E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers: prevention of invasive disease caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F and prevention of otitis media caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
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E.1.1.1 | Medical condition in easily understood language |
Protection against S pneumoniae |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 |
Immunogenicity
- To assess and describe the immunogenicity for 12 serotypes of the study
vaccines one month after the booster vaccination in both groups
Safety
- To describe the safety of the study vaccines after the booster vaccination |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Aged 12 to 18 months on the day of inclusion
2. Informed consent form signed by the parent/legally acceptable representative and
by an independent witness if requested by local Ethics Committee regulation
or/and if the parent/legally acceptable representative is illiterate
3. Child having completed the three-dose primary vaccination of Prevnar® in the
hexavalent combined vaccine study (study A3L12)
4. Subjects and parent/guardian able to attend all scheduled visits and comply with
all study procedures |
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E.4 | Principal exclusion criteria |
1. Participation in another clinical study investigating a vaccine, drug, medical
device, or a medical procedure in the 4 weeks preceding the study vaccination
2. Planned participation in another clinical study during the present study period
3. Known or suspected congenital or acquired immunodeficiency
immunosuppressive therapy such as long-term systemic corticosteroids therapy
4. Known systemic hypersensitivity to any of the vaccine components or history of a
life-threatening reaction to the study vaccine or to a vaccine containing any of the
same substances
5. Chronic illness at a stage that could interfere with study conduct or completion, in
the opinion of the investigator
6. Receipt of blood or blood-derived products since birth that might interfere with
the assessment of immune response
7. Receipt of any vaccine in the 4 weeks preceding the first study vaccination
8. Planned receipt of any vaccine in the 4 weeks preceding or following study
vaccination
9. History of seizures
10. Known personal Human Immunodeficiency Virus (HIV), Hepatitis B (HB)
antigen or Hepatitis C seropositivity
11. History of pneumococcal infection (confirmed either clinically, serologically or
microbiologically)
12. Previous booster vaccination against the pneumococcal disease with either the
study vaccine(s) or another vaccine
13. Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding
inclusion contraindicating IM vaccination
14. Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection
on the day of vaccination, according to investigator judgment |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity
30 Days after the booster vaccination in both groups (at V02/D30):
- Individual antibody (Ab) titers of the following serotypes 1, 3, 4, 5, 6B, 7F,
9V, 14, 18C, 19A, 19F, 23F (measured by ELISA)
- For each serotype
o Individual antibody titer ratio*
o Individual antibody titers ≥ 0.15 μg/mL, ≥ 0.35 μg/mL, ≥ 0.5 μg/mL,
and ≥ 1 μg/mL
* Individual titer ratio: post-booster vaccination / pre-booster vaccination
Safety:
• Occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA)
preferred term), time to onset, duration, intensity, relationship to vaccination to
any unsolicited systemic adverse events (AEs) reported in the 30 minutes after
vaccination
• Occurrence, time to onset, number of days of occurrence and intensity of solicited
(prelisted in the subject diary and Case Report Form [CRF]) injection site and
systemic reactions within 7 days after vaccination.
• Occurrence, nature (MedDRA preferred term), time to onset, duration, intensity,
and relationship to vaccination (for systemic adverse events only) of unsolicited
(spontaneously reported) adverse events from vaccination day to next study visit
(30 Days)
• Occurrence, nature (MedDRA preferred term), time to onset, duration,
relationship to vaccination, outcome, seriousness criteria of serious adverse events
occurring throughout the study |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Subjects will be kept under observation for 30 minutes after vaccination to ensure their safety.
After vaccination, subject’s/parents or guardians will record the following information about any AEs in a safety diary card:
- Solicited reactions will be collected from Day 0 to Day 7 after each injection.
- Unsollicicited AEs will be collected rom Day 0 to Day 30 after each injection
Blood samples of 5 mL each will be taken for antibodies titration:
- Before administration of the booster (BL01-V01),
- One month after administration of the booster (BL02-V02),
The antibody concentrations for the twelve serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the OPA assays for the five serotypes (1, 6B, 14, 19A, 23F) will be measured at the Laboratory. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 6 |