Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (NCT06824194) — Mexico Trial Details

Condition(s) studied

Pneumococcal Immunization

Investigational drug(s) / intervention(s)

PCV21 vaccine →Prevnar 20 vaccine →M-M-R II vaccine →Rotarix →RotaTeq →Vaxelis vaccine →Varivax →Priorix →VAQTA →Havrix →

PCV21 vaccine: Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Prevnar 20 vaccine: Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

M-M-R II vaccine: Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular

Rotarix: Pharmaceutical form:Solution-Route of administration:Oral

RotaTeq: Pharmaceutical form:Solution-Route of administration:Oral

Vaxelis vaccine: Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Varivax: Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular

Priorix: Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous

VAQTA: Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular

Havrix: Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular

Study summary

This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days).

The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. 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 until 15 months of age, V06 separated from V05 by 30 days.

Eligibility

Sex

ALL

Min age

42 Days

Max age

89 Days

Healthy volunteers

Accepted

Inclusion 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 as assessed by the investigator Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * 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 substances * Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legal 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. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * Receipt of any non-US Food and Drug Administration (FDA) approved vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any non-US FDA approved vaccine in the 4 weeks following the study intervention administration, including monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations. * Receipt of any Bacillus of Calmette and Guerin (BCG) vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period * Previous vaccination against S. 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 vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Primary outcome measure(s)

Presence of any immediate adverse events (AEs) — Within 30 minutes after each vaccination
Number of participants experiencing solicited and unsolicited immediate AEs
Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection — Through 7 days after each vaccine injection
Number of participants experiencing solicited injection site and systemic reactions
Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection — Through 30 days after each vaccine injection
Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection) — Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Number of participants experiencing SAEs
Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection) — Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Number of participants experiencing AESIs

Trial sites (132)

Facility	City	Region
Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013	Birmingham	Alabama
University of Alabama at Birmingham- Site Number : 8400130	Birmingham	Alabama
Lakeview Clinical Research- Site Number : 8400054	Guntersville	Alabama
Midway Medical Clinic- Site Number : 8400091	Oneonta	Alabama
Noble Clinical Research- Site Number : 8400121	Tucson	Arizona
The Children's Clinic- Site Number : 8400079	Jonesboro	Arkansas
Helios CR, Inc. - Little Rock- Site Number : 8400090	Sherwood	Arkansas
Helping Hands Healthcare Group - Fullerton- Site Number : 8400063	Fullerton	California
Advanced Investigative Medicine- Site Number : 8400055	Hawthorne	California
Century Research Institute- Site Number : 8400118	Huntington Park	California
Matrix Clinical Research - Huntington Park- Site Number : 8400117	Huntington Park	California
Matrix Clinical Research - Los Angeles- Site Number : 8400026	Los Angeles	California
Matrix Clinical Research - Los Angeles- Site Number : 8400123	Los Angeles	California
Alliance Research Institute - Lynwood- Site Number : 8400099	Lynwood	California
Madera Family Medical Group- Site Number : 8400011	Madera	California
FOMAT-Golden Valley Health Centers- Site Number : 8400084	Merced	California
Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400072	Palo Alto	California
Center for Clinical Trials - Paramount- Site Number : 8400100	Paramount	California
Integrated Clinical Research LLC- Site Number : 8400027	Sherman Oaks	California
Emanate Health - Queen of the Valley Hospital- Site Number : 8400105	West Covina	California
All In One Clinic- Site Number : 8400127	Whittier	California
Amicis Research Center-Winnetka- Site Number : 8400128	Winnetka	California
Emerson Clinical Research Institute - Washington - Connecticut Avenue- Site Number : 8400102	Washington D.C.	District of Columbia
D&H Doral Research Center- Site Number : 8400095	Doral	Florida
Dolphin Medical Research, LLC- Site Number : 8400120	Doral	Florida
Nextlevel Research Center- Site Number : 8400065	Doral	Florida
CuraCare- Site Number : 8400125	Kendall	Florida
PAS RESEARCH-Lutz- Site Number : 8400103	Lutz	Florida
Abba Medical Research- Site Number : 8400064	Miami	Florida
D&H National Research Center- Site Number : 8400085	North Miami	Florida
Alfa Medical Research LLC- Site Number : 8400111	Pembroke Pines	Florida
PAS Research - Tampa- Site Number : 8400113	Tampa	Florida
Morehouse School of Medicine - Atlanta- Site Number : 8400093	Atlanta	Georgia
CenExel - iResearch - Savannah- Site Number : 8400057	Savannah	Georgia
Bingham Memorial Hospital - Blackfoot- Site Number : 8400114	Blackfoot	Idaho
Elite Clinical Trials - Blackfoot- Site Number : 8400017	Blackfoot	Idaho
Clinical Research Prime- Site Number : 8400022	Idaho Falls	Idaho
Eagle Clinical Research- Site Number : 8400087	Chicago	Illinois
University of Chicago Medical Center- Site Number : 8400062	Chicago	Illinois
MidValley Research - Moline- Site Number : 8400096	Moline	Illinois

+ 92 more sites — see the full list on the official registry below.

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