Skip to main content
OpenTrials
Completed

NCT Number: NCT06698198

Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)

This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy Adults (19-49 years) in the United States.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pneumococcal Immunization

Age range

19 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number: 0002, Metairie, Louisiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men or women aged 19 to 49 years on the day of inclusion ("19 to 49 years" means from the day of the 19th birthday to the day before the 50th birthday)
  • Informed Consent Form (ICF) has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • Body mass index within the range of 18.5 and 29.9 kg/m2

Exclusion criteria

  • Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccine injection until at least 4 weeks after injection. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
  • Participation at the time of 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.
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial injection, except for influenza vaccination, which may be received at least 2 weeks before SP0202 or Prevnar 13 injection.
  • Previous vaccination against S. pneumoniae with either a pneumococcal conjugate vaccine (PCV) or a Pneumococcal polysaccharide vaccines (PPSV).
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months.

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

Treatment and study plan

pneumococcal conjugate vaccine

Biological

Suspension for Intramuscular injection

Prevnar 13®

Biological

Suspension for Intramuscular injection

Primary outcomes

  1. Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection

    Time frame: Up to 30 minutes post-vaccination

    Occurrence of any unsolicited (spontaneously reported) systemic Adverse Events (AEs) reported in the 30 minutes after injection of a SP0202 formulation or Prevnar 13.

  2. Occurrence of solicited injection site and systemic reactions

    Time frame: Up to 7 days post-vaccination

    Number of participants reporting solicited injection site reactions (pain, redness, swelling) and solicited systemic reactions (pyrexia, headache, malaise, myalgia, arthralgia, chills)

  3. Occurrence of unsolicited (spontaneously reported) AEs up to 30 days after injection

    Time frame: Up to 30 days after vaccination

    Occurrence of unsolicited (spontaneously reported) Adverse Events (AEs) up to 30 days after injection of a SP0202 formulation or Prevnar 13.

  4. Serotype-specific immunoglobulin type G (IgG) concentrations

    Time frame: Up to 30 days after vaccination

    Geometric Mean (GM) of serotype-specific IgG concentrations for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by electro-chemiluminescence (ECL) assay

  5. Serotype-specific opsonophagocytic activity (OPA) titers

    Time frame: Up to 30 days after vaccination

    GM of serotype-specific OPA titers for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by multiplex opsonophagocytic assay (MOPA)

Secondary outcomes

  1. Serotype-specific IgG concentrations ratio (post/pre-vaccination)

    Time frame: Up to 30 days after vaccination

    GM of serotype-specific IgG concentrations ratio (post-/pre-vaccination) for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by ECL assay

  2. ≥ 4-fold serotype-specific IgG concentrations increase

    Time frame: Up to 30 days after vaccination

    Percentage of participants with ≥ 4-fold serotype-specific IgG concentrations increase from baseline to 1 month post-vaccination for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by ECL

  3. Serotype-specific OPA titers ratio (post/pre-vaccination)

    Time frame: Up to 30 days after vaccination

    GM of serotype-specific OPA titers ratio (post-/pre-vaccination) for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by MOPA

  4. ≥ 4-fold serotype-specific OPA titers increase

    Time frame: Up to 30 days after vaccination

    Percentage of participants with ≥ 4-fold serotype-specific IgG concentrations increase from baseline to post-vaccination for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by MOPA

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.