| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| 3- or 2-dose primary vaccination against Streptococcus pneumoniae together with a 3-dose primary vaccination against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b diseases and a 2-dose primary vaccination against rotavirus disease with or without booster vaccination at 9-10 months of age against Streptococcus pneumoniae in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants. |
|
| 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 | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061353 |
| E.1.2 | Term | Pneumococcal infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061190 |
| E.1.2 | Term | Haemophilus infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| 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 and characterize the immune response to the 10Pn-PD-DiT vaccine one month following a 3-dose (6, 10 and 14 weeks of age) primary vaccination course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants. |
|
| E.2.2 | Secondary objectives of the trial |
Immunogenicity of 10Pn-PD-DiT vaccine in HIV unexposed uninfected infants after 2-dose primary vaccination.
Immunogenicity of DTPw-HBV/Hib vaccine after 3-dose primary and after booster vaccination.
Immunogenicity of HRV vaccine after 2-dose vaccination.
Immunogenicity of a booster dose of 10Pn-PD-DiT vaccine after 2- or 3-dose priming.
Persistence of antibodies against the 10Pn-PD-DiT vaccine after 2- or 3-dose primary vaccination and after booster vaccination.
Persistence of antibodies against 10Pn-PD-DiT vaccine in HIV unexposed uninfected infants after 3-dose primary vaccination without a 10Pn-PD-DiT booster dose.
Safety and reactogenicity of the 10Pn-PD-DiT, DTPw-HBV/Hib and HRV vaccines.
Immunogenicity of measles vaccine following the first and second vaccine dose.
Nasopharyngeal carriage of H.influenzae and S. pneumoniae up to 24 months of age.
Natural immune responses in terms of salivary antibodies against selected common bacterial protein antigens. |
|
| 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 informed consent obtained from the parent(s)/guardian(s) of the child.
• 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.
• A family history of hereditary immunodeficiency other than HIV infection.
• For HIV infected infants: Moderately and severely symptomatic: stages III and IV according to latest version of the WHO classification.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae.
• History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease.
• Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
• Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) 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.
• Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
• Babies whose weight for age is < 3rd percentile at Visit 1, using standard growth charts, with the exception of HIV infected infants for which the decision of enrolment is left to the investigator’s discretion. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Concentration of antibodies against the investigational pneumococcal vaccine above the protocol specified threshold value. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| One month after primary immunization |
|
| E.5.2 | Secondary end point(s) |
Concentration of antibodies against components of the investigational pneumococcal vaccine for additional parameters.
Concentration of antibodies against components of the co-administered DTPw-HBV/Hib vaccine.
Concentration of antibodies against the co-administered rotavirus vaccine.
Concentration of antibodies against the co-administered measles vaccine.
Occurrence of salivary antibodies against selected common bacterial protein antigens.
Prevalence of H. influenzae and/or S. pneumoniae and other bacterial pathogens in the nasopharynx.
Acquisition of new S. pneumoniae and/or H. influenzae strains in the nasopharynx.
Occurrence of each solicited adverse event.
Occurrence of unsolicited adverse events.
Occurrence of serious adverse events. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Antibodies against pneumococcal vaccine components: one month following primary (all groups) and booster vaccination (all groups except HIV- (EPI) Group) up to 24-27 months of age (MOA).
Antibodies DTPw-HBV/Hib, rotavirus and measles vaccines: one month after primary and booster immunization, one month after the second vaccine dose and one month after the first and second vaccine dose, respectively.
Nasopharyngeal carriage/salivary antibodies: prior to and one month following primary (all groups) and booster vaccination (all groups except HIV- (EPI) Group) up to 24-27 MOA.
Solicited and unsolicited adverse events: within 4 and 31 days after each vaccination, respectively.
Serious adverse events: after screening or first vaccination, as applicable, up to last study visit at 24-27 MOA. |
|
| 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 |
|
| 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 | 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 | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| Partially randomized (HIV uninfected unexposed group) to the different vaccination schemes |
|
| 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 |
|
| E.8.2.4 | Number of treatment arms in the trial | 5 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
| E.8.4 | Will this trial be conducted at multiple sites globally? | No |
| 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 years | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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