| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (Three dose primary vaccination of healthy infants between 6 to 10 weeks of age at the time of the first vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b diseases.) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Immunization against certain infections caused by the Streptococcus pneumoniae bacterium. This bacterium can cause ear infection, lung infection or meningitis |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10042197 |
| E.1.2 | Term | Streptococcus pneumoniae septicaemia |
| E.1.2 | System Organ Class | 100000004862 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10042195 |
| E.1.2 | Term | Streptococcus pneumoniae pneumonia |
| E.1.2 | System Organ Class | 100000004862 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054642 |
| E.1.2 | Term | Streptococcus pneumoniae septicemia |
| E.1.2 | System Organ Class | 100000004862 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10035648 |
| E.1.2 | Term | Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia] |
| E.1.2 | System Organ Class | 100000004862 |
|
| 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 evaluate the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in India, one month post dose 3. |
|
| E.2.2 | Secondary objectives of the trial |
• To assess the safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in India.
• To evaluate the immunogenicity of GSK Biologicals’ DTPw-HBV/Hib vaccine, co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
• Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
• Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
• Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study) |
|
| E.4 | Principal exclusion criteria |
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• A family history of congenital or hereditary immunodefi-ciency.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immuno-globulins at birth).
• Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject’s first study visit).
• History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of any neurological disorders or seizures.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment.
• Babies for which birth weight is < 2 kilogram. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
• Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
• Antibody concentrations against protein D |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| One month after the administration of the 3rd vaccine dose of 10Pn-PD-DiT or Hib |
|
| E.5.2 | Secondary end point(s) |
• Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
• Anti-pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations >= 0.20 µg/mL
• Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A
• Seropositivity status, defined as:
- Anti-pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations >= 0.05 µg/mL.
- Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F >= 8.
- Anti-PD antibody concentration >= 100 EL.U/mL
• Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti-B. per-tussis, and anti-hepatitis B antibody concentrations
• Seropositivity status, defined as anti-B. pertussis antibody concentration >= 15 EL.U/mL
• Seroprotection status, defined as:
- Anti-diphtheria toxoid antibody concentration >= 0.1 IU/mL.
- Anti-tetanus toxoid antibody concentration >= 0.1 IU/mL.
- Anti-PRP antibody concentration >= 0.15 µg/mL and >= 1.0 µg/mL
- Anti-HBs antibody concentration >= 10 mIU/mL
• Occurrence of fever (oral/axillary/tympanic temperature > 38.5°C or rectal temperature > 39.0°C)
• Occurrence of solicited adverse events (any and grade 3)
• Occurrence of unsolicited adverse events
• Occurrence of serious adverse events (SAEs) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Immunogenicity endpoints related to pneumococcal vaccine antigens: One month after the administration of the 3rd vaccine dose of 10Pn-PD-DiT or Hib
• Immunogenicity endpoints related to co-administered vaccine antigens: One month after the administration of the 3rd vaccine dose of DTPw-HBV/Hib or DTPw-HBV + Hib vaccines
• Fever and solicited adverse events: Within 4 days after vaccination
• Unsolicited adverse events: Within 31 days after vaccination
• SAEs: Following vaccination and throughout the entire study period |
|
| 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 | 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 |
| Immunogenicity, reactogenicity |
|
| 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 | Yes |
| 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 | No |
| 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 |
|
| E.8.7 | Trial has a data monitoring committee | No |
| 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 years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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