Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)

PHASE3CompletedINTERVENTIONAL
Enrollment

955

Participants

Timeline

Start Date

January 12, 2007

Primary Completion Date

March 27, 2008

Study Completion Date

March 27, 2008

Conditions
VaricellaMeaslesMumpsRubellaDiphtheriaTetanusPertussisPoliomyelitisHepatitis BHaemophilus Infections
Interventions
BIOLOGICAL

ProQuad®

Participants received a 0.5 mL subcutaneous injection of ProQuad® containing the following live attenuated virus strains: measles virus Enders' Edmonston strain (≥3.00 log10 50% cell culture infectious dose \[CCID\]50), mumps virus Jeryl Lynn™ (Level B) strain (≥4.30 log10 CCID50), rubella virus Wistar RA 27/3 strain (≥3.00 log10 CCID50), and varicella virus Oka/Merck strain (≥3.99 log10 plaque-forming units \[PFU\]).

BIOLOGICAL

Infanrix® hexa

Participants received a 0.5 mL intramuscular injection of Infanrix® hexa containing the following: diphtheria toxoid (≥30 IU), tetanus toxoid (≥40 IU), 3-component acellular pertussis (pertussis taxoid, filamentous haemagglutinin, and pertactin) (25 ug), Hepatitis B surface antigen recombinant (S protein) (10 ug), inactivated poliovirus types 1-3 (type 1: 40 D-antigen units; type 2: 8 D-antigen units; type 3: 32 D-antigen units), and Haemophilus influenzae type B (Hib) polysaccharide conjugate to tetanus toxoid (20-40 ug).

Trial Locations (50)

Unknown

Alsfeld

Bad Saulgau

Bad Säckingen

Bad Sobernheim

Berlin

Bielefeld

Birkenfeld

Bramsche

Bretten

Brunsbüttel

Datteln

Detmold

Espelkamp

Ettenheim

Friedrichshafen

Gerolstein

Gifhorn

Gütersloh

Hamburg

Heilbronn

Herbolzheim

Karlsruhe

Kehl

Koblenz

Lauffen am Neckar

Mannheim

Marbach

Mönchengladbach

München

Neustadt A.d. Aisch

Nidderau

Oberhausen

Oberkirch

Offenburg

Pegnitz

Rodorf

Schwäbisch Hall

Schwieberdingen

Traunreut

Veitshöchheim

Wanzleben

Welzheim

Wildeshausen

Zwiesel

Chiavari

Ferrara

Latisana

Ragusa

Sassari

Taranto

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00432042 - Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035) | Biotech Hunter | Biotech Hunter