| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Prevention of symptomatic dengue disease |
|
| E.1.1.1 | Medical condition in easily understood language |
| Prevention of dengue disease with clinical symptoms |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To demonstrate the non-inferiority of the antibody (Ab) response against all antigens (diphtheria, tetanus, pertussis, polio and Hib) in subjects receiving one booster dose of Pentaxim vaccine administered concomitantly with the second dose of CYD dengue vaccine compared to subjects receiving one booster dose of Pentaxim vaccine administered concomitantly with placebo |
|
| E.2.2 | Secondary objectives of the trial |
Safety and reactogenicity (All Subjects):
1. To describe the safety of Pentaxim vaccine administered concomitantly with the second dose of CYD dengue vaccine, or administered concomitantly with placebo
2. To describe the safety of CYD dengue vaccine after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim vaccine or administered alone
3. To describe the safety of the CYD dengue vaccine in all subjects after each dose
Immunogenicity (in a Subset):
1. To describe the antibody response to each dengue virus serotype (post-Dose 2 and post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim vaccine or administered alone
2. To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3 |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1) Aged 9 to 12 months on the day of inclusion.
2) Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
3) Subject in good health, based on medical history and physical examination.
4) Documentation of completion of the primary vaccination series with Pentaxim vaccine with 3 doses received between 2 and 8 months of age.
5) Informed consent form has been signed and dated by both parents or other legally acceptable representative (and by 2 mandatory witnesses as required by local regulations).
6) Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures. |
|
| E.4 | Principal exclusion criteria |
1) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.
2) Planned participation in another clinical trial during the present trial period.
3) Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
4) Previous vaccination against flavivirus diseases, measles, mumps, rubella, previous booster vaccination against pneumococcal diseases, diphtheria, tetanus, pertussis, Hib and/or polio.
5) Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response.
6) 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).
7) Personal seropositivity for human immunodeficiency virus (HIV) or hepatitis C as reported by the parent(s)/legally acceptable representative.
8) History of pertussis and/or Hib infection as reported by the parent(s)/legally acceptable representative.
9) Known systemic hypersensitivity to any of the vaccine 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.
10) History of contraindication to the receipt of vaccines containing components of Pentaxim vaccine (diphtheria toxoid, tetanus toxoid, PT, FHA, PRP and polio) or of MMR (measles, mumps and rubella) vaccine or of pneumococcal conjugate vaccine.
11) Thrombocytopenia, as reported by the parent(s)/legally acceptable
representative.
12) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
13) History of central nervous system disorder or disease, including seizures.
14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
15) Identified as a child (adopted or natural) of the Investigator or of site 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.
Temporary Exclusion Criteria:
A prospective subject must not be included in the study until the following conditions and/or symptoms are resolved:
16) Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute
illness/infection (according to Investigator judgment) on the day of vaccination.
17) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Diphtheria, tetanus, polio, Hib immunogenicity: Seroprotection rate (antibody titers)
Pertussis immunogenicity: Booster response (pre and post booster antibody titers) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
Diphtheria, tetanus, polio, Hib immunogenicity: 28 days after DTaP-IPV//Hib vaccine
Pertussis immunogenicity: pre and post booster 28 days after DTaP-IPV//Hib vaccine |
|
| E.5.2 | Secondary end point(s) |
Safety and reactogenicity: Adverse events including non-serious adverse events of special interest (AESIs), and serious adverse events, including serious AESIs
Dengue immunogenicity: dengue immune response (serotype specific neutralizing antibodies) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety and reactogenicity:
- AEs up to day 28 (D28) after each injection.
- Non-serious AESIs up to 7 days after each injection.
- SAEs, including serious AESIs, throughout the study
Dengue immunogenicity: on D28 after each injection in the immunogenicity subset |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| Observer-blind (first and second injections of CYD dengue vaccine), open-label (third injection) |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| At 6 Mo: DTaP-IPV//Hib vaccine (Pentaxim®) + Placebo (co-ad); At 0, 7, 12 Mo: CYD Dengue Vaccine |
|
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial months | 18 |
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