Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

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

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™ ]

2.  Primary:

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

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 ]

4.  Secondary:

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

5.  Secondary:

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

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 ]

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™ ]

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™ ]

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™ ]

10.  Secondary:

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

11.  Secondary:

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

12.  Secondary:

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

13.  Secondary:

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

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. ]