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New treatment option for Pneumococcal Immunization
Official title Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
ClinicalTrials.gov ID: NCT07348692
What this study is testing
What is PCV21 vaccine?
PCV21 vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for pneumococcal immunization.
Also referred to as 515.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 42 to 89. Healthy volunteers may be eligible.
You may be able to join if
- Aged 42 to 89 days on the day of inclusion
- Participants who are healthy as determined by medical evaluation including medical history and physical examination
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\> 28 weeks) through 36 weeks...
You likely can't join if
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation...
- History of microbiologically confirmed Streptococcus pneumoniae infection or disease
- Any contraindication to the routine pediatric vaccine being administered in the study
- History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases...
- Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions...
- Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating...
See the full eligibility criteria
- Aged 42 to 89 days on the day of inclusion
- Participants who are healthy as determined by medical evaluation including medical history and physical examination
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
- History of microbiologically confirmed Streptococcus pneumoniae infection or disease
- Any contraindication to the routine pediatric vaccine being administered in the study
- History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
- Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3
- Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration.
- Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
- Previous vaccination against Streptococcus pneumoniae
- Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus
- Receipt of more than 1 dose of hepatitis B vaccine
- Receipt of immune globulins, blood or blood-derived products since birth
- Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a...
The study team makes the final eligibility decision.
Where it's taking place
- Fayetteville, Arkansas, United States
- Huntington Park, California, United States
- Los Angeles, California, United States
- Tampa, Florida, United States
- Bardstown, Kentucky, United States
- Allen Park, Michigan, United States
- Charleston, South Carolina, United States
- Simpsonville, South Carolina, United States
- Spartanburg, South Carolina, United States
- Edinburg, Texas, United States
- Richmond, Texas, United States
- Ogden, Utah, United States
- San Pedro Sula, Honduras
- Tegucigalpa, Honduras
- Guayama, Puerto Rico
- San Juan, Puerto Rico
- Trujillo Alto, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 42 days to 89 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fayetteville, Arkansas, United States; Huntington Park, California, United States; Los Angeles, California, United States; Tampa, Florida, United States; Bardstown, Kentucky, United States; Allen Park, Michigan, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.