V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)
15. března 2017 aktualizováno: Merck Sharp & Dohme LLC
An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V221 Given Concomitantly With Pneumococcal Conjugate Vaccine in Healthy Children 12 to 15 Months of Age
The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
1027
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 rok až 1 rok (Dítě)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- In good health
- 12 to 15 months of age
- Negative clinical history to measles, mumps, rubella, varicella and/or zoster
- Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at least 2 months prior to the receipt of any of the study vaccines
- Signed consent
Exclusion Criteria:
- Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination
- Any condition resulting in depressed immunity
- Any allergy to any vaccine component as stated in the package circulars
- Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
- History of seizure disorder
- Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine within 30 days
- Recent febrile illness
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: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 1
Group 1: ProQuad™ (V221) + PREVNAR™ (pneumococcal 7-valent conjugate vaccine) followed by ProQuad™ (Day 91)
|
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
Ostatní jména:
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
Ostatní jména:
|
|
Experimentální: 2
Group 2: PREVNAR™ followed by ProQuad™ (Day 43) followed by ProQuad™ (Day 133)
|
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
Ostatní jména:
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
Ostatní jména:
|
|
Experimentální: 3
Group 3: ProQuad™ followed by PREVNAR™ (Day 43), followed by ProQuad™ (Day 91)
|
0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV)
Ostatní jména:
0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
|
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline.
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
|
|
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
|
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
|
|
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
|
Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
|
|
Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
|
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone
|
|
Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.
|
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.
|
|
Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
Další výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
|
Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F
Časové okno: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
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
1. března 2006
Primární dokončení (Aktuální)
1. září 2007
Dokončení studie (Aktuální)
1. září 2007
Termíny zápisu do studia
První předloženo
27. dubna 2005
První předloženo, které splnilo kritéria kontroly kvality
26. dubna 2005
První zveřejněno (Odhad)
27. dubna 2005
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. dubna 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. března 2017
Naposledy ověřeno
1. března 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- V221-019
- 2005_027
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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 .