Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults Aged 50 to 84 Years
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 750
- Locations
- 17
- Primary Endpoint
- Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Study Overview
Brief Summary
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
Detailed Description
The duration of each participant's participation was approximately 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SP0202-IIb
One dose at Day 1
Intervention: Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb (Biological)
SP0202-VI
One dose at Day 1
Intervention: Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI (Biological)
SP0202-VII
One dose at Day 1
Intervention: Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII (Biological)
Prevnar 13
One dose at Day 1
Intervention: Pneumococcal 13 - valent conjugate vaccine-Prevnar 13 (Biological)
Pneumovax 23
One dose at Day 1
Intervention: Pneumococcal Vaccine Polyvalent-Pneumovax 23 (Biological)
Outcomes
Primary Outcomes
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Time Frame: Within 30 minutes post-vaccination
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.
Number of Participants With Unsolicited AEs
Time Frame: Within 30 days post-vaccination
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.
Number of Participants With Solicited Systemic Reactions
Time Frame: Up to 7 Days post-vaccination (Day 8)
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.
Geometric Mean Concentrations (GMCs) of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Time Frame: Post-vaccination at Day 31
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.
Number of Participants With Solicited Injection Site Reactions
Time Frame: Up to 7 Days post-vaccination (Day 8)
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.
Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA
Time Frame: Post-vaccination at Day 31
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.
Geometric Mean Titers Ratio of Pneumococcal Serotypes Using Serotype-Specific MOPA
Time Frame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
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.
Geometric Mean Concentrations Ratio of Pneumococcal Serotypes Using Serotype-Specific IgG ECL
Time Frame: Pre-vaccination at Baseline (Day 1) and Post-vaccination at Day 31
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.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
Time Frame: From the study vaccine administration (Day 1) until the end of 6-Month follow-up, 181 days
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.
Secondary Outcomes
No secondary outcomes reported