Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

Browse trials for

• Pneumonia, Pneumococcal 121
• Streptococcal Infections 155

Keywords

• pneumococcal conjugate vaccine
• Synflorix
• Prevnar 13
• Pneumococcal diseases

Pneumonia, Pneumococcal

121 studies on the registry are indexed under Pneumonia, Pneumococcal; 7 are open to participants now.

This study's enrollment of 457 is above the median of 304 across 79 interventional studies indexed under Pneumonia, Pneumococcal.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Active comparator
  Synflorix Group

  Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.

  Biological: Synflorix (3-Dose)

• Experimental
  Prevnar 1 Group

  Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.

  Biological: Synflorix (2-Dose) · Biological: Prevenar 13 (Single Dose)

• Experimental
  Prevnar 2 Group

  Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.

  Biological: Synflorix (Single Dose) · Biological: Prevenar 13 (2-Dose)

Interventions

• BiologicalSynflorix (3-Dose)

  3 doses administered intramuscularly

• BiologicalSynflorix (2-Dose)

  2 doses administered intramuscularly

• BiologicalSynflorix (Single Dose)

  1 dose administered intramuscularly

• BiologicalPrevenar 13 (Single Dose)

  1 dose administered intramuscularly

• BiologicalPrevenar 13 (2-Dose)

  2 doses administered intramuscularly

Primary outcomes

1. Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period

   The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.

   Time frame: Within 31-day (Day 0-Day 30) after any dose of primary vaccination

Secondary outcomes

1. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period

   Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

   Time frame: During the 4-day (Days 0-3) post-vaccination period following each primary dose

2. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period

   Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

   Time frame: During the 4-day (Days 0-3) post-booster vaccination period

3. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period

   Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (\>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

   Time frame: During the 4-day (Days 0-3) post-vaccination period following each primary dose

4. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period

   Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (\>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

   Time frame: During the 4-day (Days 0-3) post-booster vaccination period

5. Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period

   The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.

   Time frame: During the 31-day (Days 0-30) post-booster vaccination period

6. Number of Subjects With Unsolicited AEs - Primary Period

   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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

   Time frame: During the 31-day (Days 0-30) post-primary vaccination period

7. Number of Subjects With Unsolicited AEs - Booster Period

   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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

   Time frame: During the 31-day (Days 0-30) post-booster vaccination period

8. Number of Subjects With Serious Adverse Events (SAEs)

   SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

   Time frame: From first vaccination (Month 0) up to study end (11-14 months)

9. Antibody Concentrations Against Pneumococcal Serotypes

   Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). 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.

   Time frame: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)

10. Concentrations of Antibodies Against Protein D (Anti-PD)

    Anti-PD antibody concentrations were measured by Enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.

    Time frame: At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)

11. Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes

    The immunogenicity assessment was based on multiplex opsonophagocytic activity assay (MOPA). Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a serotype specific titer for opsonophagocytic activity higher than or equal to (≥) the Lower Limit of Quantification (LLOQ) i.e.: 14 for OPA-1, 11 for OPA-3; 40 for OPA-4; 15 for OPA-5; 45 for OPA-6A; 29 for OPA-6B; 28 for OPA-7F; 39 for OPA-9V; 16 for OPA-14; 40 for OPA-18C; 13 for OPA-19A; 33 for OPA-19F and 40 for OPA-23F.

    Time frame: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)

Baseline characteristics

Publications

• de Los Santos AM, Rodriguez-Weber MA, Sanchez-Marquez P, Traskine M, Carreno-Manjarrez R, Cervantes-Apolinar MY, Strezova A, Ruiz-Guinazu J, Ortega-Barria E, Borys D. Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomized trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine. Expert Rev Vaccines. 2020 Nov;19(11):995-1010. doi: 10.1080/14760584.2020.1843431. PubMed 33297773 ↗

Individual participant data

Plan to share: Yes — IPD for this study is available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr