E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (Three dose primary vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b diseases and a two dose primary vaccination against rotavirus in healthy infants between 6 to 8 weeks of age at the time of the first vaccination.) |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 Taiwan, one month post dose 3, when co-administered with GSK Biologicals’ Infanrix hexa and GSK Biologicals’ Rotarix vaccines |
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E.2.2 | Secondary objectives of the trial |
• To assess the safety and reactogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine in Taiwan, when co-administered with GSK Biologicals' Infanrix hexa and GSK Biologicals' Rotarix vaccines.
• To assess the immunogenicity of GSK Biologicals' Infanrix hexa and Rotarix vaccines, when co-administered with GSK Biologicals' 10-valent pneumococcal conjugate vaccine |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female subjects between, and including 6-8 weeks (42-62 days) 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 informed consent obtained from the parent(s) or guardian(s) of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of 36 to 42 weeks inclusive |
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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.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3.
• 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 immunodeficiency.
• 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.
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations).
• History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease.
• Gastroenteritis within 7 days preceding the study vaccine administration.
• Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
• 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Antibody concentrations to pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
• Antibody concentrations to protein D |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after the administration of the 3rd vaccine dose of 10Pn vaccine |
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E.5.2 | Secondary end point(s) |
• Antibody concentrations to pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
• Antibody concentrations protein D
• Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL
• Seropositivity status, defined as:
- Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 µg/mL.
- Anti-PD antibody concentrations >= 100 EL.U/mL
• Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
• Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations >= 0.20 µg/mL
• Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A
• Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A
• Seropositivity status, defined as:
- Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 µg/mL.
- Opsonophagocytic activity against pneumococcal sero-types 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8.
- Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations >= 0.05 µg/mL.
- Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >= 8.
- Anti-PD antibody concentrations >= 100 EL.U/mL
• Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti-PT, anti-FHA and anti-PRN, anti-HBs antibody concentrations, and anti-polio types 1, 2 and 3 titres
• Seropositivity status, defined as anti-PT, anti-FHA and anti-PRN antibody concentrations >= 5 EL.U/mL
• Seroprotection status, defined as:
- Anti-diphtheria and anti-tetanus toxoids antibody concen-trations >= 0.1 IU/mL.
- Anti-PRP antibody concentration >= 0.15 µg/mL and >= 1.0 µg/mL.
- Anti-HBs antibody concentration >= 10 mIU/mL.
- Anti-polio type 1 titre >= 8.
- Anti-polio type 2 titre >= 8.
- Anti-polio type 3 titre >= 8.
• Anti-rotavirus IgA antibody concentration
• Seropositivity status, defined as anti-rotavirus IgA antibody concentration >=20 U/mL
• Occurrence of solicited local symptoms (any and grade 3)
• Occurrence of solicited general symptoms (any and grade 3)
• Occurrence of unsolicited adverse events
• Occurrence of serious adverse events (SAEs) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Immunogenicity endpoints related to anti-pneumococcal vaccine serotypes and protein D: Prior to vaccination and one month after the 3rd dose of 10Pn vaccine
• Immunogenicity endpoints related to OPA and cross-reactive serotypes: one month after the 3rd dose of 10Pn vaccine
• Immunogenicity endpoints related to DTPa-HBV-IPV/Hib vaccine: One month after the 3rd dose of DTPa-HBV-IPV/Hib vaccine
• Immunogenicity endpoints related to HRV vaccine: Four months after the 2nd dose of HRV vaccine
• Solicited symptoms: Within 4 (days 0 to 3) days after each vaccination dose
• Unsolicited symptoms: Within 31 (days 0 to 30) days after each vaccination dose
• SAEs: Following the administration of the first dose of study vaccine throughout the entire study period up to the last visit. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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 |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 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
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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 years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 15 |