Primary Objectives: * Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination * Assessed the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
The duration of each participant's participation was approximately 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
750
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Emmaus Research Center, Inc Site Number : 8400014
Anaheim, California, United States
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution.
Time frame: Post-vaccination at Day 31
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.
Time frame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Time frame: Post-vaccination at Day 31
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.
Time frame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.
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Pharmaceutical form:Suspension for injection Route of administration: intramuscular
Pharmaceutical form:Solution for injection Route of administration: intramuscular
Peninsula Research Associates Site Number : 8400012
Rolling Hills Estates, California, United States
Paradigm Clinical Research Center Wheat Ridge Site Number : 8400002
Wheat Ridge, Colorado, United States
Jacksonville Center for Clinical Research Site Number : 8400016
Jacksonville, Florida, United States
Suncoast Research Associates, LLC Site Number : 8400017
Miami, Florida, United States
Advanced Clinical Research - Magic View Site Number : 8400003
Meridian, Idaho, United States
Velocity Clinical Research Valparaiso Site Number : 8400001
Valparaiso, Indiana, United States
Velocity Clinical Research Site Number : 8400005
Metairie, Louisiana, United States
Be Well Clinical Studies Site Number : 8400018
Lincoln, Nebraska, United States
WR-CRCN, LLC Site Number : 8400013
Las Vegas, Nevada, United States
...and 7 more locations
Time frame: Within 30 minutes post-vaccination
Number of Participants With Solicited Injection Site Reactions
A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site pain, injection site erythema and injection site swelling.
Time frame: Up to 7 Days post-vaccination (Day 8)
Number of Participants With Solicited Systemic Reactions
A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia and shivering.
Time frame: Up to 7 Days post-vaccination (Day 8)
Number of Participants With Unsolicited AEs
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination.
Time frame: Within 30 days post-vaccination
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. AESI included analyphylaxis.
Time frame: From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days