Clinical trial NCT00447525: REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children
Official title: Comparison of the Immunogenicity and Safety of a Combined Adsorbed Low Dose Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (REVAXIS®) With a Combined Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (DT Polio®) When Given as a Booster Dose at 6 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Poliomyelitis
Keywords: Prevention of : Diphtheria, Tetanus and Poliomyelitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-14
Enrollment: 760
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary objective:

To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .

Secondary objectives:

* Additional immunogenicity assessments.
* To describe the safety profile of a single dose of REVAXIS® or DT-Polio®


Eligibility criteria: Inclusion Criteria:

1. Healthy child without chronic severe disease of either gender,
2. 6 year-old child on vaccination day,
3. Child previously vaccinated with three doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life and a booster dose of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination at 16 - 18 months of life (±2 months),
4. Consent form signed by both parents, or by the legal representative, properly informed about the study.

Exclusion Criteria:

1. Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine,
2. Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
3. Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
4. Child who present with immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
5. Child who had received within the previous 150 days or who will receive during the course of the study, any immunoglobulins or blood derived products,
6. Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
8. Child who had presented severe hypersensitivity following an earlier immunization against diphtheria and/or tetanus,
9. Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
10. Acute severe febrile illness and/or oral temperature ≥37.5°C at the time of vaccination

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albertville
country: France
city: Albi
country: France
city: Angers
country: France
city: Annecy
country: France
city: Anzin
country: France
city: Arras
country: France
city: Asnieres
country: France
city: Avion
country: France
city: Bassens
country: France
city: Bersee
country: France
city: Besancon
country: France
city: Blois
country: France
city: Boulogne
country: France
city: Brest
country: France
city: Broglie
country: France
city: Caen
country: France
city: Chalon-en-champagne
country: France
city: Champdeniers
country: France
city: Chigny Les Roses
country: France
city: Cholet
country: France
city: Claix
country: France
city: Clamart
country: France
city: Collombey Les Belles
country: France
city: Draguignan
country: France
city: Enghien-les-bains
country: France
city: Floirac
country: France
city: Frouard
country: France
city: Haguenau
country: France
city: Illkirch-graffenstaden
country: France
city: Issy Les Moulineaux
country: France
city: La Neuville Roy
country: France
city: Laon
country: France
city: Le Havre
country: France
city: Les Pieux
country: France
city: Louverne
country: France
city: Louvigne de Bais
country: France
city: Manduel
country: France
city: Marcq-en-barouel
country: France
city: Maromme
country: France
city: Marseille
country: France
city: Miniac Morvan
country: France
city: Montpellier
country: France
city: Montsang/orge
country: France
city: Morangis
country: France
city: Nancy
country: France
city: Nantes
country: France
city: Nogent Sur Marne
country: France
city: Ostwald
country: France
city: Paris
country: France
city: Paris
country: France
city: Plouzane
country: France
city: Poitiers
country: France
city: Pont A Mousson
country: France
city: Quimper
country: France
city: Rouen
country: France
city: Rouen
country: France
city: Saint Sebastien Sur Loir
country: France
city: Saint-ouen
country: France
city: Saint-raphael
country: France
city: Sanary Mer
country: France
city: Sevres
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Villemomble
country: France
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Gajdos V, Soubeyrand B, Vidor E, Richard P, Boyer J, Sadorge C, Fiquet A. Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS ((R))) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio ((R))) given as a booster dose at 6 years of age. Hum Vaccin. 2011 May;7(5):549-56. doi: 10.4161/hv.7.5.14982. Epub 2011 May 1.