A Phase 3 interventional study of Pneumosil and Prevenar 13 in Pneumonia, Pneumococcal, sponsored by PATH. Completed at 1 site in Gambia. Open to participants aged 42 Days to 56 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by PATH · Phase 3, Interventional, and Prevention
The primary objectives of this study are to evaluate the immunogenicity (antibody response) and safety and tolerability of a 2-dose primary series and booster dose (2+1 schedule) of Pneumosil co-administered with routine pediatric vaccines in healthy infants in The Gambia.
This study will provide data necessary to evaluate the safety and immunogenicity of Pneumosil when administered in an alternative schedule to the 3 dose primary schedule (3+0) evaluated in the Phase 3 pivotal trial (VAC-056; NCT03197376) - namely in a 2 dose primary and booster (2+1) schedule - and compare immunogenicity to that of both currently licensed second-generation pneumococcal conjugate vaccines (Synflorix and Prevenar 13) administered in the same 2+1 schedule.
In this prospective, single center, randomized, active-controlled, observer-blind, Phase 3 descriptive study, 660 healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve infants will be randomized 1:1:1 to receive 3 doses of either Pneumosil, Synflorix or Prevenar 13 at 6 weeks, 14 weeks and 9-10 months of age. Standard Expanded Program on Immunization (EPI) vaccinations in The Gambia will be given concomitantly with all 3 doses of study vaccine.
The booster vaccination window was extended up to 18 months of age due to a pause in the study due to the coronavirus disease 2019 (COVID-19) pandemic. The study schedule for participants is as follows:
44 studies on the registry are indexed under Pneumonia, Pneumococcal; 2 are open to participants now.
This study's enrollment of 660 is above the median of 388 across 37 interventional studies indexed under Pneumonia, Pneumococcal.
Browse Pneumonia, Pneumococcal studies →PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
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The human immunodeficiency virus, which weakens the immune system.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Biological: Pneumosil
Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Biological: Synflorix
Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age.
Biological: Prevenar 13
One single dose contains 2 μg of polysaccharide for serotypes 1, 5, 6A, 7F, 9V, 14, 19A, 19F and 23F, and 4 μg for serotype 6B formulated with aluminium phosphate as an adjuvant in an appropriate buffer
Also known as: Serum Institute of India Pneumococcal conjugate vaccine (SIIPL-PCV )
One single dose contains 2.2 µg of the following pneumococcal polysaccharides serotypes - 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F - and 4.4 µg of pneumococcal polysaccharide serotype 6B, all conjugated to CRM197 and absorbed onto aluminum phosphate
One single dose contains 1 μg of polysaccharide for serotypes 1, 5, 6B, 7F, 9V, 14, and 23F, and 3μg of serotypes 4, 18C, and 19F formulated with aluminum phosphate as an adjuvant.
Also known as: Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster
The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by enzyme-linked immunosorbent assay (ELISA) in serum samples collected 4 weeks after the booster dose (Visit 6). The pneumococcal serotype-specific IgG ELISAs were performed using the World Health Organisation (WHO) reference assay at the WHO Pneumococcal Serology Reference Laboratory, at the Institute of Child Health, University College London, United Kingdom (UK), where the assay was validated.
Time frame: 4 weeks post booster dose
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination
Solicited local reactions included tenderness, erythema/redness and induration/swelling at the study vaccine injection site. Solicited systemic reactions included cutaneous rash, fever (based on axillary temperature), irritability, drowsiness, and decreased appetite. The severity of all solicited AEs was graded from mild (Grade 1) to potentially life threatening (Grade 4), based on protocol-defined criteria that were derived from Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 2.0, November 2014).
Time frame: Day 0 to Day 6 after each vaccination
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs)
AEs include any intercurrent illness or injury during the study, clinically significant worsening of a preexisting condition, and any solicited AE that occurred or was ongoing 6 days after study vaccine administration. A TEAE is an event that was not present prior to administration of the study vaccine, or increased in intensity after administration of the study vaccine. Unsolicited AEs were graded using the scale below: Grade 1: Mild; asymptomatic or mild symptoms; intervention not indicated. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Related AEs are AEs where the Investigator determined a reasonable causal relationship between the vaccine administered and the AE based on medical judgement.
Time frame: AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post vaccination; approximately 8.5 months overall.
Number of Participants With Serious Adverse Events (SAEs)
An SAE was a specific AE that: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of an existing hospitalization. * Resulted in a persistent or significant disability or incapacity. * Resulted in a congenital anomaly or birth defect
Time frame: SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall.
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster
The functional activity of the antibody response to the 10 serotypes contained in Pneumosil was determined in serum samples collected 4 weeks after the booster dose in a subset of 50 participants per group. This activity was determined using the 4-fold multiplexed opsonophagocytic assay (MOPA) developed at the University of Alabama at Birmingham, and performed at the WHO Pneumococcal Serology Reference Laboratory, at the Institute of Child Health, University College London, UK, where the assay was validated. A higher titer indicates increased antibody-mediated opsonophagocytosis.
Time frame: 4 weeks post booster dose
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster
The seroresponse rate was defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the booster dose.
Time frame: 4 weeks post booster dose
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster
Seroresponse rate was also defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 1.0 μg/mL. The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the booster dose.
Time frame: 4 weeks post booster dose
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster
The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples taken 4 weeks after the booster vaccination.
Time frame: 4 weeks post booster dose
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations
The seroresponse rate was defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the second primary vaccination dose.
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks)
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations
The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the second primary vaccination dose.
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks)
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations
The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA).
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks)
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations
Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA).
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks)
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster
The seroresponse rate was defined as the percentage of infants with serotype-specific IgG concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected immediately prior to the booster vaccination dose.
Time frame: Prior to the booster dose at approximately 9 to 16 months of age
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster
The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected immediately prior to the booster vaccination dose.
Time frame: Prior to the booster dose at approximately 9 to 16 months of age
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster
The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples collected immediately prior to the booster vaccination dose.
Time frame: Prior to the booster dose at approximately 9 to 16 months of age
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster
Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples collected immediately prior to the booster vaccination dose.
Time frame: Prior to the booster dose at approximately 9 to 16 months of age
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations
Booster response was measured by the ratio of IgG GMCs measured at the post-booster visit to those measured 4 weeks after completion of primary vaccinations.
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks) and 4 weeks post booster
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations
OPA booster response was measured by the ratio of OPA GMTs measured at the post-booster visit to those measured 4 weeks after completion of primary vaccinations.
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks) and 4 weeks post booster
Healthy, Gambian male and female, pneumococcal conjugate vaccine (PCV)-naïve infants were screened and enrolled at the Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine (MRCG at LSHTM).
| Milestone | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Started | 220 | 220 | 220 |
| Received first vaccination | 220 | 220 | 220 |
| Received second vaccination | 217 | 213 | 213 |
| Received booster vaccination | 208 | 206 | 206 |
| Completed | 203 | 200 | 200 |
| Not completed | 17 | 20 | 20 |
| Withdrew: Met ineligibility criteria during the study | 1 | 1 | 2 |
| Withdrew: Parent requested withdrawal | 8 | 12 | 9 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Other | 5 | 6 | 7 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 |
The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by enzyme-linked immunosorbent assay (ELISA) in serum samples collected 4 weeks after the booster dose (Visit 6). The pneumococcal serotype-specific IgG ELISAs were performed using the World Health Organisation (WHO) reference assay at the WHO Pneumococcal Serology Reference Laboratory, at the Institute of Child Health, University College London, United Kingdom (UK), where the assay was validated.
| μg/mL | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 8.45 (7.54 to 9.48) | 2.90 (2.57 to 3.28) | 5.87 (5.26 to 6.56) |
| Serotype 5 | 1.54 (1.38 to 1.73) | 0.80 (0.72 to 0.88) | 2.04 (1.86 to 2.24) |
| Serotype 6A | 9.56 (8.26 to 11.05) | 0.60 (0.50 to 0.71) | 10.95 (9.57 to 12.54) |
| Serotype 6B | 12.46 (11.07 to 14.01) | 4.96 (4.44 to 5.53) | 15.54 (13.71 to 17.60) |
| Serotype 7F | 6.66 (5.96 to 7.44) | 3.15 (2.87 to 3.45) | 6.31 (5.75 to 6.93) |
| Serotype 9V | 3.46 (3.08 to 3.88) | 2.45 (2.21 to 2.72) | 3.87 (3.47 to 4.32) |
| Serotype 14 | 8.28 (6.97 to 9.82) | 5.02 (4.22 to 5.97) | 9.17 (8.06 to 10.45) |
| Serotype 19A | 8.82 (7.65 to 10.15) | 2.39 (1.97 to 2.89) | 12.21 (10.83 to 13.76) |
| Serotype 19F | 11.11 (9.70 to 12.73) | 17.31 (14.83 to 20.20) | 14.99 (13.25 to 16.96) |
| Serotype 23F | 4.95 (4.28 to 5.73) | 2.16 (1.92 to 2.44) | 4.97 (4.34 to 5.69) |
Solicited local reactions included tenderness, erythema/redness and induration/swelling at the study vaccine injection site. Solicited systemic reactions included cutaneous rash, fever (based on axillary temperature), irritability, drowsiness, and decreased appetite. The severity of all solicited AEs was graded from mild (Grade 1) to potentially life threatening (Grade 4), based on protocol-defined criteria that were derived from Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 2.0, November 2014).
| Participants | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Any local reaction | 72 | 84 | 63 |
| Any local reaction Grade 3 or higher | 0 | 0 | 0 |
| Tenderness | 70 | 83 | 61 |
| Erythema/Redness | 1 | 3 | 1 |
| Induration/Swelling | 3 | 5 | 1 |
| Any systemic reaction | 160 | 167 | 160 |
| Any systemic reaction Grade 3 or higher | 3 | 0 | 2 |
| Fever | 98 | 105 | 108 |
| Fever Grade 3 or higher | 3 | 0 | 2 |
| Cutaneous Rash | 16 | 7 | 6 |
| Cutaneous Rash Grade 3 or higher | 0 | 0 | 0 |
| Irritability | 105 | 110 | 101 |
| Irritability Grade 3 or higher | 0 | 0 | 0 |
| Drowsiness | 12 | 15 | 18 |
| Drowsiness Grade 3 or higher | 0 | 0 | 0 |
| Decreased Appetite | 25 | 18 | 28 |
| Decreased Appetite Grade 3 or higher | 0 | 0 | 0 |
AEs include any intercurrent illness or injury during the study, clinically significant worsening of a preexisting condition, and any solicited AE that occurred or was ongoing 6 days after study vaccine administration. A TEAE is an event that was not present prior to administration of the study vaccine, or increased in intensity after administration of the study vaccine. Unsolicited AEs were graded using the scale below: Grade 1: Mild; asymptomatic or mild symptoms; intervention not indicated. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Related AEs are AEs where the Investigator determined a reasonable causal relationship between the vaccine administered and the AE based on medical judgement.
| Participants | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Any treatment-emergent adverse event (TEAE) | 198 | 197 | 189 |
| Any vaccine-related TEAE | 1 | 2 | 0 |
| Grade 1 TEAE | 196 | 195 | 186 |
| Vaccine-related Grade 1 TEAE | 1 | 1 | 0 |
| Grade 2 TEAE | 22 | 20 | 17 |
| Vaccine-related Grade 2 TEAE | 0 | 0 | 0 |
| Grade 3 TEAE | 11 | 10 | 6 |
| Vaccine-related Grade 3 TEAE | 0 | 1 | 0 |
| Grade 4 TEAE | 0 | 0 | 0 |
| Grade 5 TEAE | 1 | 0 | 1 |
| Vaccine related Grade 5 TEAE | 0 | 0 | 0 |
| TEAEs leading to study discontinuation | 0 | 0 | 1 |
An SAE was a specific AE that: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of an existing hospitalization. * Resulted in a persistent or significant disability or incapacity. * Resulted in a congenital anomaly or birth defect
| Participants | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Any serious adverse event | 12 | 10 | 7 |
| Vaccine-related serious adverse events | 0 | 0 | 0 |
The functional activity of the antibody response to the 10 serotypes contained in Pneumosil was determined in serum samples collected 4 weeks after the booster dose in a subset of 50 participants per group. This activity was determined using the 4-fold multiplexed opsonophagocytic assay (MOPA) developed at the University of Alabama at Birmingham, and performed at the WHO Pneumococcal Serology Reference Laboratory, at the Institute of Child Health, University College London, UK, where the assay was validated. A higher titer indicates increased antibody-mediated opsonophagocytosis.
| titer | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 631.29 (467.98 to 851.59) | 282.35 (190.44 to 418.60) | 429.13 (310.99 to 592.14) |
| Serotype 5 | 885.98 (662.20 to 1185.37) | 484.66 (361.73 to 649.38) | 703.15 (556.01 to 889.24) |
| Serotype 6A | 3651.54 (2593.53 to 5141.16) | 53.86 (25.10 to 115.56) | 6464.88 (5120.52 to 8162.19) |
| Serotype 6B | 3931.21 (2969.79 to 5203.89) | 1294.61 (929.52 to 1803.11) | 6012.88 (4130.89 to 8752.29) |
| Serotype 7F | 7053.37 (5904.91 to 8425.18) | 4401.18 (3593.44 to 5390.50) | 8288.88 (6756.83 to 10168.3) |
| Serotype 9V | 1408.68 (1092.33 to 1816.64) | 845.47 (631.39 to 1132.13) | 2464.43 (1957.36 to 3102.85) |
| Serotype 14 | 2622.36 (1845.88 to 3725.47) | 1381.52 (883.30 to 2160.74) | 3131.96 (2245.73 to 4367.91) |
| Serotype 19A | 1620.76 (1200.51 to 2188.13) | 305.46 (177.87 to 524.57) | 3679.06 (2920.79 to 4634.19) |
| Serotype 19F | 1384.38 (937.18 to 2044.98) | 2541.40 (1666.99 to 3874.49) | 2094.57 (1410.71 to 3109.94) |
| Serotype 23F | 2998.53 (2272.86 to 3955.89) | 1427.66 (1110.72 to 1835.05) | 5687.60 (3891.57 to 8312.54) |
The seroresponse rate was defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the booster dose.
| percentage of participants | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 100 (98.2 to 100.0) | 100 (98.1 to 100.0) | 99.5 (97.3 to 100.0) |
| Serotype 5 | 97.5 (94.3 to 99.2) | 89.9 (84.9 to 93.8) | 99.0 (96.4 to 99.9) |
| Serotype 6A | 98.0 (95.0 to 99.5) | 66.2 (59.1 to 72.8) | 99.0 (96.4 to 99.9) |
| Serotype 6B | 100 (98.2 to 100.0) | 99.5 (97.3 to 100.0) | 99.5 (97.3 to 100.0) |
| Serotype 7F | 100 (98.2 to 100.0) | 99.5 (97.3 to 100.0) | 100 (98.2 to 100.0) |
| Serotype 9V | 99.0 (96.5 to 99.9) | 99.5 (97.3 to 100.0) | 100 (98.2 to 100.0) |
| Serotype 14 | 98.5 (95.7 to 99.7) | 97.5 (94.3 to 99.2) | 99.5 (97.3 to 100.0) |
| Serotype 19A | 100 (98.2 to 100.0) | 91.5 (86.7 to 94.9) | 100 (98.2 to 100.0) |
| Serotype 19F | 100 (98.2 to 100.0) | 100 (98.1 to 100.0) | 100 (98.1 to 100.0) |
| Serotype 23F | 98.0 (95.0 to 99.5) | 98.0 (95.0 to 99.5) | 98.5 (95.6 to 99.7) |
Seroresponse rate was also defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 1.0 μg/mL. The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the booster dose.
| percentage of participants | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 98.5 (95.7 to 99.7) | 88.3 (83.0 to 92.5) | 97.5 (94.3 to 99.2) |
| Serotype 5 | 68.6 (61.9 to 75.1) | 37.7 (30.9 to 44.8) | 87.5 (82.1 to 91.7) |
| Serotype 6A | 96.5 (93.0 to 98.6) | 37.9 (31.1 to 45.2) | 98.0 (94.9 to 99.5) |
| Serotype 6B | 100 (98.2 to 100.0) | 96.5 (92.9 to 98.6) | 99.5 (97.3 to 100.0) |
| Serotype 7F | 98.0 (95.0 to 99.5) | 95.0 (91.0 to 97.6) | 99.5 (97.3 to 100.0) |
| Serotype 9V | 94.6 (90.5 to 97.3) | 89.5 (84.4 to 93.4) | 95.5 (91.6 to 97.9) |
| Serotype 14 | 95.0 (91.1 to 97.6) | 90.0 (85.0 to 93.8) | 99.0 (96.4 to 99.9) |
| Serotype 19A | 96.0 (92.3 to 98.3) | 77.4 (70.9 to 83.0) | 99.5 (97.2 to 100.0) |
| Serotype 19F | 98.5 (95.7 to 99.7) | 96.9 (93.4 to 98.9) | 99.0 (96.4 to 99.9) |
| Serotype 23F | 94.6 (90.5 to 97.3) | 83.0 (77.1 to 87.9) | 96.0 (92.2 to 98.2) |
The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples taken 4 weeks after the booster vaccination.
| percentage of participants | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 100 (92.9 to 100.0) | 96.0 (86.3 to 99.5) | 98.0 (89.2 to 100.0) |
| Serotype 5 | 100 (92.9 to 100.0) | 100 (92.9 to 100.0) | 100 (92.9 to 100.0) |
| Serotype 6A | 100 (92.9 to 100.0) | 55.6 (40.0 to 70.4) | 100 (92.9 to 100.0) |
| Serotype 6B | 100 (92.9 to 100.0) | 98.0 (89.4 to 100.0) | 98.0 (89.4 to 100.0) |
| Serotype 7F | 100 (92.9 to 100.0) | 100 (92.9 to 100.0) | 100 (92.9 to 100.0) |
| Serotype 9V | 100 (92.9 to 100.0) | 100 (92.8 to 100.0) | 100 (92.9 to 100.0) |
| Serotype 14 | 100 (92.9 to 100.0) | 96.0 (86.3 to 99.5) | 100 (92.9 to 100.0) |
| Serotype 19A | 100 (92.9 to 100.0) | 90.0 (78.2 to 96.7) | 100 (92.9 to 100.0) |
| Serotype 19F | 98.0 (89.4 to 100.0) | 98.0 (89.4 to 100.0) | 98.0 (89.4 to 100.0) |
| Serotype 23F | 100 (92.9 to 100.0) | 100 (92.9 to 100.0) | 100 (92.9 to 100.0) |
The seroresponse rate was defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the second primary vaccination dose.
| percentage of participants | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 99.5 (97.5 to 100.0) | 96.2 (92.7 to 98.4) | 100 (98.3 to 100.0) |
| Serotype 5 | 96.8 (93.4 to 98.7) | 92.0 (87.5 to 95.3) | 96.2 (92.7 to 98.4) |
| Serotype 6A | 83.3 (77.7 to 88.1) | 12.8 (8.6 to 18.1) | 91.5 (86.9 to 94.9) |
| Serotype 6B | 84.7 (79.2 to 89.2) | 71.2 (64.6 to 77.2) | 89.0 (84.0 to 92.9) |
| Serotype 7F | 99.5 (97.5 to 100.0) | 97.2 (93.9 to 99.0) | 100 (98.3 to 100.0) |
| Seroytpe 9V | 94.9 (91.1 to 97.4) | 91.0 (86.4 to 94.5) | 98.1 (95.2 to 99.5) |
| Serotype 14 | 98.6 (96.0 to 99.7) | 95.3 (91.5 to 97.7) | 97.2 (93.9 to 99.0) |
| Serotype 19A | 97.7 (94.7 to 99.2) | 75.2 (68.8 to 80.9) | 97.6 (94.6 to 99.2) |
| Serotype 19F | 100 (98.3 to 100.0) | 99.5 (97.4 to 100.0) | 100 (98.3 to 100.0) |
| Serotype 23F | 95.8 (92.2 to 98.1) | 63.2 (56.3 to 69.7) | 89.6 (84.7 to 93.4) |
The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the second primary vaccination dose.
| μg/mL | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 3.63 (3.32 to 3.98) | 1.36 (1.23 to 1.51) | 3.40 (3.10 to 3.74) |
| Serotype 5 | 1.19 (1.10 to 1.28) | 0.87 (0.79 to 0.96) | 1.81 (1.62 to 2.01) |
| Serotype 6A | 1.19 (1.00 to 1.41) | 0.14 (0.13 to 0.16) | 2.62 (2.24 to 3.08) |
| Serotype 6B | 1.82 (1.48 to 2.23) | 0.91 (0.75 to 1.10) | 1.75 (1.49 to 2.07) |
| Serotype 7F | 3.46 (3.09 to 3.88) | 1.73 (1.55 to 1.92) | 4.67 (4.19 to 5.20) |
| Serotype 9V | 1.93 (1.74 to 2.16) | 1.31 (1.17 to 1.46) | 2.56 (2.28 to 2.88) |
| Serotype 14 | 4.03 (3.50 to 4.64) | 2.58 (2.18 to 3.04) | 3.27 (2.70 to 3.96) |
| Serotype 19A | 1.75 (1.57 to 1.96) | 0.65 (0.57 to 0.73) | 4.38 (3.73 to 5.15) |
| Serotype 19F | 5.45 (4.94 to 6.01) | 8.86 (7.71 to 10.17) | 9.06 (7.97 to 10.30) |
| Serotype 23F | 2.21 (1.92 to 2.56) | 0.57 (0.48 to 0.68) | 1.64 (1.39 to 1.93) |
The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA).
| percentage of participants | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 98.0 (89.4 to 100.0) | 73.5 (58.9 to 85.1) | 96.0 (86.3 to 99.5) |
| Serotype 5 | 98.0 (89.4 to 100.0) | 96.0 (86.3 to 99.5) | 100 (92.9 to 100.0) |
| Serotype 6A | 92.0 (80.8 to 97.8) | 10.2 (3.4 to 22.2) | 98.0 (89.4 to 100.0) |
| Serotype 6B | 96.0 (86.3 to 99.5) | 69.4 (54.6 to 81.8) | 92.0 (80.8 to 97.8) |
| Serotype 7F | 100 (92.9 to 100.0) | 100 (92.9 to 100.0) | 100 (92.9 to 100.0) |
| Serotype 9V | 100 (92.5 to 100.0) | 100 (92.9 to 100.0) | 100 (92.9 to 100.0) |
| Serotype 14 | 94.0 (83.5 to 98.8) | 97.9 (88.9 to 100.0) | 90.0 (78.2 to 96.7) |
| Serotype 19A | 91.8 (80.4 to 97.7) | 56.5 (41.1 to 71.1) | 96.0 (86.3 to 99.5) |
| Serotype 19F | 96.0 (86.3 to 99.5) | 95.9 (86.0 to 99.5) | 98.0 (89.4 to 100.0) |
| Serotype 23F | 100 (92.6 to 100.0) | 100 (92.5 to 100.0) | 100 (92.8 to 100.0) |
Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA).
| titer | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 99.67 (71.83 to 138.30) | 26.70 (17.72 to 40.22) | 98.63 (70.61 to 137.78) |
| Serotype 5 | 182.18 (134.53 to 246.70) | 85.09 (58.98 to 122.75) | 291.98 (221.91 to 384.18) |
| Serotype 6A | 400.49 (238.40 to 672.79) | 5.35 (4.04 to 7.08) | 1524.31 (1066.28 to 2179.09) |
| Serotype 6B | 923.86 (589.56 to 1447.73) | 166.74 (88.71 to 313.43) | 920.43 (573.35 to 1477.61) |
| Serotype 7F | 2069.84 (1622.83 to 2639.98) | 1096.84 (853.88 to 1408.93) | 3069.95 (2435.98 to 3868.91) |
| Serotype 9V | 134.50 (87.35 to 207.10) | 58.24 (38.29 to 88.58) | 331.79 (241.48 to 455.89) |
| Serotype 14 | 669.79 (383.93 to 1168.50) | 577.98 (376.06 to 888.33) | 489.56 (224.00 to 1069.94) |
| Serotype 19A | 69.15 (46.95 to 101.85) | 22.40 (13.27 to 37.83) | 324.64 (204.39 to 515.65) |
| Serotype 19F | 381.46 (269.27 to 540.40) | 690.36 (461.10 to 1033.61) | 647.79 (460.50 to 911.24) |
| Serotype 23F | 806.12 (584.18 to 1112.39) | 180.97 (106.19 to 308.44) | 748.96 (458.35 to 1223.84) |
The seroresponse rate was defined as the percentage of infants with serotype-specific IgG concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected immediately prior to the booster vaccination dose.
| percentage of participants | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 50.2 (43.2 to 57.3) | 17.2 (12.3 to 23.2) | 53.4 (46.3 to 60.4) |
| Serotype 5 | 13.7 (9.3 to 19.1) | 16.4 (11.6 to 22.3) | 33.8 (27.4 to 40.8) |
| Serotype 6A | 76.0 (69.6 to 81.6) | 32.7 (26.3 to 39.6) | 70.4 (63.7 to 76.5) |
| Serotype 6B | 89.9 (85.0 to 93.6) | 74.6 (68.1 to 80.4) | 60.7 (53.7 to 67.4) |
| Serotype 7F | 74.5 (68.0 to 80.3) | 65.4 (58.4 to 71.9) | 84.5 (78.8 to 89.1) |
| Serotype 9V | 35.1 (28.6 to 42.1) | 36.1 (29.5 to 43.1) | 37.7 (31.1 to 44.8) |
| Serotype 14 | 69.6 (62.8 to 75.8) | 59.3 (52.2 to 66.1) | 86.3 (80.9 to 90.7) |
| Serotype 19A | 58.1 (51.0 to 65.0) | 54.9 (47.8 to 61.9) | 65.7 (58.7 to 72.2) |
| Serotype 19F | 84.1 (78.4 to 88.8) | 95.1 (91.2 to 97.6) | 80.6 (74.5 to 85.8) |
| Serotype 23F | 46.2 (39.2 to 53.2) | 19.4 (14.3 to 25.5) | 24.9 (19.1 to 31.4) |
The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected immediately prior to the booster vaccination dose.
| μg/mL | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 0.36 (0.33 to 0.41) | 0.16 (0.15 to 0.18) | 0.37 (0.33 to 0.41) |
| Serotype 5 | 0.17 (0.15 to 0.18) | 0.16 (0.14 to 0.17) | 0.24 (0.22 to 0.27) |
| Serotype 6A | 0.62 (0.55 to 0.70) | 0.22 (0.19 to 0.25) | 0.50 (0.45 to 0.56) |
| Serotype 6B | 0.97 (0.87 to 1.08) | 0.56 (0.50 to 0.62) | 0.45 (0.39 to 0.50) |
| Serotype 7F | 0.60 (0.53 to 0.68) | 0.43 (0.39 to 0.48) | 0.72 (0.64 to 0.80) |
| Serotype 9V | 0.25 (0.23 to 0.28) | 0.29 (0.26 to 0.32) | 0.28 (0.25 to 0.31) |
| Serotype 14 | 0.71 (0.60 to 0.83) | 0.48 (0.41 to 0.56) | 1.16 (1.00 to 1.35) |
| Serotype 19A | 0.49 (0.42 to 0.56) | 0.40 (0.35 to 0.45) | 0.53 (0.46 to 0.62) |
| Serotype 19F | 0.83 (0.73 to 0.94) | 1.25 (1.11 to 1.40) | 0.72 (0.63 to 0.83) |
| Serotype 23F | 0.32 (0.27 to 0.37) | 0.16 (0.15 to 0.19) | 0.17 (0.15 to 0.20) |
The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples collected immediately prior to the booster vaccination dose.
| percentage of participants | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 22.4 (11.8 to 36.6) | 16.0 (7.2 to 29.1) | 25.5 (13.9 to 40.3) |
| Serotype 5 | 58.3 (43.2 to 72.4) | 49.0 (34.4 to 63.7) | 63.3 (48.3 to 76.6) |
| Serotype 6A | 76.6 (62.0 to 87.7) | 14.0 (5.8 to 26.7) | 63.8 (48.5 to 77.3) |
| Serotype 6B | 87.5 (74.8 to 95.3) | 62.5 (47.3 to 76.1) | 54.2 (39.2 to 68.6) |
| Serotype 7F | 100 (92.8 to 100.0) | 100 (92.8 to 100.0) | 100 (92.6 to 100.0) |
| Serotype 9V | 100 (92.0 to 100.0) | 100 (91.8 to 100.0) | 100 (92.1 to 100.0) |
| Serotype 14 | 75.5 (61.1 to 86.7) | 52.1 (37.2 to 66.7) | 72.9 (58.2 to 84.7) |
| Serotype 19A | 35.4 (22.2 to 50.5) | 40.8 (27.0 to 55.8) | 63.3 (48.3 to 76.6) |
| Serotype 19F | 60.4 (45.3 to 74.2) | 79.6 (65.7 to 89.8) | 36.7 (23.4 to 51.7) |
| Serotype 23F | 100 (91.8 to 100.0) | 100 (91.6 to 100.0) | 100 (91.6 to 100.0) |
Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples collected immediately prior to the booster vaccination dose.
| titer | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 5.57 (4.56 to 6.80) | 5.19 (4.27 to 6.30) | 5.45 (4.57 to 6.49) |
| Serotype 5 | 12.53 (9.03 to 17.37) | 12.01 (8.28 to 17.43) | 16.03 (10.95 to 23.45) |
| Serotype 6A | 42.59 (26.46 to 68.55) | 6.41 (4.49 to 9.15) | 40.66 (22.34 to 74.00) |
| Serotype 6B | 121.60 (78.09 to 189.36) | 40.08 (25.20 to 63.72) | 32.27 (19.77 to 52.68) |
| Serotype 7F | 1756.80 (1234.91 to 2499.24) | 1725.63 (1206.66 to 2467.79) | 1688.30 (1160.23 to 2456.74) |
| Serotype 9V | 27.60 (15.80 to 48.21) | 27.95 (17.48 to 44.67) | 48.64 (29.08 to 81.36) |
| Serotype 14 | 60.53 (32.55 to 112.55) | 17.67 (10.31 to 30.29) | 62.77 (33.95 to 116.08) |
| Serotype 19A | 13.43 (7.80 to 23.11) | 12.88 (8.25 to 20.12) | 28.20 (16.96 to 46.89) |
| Serotype 19F | 24.09 (13.90 to 41.77) | 57.66 (33.74 to 98.52) | 12.27 (7.34 to 20.50) |
| Serotype 23F | 65.62 (38.19 to 112.74) | 41.99 (23.29 to 75.68) | 81.42 (44.08 to 150.40) |
Booster response was measured by the ratio of IgG GMCs measured at the post-booster visit to those measured 4 weeks after completion of primary vaccinations.
| ratio | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 2.31 (2.10 to 2.55) | 2.09 (1.86 to 2.34) | 1.74 (1.54 to 1.97) |
| Serotype 5 | 1.29 (1.15 to 1.44) | 0.90 (0.81 to 1.01) | 1.15 (1.02 to 1.30) |
| Serotype 6A | 7.86 (6.54 to 9.44) | 4.30 (3.61 to 5.12) | 4.14 (3.49 to 4.91) |
| Serotype 6B | 6.71 (5.48 to 8.21) | 5.32 (4.46 to 6.35) | 8.92 (7.47 to 10.66) |
| Serotype 7F | 1.91 (1.69 to 2.17) | 1.84 (1.64 to 2.05) | 1.36 (1.22 to 1.52) |
| Serotype 9V | 1.76 (1.55 to 1.98) | 1.86 (1.65 to 2.09) | 1.55 (1.34 to 1.79) |
| Serotype 14 | 1.98 (1.69 to 2.33) | 1.93 (1.61 to 2.33) | 2.80 (2.29 to 3.43) |
| Serotype 19A | 4.98 (4.33 to 5.74) | 3.69 (3.08 to 4.42) | 2.69 (2.25 to 3.22) |
| Serotype 19F | 1.98 (1.74 to 2.26) | 1.96 (1.68 to 2.29) | 1.68 (1.46 to 1.94) |
| Serotype 23F | 2.24 (1.95 to 2.58) | 3.67 (3.10 to 4.36) | 3.00 (2.55 to 3.52) |
OPA booster response was measured by the ratio of OPA GMTs measured at the post-booster visit to those measured 4 weeks after completion of primary vaccinations.
| ratio | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Serotype 1 | 6.70 (5.07 to 8.86) | 9.35 (6.50 to 13.46) | 4.45 (2.94 to 6.74) |
| Serotype 5 | 4.91 (3.71 to 6.49) | 5.36 (3.78 to 7.61) | 2.46 (1.86 to 3.25) |
| Serotype 6A | 10.36 (6.54 to 16.41) | 10.12 (4.98 to 20.53) | 3.89 (2.70 to 5.61) |
| Serotype 6B | 4.62 (2.84 to 7.53) | 7.70 (4.40 to 13.46) | 6.54 (4.03 to 10.60) |
| Serotype 7F | 3.51 (2.67 to 4.62) | 4.03 (2.93 to 5.54) | 2.71 (2.08 to 3.53) |
| Serotype 9V | 10.24 (6.36 to 16.50) | 14.90 (9.12 to 24.35) | 7.64 (5.58 to 10.45) |
| Serotype 14 | 4.27 (2.38 to 7.64) | 2.25 (1.32 to 3.83) | 5.73 (2.84 to 11.60) |
| Serotype 19A | 23.79 (15.61 to 36.25) | 12.25 (6.86 to 21.87) | 11.63 (7.59 to 17.81) |
| Serotype 19F | 3.74 (2.47 to 5.65) | 3.30 (2.32 to 4.68) | 3.55 (2.35 to 5.39) |
| Serotype 23F | 3.81 (2.69 to 5.40) | 8.71 (5.63 to 13.45) | 7.41 (4.32 to 12.72) |
Collected over All-cause mortality and SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. Non-serious AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post booster vaccination; approximately 8.5 months overall.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pneumosil | 1/220 (0.5%) | 12/220 (5.5%) | 212/220 (96.4%) |
| Synflorix | 0/220 (0%) | 10/220 (4.5%) | 213/220 (96.8%) |
| Prevenar 13 | 1/220 (0.5%) | 7/220 (3.2%) | 211/220 (95.9%) |
| Event | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| GastroenteritisInfections and infestations | 5/220 | 2/220 | 0/220 |
| BronchiolitisInfections and infestations | 3/220 | 1/220 | 2/220 |
| Periorbital cellulitisInfections and infestations | 0/220 | 3/220 | 2/220 |
| CellulitisInfections and infestations | 1/220 | 0/220 | 2/220 |
| PneumoniaInfections and infestations | 0/220 | 2/220 | 1/220 |
| Infected dermal cystInfections and infestations | 0/220 | 1/220 | 0/220 |
| Meningitis bacterialInfections and infestations | 1/220 | 0/220 | 0/220 |
| Vulval cellulitisInfections and infestations | 1/220 | 0/220 | 0/220 |
| Atrioventricular septal defectCongenital, familial and genetic disorders | 0/220 | 0/220 | 1/220 |
| Dermoid cystCongenital, familial and genetic disorders | 0/220 | 1/220 | 0/220 |
| Event | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 111/220 | 112/220 | 99/220 |
| Irritability postvaccinalGeneral disorders | 105/220 | 110/220 | 101/220 |
| PyrexiaGeneral disorders | 96/220 | 104/220 | 108/220 |
| Vaccination site painGeneral disorders | 70/220 | 83/220 | 61/220 |
| DiarrhoeaGastrointestinal disorders | 52/220 | 58/220 | 45/220 |
| FuruncleInfections and infestations | 52/220 | 40/220 | 39/220 |
| ConjunctivitisInfections and infestations | 29/220 | 42/220 | 36/220 |
| GastroenteritisInfections and infestations | 24/220 | 21/220 | 29/220 |
| Rash papularSkin and subcutaneous tissue disorders | 25/220 | 29/220 | 15/220 |
| Decreased appetiteMetabolism and nutrition disorders | 25/220 | 18/220 | 29/220 |
| Age, Continuous(days) | Pneumosil | Synflorix | Prevenar 13 | Total |
|---|---|---|---|---|
| Mean | 47.3 ± 3.86 | 46.8 ± 3.96 | 46.7 ± 3.74 | 46.9 ± 3.86 |
| Sex: Female, Male(Participants) | Pneumosil | Synflorix | Prevenar 13 | Total |
|---|---|---|---|---|
| Female | 125 | 108 | 109 | 342 |
| Male | 95 | 112 | 111 | 318 |
| Race/Ethnicity, Customized(Participants) | Pneumosil | Synflorix | Prevenar 13 | Total |
|---|---|---|---|---|
| African | 220 | 220 | 220 | 660 |
| Ethnicity(Participants) | Pneumosil | Synflorix | Prevenar 13 | Total |
|---|---|---|---|---|
| Mandinka | 109 | 118 | 124 | 351 |
| Wolof | 21 | 17 | 22 | 60 |
| Fula | 26 | 25 | 25 | 76 |
| Jola | 28 | 31 | 15 | 74 |
| Serahule | 9 | 9 | 9 | 27 |
| Serere | 9 | 8 | 8 | 25 |
| Manjago | 5 | 1 | 4 | 10 |
| Other | 13 | 11 | 13 | 37 |
| Primary Cooking Fuel Source(Participants) | Pneumosil | Synflorix | Prevenar 13 | Total |
|---|---|---|---|---|
| Wood/charcoal | 218 | 219 | 219 | 656 |
| Gas/electricity | 2 | 1 | 1 | 4 |
| Primary Water Source for Cooking/Drinking(Participants) | Pneumosil | Synflorix | Prevenar 13 | Total |
|---|---|---|---|---|
| Private tap, well or borehole | 168 | 180 | 178 | 526 |
| Community tap, well or borehole | 52 | 40 | 42 | 134 |
| Weight(kg) | Pneumosil | Synflorix | Prevenar 13 | Total |
|---|---|---|---|---|
| Mean | 4.64 ± 0.55 | 4.68 ± 0.58 | 4.67 ± 0.65 | 4.66 ± 0.59 |
| Length(cm) | Pneumosil | Synflorix | Prevenar 13 | Total |
|---|---|---|---|---|
| Mean | 55.44 ± 1.91 | 55.48 ± 2.02 | 55.29 ± 2.11 | 55.40 ± 2.02 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2019 to primary completion in Dec 2020, 16 months.
Results were first posted in Apr 2022, 1 year 4 months after primary completion.
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