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OpenTrials
Completed

NCT Number: NCT04583618

Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.

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

Completed

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Key information

Conditions

Pneumococcal Immunization

Age range

50 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emmaus Research Center, Inc Site Number : 8400014, Anaheim, California, United States

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About this study

The duration of each participant's participation was approximately 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 50 to 84 years on the day of inclusion .

Exclusion criteria

  • Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, the female must have been post-menopausal for at least 1 year, or surgically sterile.
  • Participation at the time of the study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure.
  • Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit, except for influenza vaccination, which may be received at least 2 weeks before study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against S. pneumoniae with either a pneumococcal conjugated vaccine (PCV) or a pneumococcal polysaccharide vaccine (PPSV).
  • Received immune globulins, blood or blood-derived products in the past 3 months.
  • Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • History of S. pneumoniae infection or disease, confirmed either serologically, or microbiologically.
  • History of Guillain-Barré syndrome occurring within 6 weeks after a prior dose of a TTxd-containing vaccine.
  • Experienced an Arthus-type hypersensitivity reaction following a prior dose of a TTxd-containing vaccine < 10 years ago.
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances .
  • Verbal report of thrombocytopenia contraindicating IM vaccination in the Investigator's opinion.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion.
  • At risk of invasive pneumococcal disease (eg, participants with functional or anatomic asplenia, participants with severe asthma, participants travelling to countries with high endemicity).
  • Current alcohol abuse or drug addiction.
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
  • Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine (eg, under investigation or monitoring for possible coronavirus disease 2019 [COVID-19]).
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has subsided.
  • Received oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Treatment and study plan

Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb

Biological

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI

Biological

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII

Biological

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

Pneumococcal 13 - valent conjugate vaccine-Prevnar 13

Biological

Pharmaceutical form:Suspension for injection Route of administration: intramuscular

Pneumococcal Vaccine Polyvalent-Pneumovax 23

Biological

Pharmaceutical form:Solution for injection Route of administration: intramuscular

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults Aged 50 to 84 Years

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 12, 2020
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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