Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

This study has been completed.

Sponsor:

Collaborator:

Novartis Vaccines

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00481065

First received: May 31, 2007

Last updated: December 31, 2013

Last verified: December 2013

History of Changes

Results First Received: August 26, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Pandemic Avian Influenza
Interventions:	Biological: MF59-eH5N1 Biological: eTIV_a Biological: MF59-eH5N1 + eTIV_a

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
Participants were enrolled at 1 center in Colombia.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects enrolled were included in the trial. A total of 405 subjects was enrolled and randomized into 8 groups in this study. The participant flow data are from the all randomized set.

Reporting Groups

	Description
Concomitant Alone	1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Concomitant+Mixed	1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Concomitant+MF59-eH5N1	1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Mixed	1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Mixed + Mixed	dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
Mixed+MF59-eH5N1	1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
MF59-eH5N1+eTIV_a	1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
eTIV_a+MF59-eH5N1	1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

Participant Flow: Overall Study

	Concomitant Alone	Concomitant+Mixed	Concomitant+MF59-eH5N1	Mixed	Mixed + Mixed	Mixed+MF59-eH5N1	MF59-eH5N1+eTIV_a	eTIV_a+MF59-eH5N1
STARTED	51	50	51	52	51	51	50	49
COMPLETED	29	33	32	37	28	27	34	30
NOT COMPLETED	22	17	19	15	23	24	16	19
Adverse event or death	1	1	3	0	2	0	1	1
Withdrawal by Subject	11	12	7	11	13	12	9	10
Lost to Follow-up	4	2	4	3	3	3	2	5
Inappropriate enrollment	4	0	2	0	2	1	0	1
Administrative reason	0	0	0	0	0	2	1	0
Protocol Violation	2	1	1	1	2	6	3	2
Unable to classify	0	1	2	0	1	0	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The demographic characteristics of the randomized population are summarized in this section.

Reporting Groups

	Description
Concomitant Alone	1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Concomitant+Mixed	1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Concomitant+MF59-eH5N1	1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Mixed	1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Mixed + Mixed	dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
Mixed+MF59-eH5N1	1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
MF59-eH5N1+eTIV_a	1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
eTIV_a+MF59-eH5N1	1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Total	Total of all reporting groups

Baseline Measures

	Concomitant Alone	Concomitant+Mixed	Concomitant+MF59-eH5N1	Mixed	Mixed + Mixed	Mixed+MF59-eH5N1	MF59-eH5N1+eTIV_a	eTIV_a+MF59-eH5N1	Total
Number of Participants [units: participants]	51	50	51	52	51	51	50	49	405
Age [units: years] Mean (Standard Deviation)	29 (6.2)	29.4 (5.8)	29.5 (6.5)	29.8 (6.8)	29.6 (6.1)	28.8 (6.2)	27.9 (6.2)	30.1 (6.2)	29.3 (6.2)
Gender [units: participants]
Female	42	31	36	30	36	39	30	32	276
Male	9	19	15	22	15	12	20	17	129

Outcome Measures

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1. Primary:

Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]

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2. Primary:

Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine [ Time Frame: 21 days after second and third vaccinations (day 22 and day 43) ]

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3. Primary:

Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1) [ Time Frame: 21 days after second vaccination (day 43) ]

Show Outcome Measure 3

4. Primary:

Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]

Show Outcome Measure 4

5. Primary:

Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]

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6. Primary:

Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1) [ Time Frame: 21 days after second vaccination (day 43) ]

Show Outcome Measure 6

7. Primary:

Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]

Show Outcome Measure 7

8. Primary:

Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B) [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]

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9. Secondary:

Number of Subjects Reporting Local and Systemic Reactions by Vaccination [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]

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10. Secondary:

Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine [ Time Frame: 21 days after booster vaccination (day 403) ]

Show Outcome Measure 10

11. Secondary:

Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine [ Time Frame: 21 days after booster vaccination (day 403) ]

Show Outcome Measure 11

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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.

Results Point of Contact:

Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com

Publications of Results:

Lopez P, Caicedo Y, Sierra A, Tilman S, Banzhoff A, Clemens R. Combined, concurrent, and sequential administration of seasonal influenza and MF59-adjuvanted A/H5N1 vaccines: a phase II randomized, controlled trial of immunogenicity and safety in healthy adults. J Infect Dis. 2011 Jun 15;203(12):1719-28. doi: 10.1093/infdis/jir191.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lopez P, Caicedo Y, Sierra A, Tilman S, Clemens R, Banzhoff A. Combined administration of MF59-adjuvanted A/H5N1 prepandemic and seasonal influenza vaccines: long-term antibody persistence and robust booster responses 1 year after a one-dose priming schedule. Clin Vaccine Immunol. 2013 May;20(5):753-8. doi: 10.1128/CVI.00626-12. Epub 2013 Mar 27.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00481065 History of Changes
Other Study ID Numbers:	V87P5
Study First Received:	May 31, 2007
Results First Received:	August 26, 2011
Last Updated:	December 31, 2013
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

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