Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
29. dubna 2019 aktualizováno: MCM Vaccines B.V.
A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months (V419-007-03)
This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine.
The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
1250
Fáze
- Fáze 3
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
1 měsíc až 2 měsíce (Dítě)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria
- Healthy infants able to attend all study visits
- Parent(s)/legal representative able to read, understand, and complete study questionnaires
Exclusion Criteria
- History of congenital or acquired immunodeficiency
- Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids
- History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder
- Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines
- Has any chronic illness that could interfere with study conduct or completion
- Received any immune globulin, blood, or blood-derived products since birth
- Received a dose of hepatitis B vaccine prior to the study
- Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines, or any combination thereof
- Fever within 24 hours prior to enrollment
- Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment
- Has a coagulation disorder
- Has developmental delay or neurological disorder
- Participant or his/her mother has a medical history of hepatitis B surface antigen (HBsAg) seropositivity
- History of measles, mumps, rubella, varicella, Haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: PR5I
V419 + RotaTeq + Prevenar 13 + ProQuad
|
V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age
Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age
ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age
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Aktivní komparátor: INFANRIX™ hexa
INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad
|
RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age
Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age
ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age
INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
Časové okno: One month after post-dose 3 of PRI5 (5 months old)
|
Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria & poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus.
Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria & tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 & 3 (IPV1, 2 & 3) are reported.
95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson.
The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 & 3 (90%).
|
One month after post-dose 3 of PRI5 (5 months old)
|
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Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months
Časové okno: One month after Toddler dose of PRI5 (13 months old)
|
Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria & poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 & 3 (FIM) & Pertactin (PRN).
Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria & tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 & 3, and seroresponse to PT, FHA, FIM and PRN are reported.
95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson.
The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%).
|
One month after Toddler dose of PRI5 (13 months old)
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Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
Časové okno: One month after post-dose 3 of PRI5 (5 months old)
|
Antibody titres were measured by RIA for PRP, MIT for diphtheria & poliovirus, and ELISA for tetanus.
Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria & tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 & 3 (IPV1, 2 & 3) are reported.
The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
|
One month after post-dose 3 of PRI5 (5 months old)
|
|
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old
Časové okno: One month after Toddler dose of PRI5 (13 months old)
|
Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, & PRN.
Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 & 3, and seroresponse to PT, FHA, and PRN are reported.
The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
|
One month after Toddler dose of PRI5 (13 months old)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
Časové okno: One month after Toddler dose of PRI5 (13 months old)
|
Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA.
Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported.
95% CI were calculated based on the exact binomial method by Clopper and Pearson.
The immune response to ProQuad vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits: 90% for measles, mumps & rubella, and 76% for varicella.
|
One month after Toddler dose of PRI5 (13 months old)
|
|
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
Časové okno: One month after Toddler dose of PRI5 (13 months old)
|
Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA.
Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported.
The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
|
One month after Toddler dose of PRI5 (13 months old)
|
|
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination
Časové okno: Day 1 to Day 15 after any vaccination
|
Global safety was assessed by measuring injection-site and systemic AEs reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 to Day 15 (D1-D15) after each hexavalent vaccination.
Solicited injection-site and systemic AEs were reported daily from Day 1 to Day 5 (D1-D5) after each hexavalent vaccination.
AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)).
The investigator assessed whether systemic AEs were related (V-related) or not to the vaccine.
All AEs (related and unrelated) are reported.
|
Day 1 to Day 15 after any vaccination
|
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Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination
Časové okno: Day 1 to Day 5 after any vaccination
|
Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from Day 1 (D1) to Day 5 (D5) after vaccination.
AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)).
|
Day 1 to Day 5 after any vaccination
|
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Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination
Časové okno: Day 1 to Day 15 after any vaccination
|
Unsolicited ISRs with incidence ≥1% after any vaccination were reported daily on the VRC by the parent(s) or legal representative from (D1-D15).
AEs at injection sites were always considered as vaccine-related ISRs
|
Day 1 to Day 15 after any vaccination
|
|
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination
Časové okno: Day 1 to Day 5 after any vaccination
|
Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination.
The investigator assessed whether these systemic AEs were related or not to the vaccines.
All (related and unrelated) AEs are reported.
|
Day 1 to Day 5 after any vaccination
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
26. května 2011
Primární dokončení (Aktuální)
13. března 2013
Dokončení studie (Aktuální)
13. března 2013
Termíny zápisu do studia
První předloženo
22. dubna 2011
První předloženo, které splnilo kritéria kontroly kvality
22. dubna 2011
První zveřejněno (Odhad)
26. dubna 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
30. dubna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
29. dubna 2019
Naposledy ověřeno
1. dubna 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- V419-007
- 2010-021490-37 (Číslo EudraCT)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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