. Secondary:

Number of Subjects Reporting Solicited General Adverse Events (AEs) [ 4-day period following each dose of study vaccine(s) ]

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13. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ 31-day period following each dose of study vaccine(s) ]

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14. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events [ Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase. ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Havrix Group	Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
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.
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.

Other Adverse Events

	Havrix Group	Havrix + Infanrix + ActHIB Group	Infanrix + ActHIB→Havrix Group
Total, other (not including serious) adverse events
# participants affected	56	62	70
Gastrointestinal disorders
Diarrhea * ^A # participants affected / at risk	9/135 (6.67%)	4/127 (3.15%)	7/132 (5.30%)
Teething * # participants affected / at risk	3/135 (2.22%)	8/127 (6.30%)	4/132 (3.03%)
Vomiting * # participants affected / at risk	7/135 (5.19%)	4/127 (3.15%)	4/132 (3.03%)
General disorders
Pyrexia * # participants affected / at risk	9/135 (6.67%)	7/127 (5.51%)	9/132 (6.82%)
Pain at the injection site ^† # participants affected / at risk	44/130 (33.85%)	60/118 (50.85%)	70/122 (57.38%)
Redness at the injection site ^† # participants affected / at risk	34/130 (26.15%)	54/118 (45.76%)	63/122 (51.64%)
Swelling at the injection site ^† # participants affected / at risk	21/130 (16.15%)	38/118 (32.20%)	46/122 (37.70%)
Drowsiness ^† # participants affected / at risk	44/130 (33.85%)	50/118 (42.37%)	53/123 (43.09%)
Fever ^† # participants affected / at risk	16/130 (12.31%)	26/118 (22.03%)	31/123 (25.20%)
Irritability ^† # participants affected / at risk	56/130 (43.08%)	62/118 (52.54%)	70/123 (56.91%)
Loss of appetite ^† # participants affected / at risk	33/130 (25.38%)	40/118 (33.90%)	48/123 (39.02%)
Infections and infestations
Otitis media * # participants affected / at risk	13/135 (9.63%)	11/127 (8.66%)	22/132 (16.67%)
Upper respiratory tract infection * # participants affected / at risk	18/135 (13.33%)	18/127 (14.17%)	16/132 (12.12%)
Viral infection * # participants affected / at risk	3/135 (2.22%)	7/127 (5.51%)	3/132 (2.27%)
Respiratory, thoracic and mediastinal disorders
Cough * # participants affected / at risk	8/135 (5.93%)	4/127 (3.15%)	14/132 (10.61%)
Rhinorrhea * # participants affected / at risk	5/135 (3.70%)	4/127 (3.15%)	14/132 (10.61%)

^†	Indicates events were collected by systematic assessment.
*	Indicates events were collected by non-systematic assessment.
^A	Term from vocabulary, MedDRA

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	208109/232
Study First Received:	September 15, 2005
Results First Received:	December 2, 2008
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00197236 History of Changes
Health Authority:	United States: Food and Drug Administration