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

This study has been completed.

Study NCT00197236 Information provided by GlaxoSmithKline

First Received: September 15, 2005 Last Updated: July 24, 2009 History of Changes

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

Participant Flow

Hide Participant Flow

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

Baseline Characteristics

Hide Baseline Characteristics

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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Primary:

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

Show Outcome Measure 2

3. Primary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

Number of Subjects With Vaccine Response to Havrix™.

Show Outcome Measure 10

11. Secondary:

Number of Subjects Reporting Solicited Local Adverse Events (AEs)

Show Outcome Measure 11

12. Secondary:

Number of Subjects Reporting Solicited General Adverse Events (AEs)

Show Outcome Measure 12

13. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Show Outcome Measure 13

14. Secondary:

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

Show Outcome Measure 14

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

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