Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:April 2011
End Date:March 2014
Contact:Public Registry Sanofi Pasteur
Email:RegistryContactUs@sanofipasteur.com

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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


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 IPV 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.


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.

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.
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