Brief Title
Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
Official Title
Safety and Immunogenicity of DTap-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined With Inactivated Poliovirus Vaccine) Compared to DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL® (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age
Brief Summary
The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® +
IPOL® as the 5th dose booster in children ≥ 4 to < 7 years of age in the US and Puerto Rico
who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only.
Primary Objectives:
- To compare the pertussis [Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA),
Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)] booster responses and geometric mean
concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay [ELISA])
following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination
when administered as a 5th dose.
- To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA)
following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL®
vaccinations when administered as a 5th dose .
- To compare the Inactivated Poliovirus Vaccine booster responses (as measured by
neutralizing assay) following DTap-IPV vaccination with those elicited following
DAPTACEL® + IPOL® vaccinations.
Observational Objectives:
- To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV
vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.
- To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered
as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL
and/or Pentacel vaccines.
Detailed Description
All participants will be randomized to receive either one dose each of DTap-IPV + Measles,
Mumps, and Rubella Virus Vaccine Live (M-M-R®II) + VARIVAX® or one dose each of DAPTACEL® +
IPOL® + M-M-R®II + VARIVAX® on Day 0.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Condition
Tetanus
Intervention
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
Study Arms / Comparison Groups
Study Group 1
Description: Participants will receive concomitantly a dose of DTap-IPV, a dose of M-M-R®II, and a dose of VARIVAX® vaccine on Day 0
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
3372
Start Date
April 2011
Completion Date
September 2013
Primary Completion Date
May 2013
Eligibility Criteria
Inclusion Criteria:
- Aged ≥ 4 to < 7 years on the day of inclusion
- Informed consent form has been signed and dated by the parent/guardian before the
first study-related procedure
- Subject and parent/guardian are able to attend all scheduled visits and to comply with
all trial procedures
- Subject has documented completion of primary infant series and booster with DAPTACEL®
and/or Pentacel® vaccine(s) only.
Exclusion Criteria:
- Participation in another clinical trial investigating a vaccine, drug, medical device,
or medical procedure in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for any
influenza vaccine, which may be received at least 2 weeks before study vaccines
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination except
for any influenza vaccine, which may be received at least 2 weeks after study vaccines
- Receipt of blood or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or
equivalent for more than 2 consecutive weeks within the past 3 months)
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- History of diphtheria, tetanus, or pertussis infection, confirmed either clinically,
serologically, or microbiologically
- Known systemic hypersensitivity to any of the vaccines' components, or history of a
life-threatening reaction to the vaccines used in the trial or to a vaccine containing
any of the same substances
- Laboratory-confirmed thrombocytopenia, contraindicating intramuscular vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular vaccination
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might
interfere with trial conduct or completion
- Identified as employees of the Investigator or study center, with direct involvement
in the proposed study or other studies under the direction of that Investigator or
study center, as well as family members (i.e., immediate, husband, wife and their
children, adopted or natural) of the employees or the investigator.
Gender
All
Ages
4 Years - 6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
Puerto Rico
Location Countries
Puerto Rico
Administrative Informations
NCT ID
NCT01346293
Organization ID
M5I02
Secondary IDs
U1111-1116-4842
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
May 2015