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

NCT ID: NCT00432042

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 955 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-12
• Study Completion Date: 2008-03-27

Brief Summary

Primary Objective:

• To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days following vaccination.

Secondary Objectives:

• To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix® hexa primary series schedule and all data are pooled.
• To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data are pooled.

Conditions

Varicella; Measles; Mumps; Rubella; Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B; Haemophilus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ProQuad® + Infanrix® hexa

Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).

Group Type: EXPERIMENTAL

ProQuad®

Intervention Type: BIOLOGICAL

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 \[PFU\]).

Infanrix® hexa

Intervention Type: BIOLOGICAL

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).

ProQuad®

Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).

Group Type: ACTIVE_COMPARATOR

ProQuad®

Intervention Type: BIOLOGICAL

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 \[PFU\]).

Infanrix® hexa

Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).

Group Type: ACTIVE_COMPARATOR

Infanrix® hexa

Intervention Type: BIOLOGICAL

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).

Interventions

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 \[PFU\]).

Intervention Type: 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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy participants of either gender
• Aged 12 to 23 months
• No clinical history of measles, mumps, rubella, varicella and zoster
• For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 2-dose schedule, with receipt of the second dose ≥ 6 months prior to inclusion
• For Germany: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 3-dose schedule, with receipt of the third dose ≥ 6 months prior to inclusion
• Consent form signed by parent(s) according to local regulations or by the legal representative properly informed about the study
• Parent(s)/legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria

• Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination
• Any recent (<= 30 days) exposure to measles, mumps, rubella, varicella and/or zoster
• Receipt of any other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b containing vaccine (either alone or in any combination) than Infanrix® hexa
• Any recent (<= 3 days) history of febrile illness
• Any severe chronic disease
• Active untreated tuberculosis
• Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
• Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems
• Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
• Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin
• Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity
• Any recent (<= 2 days) tuberculin test or scheduled tuberculin test through Visit 2
• Any previous (<= 150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through Visit 2
• Any recent (<= 30 days) receipt of an inactivated or a live non-study vaccine or scheduled non-study vaccination through Visit 2
• Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
• Any recent (≤30 days) participation or scheduled participation in any other clinical trial through Visit 2

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Fiquet, MD

Role: STUDY_DIRECTOR

SPMSD

Locations

Alsfeld, , Germany

Bad Saulgau, , Germany

Bad Säckingen, , Germany

Bad Sobernheim, , Germany

Berlin, , Germany

Bielefeld, , Germany

Birkenfeld, , Germany

Bramsche, , Germany

Bretten, , Germany

Brunsbüttel, , Germany

Datteln, , Germany

Detmold, , Germany

Espelkamp, , Germany

Ettenheim, , Germany

Friedrichshafen, , Germany

Gerolstein, , Germany

Gifhorn, , Germany

Gütersloh, , Germany

Hamburg, , Germany

Heilbronn, , Germany

Herbolzheim, , Germany

Karlsruhe, , Germany

Kehl, , Germany

Koblenz, , Germany

Lauffen am Neckar, , Germany

Mannheim, , Germany

Marbach, , Germany

Mönchengladbach, , Germany

München, , Germany

Neustadt A.d. Aisch, , Germany

Nidderau, , Germany

Oberhausen, , Germany

Oberkirch, , Germany

Offenburg, , Germany

Pegnitz, , Germany

Rodorf, , Germany

Schwäbisch Hall, , Germany

Schwieberdingen, , Germany

Traunreut, , Germany

Veitshöchheim, , Germany

Wanzleben, , Germany

Welzheim, , Germany

Wildeshausen, , Germany

Zwiesel, , Germany

Chiavari, , Italy

Ferrara, , Italy

Latisana, , Italy

Ragusa, , Italy

Sassari, , Italy

Taranto, , Italy

Countries

Germany; Italy

References

Deichmann KA, Ferrera G, Tran C, Thomas S, Eymin C, Baudin M. Immunogenicity and safety of a combined measles, mumps, rubella and varicella live vaccine (ProQuad (R)) administered concomitantly with a booster dose of a hexavalent vaccine in 12-23-month-old infants. Vaccine. 2015 May 11;33(20):2379-86. doi: 10.1016/j.vaccine.2015.02.070. Epub 2015 Mar 9.

Reference Type: DERIVED

PMID: 25765966 (View on PubMed)

Other Identifiers

X06-MMRV-302

Identifier Type: OTHER

Identifier Source: secondary_id

2006-004129-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V221-035

Identifier Type: -

Identifier Source: org_study_id