Active, not recruiting
Phase 1/2
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
Condition(s) studied
Meningococcal ImmunizationHealthy Volunteers
Investigational drug(s) / intervention(s)
Pentavalent Meningococcal ABCYW vaccineMenACYW conjugate vaccineMenACYW conjugate vaccineMeningococcal group B vaccineParacetamolDTap-HepB-IPV-Hib vaccineDTap-HepB-IPV-Hib vaccineDTap-HepB-IPV-Hib vaccineRotavirus vaccinePneumococcal 13-valent conjugate vaccine
Pentavalent Meningococcal ABCYW vaccine: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
MenACYW conjugate vaccine: Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM)
MenACYW conjugate vaccine: Pharmaceutical form: Powder and solvent for injectable solution in a pre-filled syringe Route of administration: Intramuscular (IM)
Meningococcal group B vaccine: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Paracetamol: Pharmaceutical form:Suspension-Route of administration:oral
DTap-HepB-IPV-Hib vaccine: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DTap-HepB-IPV-Hib vaccine: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DTap-HepB-IPV-Hib vaccine: Pharmaceutical form: Oral solution in tube Route of administration: oral
Rotavirus vaccine: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Pneumococcal 13-valent conjugate vaccine: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Study summary
This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).
Study details include:
The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.
Eligibility
Inclusion Criteria:
* Aged 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3) on the day of inclusion
* For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 Kg or born after a gestation period of 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, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of 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, within the preceding 6 months or since birth for infants; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for and infants)
* History of any meningitis infection, confirmed either clinically, serologically, or microbiologically
* At high risk of meningococcal infection during the study
* Known systemic hypersensitivity to any of the study intervention 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
* Individual with active tuberculosis
* History of Guillain-Barré syndrome
* For Stage 3 infants: History of intussusception
* Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with an investigational or marketed vaccine
* For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary outcome measure(s)
- Number of participants with unsolicited immediate adverse events (AEs) — Within 30 minutes after each vaccination
Unsolicited systemic AEs that occur within 30 minutes after vaccination
- Number of participants with solicited injection site reactions or systemic reactions — Within 7 days after each vaccination
Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF
- Number of participants with unsolicited AEs — Within 30 days after each vaccination
Unsolicited AEs other than solicited reactions
- Number of participants with serious adverse events (SAEs) — Throughout the study, from first visit until 180 days after the last vaccination
SAEs (including adverse events of special interest \[AESIs\]) reported throughout the study
- hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 30 days after the second and third dose in infant participants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
hSBA titers ≥ 1:8 post-vaccination (post-second and third dose)
- hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second and third dose in infant participants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ
- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second and third dose in infant participants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
Geometric mean titers (pre-dose and post-second and third dose)
- Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y pre-dose and 1 month after the second and third dose in infant participants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose and 1 month after second dose of vaccination against serogroup B, before and 30 days after third dose in infants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
hSBA titers ≥ 1:4 for reference MenB strains
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
hSBA titers ≥ 1:8 for reference MenB strains
- hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
Seroresponse defined as a 4-fold increase in hSBA titers
- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants — Day 01, Day 91, Day 181 and Day 211 (for Stage 3)
Geometric mean titers (pre-dose and post-second dose) for the reference MenB strains
- Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (ref. MenB strains) predose and 1 month after 2nd dose against serogroup B, before and 30 days after 3rd dose in infants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
- Percentage of participants with hSBA titers less than LLOQ against all serogroup B (ref. MenB strains) pre-dose and 1 month after the 2nd dose of vaccination against serogroup B, before and 30 days after 3rd dose in infants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
- hSBA meningococcal serogroups A, C, W, and Y antibody titers in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
hSBA titers ≥ 1:8 for serogroups A, C, W, and Y
- hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ
- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
- Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
- hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Seroresponse defined as a 4-fold increase in hSBA titers
- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
- Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (reference MenB strains) in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
- Percentage of participants with hSBA titers less than the lower limit of quantification (LLOQ) against all serogroup B (reference MenB strains) in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Trial sites (39)
| Facility | City | Region | Status |
|---|
| Hospital das Clínicas da Universidade Federal de Minas Gerais- Site Number : 0760001 |
Belo Horizonte |
Minas Gerais |
|
| Private Practice - Dr. Nelson Rosário- Site Number : 0760004 |
Curitiba |
Paraná |
|
| Investigational Site Number : 2030003 |
Jindřichův Hradec |
Czechia |
|
| Investigational Site Number : 2030004 |
Ostrava |
Czechia |
|
| Investigational Site Number : 2030007 |
Pilsen |
Czechia |
|
| Investigational Site Number : 2030008 |
Prague |
Czechia |
|
| Investigational Site Number : 2030009 |
Prague |
Czechia |
|
| Investigational Site Number : 2080002 |
Hvidovre |
Denmark |
|
| Investigational Site Number : 2080003 |
Odense |
Denmark |
|
| Investigational Site Number : 2460006 |
Espoo |
Finland |
|
| Investigational Site Number : 2460001 |
Helsinki |
Finland |
|
| Investigational Site Number : 2460008 |
Helsinki |
Finland |
|
| Investigational Site Number : 2460005 |
Jarvenpaa |
Finland |
|
| Investigational Site Number : 2460004 |
Oulu |
Finland |
|
| Investigational Site Number : 2460002 |
Seinäjoki |
Finland |
|
| Investigational Site Number : 2460007 |
Tampere |
Finland |
|
| Investigational Site Number : 2760008 |
Herxheim |
Germany |
|
| Investigational Site Number : 2760006 |
Hürth |
Germany |
|
| Investigational Site Number : 2760007 |
Hürth |
Germany |
|
| Investigational Site Number : 2760005 |
Krefeld |
Germany |
|
| Investigational Site Number : 2760009 |
Mönchengladbach |
Germany |
|
| Investigational Site Number : 2760004 |
Schönau am Königssee |
Germany |
|
| Investigational Site Number : 2760003 |
Wolfsburg |
Germany |
|
| Investigational Site Number : 3400001 |
San Pedro Sula |
Honduras |
|
| Investigational Site Number : 3400002 |
Tegucigalpa |
Honduras |
|
| Investigational Site Number : 3400003 |
Tegucigalpa |
Honduras |
|
| Investigational Site Number : 6160006 |
Bydgoszcz |
Kuyavian-Pomeranian Voivodeship |
|
| Investigational Site Number : 6160005 |
Trzebnica |
Lower Silesian Voivodeship |
|
| Investigational Site Number : 6160001 |
Lodz |
Lódzkie |
|
| Investigational Site Number : 6160003 |
Warsaw |
Masovian Voivodeship |
|
| Investigational Site Number : 6160002 |
Warsaw |
Masovian Voivodeship |
|
| Investigational Site Number : 6160004 |
Siemianowice Śląskie |
Silesian Voivodeship |
|
| Investigational Site Number : 7240007 |
Seville |
Sevilla |
|
| Investigational Site Number : 7240009 |
Madrid |
Spain |
|
| Investigational Site Number : 7240004 |
Madrid |
Spain |
|
| Investigational Site Number : 8260004 |
Exeter |
Devon |
|
| Investigational Site Number : 8260007 |
London |
England |
|
| Investigational Site Number : 8260009 |
London |
England |
|
| Investigational Site Number : 8260010 |
Southampton |
Hampshire |
|
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