REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00447525

Enrollment

760

Registered

2007-03-14

Start date

2007-02-28

Completion date

2008-01-31

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, Poliomyelitis, Tetanus

Keywords

Prevention of : Diphtheria, Tetanus and Poliomyelitis

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®

Interventions

BIOLOGICALREVAXIS®

BIOLOGICALDT-Polio®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 6 Years

Healthy volunteers

Yes

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026