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CompletedNCT02308540Updated Aug 2, 2019Results posted

Safety and Immunogenicity of a 10 Valent Pneumococcal Conjugate Vaccine (SIILPCV10) in Healthy Adults, Toddlers, Infants

A Phase 1/2 interventional study of SIILPCV10 and Pneumovax 23 in Pneumococcal Disease, sponsored by PATH. Completed at 1 site in Gambia. Open to participants aged 4 Weeks to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-02.

Sponsored by PATH · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
346
Allocation
Randomized
Ages
4 Weeks to 40 Years
Sex
All
01

Study summary

Phase 1/2, Prospective, Single Center, Randomized, ActiveControlled, Double-Blind, Age De-escalation Study to assess the safety and tolerability of SIILPCV10 administered as a single-dose regimen to healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve young adults and PCV-primed toddlers through 4 weeks post vaccination.

Each adult and toddler subject will undergo a total of 4 clinic visits. Each infant subject will undergo a total of 9 scheduled visits. Blood will be collected from all subjects during the screening visit for safety and potential immunological assessments, and 28 days after completion of the vaccination schedule for immunological assessments. For adults, the vaccine was given intramuscularly into the mid-deltoid muscle of nondominant arm using a 24-gauge needle. For toddlers and infants, the vaccine will be given IM into the anterolateral aspect of the left thigh. Blood will be collected from adults and toddlers for safety labs at the Day 7 post-vaccination visit.

Read the detailed description

This was a prospective, single-center, randomized, active-controlled, double-blind, age de escalation study in healthy Gambian PCV-naïve adults (18-40 years old), PCV primed toddlers (12-15 months old) and PCV-naïve infants (6-8 weeks old).

In the adult cohort, at least 34 eligible PCV-naïve adults (18-40 years old) were planned to be randomized into the study to receive a single dose of either SIILPCV10 or Pneumovax 23 in a 1:1 ratio on Day 0 (V1), with stratification by sex (although no fixed proportion of males and females was required in the cohort as a whole).

In the toddler cohort, at least 112 eligible PCV-primed toddlers (12-15 months old) were planned to be randomized into the study to receive a single dose of either SIILPCV10 or Prevenar 13 in a 1:1 ratio on Day 0 (V1).

Each adult and toddler subject underwent a total of 4 clinic visits, including at least 1 screening visit (V0) no more than 14 days prior to Day 0, a vaccination visit on Day 0 (V1), and follow-up clinic visits at 7 (+3) and 28 (+14) days after vaccination (V2 and V3, respectively). A total of 3 blood samples were obtained for laboratory safety and immunogenicity assessments.

In the infant cohort, at least 200 eligible PCV-naïve infants (6 to 8 weeks old) were randomized into the study to receive 3 doses of either SIILPCV10 or Prevenar 13 in a 1:1 ratio along with standard Expanded Program on Immunisation (EPI) vaccinations (pentavalent diphtheria, tetanus, whole-cell pertussis, hepatitis B, and Haemophilus influenzae type b combined vaccine [DTwP-HepB-Hib], oral poliovirus vaccine [OPV], rotavirus vaccine [RV], and inactivated poliovirus vaccine [IPV]).

Each infant subject underwent a total of 9 scheduled visits for the primary series: at least 1 screening visit (V0); 3 primary vaccination visits at 28 (+14)-day intervals (V1, 3, 5); follow-up clinic visits at 7 (+3) days after each primary vaccination (V2, 4, 6); and 2 follow-up visits 28 and 84 days after the last primary vaccination (V7 and V8, respectively). Windows for follow-up and subsequent vaccination visits were calculated based on the actual calendar date of the prior vaccination, rather than relative to the day of randomization. Vaccinations included the blinded PCV study vaccine (SIILPCV10 or Prevenar 13) and the unblinded EPI vaccines (DTwP-HepB-Hib, OPV, RV, and IPV).

A total of 2 blood samples were obtained for the primary series (V0 and V7), with the first sample used for safety laboratory eligibility assessment, and if randomized, for baseline immunogenicity testing. Immunogenicity testing was also done on the second sample.

During the supplemental booster phase, infant subjects underwent 2 additional visits: a fourth (booster) vaccination visit (V9) at ≥ 9 months of age, and a follow-up visit 28 days after the booster dose (V10). The EPI vaccines scheduled for 9 months of age in The Gambia were not given as part of the study. However, study personnel contacted parents of infant subjects to remind them of the need to attend this EPI vaccination visit at the due date to allow for effective scheduling of the subsequent booster. The vaccine (SIILPCV10 or Prevenar 13) was given at least 4 weeks after the routine EPI vaccines given at 9 months of age in The Gambia (measles and rubella, yellow fever, and OPV). Infants who received SIILPCV10 at V9 were offered a booster dose of Prevenar 13 at least 56 days following the SIILPCV10 boost. Immunogenicity testing was performed on 2 additional blood samples collected during the booster phase (V9 and V10).

In the adult and toddler cohorts, on the day of vaccination, a malaria rapid test was performed using a finger prick to rule out parasitemia and a urine pregnancy test was performed (in adult women who were not surgically sterile) to rule out pregnancy before final eligibility was confirmed and randomization occurred. In the infant cohort, on each day of vaccination, a malaria rapid test was performed using a finger prick to rule out parasitemia before vaccination occurred. Any infant showing signs of acute illness or abnormal vital signs on the day of vaccination were not vaccinated until recovery was documented by the study team.

After all vaccinations, subjects were monitored for solicited reactogenicity. All adult and toddler subjects were monitored for AEs at each clinic visit until V3, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs at each clinic visit until V8. For infants who participated in the booster phase of the study, AEs were recorded at V10, and any conditions present at V9 were considered baseline.

SAS software was used to analyze data.

02

Conditions studied

  • Pneumococcal Disease
03

Who can participate

Ages eligible
4 Weeks to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • Healthy adults (18-40 yrs), toddlers (12-15 mo), full term infants (6-8 wks) and ≥ 3.5 kg

      • Able to provide informed consent (for themselves or child)
      • Willing to comply with study requirements and procedures.
      • Toddlers have completed their Gambian infant EPI schedule
      • Infants who have received the birth doses of BCG, HepB and OPV but who have not received any additional vaccines.
      • Infants and toddlers with a weight-to-height Z score of ≥ -2.
      • Subjects resident in the study area with no plans to travel outside the study area during the period of study participation.

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational medicinal product within 90 days prior to randomization and throughout the study.
  • Ingestion of herbal or other traditional local medication within 14 days of randomization.
  • Adults and infants who have previously been vaccinated against S. pneumoniae.
  • History of S. pneumoniae infection confirmed by culture from a normally sterile site.
  • History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
  • History of anaphylactic shock.
  • Screening laboratory test or vital signs outside the normal range.
  • HIV-positive or HbsAg- positive based on testing during screening.
  • Acute illness (moderate or severe) and/or fever (axillary temperature of ≥ 38.0°C for adults or ≥ 37.5°C for toddlers and infants).
  • Use of antibiotics within 5 days of randomization (excluding treatment for malaria).
  • A positive test for malaria at time of screening, which remains positive post treatment when retested at time of randomization (Day 0).
  • Administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study participation.
  • Chronic administration of immunosuppressant or other immune modifying drugs prior to the administration of the study. The use of topical and inhaled glucocorticoids will be permitted.
  • Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or during the study period.
  • History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding.
  • Employee of, or direct descendant of any person employed by the Sponsor, the CRO, the PI, study site personnel, or site.

Adults only

  • Recent history or signs of alcohol or substance abuse.
  • History of major psychiatric disorder.
  • Female adult subjects who are pregnant or breast-feeding. Infants/Toddlers only
  • Family history of suspected primary immunodeficiency in first-degree relative.
  • Had a sibling die suddenly and without apparent other cause or preceding illness in the first year of life.
  • Evidence of a clinically significant congenital abnormality as judged by the PI.
  • Evidence of fetal alcohol syndrome or maternal history of alcohol abuse during pregnancy.
  • History of meningitis, seizures or any neurological disorder.
  • Evidence of exposure to an HIV-positive individual through maternal fetal transmission, breast milk, or other bloodborne mechanisms
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
346 participants (actual)

Study arms

  • Experimental
    Adult SIILPCV10

    Single dose of SIILPCV10 on day 0

    Biological: SIILPCV10

  • Active comparator
    Adult Pneumovax 23

    Single dose of Pneumovax 23 on day 0

    Biological: Pneumovax 23

  • Experimental
    Toddler SIILPCV10

    Single dose of SIILPCV10 on day 0

    Biological: SIILPCV10

  • Active comparator
    Toddler Prevenar 13

    Single dose of Prevenar 13 on day 0

    Biological: Prevenar 13

  • Experimental
    Infants SIIL PCV10

    A three-dose series of SIILPCV10 on day 0, day 28, and day 56

    Biological: SIILPCV10

  • Active comparator
    Infants Prevenar 13

    A three-dose series of Prevenar 13 on day 0, day 28, and day 56

    Biological: Prevenar 13

  • Experimental
    Infant Booster Dose SIILPCV 10

    One dose of SIILPCV 10 at 9 months of age

    Biological: SIILPCV10

  • Active comparator
    Infant Booster Dose Prevenar 13

    One dose of SIILPCV 10 at 9 months of age

    Biological: Prevenar 13

Interventions

  • BiologicalSIILPCV10

    10-valent Pneumococcal Conjugate Vaccine (SIILPCV10) at a dosage of 2 µg for each serotype polysaccharide, except 4 µg for 6B serotype, conjugated to a carrier protein (CRM197), with adjuvant (aluminum phosphate \[alum\]) and preservative (thiomersal).

  • BiologicalPneumovax 23

    23-valent Pneumococcal Polysaccharide Vaccine (Pneumovax 23; MSD Pharmaceuticals) for the adult cohort.

    Also known as: 23-valent Pneumococcal Polysaccharide Vaccine

  • BiologicalPrevenar 13

    13-valent Pneumococcal Conjugate Vaccine (Prevenar 13; Pfizer-Wyeth) for the toddler and infant cohorts

    Also known as: 13-valent Pneumococcal Conjugate Vaccine

05

What researchers measure

Primary outcomes

  1. Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity

    Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on Day 7 (+3) following each vaccination (Visit 2 for adults and toddlers).

    Time frame: 7 days

  2. Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1

    Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).

    Time frame: 7 days

  3. Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2

    Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).

    Time frame: 7 days

  4. Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3

    Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).

    Time frame: 7 days

  5. Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers

    Reported here are only adverse events occurring in 5% or more of subjects; unless specifically stated, AEs were regarded as unrelated.

    Time frame: 28 days

  6. Occurrence, Severity and Relatedness of All Adverse Events in Infants

    Reported here are adverse events that occurred in 5% or more of the infant cohort. Booster dose safety results are reported separately. Unless stated, AEs are regarded as unrelated.

    Time frame: 12 weeks post last vaccination

  7. Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers

    Blood samples were collected for safety hematology and clinical chemistry evaluations, organ function tests, and, for adults, coagulation panel evaluation. Laboratory assessments were only performed at baseline for infants. Testing for HIV was undertaken only following pre-test counseling of the subject/subject's parent as to the implications of the test result. Post test counseling was also undertaken, and on the basis of a positive result the subject and subject's parents would have been referred on for HIV care according to normal local practice in The Gambia.

    Time frame: 7 days after vaccination

Secondary outcomes

  1. Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults

    Serum samples were collected 28 days after the vaccination in adults to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.

    Time frame: 4 weeks after vaccination

  2. Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers

    Serum samples were collected 28 days after vaccination for toddlers to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.

    Time frame: 4 weeks after vaccination

  3. Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants

    Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.

    Time frame: 4 weeks after the third dose

  4. Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype

    Serum samples were collected before the first vaccination and 28 days after the last vaccination for adults and toddlers and 28 days after the completion of the primary series for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10. Blood samples were also collected for immunogenicity testing before and 28 days after the booster dose for infants. Baseline serum samples for infants and adults were not assayed. The IgG concentration was also determined for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) in sera from the infant cohort. If there were limitations to blood volumes, appropriate subsets and priorities for immune testing were established with the immunology laboratories to ensure measurements were unbiased and representative of the entire cohort.

    Time frame: 4 weeks after vaccination (28 days)

  5. Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype

    Seroresponse was defined as ≥ 0.35 µg/mL. In infants, serum samples were collected 28 days after receipt of three doses of the vaccine to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.

    Time frame: 4 weeks after third dose

  6. Functional Antibody (OPA) Geometric Mean Titers

    The functional activity of the IgG response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant and toddler cohorts and all adult subjects in the same serum samples collected 28 days after the last vaccinations. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham.

    Time frame: 4 weeks after last vaccination

  7. Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype

    The functional activity of the immune response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant cohort in the same serum samples collected 28 days after the completion of the primary series. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham.

    Time frame: 84 days

  8. Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components

    Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) . Seroresponse was defined as equal to or greater concentrations for: * Diptheria toxoid: 0.1 IU/mL * Hepatitis B: 10 milli-International unit (mIU) /mL * Hib: 0.15 mcg/mL * Tetanus toxoid: 0.1 IU/mL

    Time frame: 84 days

Other outcomes

  1. Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity

    Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 30 (± 10) minutes following booster vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following the vaccination

    Time frame: 7 days

  2. Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity

    Unsolicited adverse events following a booster dose of SIILPCV10 occurring in 5% or greater of study participants. Unless specifically stated, AEs are considered unrelated.

    Time frame: 4 weeks (28 days)

  3. Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose

    Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing at 4 weeks post vaccination 3, and before and 28 days after the booster dose for infants.

    Time frame: 4 weeks (28 days)

  4. Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose

    Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing before and 28 days after the booster dose for infants.

    Time frame: 4 weeks (28 days)

  5. Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose

    Defined as the ratio of IgG geometric mean concentration (GMC) measured prior to the infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 20 weeks but may have been longer.

    Time frame: 20-23 weeks

  6. Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose

    Defined as the ratio of IgG geometric mean concentration (GMC) measured 4 weeks post-infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 24 weeks but may have been longer.

    Time frame: 24-26 weeks

06

Results

Posted Aug 2, 2019

Participant flow

Participant flow — Overall Study
MilestoneAdult SIILPCV10Adult Pneumovax 23Toddler SIILPCV10Toddler Prevenar 13Infants SIILPCV10Infants Prevenar 13
Started17175656100100
Randomized17175656100100
Vaccinated17175656100100
Completed1717565610099
Not completed000001
Withdrew: Lost to follow-up000001

Outcome measures

PrimaryAdult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity

Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on Day 7 (+3) following each vaccination (Visit 2 for adults and toddlers).

Time frame:
7 days
Reported as:
Count of participants · Participants
Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity
ParticipantsAdults--PCV10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13
Temperature above 37.5 C — Grade 10056
Temperature above 37.5 C — Grade 20024
Temperature above 37.5 C — Grade 30021
Temperature above 37.5 C — Grade 40000
Temperature above 37.5 C — None reported/normal (temp)17174745
Rash — Grade 10010
Rash — Grade 20010
Rash — Grade 30000
Rash — Grade 40000
Rash — None reported/normal (temp)17175456
Fatigue/Malaise/Drowsiness (inf/tod) — Grade 11250
Fatigue/Malaise/Drowsiness (inf/tod) — Grade 20010
Fatigue/Malaise/Drowsiness (inf/tod) — Grade 30000
Fatigue/Malaise/Drowsiness (inf/tod) — Grade 40000
Fatigue/Malaise/Drowsiness (inf/tod) — None reported/normal (temp)16155056
Myalgia/Arthralgia (adults only) — Grade 10000
Myalgia/Arthralgia (adults only) — Grade 20000
Myalgia/Arthralgia (adults only) — Grade 30000
Myalgia/Arthralgia (adults only) — Grade 40000
Myalgia/Arthralgia (adults only) — None reported/normal (temp)17175656
Headache (adults only) — Grade 13400
Headache (adults only) — Grade 20000
Headache (adults only) — Grade 30000
Headache (adults only) — Grade 40000
Headache (adults only) — None reported/normal (temp)14135656
Decreased Appetite — Grade 10076
Decreased Appetite — Grade 20000
Decreased Appetite — Grade 30000
Decreased Appetite — Grade 40000
Decreased Appetite — None reported/normal (temp)17174950
Pain (adults only) — Grade 110900
Pain (adults only) — Grade 20000
Pain (adults only) — Grade 30000
Pain (adults only) — Grade 40000
Pain (adults only) — None reported/normal (temp)785656
Tenderness — Grade 1681011
Tenderness — Grade 20021
Tenderness — Grade 30000
Tenderness — Grade 40000
Tenderness — None reported/normal (temp)1194444
Redness — Grade 10012
Redness — Grade 20000
Redness — Grade 30000
Redness — Grade 40000
Redness — None reported/normal (temp)17175554
Swelling — Grade 10041
Swelling — Grade 20020
Swelling — Grade 30000
Swelling — Grade 40000
Swelling — None reported/normal (temp)17175055
Irritability (toddlers only) — Grade 10043
Irritability (toddlers only) — Grade 20000
Irritability (toddlers only) — Grade 30000
Irritability (toddlers only) — Grade 40000
Irritability (toddlers only) — None reported/normal (temp)17175253
PrimaryInfant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1

Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).

Time frame:
7 days
Reported as:
Count of participants · Participants
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1
ParticipantsInfant--PCV 10Infant--Prevenar 13
Temperature — Grade 12934
Temperature — Grade 2117
Temperature — None6059
Irritability — Grade 13329
Irritability — Grade 242
Irritability — None6369
Drowsiness — Grade 181
Drowsiness — Grade 201
Drowsiness — None9298
Decreased appetite — Grade 1101
Decreased appetite — Grade 201
Decreased appetite — None9098
Tenderness at injection site — Grade 11512
Tenderness at injection site — Grade 245
Tenderness at injection site — None8183
Erythema/redness at injection site — Grade 118
Erythema/redness at injection site — Grade 201
Erythema/redness at injection site — None9991
Induration/swelling at injection site — Grade 148
Induration/swelling at injection site — Grade 202
Induration/swelling at injection site — None9690
PrimaryInfant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2

Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).

Time frame:
7 days
Reported as:
Count of participants · Participants
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2
ParticipantsInfant--PCV 10Infant--Prevenar 13
Temperature — Grade 11113
Temperature — Grade 276
Temperature — None8281
Irritability — Grade 13530
Irritability — Grade 253
Irritability — None6067
Drowsiness — Grade 161
Drowsiness — Grade 201
Drowsiness — None9498
Decreased appetite — Grade 198
Decreased appetite — Grade 210
Decreased appetite — None9092
Tenderness at injection site — Grade 11826
Tenderness at injection site — Grade 221
Tenderness at injection site — None8073
Erythema/redness at injection site — Grade 104
Erythema/redness at injection site — Grade 211
Erythema/redness at injection site — None9995
Induration/swelling at injection site — Grade 1716
Induration/swelling at injection site — Grade 212
Induration/swelling at injection site — None9282
PrimaryInfant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3

Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 60 (± 15) minutes following primary vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants).

Time frame:
7 days
Reported as:
Count of participants · Participants
Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3
ParticipantsInfant--PCV 10Infant--Prevenar 13
Temperature — Grade 11516
Temperature — Grade 244
Temperature — Grade 310
Temperature — None8080
Irritability — Grade 13337
Irritability — Grade 234
Irritability — Grade 310
Irritability — None6359
Drowsiness — Grade 123
Drowsiness — Grade 200
Drowsiness — Grade 300
Drowsiness — None9897
Decreased appetite — Grade 169
Decreased appetite — Grade 212
Decreased appetite — Grade 300
Decreased appetite — None9389
Tenderness at injection site — Grade 12119
Tenderness at injection site — Grade 202
Tenderness at injection site — Grade 300
Tenderness at injection site — None7979
Erythema/redness at injection site — Grade 133
Erythema/redness at injection site — Grade 200
Erythema/redness at injection site — Grade 300
Erythema/redness at injection site — None9797
Induration/swelling at injection site — Grade 11113
Induration/swelling at injection site — Grade 221
Induration/swelling at injection site — Grade 300
Induration/swelling at injection site — None8786
PrimaryOccurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers

Reported here are only adverse events occurring in 5% or more of subjects; unless specifically stated, AEs were regarded as unrelated.

Time frame:
28 days
Reported as:
Count of participants · Participants
Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers
ParticipantsAdults--PCV 10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13
Microcytic Anemia (Toddlers) — Mild0013
Microcytic Anemia (Toddlers) — Moderate0001
Microcytic Anemia (Toddlers) — Severe0020
Microcytic Anemia (Toddlers) — None17175352
Diarrhea (Both) — Mild0175
Diarrhea (Both) — Moderate0001
Diarrhea (Both) — Severe0000
Diarrhea (Both) — None17164950
Diarrhea--related — Mild0010
Diarrhea--related — Moderate0000
Diarrhea--related — Severe0000
Diarrhea--related — None17175556
Pyrexia (Toddlers) — Mild0012
Pyrexia (Toddlers) — Moderate0012
Pyrexia (Toddlers) — Severe0000
Pyrexia (Toddlers) — None17175452
Furuncle (Toddlers) — Mild0015
Furuncle (Toddlers) — Moderate0000
Furuncle (Toddlers) — Severe0000
Furuncle (Toddlers) — None17175551
Gastroenteritis (Toddlers) — Mild0024
Gastroenteritis (Toddlers) — Moderate0001
Gastroenteritis (Toddlers) — Severe0010
Gastroenteritis (Toddlers) — None17175351
Nasopharyngitis (Toddlers) — Mild0075
Nasopharyngitis (Toddlers) — Moderate0000
Nasopharyngitis (Toddlers) — Severe0000
Nasopharyngitis (Toddlers) — None17174951
Tinea infection (Toddlers) — Mild0041
Tinea infection (Toddlers) — Moderate0000
Tinea infection (Toddlers) — Severe0000
Tinea infection (Toddlers) — None17175255
Upper respiratory infection (Both) — Mild1167
Upper respiratory infection (Both) — Moderate0022
Upper respiratory infection (Both) — Severe0000
Upper respiratory infection (Both) — None16164847
Abdominal pain (Adults) — Mild1300
Abdominal pain (Adults) — Moderate0300
Abdominal pain (Adults) — Severe0000
Abdominal pain (Adults) — None16115656
Food poisoning (Adults) — Mild0000
Food poisoning (Adults) — Moderate0100
Food poisoning (Adults) — Severe0000
Food poisoning (Adults) — None17165656
Toothache (Adults) — Mild0100
Toothache (Adults) — Moderate1100
Toothache (Adults) — Severe0000
Toothache (Adults) — None16155656
Axillary pain (Adults) — Mild1100
Axillary pain (Adults) — Moderate0000
Axillary pain (Adults) — Severe0000
Axillary pain (Adults) — None16165656
Axillary pain--related — Mild1100
Axillary pain--related — Moderate0000
Axillary pain--related — Severe0000
Axillary pain--related — None16165656
Vaccination site pruritis (Both) — Mild0101
Vaccination site pruritis (Both) — Moderate0000
Vaccination site pruritis (Both) — Severe0000
Vaccination site pruritis (Both) — None17165655
Vaccination site pruritis--related — Mild0101
Vaccination site pruritis--related — Moderate0000
Vaccination site pruritis--related — Severe0000
Vaccination site pruritis--related — None17165655
Vaccination site swelling (Adults) — Mild0100
Vaccination site swelling (Adults) — Moderate0000
Vaccination site swelling (Adults) — Severe0000
Vaccination site swelling (Adults) — None17165656
Vaccination site swelling--related — Mild0100
Vaccination site swelling--related — Moderate0000
Vaccination site swelling--related — Severe0000
Vaccination site swelling--related — None17165656
Abscess (Adults) — Mild0000
Abscess (Adults) — Moderate0100
Abscess (Adults) — Severe0000
Abscess (Adults) — None17165656
Otitis media (Adults) — Mild1000
Otitis media (Adults) — Moderate0000
Otitis media (Adults) — Severe0000
Otitis media (Adults) — None16175656
Tonsillitis (Adults) — Mild0100
Tonsillitis (Adults) — Moderate0000
Tonsillitis (Adults) — Severe0000
Tonsillitis (Adults) — None17165656
Urinary tract infection (Adults) — Mild0000
Urinary tract infection (Adults) — Moderate0100
Urinary tract infection (Adults) — Severe0000
Urinary tract infection (Adults) — None17165656
Dizziness (Adults) — Mild0100
Dizziness (Adults) — Moderate1000
Dizziness (Adults) — Severe0000
Dizziness (Adults) — None16165656
Dizziness--related — Mild0100
Dizziness--related — Moderate0000
Dizziness--related — Severe0000
Dizziness--related — None17165656
PrimaryOccurrence, Severity and Relatedness of All Adverse Events in Infants

Reported here are adverse events that occurred in 5% or more of the infant cohort. Booster dose safety results are reported separately. Unless stated, AEs are regarded as unrelated.

Time frame:
12 weeks post last vaccination
Reported as:
Count of participants · Participants
Occurrence, Severity and Relatedness of All Adverse Events in Infants
ParticipantsInfant--PCV 10Infant--Prevenar 13
Diarrhea2919
Pyrexia93
Vaccination site reaction (routine vaccines)114
Vaccination site swelling (routine vaccines)5561
Vaccination site swelling (study vaccine)16
Bronchiolitis56
Conjunctivitis2719
Furuncle86
Gastroenteritis1310
Impetigo54
Nasopharyngitis1917
Otitis media--acute54
Pneumonia88
Tinea infection3121
Upper respiratory tract infection6448
Cough127
Diaper dermatitis45
Papular rash58
Serious Adverse Event (SAE): Diarrhea10
SAE: Gastroenteritis10
SAE: Bronchiolitis31
SAE: Atypical pneumonia10
SAE: Sepsis01
PrimaryOccurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers

Blood samples were collected for safety hematology and clinical chemistry evaluations, organ function tests, and, for adults, coagulation panel evaluation. Laboratory assessments were only performed at baseline for infants. Testing for HIV was undertaken only following pre-test counseling of the subject/subject's parent as to the implications of the test result. Post test counseling was also undertaken, and on the basis of a positive result the subject and subject's parents would have been referred on for HIV care according to normal local practice in The Gambia.

Time frame:
7 days after vaccination
Reported as:
Count of participants · Participants
Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers
ParticipantsAdult SIILPCV10Adult Pneumovax 23Toddler SIILPCV10Toddler Prevenar 13
Decreased WBCs--not related — Mild0000
Decreased WBCs--not related — Moderate1000
Decreased WBCs--not related — Severe0100
Decreased WBCs--not related — None16165656
Decreased WBCs--vaccine related — Mild0000
Decreased WBCs--vaccine related — Moderate0100
Decreased WBCs--vaccine related — Severe0000
Decreased WBCs--vaccine related — None17165656
Increased WBCs--not related — Mild0000
Increased WBCs--not related — Moderate0011
Increased WBCs--not related — Severe0000
Increased WBCs--not related — None17175555
Increased WBCs--vaccine related — Mild0000
Increased WBCs--vaccine related — Moderate0010
Increased WBCs--vaccine related — Severe0000
Increased WBCs--vaccine related — None17175556
Decreased hemoglobin--not related — Mild0000
Decreased hemoglobin--not related — Moderate0000
Decreased hemoglobin--not related — Severe00510
Decreased hemoglobin--not related — None17175146
Decreased hemoglobin--vaccine related — Mild0000
Decreased hemoglobin--vaccine related — Moderate0000
Decreased hemoglobin--vaccine related — Severe0000
Decreased hemoglobin--vaccine related — None17175656
Increased ALT--not related — Mild0000
Increased ALT--not related — Moderate0000
Increased ALT--not related — Severe0000
Increased ALT--not related — None17175656
Increased ALT--vaccine related — Mild0010
Increased ALT--vaccine related — Moderate0000
Increased ALT--vaccine related — Severe0000
Increased ALT--vaccine related — None17175556
Decreased platelets--not related — Mild0000
Decreased platelets--not related — Moderate0000
Decreased platelets--not related — Severe0000
Decreased platelets--not related — None17175656
Decreased platelets--vaccine related — Mild0001
Decreased platelets--vaccine related — Moderate0000
Decreased platelets--vaccine related — Severe0000
Decreased platelets--vaccine related — None17175655
SecondaryGeometric Mean Concentration of Immunoglobulin G (IgG) for Adults

Serum samples were collected 28 days after the vaccination in adults to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.

Time frame:
4 weeks after vaccination
Reported as:
Geometric mean · µg/mL
Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults
µg/mLAdults--PCV 10Adults--Pneumovax 23
PnC-IgG-ELISA type 13.96 (2.51 to 6.24)12.79 (8.34 to 19.61)
PnC-IgG-ELISA type 53.56 (2.11 to 6.01)4.80 (3.07 to 7.51)
PnC-IgG-ELISA type 6A17.09 (9.64 to 30.29)3.64 (2.59 to 5.12)
PnC-IgG-ELISA type 6B26.87 (15.24 to 47.36)12.12 (8.12 to 18.07)
PnC-IgG-ELISA type 7F4.62 (3.44 to 6.20)6.07 (4.10 to 9.0)
PnC-IgG-ELISA type 9V4.92 (3.45 to 7.03)8.73 (6.70 to 11.37)
PnC-IgG-ELISA type 1448.23 (31.60 to 73.62)44.78 (33.13 to 60.52)
PnC-IgG-ELISA type 19A19.47 (12.13 to 31.25)11.20 (6.26 to 20.05)
PnC-IgG-ELISA type 19F20.72 (14.62 to 29.37)12.38 (7.53 to 20.37)
PnC-IgG-ELISA type 23F10.09 (6.26 to 16.24)8.95 (5.61 to 14.28)
Statistical analysis
  • Adults--PCV 10 vs Adults--Pneumovax 23 · t-test, 2 sided · p = 0.0025 · Pn igg type 1 gmc ratio: 0.31 · 90% CI 0.17 to 0.57
  • Adults--PCV 10 vs Adults--Pneumovax 23 · t-test, 2 sided · p = 0.4540 · Pn igg type 5 gmc ratio: 0.74 · 90% CI 0.38 to 1.45
  • Adults--PCV 10 vs Adults--Pneumovax 23 · t-test, 2 sided · p = 0.0003 · Pn igg type 6a gmc ratio: 4.69 · 90% CI 2.46 to 8.94
  • Adults--PCV 10 vs Adults--Pneumovax 23 · t-test, 2 sided · p = 0.0460 · Pn igg type 6b gmc ratio: 2.22 · 90% CI 1.16 to 4.24
  • Adults--PCV 10 vs Adults--Pneumovax 23 · t-test, 2 sided · p = 0.3365 · Pn igg type 7f gmc ratio: 0.76 · 90% CI 0.47 to 1.22
  • Adults--PCV 10 vs Adults--Pneumovax 23 · t-test, 2 sided · p = 0.0313 · Pn igg type 9v gmc ratio: 0.56 · 90% CI 0.37 to 0.87
  • Adults--PCV 10 vs Adults--Pneumovax 23 · t-test, 2 sided · p = 0.8060 · Pn igg type 14 gmc ratio: 1.08 · 90% CI 0.65 to 1.79
  • Adults--PCV 10 vs Adults--Pneumovax 23 · t-test, 2 sided · p = 0.2044 · Pn igg type 19a gmc ratio: 1.74 · 90% CI 0.84 to 3.58
  • Adults--PCV 10 vs Adults--Pneumovax 23 · t-test, 2 sided · p = 0.1490 · Pn igg type 19f gmc ratio: 1.67 · 90% CI 0.93 to 3.02
  • Adults--PCV 10 vs Adults--Pneumovax 23 · t-test, 2 sided · p = 0.7565 · Pn igg type 23f gmc ratio: 1.13 · 90% CI 0.59 to 2.15
SecondaryGeometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers

Serum samples were collected 28 days after vaccination for toddlers to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.

Time frame:
4 weeks after vaccination
Reported as:
Geometric mean · µg/mL
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers
µg/mLToddler--PCV 10Toddler--Prevenar 13
PnC-IgG-ELISA type 1: Baseline0.77 (0.46 to 1.36)0.92 (0.72 to 1.26)
PnC-IgG-ELISA type 1: Post-vaccination4.59 (4.03 to 5.67)6.09 (4.93 to 10.17)
PnC-IgG-ELISA type 5: Baseline0.60 (0.36 to 1.04)0.42 (0.32 to 0.51)
PnC-IgG-ELISA type 5: Post-vaccination2.30 (1.67 to 3.48)3.35 (2.63 to 5.03)
PnC-IgG-ELISA type 6A: Baseline1.40 (0.88 to 2.67)1.29 (0.97 to 1.72)
PnC-IgG-ELISA type 6A: Post-vaccination13.33 (10.15 to 20.81)15.83 (12.52 to 25.12)
PnC-IgG-ELISA type 6B: Baseline2.02 (1.29 to 3.42)1.95 (1.41 to 2.55)
PnC-IgG-ELISA type 6B: Post-vaccination15.77 (12.20 to 22.43)19.16 (15.81 to 28.72)
PnC-IgG-ELISA type 7F: Baseline1.49 (0.96 to 2.10)1.46 (0.99 to 1.86)
PnC-IgG-ELISA type 7F: Post-vaccination9.17 (7.69 to 11.64)12.35 (9.41 to 18.55)
PnC-IgG-ELISA type 9V: Baseline0.53 (0.31 to 0.86)0.41 (0.28 to 0.51)
PnC-IgG-ELISA type 9V: Post-vaccination2.35 (1.69 to 3.25)3.90 (2.79 to 5.95)
PnC-IgG-ELISA type 14: Baseline2.89 (1.60 to 4.40)2.47 (1.70 to 3.80)
PnC-IgG-ELISA type 14: Post-vaccination14.55 (9.29 to 20.60)8.28 (6.49 to 12.55)
PnC-IgG-ELISA type 19A: Baseline1.17 (0.63 to 1.97)0.57 (0.34 to 0.72)
PnC-IgG-ELISA type 19A: Post-vaccination9.76 (7.23 to 12.18)13.68 (7.12 to 20.02)
PnC-IgG-ELISA type 19F: Baseline1.75 (0.85 to 3.43)0.97 (0.65 to 1.58)
PnC-IgG-ELISA type 19F: Post-vaccination9.75 (7.76 to 12.26)12.87 (9.08 to 20.75)
PnC-IgG-ELISA type 23F: Baseline0.71 (0.39 to 1.32)0.63 (0.44 to 1.05)
PnC-IgG-ELISA type 23F: Post-vaccination6.84 (4.76 to 10.03)10.49 (8.21 to 18.16)
Statistical analysis
  • Toddler--PCV 10 vs Toddler--Prevenar 13 · Two-tailed from z-test · p = 0.2653 · Pn igg type 1 gmc ratio: 0.75 · 90% CI 0.54 to 1.31
  • Toddler--PCV 10 vs Toddler--Prevenar 13 · Two-tailed from z-test · p = 0.2059 · Pn igg type 5 gmc ratio: 0.69 · 90% CI 0.45 to 1.20
  • Toddler--PCV 10 vs Toddler--Prevenar 13 · Two-tailed from z-test · p = 0.5664 · Pn igg type 6a gmc ratio: 0.84 · 90% CI 0.55 to 1.54
  • Toddler--PCV 10 vs Toddler--Prevenar 13 · Two-tailed from z-test · p = 0.4456 · Pn igg type 6b gmc ratio: 0.82 · 90% CI 0.57 to 1.31
  • Toddler--PCV 10 vs Toddler--Prevenar 13 · Two-tailed from z-test · p = 0.2189 · Pn igg type 7f gmc ratio: 0.74 · 90% CI 0.52 to 1.14
  • Toddler--PCV 10 vs Toddler--Prevenar 13 · Two-tailed from z-test · p = 0.0970 · Pn igg type 9v gmc ratio: 0.60 · 90% CI 0.38 to 1.03
  • Toddler--PCV 10 vs Toddler--Prevenar 13 · Two-tailed from z-test · p = 0.0713 · Pn igg type 14 gmc ratio: 1.76 · 90% CI 1.02 to 2.79
  • Toddler--PCV 10 vs Toddler--Prevenar 13 · Two-tailed from z-test · p = 0.3443 · Pn igg type 19a gmc ratio: 0.71 · 90% CI 0.42 to 1.35
  • Toddler--PCV 10 vs Toddler--Prevenar 13 · Two-tailed from z-test · p = 0.3278 · Pn igg type 19f gmc ratio: 0.76 · 90% CI 0.48 to 1.23
  • Toddler--PCV 10 vs Toddler--Prevenar 13 · Two-tailed from z-test · p = 0.2039 · Pn igg type 23f gmc ratio: 0.65 · 90% CI 0.40 to 1.16
SecondaryGeometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants

Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.

Time frame:
4 weeks after the third dose
Reported as:
Geometric mean · µg/mL
Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants
µg/mLInfant--PCV 10Infant--Prevenar 13
PnC-IgG-ELISA type 12.99 (2.61 to 3.43)3.38 (3.02 to 3.78)
PnC-IgG-ELISA type 52.09 (1.86 to 2.36)1.74 (1.53 to 1.98)
PnC-IgG-ELISA type 6A1.02 (0.83 to 1.27)1.82 (1.53 to 2.17)
PnC-IgG-ELISA type 6B1.57 (1.28 to 1.92)3.64 (3.01 to 4.42)
PnC-IgG-ELISA type 7F2.19 (1.89 to 2.53)3.88 (3.44 to 4.38)
PnC-IgG-ELISA type 9V1.07 (0.93 to 1.23)2.19 (1.91 to 2.50)
PnC-IgG-ELISA type 144.96 (4.20 to 5.87)4.47 (3.62 to 5.53)
PnC-IgG-ELISA type 19A1.49 (1.26 to 1.76)5.20 (4.37 to 6.20)
PnC-IgG-ELISA type 19F3.87 (3.35 to 4.49)5.38 (4.79 to 6.05)
PnC-IgG-ELISA type 23F1.56 (1.32 to 1.83)2.68 (2.28 to 3.15)
Statistical analysis
  • Infant--PCV 10 vs Infant--Prevenar 13 · t-test, 2 sided · p = 0.2550 · Pn igg type 1 gmc ratio: 0.89 · 90% CI 0.74 to 1.06
  • Infant--PCV 10 vs Infant--Prevenar 13 · t-test, 2 sided · p = 0.0865 · Pn igg type 5 gmc ratio: 1.20 · 90% CI 1.01 to 1.43
  • Infant--PCV 10 vs Infant--Prevenar 13 · t-test, 2 sided · p = 0.0006 · Pn igg type 6a gmc ratio: 0.56 · 90% CI 0.43 to 0.74
  • Infant--PCV 10 vs Infant--Prevenar 13 · t-test, 2 sided · p = <0.0001 · Pn igg type 6b gmc ratio: 0.43 · 90% CI 0.33 to 0.57
  • Infant--PCV 10 vs Infant--Prevenar 13 · t-test, 2 sided · p = <0.0001 · Pn igg type 7f gmc ratio: 0.56 · 90% CI 0.47 to 0.68
  • Infant--PCV 10 vs Infant--Prevenar 13 · t-test, 2 sided · p = <0.0001 · Pn igg type 9v gmc ratio: 0.49 · 90% CI 0.41 to 0.59
  • Infant--PCV 10 vs Infant--Prevenar 13 · t-test, 2 sided · p = 0.5234 · Pn igg type 14 gmc ratio: 1.11 · 90% CI 0.85 to 1.45
  • Infant--PCV 10 vs Infant--Prevenar 13 · t-test, 2 sided · p = <0.0001 · Pn igg type 19a gmc ratio: 0.29 · 90% CI 0.22 to 0.36
  • Infant--PCV 10 vs Infant--Prevenar 13 · t-test, 2 sided · p = 0.0040 · Pn igg type 19f gmc ratio: 0.72 · 90% CI 0.60 to 0.87
  • Infant--PCV 10 vs Infant--Prevenar 13 · t-test, 2 sided · p = 0.0001 · Pn igg type 23f gmc ratio: 0.58 · 90% CI 0.46 to 0.73
SecondaryGeometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype

Serum samples were collected before the first vaccination and 28 days after the last vaccination for adults and toddlers and 28 days after the completion of the primary series for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10. Blood samples were also collected for immunogenicity testing before and 28 days after the booster dose for infants. Baseline serum samples for infants and adults were not assayed. The IgG concentration was also determined for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) in sera from the infant cohort. If there were limitations to blood volumes, appropriate subsets and priorities for immune testing were established with the immunology laboratories to ensure measurements were unbiased and representative of the entire cohort.

Time frame:
4 weeks after vaccination (28 days)
Reported as:
Geometric mean · fold change
Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype
fold changeToddler--PCV 10Toddler--Prevenar 13
PnC-IgG-ELISA type 15.99 (3.94 to 10.12)6.59 (5.06 to 11.10)
PnC-IgG-ELISA type 53.82 (2.67 to 6.67)8.00 (6.79 to 12.16)
PnC-IgG-ELISA type 6A9.91 (6.14 to 19.88)12.31 (9.81 to 20.31)
PnC-IgG-ELISA type 6B7.79 (5.02 to 14.78)9.82 (8.12 to 15.03)
PnC-IgG-ELISA type 7F6.16 (4.68 to 9.94)8.44 (6.83 to 13.90)
PnC-IgG-ELISA type 9V4.43 (3.30 to 6.93)9.58 (7.81 to 15.35)
PnC-IgG-ELISA type 145.04 (3.52 to 7.42)3.35 (2.41 to 5.12)
PnC-IgG-ELISA type 19A7.89 (4.56 to 15.32)24.17 (18.51 to 36.37)
PnC-IgG-ELISA type 19F5.73 (3.24 to 13.28)13.26 (9.35 to 21.82)
PnC-IgG-ELISA type 23F9.67 (6.11 to 17.18)16.54 (12.53 to 28.13)
SecondaryNumber and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype

Seroresponse was defined as ≥ 0.35 µg/mL. In infants, serum samples were collected 28 days after receipt of three doses of the vaccine to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.

Time frame:
4 weeks after third dose
Reported as:
Count of participants · Participants
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype
ParticipantsInfant--PCV 10Infant--Prevenar 13
Pn-IgG-ELISA type 199100
Pn-IgG-ELISA type 510097
Pn-IgG-ELISA type 6A7991
Pn-IgG-ELISA type 6B8993
Pn-IgG-ELISA type 7F97100
Pn-IgG-ELISA type 9V9497
Pn-IgG-ELISA type 149896
Pn-IgG-ELISA type 19A9294
Pn-IgG-ELISA type 19F9997
Pn-IgG-ELISA type 23F9197
Statistical analysis
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for type 1: -1.0 · 90% CI -5.13 to 2.66
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for type 5: 3.0 · 90% CI -1.10 to 7.95
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for type 6a: -12.0 · 90% CI -20.94 to -2.97
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for type 6b: -7.9 · 90% CI -15.0 to -1.01
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for type 7f: -3.0 · 90% CI -7.95 to 1.10
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for type 9v: -3.0 · 90% CI -9.17 to 2.90
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for type 14: 1.00 · 90% CI -4.00 to 6.27
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for type 19a: -5.9 · 90% CI -12.38 to 0.17
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for type 19f: 0.0 · 90% CI -4.22 to 4.33
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for type 23f: -6.0 · 90% CI -12.77 to 0.40
SecondaryFunctional Antibody (OPA) Geometric Mean Titers

The functional activity of the IgG response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant and toddler cohorts and all adult subjects in the same serum samples collected 28 days after the last vaccinations. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham.

Time frame:
4 weeks after last vaccination
Reported as:
Geometric mean · titer
Functional Antibody (OPA) Geometric Mean Titers
titerAdults--PCV 10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13Infant--PCV 10Infant--Prevenar 13
MOPA - Pn 118.89 (10.14 to 45.59)85.89 (43.15 to 215.84)436.31 (365.08 to 582.46)438.14 (278.73 to 890.17)50.65 (27.91 to 96.55)29.42 (15.58 to 68.08)
MOPA - Pn 5263.06 (138.91 to 499.28)265.56 (143.22 to 521.05)1358.22 (960.34 to 2087.48)1148.43 (929.92 to 1708.67)113.92 (74.12 to 167.10)104.83 (64.11 to 181.22)
MOPA - Pn 6A17161.52 (12378.36 to 23946.20)4925.68 (3204.91 to 7661.38)19371.45 (12538.18 to 34268.51)12001.09 (8229.26 to 21545.31)1243.88 (942.40 to 1834.30)3068.16 (2267.85 to 5318.41)
MOPA - 6B13303.68 (9432.51 to 18190.05)4221.68 (2890.62 to 5925.09)8768.08 (5471.57 to 12932.67)7066.76 (4456.49 to 11894.25)1530.37 (935.24 to 2368.41)2267.44 (1175.92 to 3718.87)
MOPA - 7F7099.73 (4147.20 to 11222.44)8019.15 (4956.82 to 10917.82)10723.98 (7151.48 to 16590.09)12737.21 (8063.57 to 18328.98)876.58 (616.90 to 1221.31)3763.17 (2754.89 to 5393.72)
MOPA - 9V3928.12 (2827.41 to 5629.89)4443.95 (3275.91 to 6299.32)3770.19 (2004.45 to 6384.49)4862.30 (3128.56 to 6953.05)197.24 (95.09 to 347.56)752.77 (528.18 to 1024.26)
MOPA - 149148.12 (6271.81 to 12407.65)6707.26 (5098.03 to 7886.64)8213.23 (4526.63 to 13664.12)2557.27 (1597.17 to 3868.34)1243.39 (743.97 to 1912.05)1108.02 (501.79 to 2097.51)
MOPA - 19A3170.33 (1906.55 to 4427.88)2215.22 (1314.65 to 3458.76)1789.98 (651.04 to 3498.32)3780.56 (2358.04 to 6045.56)151.31 (64.25 to 233.45)765.71 (589.49 to 886.28)
MOPA - 19F3564.32 (2636.19 to 4898.79)2481.47 (1623.91 to 3860.16)3036.60 (2134.81 to 5126.44)3371.52 (2238.81 to 5853.53)744.92 (607.87 to 941.74)498.98 (275.77 to 723.41)
MOPA - 23F5035.73 (3417.87 to 7587.87)2844.04 (2123.33 to 3737.09)12415.92 (8018.97 to 19342.91)10517.81 (5848.87 to 19460.60)627.27 (341.95 to 975.77)921.43 (574.79 to 1419.94)
SecondaryNumber and Percentage of Functional (OPA) Infant Seroresponders, by Serotype

The functional activity of the immune response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant cohort in the same serum samples collected 28 days after the completion of the primary series. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham.

Time frame:
84 days
Reported as:
Count of participants · Participants
Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype
ParticipantsInfant--PCV 10Infant--Prevenar 13
MOPA - Pn 11511
MOPA - Pn 51919
MOPA - Pn 6A2018
MOPA - 6B1919
MOPA - 7F2020
MOPA - 9V2020
MOPA - 141918
MOPA - 19A1620
MOPA - 19F2019
MOPA - 23F2020
Statistical analysis
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for mopa type 1: 9.1 · 90% CI -15.55 to 36.11
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for mopa type 5: 0.0 · 90% CI -18.56 to 18.56
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for mopa type 6b: 5.0 · 90% CI -12.35 to 22.97
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for mopa type 14: 5.3 · 90% CI -12.15 to 24.01
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for mopa type 19a: -5.9 · 90% CI -26.41 to 11.01
  • Infant--PCV 10 vs Infant--Prevenar 13 · Absolute difference for mopa type 19f: 5.0 · 90% CI -11.64 to 22.97
SecondaryNumber and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components

Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) . Seroresponse was defined as equal to or greater concentrations for: * Diptheria toxoid: 0.1 IU/mL * Hepatitis B: 10 milli-International unit (mIU) /mL * Hib: 0.15 mcg/mL * Tetanus toxoid: 0.1 IU/mL

Time frame:
84 days
Reported as:
Count of participants · Participants
Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components
ParticipantsInfant--PCV 10Infant--Prevenar 13
Diphtheria toxoid100100
Hepatitis B100100
Hib (anti-PRP antibodies)10099
Tetanus toxoid100100
Other pre-specifiedInfant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity

Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[potentially life threatening\]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times: * At 30 (± 10) minutes following booster vaccination * Daily by field workers during Days 1 to 6 post vaccination * In the clinic on 7 days (+3) following the vaccination

Time frame:
7 days
Reported as:
Count of participants · Participants
Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity
ParticipantsInfant--PCV 10Prevenar 13
Temperature above 37 C — Grade 134
Temperature above 37 C — Grade 211
Temperature above 37 C — Grade 321
Temperature above 37 C — Grade 400
Temperature above 37 C — None reported/normal (temp)4341
Cutaneous Rash — Grade 113
Cutaneous Rash — Grade 202
Cutaneous Rash — Grade 300
Cutaneous Rash — Grade 400
Cutaneous Rash — None reported/normal (temp)4842
Irritability — Grade 157
Irritability — Grade 200
Irritability — Grade 300
Irritability — Grade 400
Irritability — None reported/normal (temp)4440
Drowsiness — Grade 101
Drowsiness — Grade 210
Drowsiness — Grade 300
Drowsiness — Grade 400
Drowsiness — None reported/normal (temp)4846
Decreased appetite — Grade 125
Decreased appetite — Grade 200
Decreased appetite — Grade 300
Decreased appetite — Grade 400
Decreased appetite — None reported/normal (temp)4742
Injection site tenderness — Grade 1811
Injection site tenderness — Grade 210
Injection site tenderness — Grade 300
Injection site tenderness — Grade 400
Injection site tenderness — None reported/normal (temp)4036
Erythema — Grade 111
Erythema — Grade 200
Erythema — Grade 300
Erythema — Grade 400
Erythema — None reported/normal (temp)4846
Induration/Swelling — Grade 144
Induration/Swelling — Grade 220
Induration/Swelling — Grade 300
Induration/Swelling — Grade 400
Induration/Swelling — None reported/normal (temp)4343
Other pre-specifiedOccurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity

Unsolicited adverse events following a booster dose of SIILPCV10 occurring in 5% or greater of study participants. Unless specifically stated, AEs are considered unrelated.

Time frame:
4 weeks (28 days)
Reported as:
Count of participants · Participants
Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity
ParticipantsInfant--PCV 10Prevenar 13
Upper respiratory tract infection — Grade 1146
Upper respiratory tract infection — Grade 200
Upper respiratory tract infection — Grade 300
Upper respiratory tract infection — Grade 400
Upper respiratory tract infection — None reported3541
Dermatitis — Grade 143
Dermatitis — Grade 200
Dermatitis — Grade 300
Dermatitis — Grade 400
Dermatitis — None reported4544
Diarrhea — Grade 125
Diarrhea — Grade 200
Diarrhea — Grade 300
Diarrhea — Grade 400
Diarrhea — None reported4742
Impetigo — Grade 133
Impetigo — Grade 200
Impetigo — Grade 300
Impetigo — Grade 400
Impetigo — None reported4644
Rash pustular — Grade 114
Rash pustular — Grade 200
Rash pustular — Grade 300
Rash pustular — Grade 400
Rash pustular — None reported4843
Pyrexia — Grade 113
Pyrexia — Grade 200
Pyrexia — Grade 300
Pyrexia — Grade 400
Pyrexia — None reported4844
SAE--severe malaria with severe anemia — Grade 100
SAE--severe malaria with severe anemia — Grade 200
SAE--severe malaria with severe anemia — Grade 310
SAE--severe malaria with severe anemia — Grade 400
SAE--severe malaria with severe anemia — None reported4847
Other pre-specifiedGeometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose

Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing at 4 weeks post vaccination 3, and before and 28 days after the booster dose for infants.

Time frame:
4 weeks (28 days)
Reported as:
Geometric mean · µg/mL
Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose
µg/mLInfant--PCV 10Infant--Prevenar 13Treatment Comparison (GMC Ratio)
PnC-IgG-ELISA Type 1: 4 weeks post Vac 32.67 (2.22 to 3.21)3.23 (2.76 to 3.78)0.83 (0.65 to 1.05)
PnC-IgG-ELISA Type 1: Pre Booster0.27 (0.22 to 0.33)0.32 (0.27 to 0.40)0.83 (0.63 to 1.10)
PnC-IgG-ELISA Type 1: Post Booster6.24 (4.62 to 8.42)5.11 (3.96 to 6.60)1.22 (0.83 to 1.81)
PnC-IgG-ELISA Type 5: 4 weeks post Vac 32.01 (1.70 to 2.38)1.45 (1.18 to 1.79)1.38 (1.06 to 1.80)
PnC-IgG-ELISA Type 5: Pre Booster0.16 (0.13 to 0.18)0.25 (0.21 to 0.30)0.62 (0.48 to 0.78)
ELISA Type 5: Post Booster2.30 (1.88 to 2.81)2.57 (2.10 to 3.13)0.90 (0.68 to 1.19)
PnC-IgG-ELISA Type 6A: 4 weeks post Vac 31.06 (0.80 to 1.42)1.56 (1.17 to 2.06)0.68 (0.46 to 1.02)
PnC-IgG-ELISA Type 6A: Pre Booster0.46 (0.38 to 0.56)0.53 (0.43 to 0.66)0.87 (0.65 to 1.16)
PnC-IgG-ELISA Type 6A: Post Booster9.50 (6.94 to 12.99)12.06 (9.98 to 14.56)0.79 (0.55 to 1.13)
PnC-IgG-ELISA Type 6B: 4 weeks post Vac 31.39 (1.03 to 1.87)3.67 (2.74 to 4.93)0.38 (0.25 to 0.57)
PnC-IgG-ELISA Type 6B: Pre Booster0.73 (0.59 to 0.90)0.50 (0.42 to 0.60)1.45 (1.10 to 1.90)
PnC-IgG-ELISA Type 6B: Post Booster12.72 (9.79 to 16.54)14.06 (11.55 to 17.11)0.91 (0.65 to 1.26)
PnC-IgG-ELISA Type 7F: 4 weeks post Vac 31.99 (1.59 to 2.49)3.43 (2.81 to 4.18)0.58 (0.43 to 0.78)
PnC-IgG-ELISA Type 7F: Pre Booster0.49 (0.39 to 0.62)0.81 (0.68 to 0.97)0.61 (0.45 to 0.81)
PnC-IgG-ELISA Type 7F: Post Booster6.76 (5.49 to 8.32)8.51 (7.05 to 10.26)0.79 (0.60 to 1.05)
PnC-IgG-ELISA Type 9V: 4 weeks post Vac 31.06 (0.89 to 1.26)2.22 (1.84 to 2.68)0.48 (0.37 to 0.62)
PnC-IgG-ELISA Type 9V: Pre Booster0.18 (0.15 to 0.21)0.22 (0.16 to 0.28)0.83 (0.60 to 1.14)
PnC-IgG-ELISA Type 9V: Post Booster2.44 (2.02 to 2.95)3.23 (2.76 to 3.79)0.76 (0.59 to 0.97)
PnC-IgG-ELISA Type 14: 4 weeks post Vac 34.38 (3.51 to 5.46)3.71 (2.67 to 5.16)1.18 (0.80 to 1.74)
PnC-IgG-ELISA Type 14: Pre Booster0.81 (0.64 to 1.03)1.52 (1.18 to 1.97)0.53 (0.38 to 0.76)
PnC-IgG-ELISA Type 14: Post Booster8.16 (6.19 to 10.77)7.60 (5.82 to 9.93)1.07 (0.73 to 1.57)
PnC-IgG-ELISA Type 19A: 4 weeks post Vac 31.35 (1.05 to 1.74)5.12 (3.92 to 6.68)0.26 (0.18 to 0.38)
PnC-IgG-ELISA Type 19A: Pre Booster0.29 (0.22 to 0.38)0.59 (0.43 to 0.80)0.49 (0.33 to 0.74)
PnC-IgG-ELISA Type 19A: Post Booster6.72 (4.87 to 9.25)15.20 (11.83 to 19.54)0.44 (0.29 to 0.66)
PnC-IgG-ELISA Type 19F: 4 weeks post Vac 33.70 (3.03 to 4.53)4.61 (3.86 to 5.51)0.80 (0.61 to 1.05)
PnC-IgG-ELISA Type 19F: Pre Booster0.63 (0.49 to 0.80)0.59 (0.45 to 0.75)1.07 (0.76 to 1.52)
PnC-IgG-ELISA Type 19F: Post Booster7.73 (5.96 to 10.03)11.85 (9.41 to 14.92)0.65 (0.46 to 0.92)
PnC-IgG-ELISA Type 23F: 4 weeks post Vac 31.35 (1.06 to 1.73)2.18 (1.67 to 2.87)0.62 (0.43 to 0.89)
PnC-IgG-ELISA Type 23F: Pre Booster0.23 (0.17 to 0.30)0.17 (0.14 to 0.22)1.32 (0.93 to 1.87)
PnC-IgG-ELISA Type 23F: Post Booster5.11 (3.93 to 6.65)5.28 (4.04 to 6.90)0.97 (0.67 to 1.40)
Other pre-specifiedGeometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose

Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing before and 28 days after the booster dose for infants.

Time frame:
4 weeks (28 days)
Reported as:
Geometric mean · fold change
Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose
fold changeInfant--PCV 10Infant--Prevenar 13GMFR Ratio
PnC-IgG-ELISA type 122.52 (17.60 to 28.82)15.75 (12.16 to 20.41)1.43 (1.00 to 2.04)
PnC-IgG-ELISA type 514.83 (12.32 to 17.85)10.17 (8.62 to 11.99)1.46 (1.14 to 1.86)
PnC-IgG-ELISA type 6A20.70 (16.13 to 26.56)22.98 (17.88 to 29.54)0.90 (0.63 to 1.28)
PnC-IgG-ELISA type 6B17.81 (14.55 to 21.80)28.66 (23.43 to 35.05)0.62 (0.47 to 0.82)
PnC-IgG-ELISA type 7F13.37 (10.86 to 16.45)10.44 (8.59 to 12.70)1.28 (0.96 to 1.70)
PnC-IgG-ELISA type 9V13.48 (11.26 to 16.13)15.02 (11.73 to 19.23)0.90 (0.66 to 1.21)
PnC-IgG-ELISA type 1410.03 (7.38 to 13.63)4.99 (3.78 to 6.60)2.01 (1.33 to 3.03)
PnC-IgG-ELISA Type 19A23.20 (15.67 to 34.36)25.73 (18.25 to 36.28)0.90 (0.54 to 1.51)
PnC-IgG-ELISA Type 19F12.44 (8.74 to 17.72)20.60 (14.68 to 28.92)0.60 (0.37 to 0.98)
PnC-IgG-ELISA Type 23F22.10 (17.30 to 28.23)30.75 (23.34 to 40.52)0.72 (0.50 to 1.03)
Other pre-specifiedAntibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose

Defined as the ratio of IgG geometric mean concentration (GMC) measured prior to the infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 20 weeks but may have been longer.

Time frame:
20-23 weeks
Reported as:
Geometric mean · concentration ratio
Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose
concentration ratioInfant--PCV 10Infant--Prevenar 13
PnC-IgG-ELISA type 10.10 (0.08 to 0.13)0.10 (0.08 to 0.13)
PnC-IgG-ELISA type 50.08 (0.06 to 0.10)0.17 (0.13 to 0.23)
PnC-IgG-ELISA type 6A0.43 (0.30 to 0.61)0.34 (0.24 to 0.49)
PnC-IgG-ELISA type 6B0.52 (0.36 to 0.75)0.14 (0.10 to 0.19)
PnC-IgG-ELISA type 7F0.25 (0.18 to 0.34)0.24 (0.18 to 0.31)
PnC-IgG-ELISA type 9V0.17 (0.13 to 0.22)0.10 (0.07 to 0.13)
PnC-IgG-ELISA type 140.19 (0.13 to 0.26)0.41 (0.27 to 0.62)
PnC-IgG-ELISA Type 19A0.22 (0.15 to 0.31)0.12 (0.08 to 0.17)
PnC-IgG-ELISA Type 19F0.17 (0.12 to 0.23)0.13 (0.09 to 0.17)
PnC-IgG-ELISA Type 23F0.17 (0.12 to 0.24)0.08 (0.06 to 0.11)
Other pre-specifiedBooster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose

Defined as the ratio of IgG geometric mean concentration (GMC) measured 4 weeks post-infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 24 weeks but may have been longer.

Time frame:
24-26 weeks
Reported as:
Geometric mean · concentration ratio
Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose
concentration ratioInfant--PCV 10Infant--Prevenar 13
PnC-IgG-ELISA type 12.34 (1.65 to 3.31)1.58 (1.17 to 2.13)
PnC-IgG-ELISA type 51.14 (0.88 to 1.48)1.77 (1.33 to 2.35)
PnC-IgG-ELISA type 6A8.93 (5.86 to 13.62)7.75 (5.53 to 10.85)
PnC-IgG-ELISA type 6B9.18 (6.18 to 13.63)3.83 (2.70 to 5.43)
PnC-IgG-ELISA type 7F3.40 (2.51 to 4.59)2.48 (1.89 to 3.25)
PnC-IgG-ELISA type 9V2.31 (1.79 to 2.98)1.46 (1.14 to 1.86)
PnC-IgG-ELISA type 141.87 (1.31 to 2.65)2.05 (1.35 to 3.12)
PnC-IgG-ELISA Type 19A4.96 (3.32 to 7.41)2.97 (2.07 to 4.27)
PnC-IgG-ELISA Type 19F2.09 (1.51 to 2.89)2.57 (1.93 to 3.42)
PnC-IgG-ELISA Type 23F3.78 (2.65 to 5.40)2.42 (1.66 to 3.52)

Adverse events

Collected over All adult and toddler subjects were monitored for AEs until 28 days after receipt of vaccine, and ongoing AEs at study exit were followed until last subject last visit (LSLV). Infant subjects were monitored for AEs until 28 days after receipt of three doses of the vaccine. For infants who participated in the booster phase of the study, AEs were recorded at 28 days post booster dose, and any conditions present at the visit when booster dose was given were considered baseline.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Adult SIILPCV 100/17 (0%)0/17 (0%)4/17 (23.5%)
Adult Pneumovax 230/17 (0%)0/17 (0%)10/17 (58.8%)
Toddler SIILPCV 100/56 (0%)1/56 (1.8%)35/56 (62.5%)
Toddler Prevenar 130/56 (0%)1/56 (1.8%)36/56 (64.3%)
Infants SIILPCV 100/100 (0%)6/100 (6%)97/100 (97%)
Infants Prevenar 130/100 (0%)2/100 (2%)96/100 (96%)
Booster Infants SIILPCV 100/49 (0%)1/49 (2%)25/49 (51%)
Booster Infants Prevenar 130/47 (0%)0/47 (0%)24/47 (51.1%)
Most frequent serious events
Most frequent serious events
EventAdult SIILPCV 10Adult Pneumovax 23Toddler SIILPCV 10Toddler Prevenar 13Infants SIILPCV 10Infants Prevenar 13Booster Infants SIILPCV 10Booster Infants Prevenar 13
GastroenteritisInfections and infestations0/170/171/561/566/1002/1000/490/47
MalariaInfections and infestations0/170/170/560/560/1000/1001/490/47
AnemiaBlood and lymphatic system disorders0/170/170/560/560/1000/1001/490/47
Most frequent other events
Showing 10 of 29
Most frequent other events
EventAdult SIILPCV 10Adult Pneumovax 23Toddler SIILPCV 10Toddler Prevenar 13Infants SIILPCV 10Infants Prevenar 13Booster Infants SIILPCV 10Booster Infants Prevenar 13
Upper respiratory tract infectionInfections and infestations1/171/178/569/5664/10048/10014/496/47
Vaccination site swellingGeneral disorders0/171/170/560/5655/10061/1000/490/47
Tinea infectionInfections and infestations0/170/174/561/5631/10021/1000/490/47
DiarrheaGastrointestinal disorders0/171/177/565/5629/10022/1002/495/47
ConjunctivitisInfections and infestations0/170/170/560/5627/10019/1000/490/47
Abdominal painGastrointestinal disorders1/174/170/560/560/1000/1000/490/47
NasopharyngitisInfections and infestations0/170/177/565/5619/10017/1000/490/47
ToothacheGastrointestinal disorders1/173/170/560/560/1000/1000/490/47
CoughInfections and infestations0/170/170/560/5612/1007/1000/490/47
Vaccination site reactionGeneral disorders0/170/170/560/5611/1004/1000/490/47

Baseline characteristics

Age, Continuous
Age, Continuous(years)Adults--PCV 10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13Infant--PCV 10Infant--Prevenar 13Infant Boost--PCV 10Infant Boost--Prevenar 13Total
Adults in years25.9 ± 4.125.9 ± 4.4——————25.9 ± 4.1
Age, Continuous
Age, Continuous(Days)Adults--PCV 10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13Infant--PCV 10Infant--Prevenar 13Infant Boost--PCV 10Infant Boost--Prevenar 13Total
Infants--Age in Days————47.2 ± 447.3 ± 3.8——47.2 ± 3.9
Age, Continuous
Age, Continuous(Months)Adults--PCV 10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13Infant--PCV 10Infant--Prevenar 13Infant Boost--PCV 10Infant Boost--Prevenar 13Total
Toddler--Age in months——13.3 ± 0.913.3 ± 0.8————13.3 ± 0.9
Age, Continuous
Age, Continuous(months)Adults--PCV 10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13Infant--PCV 10Infant--Prevenar 13Infant Boost--PCV 10Infant Boost--Prevenar 13Total
Infant Booster age in Months——————11.4 ± 0.811.5 ± 0.911.4 ± 0.8
Sex: Female, Male
Sex: Female, Male(Participants)Adults--PCV 10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13Infant--PCV 10Infant--Prevenar 13Infant Boost--PCV 10Infant Boost--Prevenar 13Total
Female44303252492020211
Male1313262448512927231
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Adults--PCV 10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13Infant--PCV 10Infant--Prevenar 13Infant Boost--PCV 10Infant Boost--Prevenar 13Total
African17175656100994947441
Asian000000000
Other000001001
Region of Enrollment
Region of Enrollment(participants)Adults--PCV 10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13Infant--PCV 10Infant--Prevenar 13Infant Boost--PCV 10Infant Boost--Prevenar 13Total
Gambia171756561001004947442
Ethnicity
Ethnicity(Participants)Adults--PCV 10Adults--Pneumovax 23Toddler--PCV 10Toddler--Prevenar 13Infant--PCV 10Infant--Prevenar 13Infant Boost--PCV 10Infant Boost--Prevenar 13Total
Mandinka107282742552328220
Wolof3141118109258
Fula246712106552
Jola1211312125349
Serahule0222531318
Serere0033855529
Manjago011001003
Other1013340113
07

Study locations

1 site
  • Medical Research Council (MRC) Unit, The Gambia
    Fajara, Gambia
08

References and documents

Publications

  • Clarke E, Bashorun AO, Okoye M, Umesi A, Badjie Hydara M, Adigweme I, Dhere R, Sethna V, Kampmann B, Goldblatt D, Tate A, Weiner DH, Flores J, Alderson MR, Lamola S. Safety and immunogenicity of a novel 10-valent pneumococcal conjugate vaccine candidate in adults, toddlers, and infants in The Gambia-Results of a phase 1/2 randomized, double-blinded, controlled trial. Vaccine. 2020 Jan 10;38(2):399-410. doi: 10.1016/j.vaccine.2019.08.072. Epub 2019 Dec 14. PubMed 31843266 ↗

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT02308540
Lead sponsor
PATH
Responsible party
Sponsor
First posted
Dec 4, 2014
Start date
Jan 12, 2015
Primary completion
Apr 2016
Completion
Nov 3, 2016
Results posted
Aug 2, 2019
Last update
Aug 2, 2019

Study contacts

Ed Clarke, MD PhD
principal investigator · Medical Research Council (MRC) Unit, The Gambia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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