Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age42-89
SponsorSanofi
About this trial
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. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PCV21 vaccine
Biological/VaccinePharmaceutical form: Suspension for injection Route of administration: Intramuscular
20vPCV licensed vaccine
Biological/VaccinePharmaceutical form: Suspension for injection Route of administration: Intramuscular
Treatment groups
2,195 Participants
are divided into 4 treatment groupsGroup A: Group 1: PCV21Experimental treatment 1 intervention
Group B: Group 2: PCV21Experimental treatment 1 intervention
Group C: Group 3: PCV21Experimental treatment 1 intervention
Group D: Group 4: 20vPCV (Cohort A only)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL)
Time frame
30 days after the third dose of PCV21 vaccineSecondary outcomes
1
For all participants: Serotype specific IgG concentration ≥ 0.35 µg/mL
Serotype specific IgG concentration ≥ 0.35 μg/mL (seroresponse) for all serotypes included in PCV21 as measured by ECL
Time frame
30 days after the third dose of PCV21 vaccine2
For all participants: Presence of any immediate adverse events (AEs)
Number of participants experiencing immediate AEs
Time frame
Within 30 minutes after each vaccine injection3
For participants in Cohort A (reactogenicity subset): Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
Number of participants experiencing solicited injection site and systemic reactions
Time frame
Through 7 days after each vaccine injection4
For all participants: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs
Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Time frame
Through 30 days after each vaccine injection Source ClinicalTrials.gov