Bacterial Meningitis, Diphtheria, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Tetanus, Diphtheria, Pertussis, Poliomyelitis, Bacterial meningitis, DTaP-IPV/Hib Combination vaccine
Brief summary
Primary objective: * To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens). Secondary objectives: * To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B). * To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B). * To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)
Detailed description
Participants will be enrolled in two steps (Cohort 1 and Cohort 2). Step one will enroll Cohort 1 made of 40 participants randomized in two groups with a 1:1 ratio. After review of the local and systemic adverse events occurring during the 7 Days following the first dose administered in these subjects, 2nd vaccination of Cohort 1 participants will resume and enrollment of the participants of Cohort number 2 will start. Step two will enroll Cohort 2 made of subjects randomized in two groups with a 1:1 ratio. A sub-study Group C will be enrolled and will receive the vaccine by intramuscular route.
Interventions
BIOLOGICALDTaP-IPV/Hib Combined vaccine
0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart
BIOLOGICALDTaP-IPV vaccine and Hib vaccine
0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 68 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 2 months to 68 months inclusive (recommended 3 to 8 months for Groups A and B; 2 months for Group C) on the day of inclusion * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Fever ≥ 37.5°C (axillary temperature) on the day of inclusion * Any serious disease whether acute or chronic * Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy * History of diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b infections * History of a life threatening reaction to a vaccine containing the same substances of the study vaccine * History of anaphylaxis to any of the study vaccine components * Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b infections with a trial vaccine or another vaccine * Congenital or current acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * Participation in another clinical trial preceding the trial inclusion * Planned participation in another clinical trial during the present trial period * Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins) * Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination * Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination * Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection * Subject ineligible according to the Investigator's clinical judgment * Identified as employee 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 member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3 | 21 Days post-dose 3 | Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with Seroprotection to vaccine antigens following vaccination | Day 0 (pre-vaccination ) and 21 Days post-dose 3 | Seroprotection is defined as: percentage of participants with anti-Diphtheria and anti Tetanus antibody levels ≥0.01, ≥0.1 and ≥1.0 IU/mL |
| Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination | 21 Days post-dose 3 | Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization) |
| Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with DTaP IPV/Hib vaccine. | Day 0 (post-vaccination) up to 21 days post each vaccination | Solicited injection site reactions: Tenderness, Erythema, Swelling and Induration; Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability. |
Countries
Japan
Outcome results
None listed