AzTrials
AzTrials

Infections, StreptococcalPhase 2NCT01262872

Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants

A Phase 2 study testing Pneumococcal vaccine GSK 2189242A (LD formulation 1), Pneumococcal vaccine GSK 2189242A (HD formulation 2) and Synflorix™ in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in The Gambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Read more about this study

Who is it for?
Ages 56 days to 4 yearsHealthy volunteers can take part
Conditions the study is for
Infections, Streptococcal
What is being tested?
Pneumococcal vaccine GSK 2189242A (LD formulation 1), Pneumococcal vaccine GSK 2189242A (HD formulation 2) and Synflorix™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,320 participants
Where
1 siteThe Gambia
Study dates
9 Feb 2011to 18 Mar 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 56 days to 4 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Inclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
  • Male or female between, and including,
  • 2 to 4 years of age at the time of the first vaccination for subjects in Cohort 1 (children).
  • 8 to 10 weeks (56-76 days) of age at the time of the first vaccination for subjects in Cohort 2 (infants).
  • Signed or thumb-printed informed consent obtained from the parents/LAR(s) of the subject.
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  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Permanent residence in the study area and no intention of leaving during the study period.
  • Additional inclusion criteria for subjects in Cohort 1:
  • Previously completed three-dose primary course of diphtheria-tetanus-pertussis (DTP) vaccination.

Who cannot join

  • Exclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines.
  • 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
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  • Previous vaccination against S. pneumoniae.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Malnutrition
  • A family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or any chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Contraindications to any co-administered vaccine.
  • Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
  • Additional exclusion criteria for subjects in Cohort 1:
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b with the exception of vaccines where the first dose should be given within the first two weeks of life according to the national recommendations (for example Bacillus Calmette-Guérin [BCG] and hepatitis B vaccination).

Trial locations and contacts

1 site in 1 country.

The Gambia1 site

  • GSK Investigational Site

    Banjul

Other trials in The Gambia

About this study

Official title: Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety and Immunogenicity When Co-administered With Routine EPI Vaccines in Infants Following Safety Assessment in Children Aged 2-4 Years in The Gambia

This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.

Read the detailed description

There will be two cohorts in the study: Cohort 1 (children aged 2-4 years) and Cohort 2 (infants aged 8-10 weeks), and two steps in the study, Step 1 and Step 2. Step 1 will consist in a safety evaluation of the GSK Biologicals' pneumococcal vaccine 2189242A (GSK 2189242A or 10PP vaccine). Before evaluating the two formulations of the 10PP vaccine in infants (Cohort 2), safety and reactogenicity of the highest dose formulation of this vaccine will be evaluated in children (Cohort 1). Prevnar 13™ will be used as a control. In the second step of the study, Step 2, two investigational formulations of the 10PP vaccine will be tested in infants (Cohort 2) as regards immunogenicity, reactogenicity and safety. Both formulations of the 10PP vaccine will be evaluated according to the Expanded Programme on Immunization (EPI) schedule i.e. a 2, 3, 4 months vaccination schedule, using licensed Synflorix™ and Prevnar 13™ vaccines as comparators. The higher dose (HD) formulation of the 10PP vaccine will be also evaluated according to the 2, 4, 9 months vaccination schedule using licensed Synflorix™ vaccine as comparator. The study in infants will also assess the immune responses to routine vaccines when co-administered with the candidate pneumococcal vaccine, using licensed Synflorix™ and Prevnar 13™ vaccines as comparators.

Being tested
Pneumococcal vaccine GSK 2189242A (LD formulation 1), Pneumococcal vaccine GSK 2189242A (HD formulation 2), Synflorix™, Prevnar13™, Tritanrix™-HepB/Hib
Keywords
Haemophilus influenzae, Streptococcus pneumoniae, The Gambia, immunogenicity, nasopharyngeal carriage, infants, safety, Pneumococcal vaccine, children
Medical subject headings
Streptococcal Infections, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pneumococcal vaccine GSK 2189242A (LD formulation 1)Biological

    Also called 10PP, LD Formulation

    Intramuscular injection

  • Pneumococcal vaccine GSK 2189242A (HD formulation 2)Biological

    Also called 10PP, HD Formulation

    Intramuscular injection

  • Synflorix™Biological

    Intramuscular injection

  • Prevnar13™Biological

    Intramuscular injection

  • Tritanrix™-HepB/HibBiological

    Intramuscular injection

  • Polio Sabin™Biological

    Orally

  • M-Vac™Biological

    Intramuscular injection

  • Stamaril™Biological

    Intramuscular injection

Study groups in NCT01262872
Study groupRoleWhat they receive
10PP-HD 1d GroupExperimentalThis group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
Receives: Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)
Prevnar13 1d GroupActive comparatorThis group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Receives: Biological: Prevnar13™
10PP-LD 3+0d GroupExperimentalThis group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Receives: Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1); Biological: Tritanrix™-HepB/Hib; Biological: Polio Sabin™; Biological: M-Vac™; Biological: Stamaril™
10PP-HD 3+0d GroupExperimentalThis group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Receives: Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2); Biological: Tritanrix™-HepB/Hib; Biological: Polio Sabin™; Biological: M-Vac™; Biological: Stamaril™
Synflorix 3+0d GroupActive comparatorThis group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Receives: Biological: Synflorix™; Biological: Tritanrix™-HepB/Hib; Biological: Polio Sabin™; Biological: M-Vac™; Biological: Stamaril™
Prevnar13 3+0d GroupActive comparatorThis group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Receives: Biological: Prevnar13™; Biological: Tritanrix™-HepB/Hib; Biological: Polio Sabin™; Biological: M-Vac™; Biological: Stamaril™
10PP-HD 2+1d GroupExperimentalThis group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Receives: Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2); Biological: Tritanrix™-HepB/Hib; Biological: Polio Sabin™; Biological: M-Vac™; Biological: Stamaril™
Synflorix 2+1d GroupActive comparatorThis group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Receives: Biological: Synflorix™; Biological: Tritanrix™-HepB/Hib; Biological: Polio Sabin™; Biological: M-Vac™; Biological: Stamaril™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination - For Step 1/Cohort 1 Subjects

    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  2. Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects

    Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Primary results correspond to results for occurrences of Grade 3 symptoms assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  3. Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects

    An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  4. Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: From Day 0 to Month 1

  5. Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule

    Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  6. Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule

    Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

Secondary outcomes (78)

  1. Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects

    Assessed biochemical and haematological parameters were: Haemoglobin (Hgb), White cell count (WBC), Platelet counts, Alanine aminotransferase (ALT) and Creatinine (CREA). Per parameter, it was assessed whether subjects had laboratory values below normal, normal, or above normal range. Below = value below the laboratory reference range defined for the specified time point and laboratory parameter. Within = value within the laboratory reference range defined for the specified time point and laboratory parameter. Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. Unknown = value unknown for the specified time point and laboratory parameter. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  2. Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: From Day 0 to Month 6

  3. Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects

    Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  4. Antibody Concentrations Against Protein D (PD) - For Cohort 1/Step 1 Subjects

    Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  5. Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects

    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  6. Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects

    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  7. Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 1/Step 1 Subjects

    No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  8. Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects

    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  9. Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects

    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  10. Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 1/Step 1 Subjects

    No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  11. Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 1/Step 1 Subjects

    Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.

    Measured: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

  12. Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  13. Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  14. Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  15. Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  16. Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule

    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  17. Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule

    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  18. Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule

    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  19. Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule

    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  20. Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule

    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  21. Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule

    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  22. Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule

    No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  23. Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule

    No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  24. Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  25. Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  26. Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  27. Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  28. Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  29. Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  30. Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  31. Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  32. Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  33. Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  34. Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.

    Measured: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  35. Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.

    Measured: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  36. Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.

    Measured: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  37. Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.

    Measured: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  38. Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.

    Measured: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  39. Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.

    Measured: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  40. Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.

    Measured: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  41. Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.

    Measured: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  42. Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.

    Measured: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  43. Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.

    Measured: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  44. Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.

    Measured: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™

  45. Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.

    Measured: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™

  46. Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.

    Measured: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™

  47. Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.

    Measured: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™

  48. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.

    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 3+0 Schedule.

    Measured: Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses

  49. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.

    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.

    Measured: Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses

  50. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.

    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.

    Measured: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)

  51. Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule

    Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.

    Measured: Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses

  52. Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule

    Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.

    Measured: Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses

  53. Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule

    Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.

    Measured: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)

  54. Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule

    An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.

    Measured: Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses

  55. Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule

    An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.

    Measured: Within the 31-day (Days 0-30) periods post vaccination with the first 2 doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses

  56. Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule

    An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.

    Measured: Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)

  57. Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: From Day 0 to Month 10

  58. Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: From Day 0 to Month 10

  59. Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  60. Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  61. Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  62. Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  63. Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  64. Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  65. Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  66. Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  67. Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  68. Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  69. Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed.This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  70. Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  71. Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)

  72. Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  73. Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  74. Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  75. Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  76. Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  77. Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.

    Measured: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)

  78. Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule

    This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.

    Measured: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2010 (estimated)
  2. Study start9 Feb 2011
  3. Primary completion18 Mar 2013
  4. Study completion18 Mar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01262872
Sponsor's protocol ID
114174
Other IDs
2012-002727-15
Status last verified
Jun 2019
First submitted
2 Dec 2010
Last updated
19 Jun 2019
Individual data sharing
Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

  • Odutola A, Antonio M, Owolabi O, Bojang A, Foster-Nyarko E, Donkor S, Adetifa I, Taylor S, Bottomley C, Greenwood B, Ota M. Comparison of the prevalence of common bacterial pathogens in the oropharynx and nasopharynx of gambian infants. PLoS One. 2013 Sep 23;8(9):e75558. doi: 10.1371/journal.pone.0075558. eCollection 2013.

    PubMed 24086570

  • Odutola A, Ota MO, Ogundare EO, Antonio M, Owiafe P, Worwui A, Greenwood B, Alderson M, Traskine M, Verlant V, Dobbelaere K, Borys D. Reactogenicity, safety and immunogenicity of a protein-based pneumococcal vaccine in Gambian children aged 2-4 years: A phase II randomized study. Hum Vaccin Immunother. 2016;12(2):393-402. doi: 10.1080/21645515.2015.1111496.

    PubMed 26618243

  • Odutola A, Ota MOC, Antonio M, Ogundare EO, Saidu Y, Foster-Nyarko E, Owiafe PK, Ceesay F, Worwui A, Idoko OT, Owolabi O, Bojang A, Jarju S, Drammeh I, Kampmann B, Greenwood BM, Alderson M, Traskine M, Devos N, Schoonbroodt S, Swinnen K, Verlant V, Dobbelaere K, Borys D. Efficacy of a novel, protein-based pneumococcal vaccine against nasopharyngeal carriage of Streptococcus pneumoniae in infants: A phase 2, randomized, controlled, observer-blind study. Vaccine. 2017 May 2;35(19):2531-2542. doi: 10.1016/j.vaccine.2017.03.071. Epub 2017 Apr 4.

    PubMed 28389097

  • Odutola A, Ota MOC, Antonio M, Ogundare EO, Saidu Y, Owiafe PK, Worwui A, Idoko OT, Owolabi O, Kampmann B, Greenwood BM, Alderson M, Traskine M, Swinnen K, Verlant V, Dobbelaere K, Borys D. Immunogenicity of pneumococcal conjugate vaccine formulations containing pneumococcal proteins, and immunogenicity and reactogenicity of co-administered routine vaccines - A phase II, randomised, observer-blind study in Gambian infants. Vaccine. 2019 May 1;37(19):2586-2599. doi: 10.1016/j.vaccine.2019.03.033. Epub 2019 Apr 8.

    PubMed 30975570

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pneumococcal vaccine GSK 2189242A (LD formulation 1), Pneumococcal vaccine GSK 2189242A (HD formulation 2) and Synflorix™ in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in The Gambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination - For Step 1/Cohort 1 Subjects (time frame: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01262872, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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