Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00611559

First received: January 29, 2008

Last updated: October 15, 2009

Last verified: October 2009

History of Changes

Results First Received: June 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Haemophilus Influenzae Type b Disease
Interventions:	Biological: Infanrix™ penta Biological: Infanrix™ hexa

Participant Flow

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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
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Reporting Groups

	Description
Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta

Participant Flow: Overall Study

	Infanrix Hexa Preservative-free Formulation Group	Infanrix Hexa Preservative-containing Formulation Group	Infanrix Penta Preservative-free Formulation Group
STARTED	111	115	57
COMPLETED	110	114	56
NOT COMPLETED	1	1	1
Lost to Follow-up	0	1	0
Protocol Violation	1	0	1

Baseline Characteristics

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Reporting Groups

	Description
Infanrix Hexa Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
Infanrix Hexa Preservative-containing Formulation Group	Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
Infanrix Penta Preservative-free Formulation Group	Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
Total	Total of all reporting groups

Baseline Measures

	Infanrix Hexa Preservative-free Formulation Group	Infanrix Hexa Preservative-containing Formulation Group	Infanrix Penta Preservative-free Formulation Group	Total
Number of Participants [units: participants]	111	115	57	283
Age [units: months] Mean ± Standard Deviation	21.2 ± 1.61	21.3 ± 1.57	21.2 ± 1.62	21.2 ± 1.59
Gender [units: subjects]
Female	56	46	35	137
Male	55	69	22	146

Outcome Measures

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1. Primary:

Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose [ Time Frame: One month after the booster dose ]

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2. Primary:

Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose [ Time Frame: One month after the booster dose ]

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3. Primary:

Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose [ Time Frame: One month after the booster dose ]

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4. Primary:

Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose [ Time Frame: One month after the booster dose ]

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5. Primary:

Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose [ Time Frame: One month after the booster dose ]

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6. Secondary:

Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

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7. Secondary:

Anti-HB Antibodies Concentration [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

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8. Secondary:

Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

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9. Secondary:

Anti-PRP Antibodies Concentration [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

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10. Secondary:

Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose [ Time Frame: Before the booster dose administration (at baseline) ]

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11. Secondary:

Anti-diphtheria and Anti-tetanus Antibodies Concentration [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

Show Outcome Measure 11

12. Secondary:

Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

Show Outcome Measure 12

13. Secondary:

Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose [ Time Frame: Before the booster dose administration (at baseline) ]

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14. Secondary:

Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose [ Time Frame: Before the booster dose ]

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15. Secondary:

Anti-poliovirus Antibodies Titer [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

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16. Secondary:

Number of Subjects Reporting Solicited Symptoms [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ]

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17. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: Within the 31-day (Day 0-30) post-vaccination period ]

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18. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: Up to one month after the booster dose administration ]

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Serious Adverse Events

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Other Adverse Events

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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:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00611559 History of Changes
Other Study ID Numbers:	110478
Study First Received:	January 29, 2008
Results First Received:	June 22, 2009
Last Updated:	October 15, 2009
Health Authority:	Russia: Ministry of Health of the Russian Federation

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