Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

This study has been completed.

Study NCT00355121 Information provided by Sanofi-Aventis

First Received on July 20, 2006. Last Updated on August 22, 2011 History of Changes

Results First Received: July 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Meningococcal Meningitis Tetanus Diphtheria Pertussis Poliomyelitis
Intervention:	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

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 from 16 October 2006 to 21 June 2007 in 45 medical centers in the US.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 881 participants who met the inclusion and exclusion criteria were enrolled. Data on 879 that were vaccinated are presented in this reported.

Reporting Groups

	Description
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30	Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2

Participant Flow: Overall Study

	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30
STARTED	353	353	175
COMPLETED	332	324	170
NOT COMPLETED	21	29	5
Did not receive study vaccine	1	0	1
Adverse Event	0	1	0
Protocol Violation	7	9	1
Lost to Follow-up	4	7	1
Withdrawal by Subject	9	10	2
Serious adverse events	0	2	0

Baseline Characteristics

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Reporting Groups

	Description
Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30	Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2

Baseline Measures

	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30	Total
Number of Participants [units: participants]	353	353	175	881
Age [units: participants]
<=18 years	353	353	175	881
Between 18 and 65 years	0	0	0	0
>=65 years	0	0	0	0
Age [units: Years] Mean ± Standard Deviation	4.5 ± 0.48	4.5 ± 0.51	4.5 ± 0.49	4.5 ± 0.50
Gender [units: participants]
Female	172	182	73	427
Male	181	171	102	454
Region of Enrollment [units: participants]
United States	353	353	175	881

Outcome Measures

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1. Primary:

Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination [ Time Frame: Day 30 post-vaccination (Visit 1) ]

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2. Primary:

Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. [ Time Frame: Day 30 post-vaccination (Visit 1) ]

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3. Secondary:

Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 [ Time Frame: Day 30 post-vaccination 1 ]

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4. Secondary:

Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination [ Time Frame: Day 30 post-vaccination ]

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5. Secondary:

Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine [ Time Frame: Day 0 through Day 7 post-vaccination at Visit 1 ]

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6. Other Pre-specified:

Geometric Mean Titers Against Poliovirus After IPOL Vaccination. [ Time Frame: Day 30 post-vaccination ]

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7. Other Pre-specified:

Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1 [ Time Frame: Day 0 through Day 7 post-vaccination ]

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8. Other Pre-specified:

Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2 [ Time Frame: Day 0 through Day 7 post-vaccination ]

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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: Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications

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: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00355121 History of Changes
Other Study ID Numbers:	MTA43
Study First Received:	July 20, 2006
Results First Received:	July 25, 2011
Last Updated:	August 22, 2011
Health Authority:	United States: Food and Drug Administration